Sample records for immunologic tests

  1. 21 CFR 866.5210 - Ceruloplasmin immunolog-ical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5210 Ceruloplasmin immunolog-ical test system. (a) Identification. A ceruloplasmin immunological test system is a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ceruloplasmin immunolog-ical test system. 866.5210...

  2. 21 CFR 866.5160 - Beta-globulin immunolog-ical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5160 Beta-globulin immunolog-ical test system. (a) Identification. A beta-globulin immunological test system is a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Beta-globulin immunolog-ical test system. 866.5160...

  3. 21 CFR 866.5230 - Colostrum immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5230 Colostrum immunological test system. (a) Identification. A colostrum immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Colostrum immunological test system. 866.5230...

  4. 21 CFR 866.5570 - Lactoferrin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5570 Lactoferrin immunological test system. (a) Identification. A lactoferrin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lactoferrin immunological test system. 866.5570...

  5. 21 CFR 866.5340 - Ferritin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5340 Ferritin immunological test system. (a) Identification. A ferritin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ferritin immunological test system. 866.5340...

  6. 21 CFR 866.5735 - Prothrombin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5735 Prothrombin immunological test system. (a) Identification. A prothrombin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prothrombin immunological test system. 866.5735...

  7. 21 CFR 866.5680 - Myoglobin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5680 Myoglobin immunological test system. (a) Identification. A myoglobin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Myoglobin immunological test system. 866.5680...

  8. 21 CFR 866.5715 - Plasminogen immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5715 Plasminogen immunological test system. (a) Identification. A plasminogen immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Plasminogen immunological test system. 866.5715...

  9. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5470 Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hemoglobin immunological test system. 866.5470...

  10. 21 CFR 866.5880 - Transferrin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5880 Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Transferrin immunological test system. 866.5880...

  11. 21 CFR 866.5060 - Prealbumin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5060 Prealbumin immunological test system. (a) Identification. A prealbumin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prealbumin immunological test system. 866.5060...

  12. 21 CFR 866.5460 - Haptoglobin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5460 Haptoglobin immunological test system. (a) Identification. A haptoglobin immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Haptoglobin immunological test system. 866.5460...

  13. 21 CFR 866.5170 - Breast milk immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5170 Breast milk immunological test system. (a) Identification. A breast milk immunological test system is a device... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Breast milk immunological test system. 866.5170...

  14. 21 CFR 866.5040 - Albumin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5040 Albumin immunological test system. (a) Identification. An albumin immunological test system is a device that consists of... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Albumin immunological test system. 866.5040...

  15. 21 CFR 866.5590 - Lipoprotein X immunolog-ical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Lipoprotein X immunolog-ical test system. 866.5590... Lipoprotein X immunolog-ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high...

  16. 21 CFR 866.5590 - Lipoprotein X immunolog-ical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lipoprotein X immunolog-ical test system. 866.5590... Lipoprotein X immunolog-ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high...

  17. 21 CFR 866.5590 - Lipoprotein X immunolog-ical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Lipoprotein X immunolog-ical test system. 866.5590... Lipoprotein X immunolog-ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high...

  18. 21 CFR 866.5590 - Lipoprotein X immunolog-ical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lipoprotein X immunolog-ical test system. 866.5590... Lipoprotein X immunolog-ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high...

  19. 21 CFR 866.5590 - Lipoprotein X immunolog-ical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Lipoprotein X immunolog-ical test system. 866.5590... Lipoprotein X immunolog-ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high...

  20. 21 CFR 866.5400 - Alpha-globulin immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5400 Alpha-globulin immuno-logical test system. (a) Identification. An alpha-globulin immunological... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha-globulin immuno-logical test system. 866...

  1. 21 CFR 866.5350 - Fibrinopeptide A immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5350 Fibrinopeptide A immuno-logical test system. (a) Identification. A fibrinopeptide A immunological... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fibrinopeptide A immuno-logical test system. 866...

  2. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5360 Cohn fraction IV immuno-logical test system. (a) Identification. A Cohn fraction IV immunological... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cohn fraction IV immuno-logical test system. 866...

  3. 21 CFR 866.5090 - Antimitochondrial antibody immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5090 Antimitochondrial antibody immunological test system. (a) Identification. An... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antimitochondrial antibody immunological test...

  4. 21 CFR 866.5750 - Radioallergosorbent (RAST) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5750 Radioallergosorbent (RAST) immunological test system. (a) Identification. A... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radioallergosorbent (RAST) immunological test...

  5. 21 CFR 866.5500 - Hypersensitivity pneumonitis immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5500 Hypersensitivity pneumonitis immunological test system. (a) Identification. A... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hypersensitivity pneumonitis immunological test...

  6. 21 CFR 866.5180 - Fecal calprotectin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5180 Fecal calprotectin immunological test system. (a) Identification. A fecal calprotectin... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fecal calprotectin immunological test system. 866...

  7. 21 CFR 866.5560 - Lactic dehydrogenase immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5560 Lactic dehydrogenase immunological test system. (a) Identification. A lactic dehydrogenase... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lactic dehydrogenase immunological test system...

  8. 21 CFR 866.5660 - Multiple autoantibodies immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5660 Multiple autoantibodies immunological test system. (a) Identification. A multiple autoantibodies... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Multiple autoantibodies immunological test system...

  9. 21 CFR 866.5870 - Thyroid autoantibody immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5870 Thyroid autoantibody immunological test system. (a) Identification. A thyroid autoantibody... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Thyroid autoantibody immunological test system...

  10. 21 CFR 866.5110 - Antiparietal antibody immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5110 Antiparietal antibody immunological test system. (a) Identification. An antiparietal antibody... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antiparietal antibody immunological test system...

  11. 21 CFR 866.5100 - Antinuclear antibody immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5100 Antinuclear antibody immunological test system. (a) Identification. An antinuclear antibody... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antinuclear antibody immunological test system...

  12. 21 CFR 866.5240 - Complement components immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5240 Complement components immunological test system. (a) Identification. A complement components... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Complement components immunological test system...

  13. 21 CFR 866.5080 - Alpha-1-antichymotrypsin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5080 Alpha-1-antichymotrypsin immunological test system. (a) Identification. An alpha-1... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha-1-antichymotrypsin immunological test system...

  14. 21 CFR 866.5120 - Antismooth muscle antibody immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5120 Antismooth muscle antibody immunological test system. (a) Identification. An antismooth... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antismooth muscle antibody immunological test...

  15. 21 CFR 866.5630 - Beta-2-microglobulin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5630 Beta-2-microglobulin immunological test system. (a) Identification. A beta-2-microglobulin... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Beta-2-microglobulin immunological test system...

  16. 21 CFR 866.5530 - Immunoglobulin G (Fc fragment specific) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) immunological test system. 866.5530 Section 866.5530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system. (a...

  17. 21 CFR 866.5620 - Alpha-2-macroglobulin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5620 Alpha-2-macroglobulin immunological test system. (a) Identification. An alpha-2-macroglobulin... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha-2-macroglobulin immunological test system...

  18. 21 CFR 866.5540 - Immunoglobulin G (Fd fragment specific) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) immunological test system. 866.5540 Section 866.5540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5540 Immunoglobulin G (Fd fragment specific) immunological test system. (a...

  19. 21 CFR 866.5130 - Alpha-1-antitrypsin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5130 Alpha-1-antitrypsin immunological test system. (a) Identification. An alpha-1-antitrypsin... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha-1-antitrypsin immunological test system. 866...

  20. 21 CFR 866.5800 - Seminal fluid (sperm) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5800 Seminal fluid (sperm) immunological test system. (a) Identification. A seminal fluid (sperm... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Seminal fluid (sperm) immunological test system...

  1. 21 CFR 866.5600 - Low-density lipoprotein immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5600 Low-density lipoprotein immunological test system. (a) Identification. A low-density lipoprotein... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Low-density lipoprotein immunological test system...

  2. 21 CFR 866.5890 - Inter-alpha trypsin inhibitor immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5890 Inter-alpha trypsin inhibitor immunological test system. (a) Identification. An inter... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Inter-alpha trypsin inhibitor immunological test...

  3. 21 CFR 866.5065 - Human allotypic marker immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5065 Human allotypic marker immunological test system. (a) Identification. A human allotypic marker... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Human allotypic marker immunological test system...

  4. 21 CFR 866.5765 - Retinol-binding protein immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5765 Retinol-binding protein immunological test system. (a) Identification. A retinol-binding protein... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Retinol-binding protein immunological test system...

  5. 21 CFR 866.5380 - Free secretory component immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5380 Free secretory component immuno-logical test system. (a) Identification. A free... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Free secretory component immuno-logical test...

  6. 21 CFR 866.6010 - Tumor-associated antigen immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tumor-associated antigen immunological test system... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Tumor Associated Antigen immunological Test Systems § 866.6010 Tumor-associated antigen immunological test system. (a) Identification. A...

  7. 21 CFR 866.5270 - C-reactive protein immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5270 C-reactive protein immuno-logical test system. (a) Identification. A C-reactive protein... 21 Food and Drugs 8 2010-04-01 2010-04-01 false C-reactive protein immuno-logical test system. 866...

  8. 21 CFR 866.5440 - Beta-2-glycoprotein III immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5440 Beta-2-glycoprotein III immunological test system. (a) Identification. A beta-2-glycoprotein III... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Beta-2-glycoprotein III immunological test system...

  9. 21 CFR 866.5200 - Carbonic anhydrase B and C immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5200 Carbonic anhydrase B and C immunological test system. (a) Identification. A carbonic... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Carbonic anhydrase B and C immunological test...

  10. 21 CFR 866.5430 - Beta-2-glycoprotein I immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5430 Beta-2-glycoprotein I immunological test system. (a) Identification. A beta-2-glycoprotein I... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Beta-2-glycoprotein I immunological test system...

  11. 21 CFR 866.5260 - Complement C3b inactivator immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5260 Complement C3b inactivator immunological test system. (a) Identification. A complement... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Complement C3b inactivator immunological test...

  12. 21 CFR 866.5580 - Alpha-1-lipoprotein immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5580 Alpha-1-lipoprotein immuno-logical test system. (a) Identification. An alpha-1-lipoprotein... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha-1-lipoprotein immuno-logical test system...

  13. 21 CFR 866.5330 - Factor XIII, A, S, immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5330 Factor XIII, A, S, immuno-logical test system. (a) Identification. A factor XIII, A, S... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Factor XIII, A, S, immuno-logical test system. 866...

  14. 21 CFR 866.6030 - AFP-L3% immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false AFP-L3% immunological test system. 866.6030 Section 866.6030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Tumor Associated Antigen immunological Test Systems § 866.6030 AFP-L3% immunological test...

  15. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... test system. 866.5510 Section 866.5510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system. (a) Identification...

  16. 21 CFR 866.5230 - Colostrum immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Colostrum immunological test system. 866.5230... Colostrum immunological test system. (a) Identification. A colostrum immunological test system is a device... colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of...

  17. 21 CFR 866.5170 - Breast milk immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Breast milk immunological test system. 866.5170... milk immunological test system. (a) Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins. (b...

  18. 21 CFR 866.5170 - Breast milk immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Breast milk immunological test system. 866.5170... milk immunological test system. (a) Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins. (b...

  19. 21 CFR 866.5170 - Breast milk immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Breast milk immunological test system. 866.5170... milk immunological test system. (a) Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins. (b...

  20. 21 CFR 866.5170 - Breast milk immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breast milk immunological test system. 866.5170... milk immunological test system. (a) Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins. (b...

  1. 21 CFR 866.5820 - Systemic lupus erythema-tosus immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Systemic lupus erythema-tosus immunological test... Systems § 866.5820 Systemic lupus erythema-tosus immunological test system. (a) Identification. A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to...

  2. 42 CFR 493.921 - Diagnostic immunology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Diagnostic immunology. 493.921 Section 493.921... Testing Proficiency Testing Programs by Specialty and Subspecialty § 493.921 Diagnostic immunology. The subspecialties under the specialty of immunology for which a program may offer proficiency testing are syphilis...

  3. 42 CFR 493.921 - Diagnostic immunology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Diagnostic immunology. 493.921 Section 493.921... Testing Proficiency Testing Programs by Specialty and Subspecialty § 493.921 Diagnostic immunology. The subspecialties under the specialty of immunology for which a program may offer proficiency testing are syphilis...

  4. 42 CFR 493.921 - Diagnostic immunology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Diagnostic immunology. 493.921 Section 493.921... Testing Proficiency Testing Programs by Specialty and Subspecialty § 493.921 Diagnostic immunology. The subspecialties under the specialty of immunology for which a program may offer proficiency testing are syphilis...

  5. 42 CFR 493.921 - Diagnostic immunology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Diagnostic immunology. 493.921 Section 493.921... Testing Proficiency Testing Programs by Specialty and Subspecialty § 493.921 Diagnostic immunology. The subspecialties under the specialty of immunology for which a program may offer proficiency testing are syphilis...

  6. 42 CFR 493.921 - Diagnostic immunology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Diagnostic immunology. 493.921 Section 493.921... Testing Proficiency Testing Programs by Specialty and Subspecialty § 493.921 Diagnostic immunology. The subspecialties under the specialty of immunology for which a program may offer proficiency testing are syphilis...

  7. 21 CFR 866.5700 - Whole human plasma or serum immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Whole human plasma or serum immunological test... Systems § 866.5700 Whole human plasma or serum immunological test system. (a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by...

  8. 21 CFR 866.5700 - Whole human plasma or serum immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Whole human plasma or serum immunological test... Systems § 866.5700 Whole human plasma or serum immunological test system. (a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by...

  9. 21 CFR 866.5700 - Whole human plasma or serum immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Whole human plasma or serum immunological test... Systems § 866.5700 Whole human plasma or serum immunological test system. (a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by...

  10. 21 CFR 866.5700 - Whole human plasma or serum immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Whole human plasma or serum immunological test... Systems § 866.5700 Whole human plasma or serum immunological test system. (a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by...

  11. 21 CFR 866.5700 - Whole human plasma or serum immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Whole human plasma or serum immunological test... Systems § 866.5700 Whole human plasma or serum immunological test system. (a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by...

  12. 21 CFR 866.5860 - Total spinal fluid immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... diagnosis of multiple sclerosis and other diseases of the nervous system. (b) Classification. Class I... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total spinal fluid immuno-logical test system. 866... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866...

  13. 21 CFR 866.5860 - Total spinal fluid immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... diagnosis of multiple sclerosis and other diseases of the nervous system. (b) Classification. Class I... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Total spinal fluid immuno-logical test system. 866... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866...

  14. 21 CFR 866.5860 - Total spinal fluid immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... diagnosis of multiple sclerosis and other diseases of the nervous system. (b) Classification. Class I... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total spinal fluid immuno-logical test system. 866... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866...

  15. 21 CFR 866.5860 - Total spinal fluid immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... diagnosis of multiple sclerosis and other diseases of the nervous system. (b) Classification. Class I... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Total spinal fluid immuno-logical test system. 866... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866...

  16. 21 CFR 866.5860 - Total spinal fluid immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... diagnosis of multiple sclerosis and other diseases of the nervous system. (b) Classification. Class I... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total spinal fluid immuno-logical test system. 866... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866...

  17. 21 CFR 866.5880 - Transferrin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell... Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device...

  18. 21 CFR 866.5880 - Transferrin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell... Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device...

  19. 21 CFR 866.5880 - Transferrin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell... Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device...

  20. 21 CFR 866.5880 - Transferrin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell... Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device...

  1. 42 CFR 493.833 - Condition: Diagnostic immunology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Condition: Diagnostic immunology. 493.833 Section..., Or Any Combination of These Tests § 493.833 Condition: Diagnostic immunology. The specialty of diagnostic immunology includes for purposes of proficiency testing the subspecialties of syphilis serology...

  2. 42 CFR 493.833 - Condition: Diagnostic immunology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Condition: Diagnostic immunology. 493.833 Section..., Or Any Combination of These Tests § 493.833 Condition: Diagnostic immunology. The specialty of diagnostic immunology includes for purposes of proficiency testing the subspecialties of syphilis serology...

  3. 42 CFR 493.833 - Condition: Diagnostic immunology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Condition: Diagnostic immunology. 493.833 Section..., Or Any Combination of These Tests § 493.833 Condition: Diagnostic immunology. The specialty of diagnostic immunology includes for purposes of proficiency testing the subspecialties of syphilis serology...

  4. 21 CFR 866.5640 - Infectious mononucleosis immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Infectious mononucleosis immunological test system....5640 Infectious mononucleosis immunological test system. (a) Identification. An infectious... immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum...

  5. 21 CFR 866.5640 - Infectious mononucleosis immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Infectious mononucleosis immunological test system....5640 Infectious mononucleosis immunological test system. (a) Identification. An infectious... immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum...

  6. 21 CFR 866.5640 - Infectious mononucleosis immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Infectious mononucleosis immunological test system....5640 Infectious mononucleosis immunological test system. (a) Identification. An infectious... immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum...

  7. 21 CFR 866.5640 - Infectious mononucleosis immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Infectious mononucleosis immunological test system....5640 Infectious mononucleosis immunological test system. (a) Identification. An infectious... immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum...

  8. 21 CFR 866.5640 - Infectious mononucleosis immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Infectious mononucleosis immunological test system....5640 Infectious mononucleosis immunological test system. (a) Identification. An infectious... immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum...

  9. 21 CFR 866.5210 - Ceruloplasmin immunolog-ical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ceruloplasmin immunolog-ical test system. 866.5210 Section 866.5210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  10. 21 CFR 866.5210 - Ceruloplasmin immunolog-ical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ceruloplasmin immunolog-ical test system. 866.5210 Section 866.5210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  11. 21 CFR 866.5210 - Ceruloplasmin immunolog-ical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ceruloplasmin immunolog-ical test system. 866.5210 Section 866.5210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  12. 21 CFR 866.5210 - Ceruloplasmin immunolog-ical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ceruloplasmin immunolog-ical test system. 866.5210 Section 866.5210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  13. 21 CFR 866.5520 - Immunoglobulin G (Fab fragment specific) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Immunoglobulin G (Fab fragment specific... Test Systems § 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system. (a) Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists...

  14. 21 CFR 866.5380 - Free secretory component immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  15. 21 CFR 866.5380 - Free secretory component immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  16. 21 CFR 866.5380 - Free secretory component immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  17. 21 CFR 866.5380 - Free secretory component immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  18. 21 CFR 866.5090 - Antimitochondrial antibody immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Systems § 866.5090 Antimitochondrial antibody immunological test system. (a) Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by... of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own...

  19. 21 CFR 866.5870 - Thyroid autoantibody immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid. (b... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thyroid autoantibody immunological test system....5870 Thyroid autoantibody immunological test system. (a) Identification. A thyroid autoantibody...

  20. 21 CFR 866.5870 - Thyroid autoantibody immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid. (b... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Thyroid autoantibody immunological test system....5870 Thyroid autoantibody immunological test system. (a) Identification. A thyroid autoantibody...

  1. 21 CFR 866.5870 - Thyroid autoantibody immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid. (b... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Thyroid autoantibody immunological test system....5870 Thyroid autoantibody immunological test system. (a) Identification. A thyroid autoantibody...

  2. 21 CFR 866.5870 - Thyroid autoantibody immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid. (b... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Thyroid autoantibody immunological test system....5870 Thyroid autoantibody immunological test system. (a) Identification. A thyroid autoantibody...

  3. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  4. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  5. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  6. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  7. 21 CFR 866.5500 - Hypersensitivity pneumonitis immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... system. 866.5500 Section 866.5500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Systems § 866.5500 Hypersensitivity pneumonitis immunological test system. (a) Identification. A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by...

  8. 21 CFR 866.5500 - Hypersensitivity pneumonitis immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... system. 866.5500 Section 866.5500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Systems § 866.5500 Hypersensitivity pneumonitis immunological test system. (a) Identification. A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by...

  9. 21 CFR 866.5500 - Hypersensitivity pneumonitis immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... system. 866.5500 Section 866.5500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Systems § 866.5500 Hypersensitivity pneumonitis immunological test system. (a) Identification. A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by...

  10. 21 CFR 866.5500 - Hypersensitivity pneumonitis immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... system. 866.5500 Section 866.5500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Systems § 866.5500 Hypersensitivity pneumonitis immunological test system. (a) Identification. A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by...

  11. 21 CFR 866.5460 - Haptoglobin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and... Haptoglobin immunological test system. (a) Identification. A haptoglobin immunological test system is a device...

  12. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  13. 21 CFR 866.5460 - Haptoglobin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and... Haptoglobin immunological test system. (a) Identification. A haptoglobin immunological test system is a device...

  14. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  15. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  16. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  17. 21 CFR 866.5460 - Haptoglobin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and... Haptoglobin immunological test system. (a) Identification. A haptoglobin immunological test system is a device...

  18. 21 CFR 866.5460 - Haptoglobin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and... Haptoglobin immunological test system. (a) Identification. A haptoglobin immunological test system is a device...

  19. 21 CFR 866.5765 - Retinol-binding protein immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Retinol-binding protein immunological test system....5765 Retinol-binding protein immunological test system. (a) Identification. A retinol-binding protein... the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of...

  20. 21 CFR 866.5120 - Antismooth muscle antibody immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Systems § 866.5120 Antismooth muscle antibody immunological test system. (a) Identification. An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by... serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and...

  1. 21 CFR 866.5775 - Rheumatoid factor immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. (b) Classification. Class... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Rheumatoid factor immuno-logical test system. 866....5775 Rheumatoid factor immuno-logical test system. (a) Identification. A rheumatoid factor...

  2. 21 CFR 866.5775 - Rheumatoid factor immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. (b) Classification. Class... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Rheumatoid factor immuno-logical test system. 866....5775 Rheumatoid factor immuno-logical test system. (a) Identification. A rheumatoid factor...

  3. 21 CFR 866.5775 - Rheumatoid factor immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    .... Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. (b) Classification. Class... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rheumatoid factor immuno-logical test system. 866....5775 Rheumatoid factor immuno-logical test system. (a) Identification. A rheumatoid factor...

  4. 21 CFR 866.5765 - Retinol-binding protein immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Retinol-binding protein immunological test system....5765 Retinol-binding protein immunological test system. (a) Identification. A retinol-binding protein... the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of...

  5. 21 CFR 866.5765 - Retinol-binding protein immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Retinol-binding protein immunological test system....5765 Retinol-binding protein immunological test system. (a) Identification. A retinol-binding protein... the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of...

  6. 21 CFR 866.5765 - Retinol-binding protein immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Retinol-binding protein immunological test system....5765 Retinol-binding protein immunological test system. (a) Identification. A retinol-binding protein... the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of...

  7. 21 CFR 866.5065 - Human allotypic marker immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Human allotypic marker immunological test system. 866.5065 Section 866.5065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN....5065 Human allotypic marker immunological test system. (a) Identification. A human allotypic marker...

  8. 21 CFR 866.5065 - Human allotypic marker immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Human allotypic marker immunological test system. 866.5065 Section 866.5065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN....5065 Human allotypic marker immunological test system. (a) Identification. A human allotypic marker...

  9. 21 CFR 866.5065 - Human allotypic marker immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Human allotypic marker immunological test system. 866.5065 Section 866.5065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN....5065 Human allotypic marker immunological test system. (a) Identification. A human allotypic marker...

  10. 21 CFR 866.5065 - Human allotypic marker immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Human allotypic marker immunological test system. 866.5065 Section 866.5065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN....5065 Human allotypic marker immunological test system. (a) Identification. A human allotypic marker...

  11. 21 CFR 866.5420 - Alpha-1-glycoproteins immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha-1-glycoproteins immunological test system....5420 Alpha-1-glycoproteins immunological test system. (a) Identification. An alpha-1-glycoproteins... alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to...

  12. 21 CFR 866.5080 - Alpha-1-antichymotrypsin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha-1-antichymotrypsin immunological test system....5080 Alpha-1-antichymotrypsin immunological test system. (a) Identification. An alpha-1... immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1...

  13. 21 CFR 866.5580 - Alpha-1-lipoprotein immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha-1-lipoprotein immuno-logical test system....5580 Alpha-1-lipoprotein immuno-logical test system. (a) Identification. An alpha-1-lipoprotein... the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1...

  14. 21 CFR 866.5620 - Alpha-2-macroglobulin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Alpha-2-macroglobulin immunological test system....5620 Alpha-2-macroglobulin immunological test system. (a) Identification. An alpha-2-macroglobulin... the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in...

  15. 21 CFR 866.5080 - Alpha-1-antichymotrypsin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha-1-antichymotrypsin immunological test system....5080 Alpha-1-antichymotrypsin immunological test system. (a) Identification. An alpha-1... immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1...

  16. 21 CFR 866.5080 - Alpha-1-antichymotrypsin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha-1-antichymotrypsin immunological test system....5080 Alpha-1-antichymotrypsin immunological test system. (a) Identification. An alpha-1... immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1...

  17. 21 CFR 866.5620 - Alpha-2-macroglobulin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha-2-macroglobulin immunological test system....5620 Alpha-2-macroglobulin immunological test system. (a) Identification. An alpha-2-macroglobulin... the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in...

  18. 21 CFR 866.5620 - Alpha-2-macroglobulin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha-2-macroglobulin immunological test system....5620 Alpha-2-macroglobulin immunological test system. (a) Identification. An alpha-2-macroglobulin... the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in...

  19. 21 CFR 866.5580 - Alpha-1-lipoprotein immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Alpha-1-lipoprotein immuno-logical test system....5580 Alpha-1-lipoprotein immuno-logical test system. (a) Identification. An alpha-1-lipoprotein... the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1...

  20. 21 CFR 866.5580 - Alpha-1-lipoprotein immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha-1-lipoprotein immuno-logical test system....5580 Alpha-1-lipoprotein immuno-logical test system. (a) Identification. An alpha-1-lipoprotein... the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1...

  1. 21 CFR 866.5580 - Alpha-1-lipoprotein immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha-1-lipoprotein immuno-logical test system....5580 Alpha-1-lipoprotein immuno-logical test system. (a) Identification. An alpha-1-lipoprotein... the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1...

  2. 21 CFR 866.5620 - Alpha-2-macroglobulin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha-2-macroglobulin immunological test system....5620 Alpha-2-macroglobulin immunological test system. (a) Identification. An alpha-2-macroglobulin... the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in...

  3. 21 CFR 866.5775 - Rheumatoid factor immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    .... Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. (b) Classification. Class... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Rheumatoid factor immuno-logical test system. 866....5775 Rheumatoid factor immuno-logical test system. (a) Identification. A rheumatoid factor...

  4. 21 CFR 866.5775 - Rheumatoid factor immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. (b) Classification. Class... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Rheumatoid factor immuno-logical test system. 866....5775 Rheumatoid factor immuno-logical test system. (a) Identification. A rheumatoid factor...

  5. 21 CFR 866.5090 - Antimitochondrial antibody immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  6. 21 CFR 866.5120 - Antismooth muscle antibody immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own...

  7. 21 CFR 866.5120 - Antismooth muscle antibody immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own...

  8. 21 CFR 866.5120 - Antismooth muscle antibody immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own...

  9. 21 CFR 866.5090 - Antimitochondrial antibody immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  10. 21 CFR 866.5090 - Antimitochondrial antibody immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test...

  11. 21 CFR 866.5200 - Carbonic anhydrase B and C immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism. (b...

  12. 21 CFR 866.5200 - Carbonic anhydrase B and C immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism. (b...

  13. 21 CFR 866.5890 - Inter-alpha trypsin inhibitor immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial...

  14. 21 CFR 866.5200 - Carbonic anhydrase B and C immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism. (b...

  15. 21 CFR 866.5890 - Inter-alpha trypsin inhibitor immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial...

  16. 21 CFR 866.5890 - Inter-alpha trypsin inhibitor immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial...

  17. 21 CFR 866.5890 - Inter-alpha trypsin inhibitor immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial...

  18. 21 CFR 866.5200 - Carbonic anhydrase B and C immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test... immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism. (b...

  19. Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

    PubMed Central

    Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

    2006-01-01

    We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

  20. Updating the immunology curriculum in clinical laboratory science.

    PubMed

    Stevens, C D

    2000-01-01

    To determine essential content areas of immunology/serology courses at the clinical laboratory technician (CLT) and clinical laboratory scientist (CLS) levels. A questionnaire was designed which listed all major topics in immunology and serology. Participants were asked to place a check beside each topic covered. For an additional list of serological and immunological laboratory testing, participants were asked to indicate if each test was performed in either the didactic or clinical setting, or not performed at all. A national survey of 593 NAACLS approved CLT and CLS programs was conducted by mail under the auspices of ASCLS. Responses were obtained from 158 programs. Respondents from all across the United States included 60 CLT programs, 48 hospital-based CLS programs, 45 university-based CLS programs, and 5 university-based combined CLT and CLS programs. The survey was designed to enumerate major topics included in immunology and serology courses by a majority of participants at two distinct educational levels, CLT and CLS. Laboratory testing routinely performed in student laboratories as well as in the clinical setting was also determined for these two levels of practitioners. Certain key topics were common to most immunology and serology courses. There were some notable differences in the depth of courses at the CLT and CLS levels. Laboratory testing associated with these courses also differed at the two levels. Testing requiring more detailed interpretation, such as antinuclear antibody patterns (ANAs), was mainly performed by CLS students only. There are certain key topics as well as specific laboratory tests that should be included in immunology/serology courses at each of the two different educational levels to best prepare students for the workplace. Educators can use this information as a guide to plan a curriculum for such courses.

  1. 21 CFR 866.5785 - Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) antibody (ASCA) test systems. 866.5785 Section 866.5785 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems...

  2. Diagnostic Testing and Interpretation of Tests for Autoimmunity

    PubMed Central

    Castro, Christine; Gourley, Mark

    2010-01-01

    Laboratory testing is of great value when evaluating a patient with a suspected autoimmune disease. The results can confirm a diagnosis, estimate disease severity, aid in assessing prognosis and are useful to follow disease activity. Components of the laboratory exam include complete blood count with differential, comprehensive metabolic panel, inflammatory markers, autoantibodies, and flow cytometry. This chapter discusses these components and includes a discussion about organ-specific immunologic diseases where immunological laboratory testing is employed. Comprehensive laboratory evaluation of a suspected autoimmune illness in conjunction with a thorough clinical evaluation provides a better understanding of a patient's immunologic disease. PMID:20061009

  3. An assessment of false positive rates for malaria rapid diagnostic tests caused by non-Plasmodium infectious agents and immunological factors.

    PubMed

    Gatton, Michelle L; Ciketic, Sadmir; Barnwell, John W; Cheng, Qin; Chiodini, Peter L; Incardona, Sandra; Bell, David; Cunningham, Jane; González, Iveth J

    2018-01-01

    Malaria rapid diagnostic tests (RDTs) can produce false positive (FP) results in patients with human African trypanosomiasis and rheumatoid factor (RF), but specificity against other infectious agents and immunological factors is largely unknown. Low diagnostic specificity caused by cross-reactivity may lead to over-estimates of the number of malaria cases and over-use of antimalarial drugs, at the cost of not diagnosing and treating the true underlying condition. Data from the WHO Malaria RDT Product Testing Programme was analysed to assess FP rates of 221 RDTs against four infectious agents (Chagas, dengue, Leishmaniasis and Schistosomiasis) and four immunological factors (anti-nuclear antibody, human anti-mouse antibody (HAMA), RF and rapid plasma regain). Only RDTs with a FP rate against clean negative samples less than 10% were included. Paired t-tests were used to compare product-specific FP rates on clean negative samples and samples containing non-Plasmodium infectious agents and immunological factors. Forty (18%) RDTs showed no FP results against any tested infectious agent or immunological factor. In the remaining RDTs significant and clinically relevant increases in FP rates were observed for samples containing HAMA and RF (P<0.001). There were significant correlations between product-matched FP rates for RF and HAMA on all RDT test bands (P<0.001), and FP rates for each infectious agent and immunological factor were also correlated between test bands of combination RDTs (P≤0.002). False positive results against non-Plasmodium infectious agents and immunological factors does not appear to be a universal property of malaria RDTs. However, since many malaria RDTs have elevated FP rates against HAMA and RF positive samples practitioners may need to consider the possibility of false positive results for malaria in patients with conditions that stimulate HAMA or RF.

  4. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  5. 21 CFR 866.5530 - Immunoglobulin G (Fc fragment specific) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming...

  6. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  7. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  8. 21 CFR 866.5530 - Immunoglobulin G (Fc fragment specific) immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming...

  9. 21 CFR 866.5530 - Immunoglobulin G (Fc fragment specific) immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming...

  10. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  11. 21 CFR 866.5530 - Immunoglobulin G (Fc fragment specific) immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming...

  12. 21 CFR 866.5800 - Seminal fluid (sperm) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... differentiate animal and human semen. The test results may be used as court evidence in alleged instances of... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Seminal fluid (sperm) immunological test system. 866.5800 Section 866.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  13. Advances in in vitro diagnostics in allergy, asthma, and immunology in 2012.

    PubMed

    Renz, Harald

    2013-12-01

    Laboratory tests play an increasing role in risk assessment, diagnostics, and disease monitoring. Great advances have been achieved lately, particularly in the field of clinical immunology and allergy. These include neonatal screening of immunodeficiencies and asthma biomarkers and investigation into the role of recombinant allergens in in vitro testing. The latter area has implications for the diagnostics of food allergy, pollen-induced allergies, asthma, and insect allergies. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  14. 42 CFR 493.837 - Standard; General immunology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard; General immunology. 493.837 Section 493.837 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.837 Standard; General immunology. (a) Failure to attain a score of at least 80 percent...

  15. 42 CFR 493.837 - Standard; General immunology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Standard; General immunology. 493.837 Section 493.837 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.837 Standard; General immunology. (a) Failure to attain a score of at least 80 percent...

  16. 42 CFR 493.837 - Standard; General immunology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Standard; General immunology. 493.837 Section 493.837 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.837 Standard; General immunology. (a) Failure to attain a score of at least 80 percent...

  17. 21 CFR 866.5750 - Radioallergosorbent (RAST) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radioallergosorbent (RAST) immunological test system. 866.5750 Section 866.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., allergies, and other pulmonary disorders. (b) Classification. Class II (performance standards). ...

  18. 21 CFR 866.5180 - Fecal calprotectin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically...

  19. 21 CFR 866.5910 - Quality control material for cystic fibrosis nucleic acid assays.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. (a... cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by...

  20. 21 CFR 866.5040 - Albumin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. (b... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Albumin immunological test system. 866.5040 Section 866.5040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  1. 21 CFR 866.5040 - Albumin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. (b... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Albumin immunological test system. 866.5040 Section 866.5040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  2. 21 CFR 866.5680 - Myoglobin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Myoglobin immunological test system. 866.5680 Section 866.5680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  3. 21 CFR 866.5040 - Albumin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. (b... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Albumin immunological test system. 866.5040 Section 866.5040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  4. 21 CFR 866.5680 - Myoglobin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Myoglobin immunological test system. 866.5680 Section 866.5680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  5. 21 CFR 866.5040 - Albumin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. (b... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Albumin immunological test system. 866.5040 Section 866.5040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  6. 21 CFR 866.5060 - Prealbumin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prealbumin immunological test system. 866.5060 Section 866.5060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  7. 21 CFR 866.5060 - Prealbumin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prealbumin immunological test system. 866.5060 Section 866.5060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  8. 21 CFR 866.5680 - Myoglobin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Myoglobin immunological test system. 866.5680 Section 866.5680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  9. 21 CFR 866.5680 - Myoglobin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Myoglobin immunological test system. 866.5680 Section 866.5680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  10. 21 CFR 866.5060 - Prealbumin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prealbumin immunological test system. 866.5060 Section 866.5060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  11. 21 CFR 866.5060 - Prealbumin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prealbumin immunological test system. 866.5060 Section 866.5060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  12. 21 CFR 866.5560 - Lactic dehydrogenase immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... immunological test system is a device that consists of the reagents used to measure by immunochemical techniques... found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood...

  13. 21 CFR 866.5560 - Lactic dehydrogenase immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... immunological test system is a device that consists of the reagents used to measure by immunochemical techniques... found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood...

  14. 21 CFR 866.5560 - Lactic dehydrogenase immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... immunological test system is a device that consists of the reagents used to measure by immunochemical techniques... found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood...

  15. 21 CFR 866.5560 - Lactic dehydrogenase immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... immunological test system is a device that consists of the reagents used to measure by immunochemical techniques... found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood...

  16. 21 CFR 866.4100 - Complement reagent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents § 866.4100... a component part of serological test kits used in the diagnosis of disease. (b) Classification...

  17. Development and testing of a mouse simulated space flight model

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald

    1987-01-01

    The development and testing of a mouse model for simulating some aspects of weightlessness that occurs during space flight, and the carrying out of immunological experiments on animals undergoing space flight is examined. The mouse model developed was an antiorthostatic, hypokinetic, hypodynamic suspension model similar to one used with rats. The study was divided into two parts. The first involved determination of which immunological parameters should be observed on animals flown during space flight or studied in the suspension model. The second involved suspending mice and determining which of those immunological parameters were altered by the suspension. Rats that were actually flown in Space Shuttle SL-3 were used to test the hypotheses.

  18. 21 CFR 866.5630 - Beta-2-microglobulin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Beta-2-microglobulin immunological test system. 866.5630 Section 866.5630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  19. 21 CFR 866.5400 - Alpha-globulin immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha-globulin immuno-logical test system. 866.5400 Section 866.5400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  20. 21 CFR 866.5420 - Alpha-1-glycoproteins immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha-1-glycoproteins immunological test system. 866.5420 Section 866.5420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  1. 21 CFR 866.5130 - Alpha-1-antitrypsin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha-1-antitrypsin immunological test system. 866.5130 Section 866.5130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  2. 21 CFR 866.5350 - Fibrinopeptide A immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Fibrinopeptide A immuno-logical test system. 866.5350 Section 866.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  3. 21 CFR 866.5630 - Beta-2-microglobulin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Beta-2-microglobulin immunological test system. 866.5630 Section 866.5630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  4. 21 CFR 866.5130 - Alpha-1-antitrypsin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha-1-antitrypsin immunological test system. 866.5130 Section 866.5130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  5. 21 CFR 866.5630 - Beta-2-microglobulin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Beta-2-microglobulin immunological test system. 866.5630 Section 866.5630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  6. 21 CFR 866.5600 - Low-density lipoprotein immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Low-density lipoprotein immunological test system. 866.5600 Section 866.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  7. 21 CFR 866.5600 - Low-density lipoprotein immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Low-density lipoprotein immunological test system. 866.5600 Section 866.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  8. 21 CFR 866.5420 - Alpha-1-glycoproteins immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha-1-glycoproteins immunological test system. 866.5420 Section 866.5420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  9. 21 CFR 866.5350 - Fibrinopeptide A immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fibrinopeptide A immuno-logical test system. 866.5350 Section 866.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  10. 21 CFR 866.5130 - Alpha-1-antitrypsin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha-1-antitrypsin immunological test system. 866.5130 Section 866.5130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  11. 21 CFR 866.5630 - Beta-2-microglobulin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Beta-2-microglobulin immunological test system. 866.5630 Section 866.5630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  12. 21 CFR 866.5350 - Fibrinopeptide A immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Fibrinopeptide A immuno-logical test system. 866.5350 Section 866.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  13. 21 CFR 866.5600 - Low-density lipoprotein immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Low-density lipoprotein immunological test system. 866.5600 Section 866.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  14. 21 CFR 866.5600 - Low-density lipoprotein immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Low-density lipoprotein immunological test system. 866.5600 Section 866.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  15. 21 CFR 866.5400 - Alpha-globulin immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha-globulin immuno-logical test system. 866.5400 Section 866.5400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  16. 21 CFR 866.5350 - Fibrinopeptide A immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fibrinopeptide A immuno-logical test system. 866.5350 Section 866.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  17. 21 CFR 866.5420 - Alpha-1-glycoproteins immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha-1-glycoproteins immunological test system. 866.5420 Section 866.5420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  18. 21 CFR 866.5130 - Alpha-1-antitrypsin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Alpha-1-antitrypsin immunological test system. 866.5130 Section 866.5130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  19. 21 CFR 866.5400 - Alpha-globulin immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha-globulin immuno-logical test system. 866.5400 Section 866.5400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  20. 21 CFR 866.5420 - Alpha-1-glycoproteins immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Alpha-1-glycoproteins immunological test system. 866.5420 Section 866.5420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  1. 21 CFR 866.5400 - Alpha-globulin immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Alpha-globulin immuno-logical test system. 866.5400 Section 866.5400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  2. Indications for laser therapy in diverse models of periodontitis

    NASA Astrophysics Data System (ADS)

    Kunin, Anatoly A.; Erina, Stanislava V.; Sokolova, Irina A.; Pankova, Svetlana N.; Ippolitov, Yu. A.; Lepechina, L. I.; Malinovskaya, L. A.; Chitrina, L. L.

    1996-11-01

    Parodontal diseases have an immunological pathogenic mechanism leading to various manifestations and can not be referred to as a common inflammation. The home and foreign research points at active and immunological reaction with the following distraction surrounding tissues of the tooth. Histochemical and biochemical examinations show metabolic disturbances of parodontal tissues. A total sample size of 604 people suffering from average height of chronic generalized parodontitis was examined in the survey. Immunological and histochemical tests were taken before and after a course of laser therapy with the use of helium-neon laser 'YAGODA', an inhibitory and stimulating dosage irradiations and anti-inflammatory dosage irradiations with infrared laser 'UZOR'. We selected a group of patients with the decreased local immunological status on the ground of immunological tests. Histochemical tests shaped the next group with the passive and active forms of parodontitis pathology. The tests data resulted in a method of laser therapy. The investigations confirm that the chronic generalized parodontitis has a shift in tissue immunity of the oral cavity and cell-bound metabolic disturbance of gum epithelium. It is expedient to use the anti-inflammatory dosage irradiations with infrared laser 'UZOR' to correct immunity, and in case of and active process to realize the DNA and RNA synthesis by means of increasing the irradiation with the apparatus 'YAGODA'. The irradiation decreases in case of a passive process.

  3. 21 CFR 866.5900 - Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR...

  4. 21 CFR 866.5430 - Beta-2-glycoprotein I immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Beta-2-glycoprotein I immunological test system. 866.5430 Section 866.5430 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  5. 21 CFR 866.5430 - Beta-2-glycoprotein I immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Beta-2-glycoprotein I immunological test system. 866.5430 Section 866.5430 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  6. 21 CFR 866.5440 - Beta-2-glycoprotein III immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Beta-2-glycoprotein III immunological test system. 866.5440 Section 866.5440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  7. 21 CFR 866.5430 - Beta-2-glycoprotein I immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Beta-2-glycoprotein I immunological test system. 866.5430 Section 866.5430 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  8. 21 CFR 866.5440 - Beta-2-glycoprotein III immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Beta-2-glycoprotein III immunological test system. 866.5440 Section 866.5440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  9. 21 CFR 866.5440 - Beta-2-glycoprotein III immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Beta-2-glycoprotein III immunological test system. 866.5440 Section 866.5440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  10. 21 CFR 866.5430 - Beta-2-glycoprotein I immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Beta-2-glycoprotein I immunological test system. 866.5430 Section 866.5430 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  11. 21 CFR 866.5440 - Beta-2-glycoprotein III immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Beta-2-glycoprotein III immunological test system. 866.5440 Section 866.5440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  12. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  13. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  14. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  15. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  16. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  17. Methods for microbiological and immunological studies of space flight crews

    NASA Technical Reports Server (NTRS)

    Taylor, G. R. (Editor); Zaloguev, S. N. (Editor)

    1978-01-01

    Systematic laboratory procedures compiled as an outgrowth of a joint U.S./U.S.S.R. microbiological-immunological experiment performed during the Apollo-Soyuz Test Project space flight are presented. Included are mutually compatible methods for the identification of aerobic and microaerophilic bacteria, yeast and yeastlike microorganisms, and filamentous fungi; methods for the bacteriophage typing of Staphylococcus aureus; and methods for determining the sensitivity of S. aureus to antibiotics. Immunological methods using blood and immunological and biochemical methods using salivary parotid fluid are also described. Formulas for media and laboratory reagents used are listed.

  18. Computational and Experimental Validation of B and T-Cell Epitopes of the In Vivo Immune Response to a Novel Malarial Antigen

    DTIC Science & Technology

    2013-08-16

    approach in the context of a novel, immunologically relevant antigen. The limited accuracy of the tested algorithms to predict the in vivo immune responses...overlapping peptides spanning the entire sequence are individually tested for antibody interacting residues. Conformational B cell epitopes, in contrast...a blind assessment of this approach in the context of a novel, immunologically relevant antigen. The limited accuracy of the tested algorithms to

  19. Immunological biomarkers associated with brain structure and executive function in late-life depression: exploratory pilot study.

    PubMed

    Smagula, Stephen F; Lotrich, Francis E; Aizenstein, Howard J; Diniz, Breno S; Krystek, Jeffrey; Wu, Gregory F; Mulsant, Benoit H; Butters, Meryl A; Reynolds, Charles F; Lenze, Eric J

    2017-06-01

    Several immunological biomarkers are altered in late-life major depressive disorder (LLD). Immunological alterations could contribute to LLD's consequences, but little is known about the relations between specific immunological biomarkers and brain health in LLD. We performed an exploratory pilot study to identify, from several candidates, the specific immunological biomarkers related to important aspects of brain health that are altered in LLD (brain structure and executive function). Adults (n = 31) were at least 60 years old and had major depressive disorder. A multiplex immunoassay assessed 13 immunological biomarkers, and we examined their associations with structural MRI (grey matter volume and white matter hyperintensity volume (WMH)) and executive function (Color-Word Interference and Trail-Making tests) measures. Vascular endothelial growth factor (VEGF) and the chemokine eotaxin had significant negative associations with grey matter volume (VEGF: n = 31, r = -0.65; eotaxin: n = 29, r = -0.44). Tumor necrosis factor alpha (TNF-α) had a significant positive relationship with WMHs (n = 30, r = 0.52); interferon-γ (IFN-γ) and macrophage inflammatory protein-1α (MIP-1α) were also significantly associated with WMHs (IFN-γ: n = 31, r = 0.48; MIP-1α: n = 29, r = 0.45). Only eotaxin was associated with executive function (set-shifting performance as measured with the Trail-making test: n = 33, r = -0.43). Immunological markers are associated with brain structure in LLD. We found the immunological correlates of grey and white matter differ. Prospective studies are needed to evaluate whether these immunological correlates of brain health increase the risk of LLD's consequences. Eotaxin, which correlated with both grey matter volume and set-shifting performance, may be particularly relevant to neurodegeneration and cognition in LLD. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  20. From glanders to globulins: A study in comparative medicine.

    PubMed

    Watkins, P E

    2017-05-01

    The anti-globulin test was described in 1945, and ever since has been synonymous with the lead author, Robin Coombs, a young veterinary surgeon, at that time embarking on a career in immunological research. This was marked by a number of important contributions in the field, including the description and categorisation of hypersensitivity reactions, co-authored with Philip Gell. Together they wrote the classical text, Clinical Aspects of Immunology, which has been updated and republished over the ensuing 50 years. Although Robin Coombs is best remembered for his contributions to medical immunology, he made a number of significant early advances in the field of veterinary immunology.

  1. Research and clinical aspects of immunology in Africa.

    PubMed

    Sibanda, E N

    2001-10-01

    There are few immunologists in Africa. Researchers predominantly study the immunology of infectious diseases (HIV, malaria and tuberculosis), HLA genotypes and cytokine secretion patterns. Lack of research funding is the problem; continued, equitable international collaboration is a short-term answer. Sustainable development will come when African countries find ways of training and retaining scientists who will produce research and diagnostic tests. The Internet should be utilized to improve communication and as a conduit for online, virtual immunology courses.

  2. 42 CFR 493.833 - Condition: Diagnostic immunology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Diagnostic immunology. 493.833 Section 493.833 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... for Laboratories Performing Tests of Moderate Complexity (including the Subcategory), High Complexity...

  3. 42 CFR 493.833 - Condition: Diagnostic immunology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Diagnostic immunology. 493.833 Section 493.833 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... for Laboratories Performing Tests of Moderate Complexity (including the Subcategory), High Complexity...

  4. Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

    PubMed

    Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice

    2014-07-01

    This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing. Copyright © 2014 Elsevier B.V. All rights reserved.

  5. A comparison of an immunological faecal occult blood test Fecatwin sensitive/FECA EIA with Haemoccult in population screening for colorectal cancer.

    PubMed Central

    Armitage, N.; Hardcastle, J. D.; Amar, S. S.; Balfour, T. W.; Haynes, J.; James, P. D.

    1985-01-01

    Two faecal occult blood tests, a simple chemical test Haemoccult and an immunological test, Fecatwin Sensitive/Feca EIA, were offered to 3,225 asymptomatic individuals as screening for colorectal cancer. One thousand three hundred and four (44%) completed and returned the tests and of these 126 (9.7%) were found to be positive - Haemoccult 40 (3%) and Feca EIA 106 (8.1%). Five cancers (4 Dukes' Stage A, 1 Dukes' Stage C) and 23 adenomas greater than 1 cm were detected - rates of 3.8 per 1000 persons screened and 17.7 per 1000 persons screened respectively. Of the five cancers identified 5 were Feca EIA positive and 3 were Haemoccult positive. Of the 23 adenomas greater than 1 cm diameter identified, J1 were Feca EIA positive and 20 were Haemoccult positive. Seventy-eight Feca EIA positive subjects were investigated and no neoplastic disease was identified. Whilst this sensitive immunological test increases the yield of carcinomas, the high false positive rate makes it unsuitable for population screening for colorectal cancer in its present form. PMID:4005139

  6. Immunological studies in patients with Crohn's disease.

    PubMed Central

    MacPherson, B R; Albertini, R J; Beeken, W L

    1976-01-01

    An investigation of immunological parameters was conducted in 38 patients with Crohn's disease. The immunological tests employed included skin tests with dinitrochlorobenzene and a battery of common skin test antigens, lymphocyte transformation with phytohaemagglutinin and pokeweed mitogen, serum immunoglobulins, and absolute lymphocyte counts. Crohn's disease patients were divided into two groups, those treated with immunosuppressive drugs and those not receiving immunosuppressive medications. The latter group was subdivided into patients with active and inactive disease. Immunosuppressed patients with Crohn's disease did not develop sensitivity to dinitrochlorobenzene and had mildly depressed skin test reactivity to common skin test procedures. Non-immunosuppressed patients with active Crohn's disease also reacted less frequently to common skin test antigens, but 16 of 17 such patients developed sensitivity to dinitrochlorobenzene. Lymphocyte transformation with phytohaemagglutinin and pokeweed mitogen was normal in all groups of patients with Crohn's disease. However, when suboptimal incubation periods were used with phytohaemagglutinin stimulation, there was a significant difference between Crohn's disease patients and controls. Serum immunoglobulin levels and absolute lymphocyte counts were normal in all Crohn's disease patients. We conclude that immunity in Crohn's disease is qualitatively normal. PMID:1261880

  7. 42 CFR 493.837 - Standard; General immunology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; General immunology. 493.837 Section 493.837 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Performing Tests of Moderate Complexity (including the Subcategory), High Complexity, Or Any Combination of...

  8. 42 CFR 493.837 - Standard; General immunology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; General immunology. 493.837 Section 493.837 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Performing Tests of Moderate Complexity (including the Subcategory), High Complexity, Or Any Combination of...

  9. Spaceflight and Immune Responses of Rhesus Monkeys

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald

    1997-01-01

    In the grant period, we perfected techniques for determination of interleukin production and leukocyte subset analysis of rhesus monkeys. These results are outlined in detail in publication number 2, appended to this report. Additionally, we participated in the ARRT restraint test to determine if restraint conditions for flight in the Space Shuttle could contribute to any effects of space flight on immune responses. All immunological parameters listed in the methods section were tested. Evaluation of the data suggests that the restraint conditions had minimal effects on the results observed, but handling of the monkeys could have had some effect. These results are outlined in detail in manuscript number 3, appended to this report. Additionally, to help us develop our rhesus monkey immunology studies, we carried out preliminary studies in mice to determine the effects of stressors on immunological parameters. We were able to show that there were gender-based differences in the response of immunological parameters to a stressor. These results are outlined in detail in manuscript number 4, appended to this report.

  10. The Journal of Allergy and Clinical Immunology: In Practice - 2016 Year in Review.

    PubMed

    Schatz, Michael; Sicherer, Scott H; Zeiger, Robert S

    As editors, we concluded that it would be helpful to our readers to write a Year in Review article that highlights the Review, Original, and Clinical Communication articles published in 2016 in The Journal of Allergy and Clinical Immunology: In Practice. We summarized articles on the topics of asthma, rhinitis/rhinosinusitis, food allergy, anaphylaxis, drug allergy, urticarial/angioedema, eosinophilic disorders, and immunodeficiency. Within each topic, epidemiologic findings are presented, relevant aspects of prevention are described, and diagnostic and therapeutic advances are enumerated. Diagnostic tools described include history, skin tests, and in vitro tests. Treatments discussed include behavioral therapy, allergen avoidance therapy, positive and negative effects of pharmacologic therapy, and various forms of immunologic and desensitization management. We hope this review will help you, our readers, consolidate and use this extensive and practical knowledge for the benefit of your patients. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  11. Accuracy of parasitological and immunological tests for the screening of human schistosomiasis in immigrants and refugees from African countries: An approach with Latent Class Analysis

    PubMed Central

    Beltrame, Anna; Guerriero, Massimo; Angheben, Andrea; Gobbi, Federico; Requena-Mendez, Ana; Zammarchi, Lorenzo; Formenti, Fabio; Perandin, Francesca; Bisoffi, Zeno

    2017-01-01

    Background Schistosomiasis is a neglected infection affecting millions of people, mostly living in sub-Saharan Africa. Morbidity and mortality due to chronic infection are relevant, although schistosomiasis is often clinically silent. Different diagnostic tests have been implemented in order to improve screening and diagnosis, that traditionally rely on parasitological tests with low sensitivity. Aim of this study was to evaluate the accuracy of different tests for the screening of schistosomiasis in African migrants, in a non endemic setting. Methodology/Principal findings A retrospective study was conducted on 373 patients screened at the Centre for Tropical Diseases (CTD) in Negrar, Verona, Italy. Biological samples were tested with: stool/urine microscopy, Circulating Cathodic Antigen (CCA) dipstick test, ELISA, Western blot, immune-chromatographic test (ICT). Test accuracy and predictive values of the immunological tests were assessed primarily on the basis of the results of microscopy (primary reference standard): ICT and WB resulted the test with highest sensitivity (94% and 92%, respectively), with a high NPV (98%). CCA showed the highest specificity (93%), but low sensitivity (48%). The analysis was conducted also using a composite reference standard, CRS (patients classified as infected in case of positive microscopy and/or at least 2 concordant positive immunological tests) and Latent Class Analysis (LCA). The latter two models demonstrated excellent agreement (Cohen’s kappa: 0.92) for the classification of the results. In fact, they both confirmed ICT as the test with the highest sensitivity (96%) and NPV (97%), moreover PPV was reasonably good (78% and 72% according to CRS and LCA, respectively). ELISA resulted the most specific immunological test (over 99%). The ICT appears to be a suitable screening test, even when used alone. Conclusions The rapid test ICT was the most sensitive test, with the potential of being used as a single screening test for African migrants. PMID:28582412

  12. Current trends of reproductive immunology practices in in vitro fertilization (IVF) - a first world survey using IVF-Worldwide.com.

    PubMed

    Kwak-Kim, Joanne; Han, Ae Ra; Gilman-Sachs, Alice; Fishel, Simon; Leong, Milton; Shoham, Zeev

    2013-01-01

    Reproductive immunology has evolved from basic research studies to clinical applications. In this study, we aim to investigate the actual application of reproductive immunology concepts and findings in clinical reproductive medicine such as recurrent pregnancy losses (RPL), repeated implantation failures (RIF), and failed in vitro fertilization (IVF) cycles. A web-based survey was performed on IVF-Worldwide.com. Collected data were analyzed by the computerized software. A significant proportion of physicians recommend thrombophilia workups (86%), parental genetic study (79%), and immunologic evaluations (69%) to IVF candidates who have a history of RPL or chemical pregnancy losses. IVF physicians consider an immunologic workup when patients have two (30%) or three (21%) failed IVF cycles. Assays for anticardiolipin antibody, lupus anticoagulant, thyroid peroxidase antibody, and antinuclear antibody are the four most commonly ordered immunologic tests for RPL (88, 84, 50, 47% each) and RIF (68, 63, 38, 38% each). Cellular immune evaluations, such as NK assay, human leukocyte antigen study, Th1/Th2 study or immunophenotype assay, are less commonly ordered. Reproductive immunology principles have been applied to the clinical management of RPL, RIF, and failed IVF cycles, and a significant proportion of IVF physicians acknowledge the importance of immunologic alterations with reproductive outcomes. © 2012 John Wiley & Sons A/S.

  13. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

  14. [Immunological status of patients with amebic hepatic abscess].

    PubMed

    Canto Solís, A; Miranda Feria, A J; Medina Martinez, J; Teran Ortíz, L A; Suárez Sánchez, F

    1975-01-01

    The authors studied 10 cases of amoebic hepatic abscess documented by clinical evidence and confirmed by laboratory tests, liver scan and a good response to treatment. The immunological state of the patients was determined by protein electrophoresis, immunoelectrophoresis, counter-immunoelectrophoresis, radial immunodiffusion and roset formation for T and B lymphocytes. It is concluded that the alterations of cellular and humoral immunity is evident in cases of amoebic hepatic abscess; this alterations are more clear in the acute form of the illness and the immunological deficiency is more significant in the celular immunity.

  15. [Immunological monitoring in kidney transplantation: 13 years experience of a Moroccan histocompatibility laboratory].

    PubMed

    Brick, C; Atouf, O; Essakalli, M

    2016-05-01

    The quality of the immunological monitoring is crucial because it determines the success of the kidney transplantation. The scope of this work is to describe the experience of the department of immunological unity of the Ibn Sina university hospital in Rabat regarding the immunological monitoring of patients transplanted between 2001 and 2014. Patient samples were collected from nephrology services of different public and private hospitals of Morocco. The tests conducted in the context of immunological monitoring are ABO typing, HLA-A, B, DR, DQ typing, anti-HLA antibodies detection and identification and cross-match. One hundred and fourteen benefited from a pre- and post-transplant immunological monitoring in our laboratory. The percentage of recipients having between 2 and 5 stored sera is 60.5 before transplantation and 56.1 after transplantation. Immunized patients account for 22.8% before the transplant and 17.6% after transplantation. Ninety-seven patients still have a functional graft, while 4 of them had DSA of low intensity before transplantation. Five immunological rejections were reported while the cross-match were negative and no DSA was identified before transplantation. Patient survival and graft at 1 year was 98.2% and 92.7% respectively. Conducting regular immunological monitoring is sometimes difficult in our context, however, the results are satisfactory in terms of graft and patients survival. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  16. Effect of endosulfan on immunological competence of layer birds.

    PubMed

    Singh, P P; Kumar, Ashok; Chauhan, R S; Pankaj, P K

    2016-07-01

    The present study was aimed to investigate the immunological competence of endosulfan insecticide after limited oral administration in White Leghorn layer chickens. A total of 20 White Leghorn birds were given endosulfan in drinking water at 30 ppm/bird/day (no observable effect level dose) for a period of 3-months. Immune competence status of layer birds and chicks hatched from endosulfan offered birds were estimated at 15-day interval in layer birds and at monthly interval in chicks using immunological, biochemical parameters, and teratological estimates. There was a significant decrease in levels of total leukocytes count, absolute lymphocyte count, absolute heterophil count, total serum protein, serum albumin, serum globulin, and serum gamma globulin in the birds fed with endosulfan as compared to control. Similarly, immune competence tests such as lymphocyte stimulation test, oxidative burst assay, and enzyme-linked immunosorbent assay tests indicated lower immunity in birds treated with endosulfan as compared to control. Subsequently, chicks produced from endosulfan-treated birds were also examined for immune competence, but no significant difference was observed between chicks of both the groups. The exposure to endosulfan in limited oral dosage was able to exhibit hemo-biochemical and other changes that could be correlated with changes in the immunological profile of layer chickens suggesting cautious usage of endosulfan insecticide in poultry sheds.

  17. Recommended Immunological Assays to Screen for Ricin-Containing Samples

    PubMed Central

    Simon, Stéphanie; Worbs, Sylvia; Avondet, Marc-André; Tracz, Dobryan M.; Dano, Julie; Schmidt, Lisa; Volland, Hervé; Dorner, Brigitte G.; Corbett, Cindi R.

    2015-01-01

    Ricin, a toxin from the plant Ricinus communis, is one of the most toxic biological agents known. Due to its availability, toxicity, ease of production and absence of curative treatments, ricin has been classified by the Centers for Disease Control and Prevention (CDC) as category B biological weapon and it is scheduled as a List 1 compound in the Chemical Weapons Convention. An international proficiency test (PT) was conducted to evaluate detection and quantification capabilities of 17 expert laboratories. In this exercise one goal was to analyse the laboratories’ capacity to detect and differentiate ricin and the less toxic, but highly homologuous protein R. communis agglutinin (RCA120). Six analytical strategies are presented in this paper based on immunological assays (four immunoenzymatic assays and two immunochromatographic tests). Using these immunological methods “dangerous” samples containing ricin and/or RCA120 were successfully identified. Based on different antibodies used the detection and quantification of ricin and RCA120 was successful. The ricin PT highlighted the performance of different immunological approaches that are exemplarily recommended for highly sensitive and precise quantification of ricin. PMID:26703725

  18. Recommended Immunological Assays to Screen for Ricin-Containing Samples.

    PubMed

    Simon, Stéphanie; Worbs, Sylvia; Avondet, Marc-André; Tracz, Dobryan M; Dano, Julie; Schmidt, Lisa; Volland, Hervé; Dorner, Brigitte G; Corbett, Cindi R

    2015-11-26

    Ricin, a toxin from the plant Ricinus communis, is one of the most toxic biological agents known. Due to its availability, toxicity, ease of production and absence of curative treatments, ricin has been classified by the Centers for Disease Control and Prevention (CDC) as category B biological weapon and it is scheduled as a List 1 compound in the Chemical Weapons Convention. An international proficiency test (PT) was conducted to evaluate detection and quantification capabilities of 17 expert laboratories. In this exercise one goal was to analyse the laboratories' capacity to detect and differentiate ricin and the less toxic, but highly homologuous protein R. communis agglutinin (RCA120). Six analytical strategies are presented in this paper based on immunological assays (four immunoenzymatic assays and two immunochromatographic tests). Using these immunological methods "dangerous" samples containing ricin and/or RCA120 were successfully identified. Based on different antibodies used the detection and quantification of ricin and RCA120 was successful. The ricin PT highlighted the performance of different immunological approaches that are exemplarily recommended for highly sensitive and precise quantification of ricin.

  19. Chapter 29: Unproved and controversial methods and theories in allergy-immunology.

    PubMed

    Shah, Rachna; Greenberger, Paul A

    2012-01-01

    Unproved methods and controversial theories in the diagnosis and management of allergy-immunology are those that lack scientific credibility. Some definitions are provided for perspective because in chronic medical conditions, frequently, nonscientifically based treatments are developed that can have a very positive psychological effect on the patients in the absence of objective physical benefit. Standard practice can be described as "the methods of diagnosis and treatment used by reputable physicians in a particular subspecialty or primary care practice" with the understanding that diagnosis and treatment options are consistent with established mechanisms of conditions or diseases.(3) Conventional medicine (Western or allopathic medicine) is that which is practiced by the majority of MDs, DOs, psychologists, RNs, and physical therapists. Complementary medicine uses the practice of conventional medicine with complementary and alternative medicine such as using acupuncture for pain relief in addition to opioids. Alternative medicine implies use of complementary and alternative practices in place of conventional medicine. Unproved and controversial methods and theories do not have supporting data, validation, and sufficient scientific scrutiny, and they should not be used in the practice of allergy-immunology. Some examples of unproven theories about allergic immunologic conditions include allergic toxemia, idiopathic environmental intolerance, association with childhood vaccinations, and adrenal fatigue. Unconventional (unproved) diagnostic methods for allergic-immunologic conditions include cytotoxic tests, provocation-neutralization, electrodermal diagnosis, applied kinesiology assessments, and serum IgG or IgG(4) testing. Unproven treatments and intervention methods for allergic-immunologic conditions include acupuncture, homeopathy ("likes cure likes"), halotherapy, and autologous urine injections.

  20. Use of bDNA testing in the immunologically nonresponding patient who has a low or undetectable viral load by RT-PCR testing.

    PubMed

    Grimes, Richard M; Lewis, Stanley T; Visnegarwala, Fehmida; Goodly, Joseph; Sutton, Richard; Rodriguez-Barradas, Maria

    2003-01-01

    Studies have shown that reverse transcription-polymerase chain reaction (RT-PCR) technology underquantifies viral loads in patients with non-B clades of HIV-1. Testing with bDNA technology gave higher viral loads in these subtypes. A study was conducted to determine whether virologically responding patients on HAART who were not immunologically responding would have higher viral loads using bDNA technology and whether these differences were due to non-B clades. Forty-eight patients receiving HAART for more than 6 months who were having inappropriate immunologic responses in spite of undetectable or very low viral loads determined by RT-PCR (<3000 copies by Roche Amplicor 1.0) were studied. These patients had bDNA viral loads performed. All patients who had bDNA viral loads equivalent to >3000 by RT-PCR had clade and genotypic studies performed. Fifteen patients had viral loads by bDNA that were equivalent to >3000 copies by RT-PCR. Four of these were found to have non-B clades (one D clade and three AG clade). The D clade patient had multidrug resistance; none of the AG clade patients had resistance. Of the remaining 11 patients, virus could not be recovered from 2 and 9 had a B clade. Six of these nine had genotypic resistance to HAART drugs. bDNA testing may be useful in the immunologically nonresponding patient.

  1. [Information content of immunologic parameters in the evaluation of the effects of hazardous substances].

    PubMed

    Litovskaia, A V; Sadovskiĭ, V V; Vifleemskiĭ, A B

    1995-01-01

    Clinical and immunologic examination including 1 and 2 level tests covered 429 staffers of chemical enterprises and 1122 of those engaged into microbiological synthesis of proteins, both the groups exposed to some irritating gases and isocyanates. Using calculation of Kulbak's criterion, the studies selected informative parameters to diagnose immune disturbances caused by occupational hazards. For integral evaluation of immune state, the authors applied general immunologic parameter, meanings of which can serve as criteria for early diagnosis of various immune disorders and for definition of risk groups among industrial workers exposed to occupational biologic and chemical hazards.

  2. An experimental test of the effects of behavioral and immunological defenses against vectors: do they interact to protect birds from blood parasites?

    PubMed Central

    2014-01-01

    Background Blood-feeding arthropods can harm their hosts in many ways, such as through direct tissue damage and anemia, but also by distracting hosts from foraging or watching for predators. Blood-borne pathogens transmitted by arthropods can further harm the host. Thus, effective behavioral and immunological defenses against blood-feeding arthropods may provide important fitness advantages to hosts if they reduce bites, and in systems involving pathogen transmission, if they lower pathogen transmission rate. Methods We tested whether Rock Pigeons (Columba livia) have effective behavioral and immunological defenses against a blood-feeding hippoboscid fly (Pseudolynchia canariensis) and, if so, whether the two defenses interact. The fly vectors the blood parasite Haemoproteus columbae; we further tested whether these defenses reduced the transmission success of blood parasites when birds were exposed to infected flies. We compared four experimental treatments in which hosts had available both purported defenses, only one of the defenses, or no defenses against the flies. Results We found that preening and immunological defenses were each effective in decreasing the survival and reproductive success of flies. However, the two defenses were additive, rather than one defense enhancing or decreasing the effectiveness of the other defense. Neither defense reduced the prevalence of H. columbae, nor the intensity of infection in birds exposed to infected flies. Conclusions Flies experience reduced fitness when maintained on hosts with immunological or preening defenses. This suggests that if vectors are given a choice among hosts, they may choose hosts that are less defended, which could impact pathogen transmission in a system where vectors can choose among hosts. PMID:24620737

  3. Monitoring non-immediate allergic reactions to iodine contrast media

    PubMed Central

    Torres, M J; Mayorga, C; Cornejo-Garcia, J A; Lopez, S; Chaves, P; Rondon, C; Fernandez, T; Blanca, M

    2008-01-01

    Non-immediate reactions to iodine contrast media (ICM) affect 2–5% of patients receiving these agents. We studied the immunological mechanisms involved in patients with a confirmed non-immediate reaction, maculopapular exanthema, after administration of ICM. The diagnosis was carried out by skin testing or drug provocation test. The immunological study was performed in sequential peripheral blood mononuclear cells taken from the onset of the reaction by flow cytometry and in skin biopsy by immunohistochemistry, with specific recognition by the lymphocyte transformation test (LTT) with different ICM. Flow cytometry showed an increase in the different activation markers [CD69, CD25 and human leucocyte antigen D-related (HLA-DR)] and the skin homing receptor [cutaneous lymphocyte-associated antigen (CLA)] in CD4 lymphocytes, whereas perforin was higher in the CD8 lymphocytes. The skin biopsy showed a perivascular mononuclear infiltrate composed of CD4 lymphocytes, expressing CD25, HLA-DR and CLA, with eosinophils. Intradermal skin tests and the LTT were positive to several ICM, including the culprit agent in four and three patients, respectively, with negative results in all 10 tolerant controls. We showed that a specific immunological mechanism was implicated in patients with non-immediate reactions to ICM. Moreover, the positive results in skin tests and lymphocyte proliferation tests indicated that an important cross-reactivity exists. PMID:18341616

  4. Syphilis in the AIDS era: diagnostic dilemma and therapeutic challenge.

    PubMed

    Scythes, John B; Jones, Colman M

    2013-06-01

    This review argues that syphilis has been underdiagnosed and undertreated, a problem that goes back to the beginning of the Wassermann era, and indeed long before. Non-treponemal tests do not detect the larger pool of persons with latent syphilis, the immunological consequences of which have not been systematically investigated in the context of HIV infection and progression to AIDS. Recent efforts to confirm the prevalence of syphilis in high-risk patients by reverse sequence screening, i.e. using a treponemal test first, as the screening test, have revealed untreated syphilis at higher rates than expected. Further testing using PCR discovered even more previously undetected cases. We suggest that latent syphilis is a chronic active immunological condition that drives the AIDS process and cannot be managed with the older Wassermann-based algorithm, and that non-treponemal tests have failed to associate syphilis with immune suppression since this screening concept was developed in 1906. In light of the overwhelming association between a past history of syphilis and HIV seroconversion, more sensitive tools, including recombinant antigen-based immunological tests and direct detection (PCR) technology, are needed to adequately assess the role of latent syphilis in persons with HIV/AIDS. Repeating older syphilis reinoculation studies may help establish a successful animal model for AIDS, and resolve many paradoxes in HIV science.

  5. A review of the basis of the immunological diagnosis of ruminant brucellosis.

    PubMed

    Ducrotoy, Marie J; Conde-Álvarez, Raquel; Blasco, José María; Moriyón, Ignacio

    2016-03-01

    Bacteria of the genus Brucella cause brucellosis, the most common bacterial zoonosis worldwide. The diagnosis of Brucella abortus and Brucella melitensis ruminant brucellosis is based on bacteriological and immunological tests, the latter being routinely used in control and eradication and surveillance programs. Infections by smooth and rough Brucella spp., the use of smooth and rough vaccines, and the false-positive serological reactions caused by Yersinia enterocolitica O:9 and other cross-reacting bacteria represent the immunological contexts in which those tests are used. This complex context explains the large number of brucellosis tests that have been developed, and that vary in antigen type, antigen presentation, antibody and conditions for the reaction, the response detected and the sample required. This wealth of information and an imperfect understanding of Brucella antigens and of the peculiarities of the immunoresponse to Brucella has created confusion and led to several misconceptions on the usefulness and limitations of the brucellosis diagnostic tests. In this review, Brucella antigens are examined focusing on cellular topology, supramolecular properties, epitopic structure and lipopolysaccharide and protein cross-reactivity in the various contexts of the immune response in ruminants. Then, the significance of these features in diagnostic tests that use whole bacteria is discussed with respect to the activities of ruminant immunoglobulins, and the effect of pH on unspecific agglutinations, non-agglutinating and blocking antibodies, pseudo-prozones and complement activation. Similarly, the bacterial surface lipopolysaccharides and cognate polysaccharides are discussed with regards to topological effects, epitope exposure, ionic strength and antibody avidity in immunoprecipitation, immunosorbent and fluorescence polarization assays. Finally, the search for immunodominant protein antigens and their use in immunological tests is reviewed. Critical review of the existing information is necessary both to select optimal tests according to the logistical means available and the epidemiological context, and to focus the development of new tests. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. Profiles of HIV-infected anti-retroviral therapy naïve children from Mumbai, India.

    PubMed

    Paranjpe, Supriya Mayur; Sarkate, Purva Pankaj; Ingole, Nayana Avinash; Raut, Shweta Sadanand; Mehta, Preeti Rajeev

    2016-11-01

    This study aimed to investigate the demographic profiles of human immunodifficiency virus (HIV) infected anti-retroviral therapy (ART) naïve children in our hospital and their relations to the clinical, immunological and nutritional status. A cross-sectional study was conducted in an Integrated Counselling and Testing Center (ICTC) at a tertiary care hospital in Mumbai. ART naïve HIV positive children were enrolled in the study. The demographic profiles, clinical features, immunological (CD4%/CD4 count) and nutritional status of these children were recorded. The agreement between clinical, immunological and nutritional staging was determined using Cohen's kappa test. In 192 HIV-infected ART naive children enrolled with a median age of 9 years (range 3 months-14 years), 97.4% acquired infection through vertical transmission. The most common clinical presentation was fever (39.6 %), followed by generalized lymphadenopathy (32.3%), cough (22.4%) and diarrhoea (9.9%). Tuberculosis was seen in 22.9% of the children. The agreement was fair between clinical and immunological staging, and slight between nutritional, immunological and clinical staging. Perinatal transmission is the most common mode of acquiring HIV infection in children. The Prevention of Parent to Child Transmission (PPTCT) program should be strengthened for lowering the transmission rate by providing extended ART to mothers during pregnancy and breast-feeding. Tuberculosis remains a major concern in HIV-infected children. The poor correlation between WHO clinical and immunological staging emphasizes the importance of making CD4 facilities available in HIV prevalent areas. Malnutrition cannot be used as a surrogate marker for predicting stage or severity as it is common at all stages of HIV disease.

  7. Antibody response against Betaferon® in immune tolerant mice: involvement of marginal zone B-cells and CD4+ T-cells and apparent lack of immunological memory.

    PubMed

    Sauerborn, Melody; van Beers, Miranda M C; Jiskoot, Wim; Kijanka, Grzegorz M; Boon, Louis; Schellekens, Huub; Brinks, Vera

    2013-01-01

    The immunological processes underlying immunogenicity of recombinant human therapeutics are poorly understood. Using an immune tolerant mouse model we previously demonstrated that aggregates are a major trigger of the antidrug antibody (ADA) response against recombinant human interferon beta (rhIFNβ) products including Betaferon®, and that immunological memory seems to be lacking after a rechallenge with non-aggregated rhIFNβ. The apparent absence of immunological memory indicates a CD4+ T-cell independent (Tind) immune response underlying ADA formation against Betaferon®. This hypothesis was tested. Using the immune tolerant mouse model we first validated that rechallenge with highly aggregated rhIFNβ (Betaferon®) does not lead to a subsequent fast increase in ADA titers, suggesting a lack of immunological memory. Next we assessed whether Betaferon® could act as Tind antigen by inactivation of marginal zone (MZ) B-cells during treatment. MZ B-cells are major effector cells involved in a Tind immune response. In a following experiment we depleted the mice from CD4+ T-cells to test their involvement in the ADA response against Betaferon®. Inactivation of MZ B-cells at the start of Betaferon® treatment drastically lowered ADA levels, suggesting a Tind immune response. However, persistent depletion of CD4+ T-cells before and during Betaferon® treatment abolished the ADA response in almost all mice. The immune response against rhIFNβ in immune tolerant mice is neither a T-cell independent nor a classical T-cell dependent immune response. Further studies are needed to confirm absence of immunological memory (cells).

  8. A Simple Test Tube-Based ELISA Experiment for the High-School Classroom

    ERIC Educational Resources Information Center

    Brokaw, Ann; Cobb, Brian A.

    2009-01-01

    Immunology is gaining prominence both in the media as well as on the Advanced Placement (AP) exam in Biology. One of the challenges of teaching modern biological topics such as immunology and biochemistry in the high-school setting is the increased reliance on expensive technology in the research world. To begin to bridge this widening gap, we…

  9. Performance of immunological response in predicting virological failure.

    PubMed

    Ingole, Nayana; Mehta, Preeti; Pazare, Amar; Paranjpe, Supriya; Sarkate, Purva

    2013-03-01

    In HIV-infected individuals on antiretroviral therapy (ART), the decision on when to switch from first-line to second-line therapy is dictated by treatment failure, and this can be measured in three ways: clinically, immunologically, and virologically. While viral load (VL) decreases and CD4 cell increases typically occur together after starting ART, discordant responses may be seen. Hence the current study was designed to determine the immunological and virological response to ART and to evaluate the utility of immunological response to predict virological failure. All treatment-naive HIV-positive individuals aged >18 years who were eligible for ART were enrolled and assessed at baseline, 6 months, and 12 months clinically and by CD4 cell count and viral load estimations. The patients were categorized as showing concordant favorable (CF), immunological only (IO), virological only (VO), and concordant unfavorable responses (CU). The efficiency of immunological failure to predict virological failure was analyzed across various levels of virological failure (VL>50, >500, and >5,000 copies/ml). At 6 months, 87(79.81%), 7(5.5%), 13 (11.92%), and 2 (1.83%) patients and at 12 months 61(69.3%), 9(10.2%), 16 (18.2%), and 2 (2.3%) patients had CF, IO, VO, and CU responses, respectively. Immunological failure criteria had a very low sensitivity (11.1-40%) and positive predictive value (8.3-25%) to predict virological failure. Immunological criteria do not accurately predict virological failure resulting in significant misclassification of therapeutic responses. There is an urgent need for inclusion of viral load testing in the initiation and monitoring of ART.

  10. Effective Immunological Guidance of Genetic Analyses Including Exome Sequencing in Patients Evaluated for Hemophagocytic Lymphohistiocytosis.

    PubMed

    Ammann, Sandra; Lehmberg, Kai; Zur Stadt, Udo; Klemann, Christian; Bode, Sebastian F N; Speckmann, Carsten; Janka, Gritta; Wustrau, Katharina; Rakhmanov, Mirzokhid; Fuchs, Ilka; Hennies, Hans C; Ehl, Stephan

    2017-11-01

    We report our experience in using flow cytometry-based immunological screening prospectively as a decision tool for the use of genetic studies in the diagnostic approach to patients with hemophagocytic lymphohistiocytosis (HLH). We restricted genetic analysis largely to patients with abnormal immunological screening, but included whole exome sequencing (WES) for those with normal findings upon Sanger sequencing. Among 290 children with suspected HLH analyzed between 2010 and 2014 (including 17 affected, but asymptomatic siblings), 87/162 patients with "full" HLH and 79/111 patients with "incomplete/atypical" HLH had normal immunological screening results. In 10 patients, degranulation could not be tested. Among the 166 patients with normal screening, genetic analysis was not performed in 107 (all with uneventful follow-up), while 154 single gene tests by Sanger sequencing in the remaining 59 patients only identified a single atypical CHS patient. Flow cytometry correctly predicted all 29 patients with FHL-2, XLP1 or 2. Among 85 patients with defective NK degranulation (including 13 asymptomatic siblings), 70 were Sanger sequenced resulting in a genetic diagnosis in 55 (79%). Eight patients underwent WES, revealing mutations in two known and one unknown cytotoxicity genes and one metabolic disease. FHL3 was the most frequent genetic diagnosis. Immunological screening provided an excellent decision tool for the need and depth of genetic analysis of HLH patients and provided functionally relevant information for rapid patient classification, contributing to a significant reduction in the time from diagnosis to transplantation in recent years.

  11. Nutritional and Immunological Correlates of Memory and Neurocognitive Development Among HIV-Infected Children Living in Kayunga, Uganda.

    PubMed

    Ruiseñor-Escudero, Horacio; Familiar-Lopez, Itziar; Sikorskii, Alla; Jambulingam, Nikita; Nakasujja, Noelline; Opoka, Robert; Bass, Judith; Boivin, Michael

    2016-04-15

    To identify the nutritional and immunological correlates of memory and neurocognitive development as measured by the Mullen Scales of Early Learning (MSEL) and by the Color Object Association Test (COAT) among children in Uganda. This analysis uses baseline data collected between 2008 and 2010 from 119 HIV-infected children aged 1-6 years, participating in a randomized controlled trial of an interventional parenting program in Kayunga, Uganda. Peripheral blood draws were performed to determine immunological biomarkers. Unadjusted and adjusted linear regression models were used to relate MSEL and COAT scores to sociodemographic characteristics, weight-for-age Z scores (WAZs), antiretroviral therapy status, and immunological biomarkers. In the final analysis, 111 children were included. Lower levels of CD4 CD38 T cells (P = 0.04) were associated to higher immediate and total recall scores (P = 0.04). Higher levels of CD8 HLA-DR T cells were associated with higher total recall score (P = 0.04) of the COAT. Higher CD4 CD38 HLA-DR T cells levels were associated with higher gross motor scores of the MSEL (P = 0.02). WAZ was positively correlated to visual reception, fine motor, expressive language, and composite score of the MSEL. Overall, WAZ was a stronger predictor of neurocognitive outcomes assessed by the MSEL. CD4 CD38 T cells were more specifically associated with memory-related outcomes. Future research should include immunological markers and standardized neurocognitive tests to further understand this relationship.

  12. Immunological Response of Hiv-Infected Children to Highly Active Antiretoviral Therapy at Gondar University Hospital, North-Western Ethiopia.

    PubMed

    Kokeb, Mehretie; Degu, Getu

    2016-01-01

    The effectiveness of highly active antiretroviral therapy (HAART) in children has not been well studied specially in developing countries where the burden of HIV is high. This study was aimed to assess the immunologic response of HIV-infected children to HAART at Pediatric ART Clinic Gondar University Hospital. Institution based cross-sectional study was conducted at the Pediatric ART Clinic Gondar University Hospital from March 01-April 30, 2014. The study included 283 HIV-infected children who were on HAART for 6 months and above. Medical records of HIV-infected children were reviewed using pre-tested questionnaire. CD4 count/percent was collected every 6 months retrospectively. For all statistical significance tests, the cut-off value was p<0.05. Poison Regression was used for further analysis. The mean age of children was 6.9 years with a standard deviation of 3.4 years. The median CD4 count/percent was 232/13%, 450/21%, 540/25% and 608/27% at the time of initiation, 6, 12 and 18 months of ART, respectively. HAART initiated at higher CD4 count, good adherence and HIV status disclosure were found to have positive effects for immunological response. The study revealed that there was good Immunological response to ART, and that the maximum response was in the 1(st) 6 months of ART. Low CD4 count at initiation, undisclosed HIV status and lack of good adherence were found to cause low immunological response to HAART.

  13. Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-Probes study of laboratory staffing at 98 institutions.

    PubMed

    Jones, Bruce A; Darcy, Teresa; Souers, Rhona J; Meier, Frederick A

    2012-02-01

    Publicly available information concerning laboratory staffing benchmarks is scarce. One of the few publications on this topic summarized the findings of a Q-Probes study performed in 2004. This publication reports a similar survey with data collected in 2010. To assess the relationship between staffing levels in specified laboratory sections and test volumes in these sections and quantify management span of control. The study defined 4 laboratory sections: anatomic pathology (including cytology), chemistry/hematology/immunology, microbiology, and transfusion medicine. It divided staff into 3 categories: management, nonmanagement (operational or bench staff), and doctoral (MD, PhD) supervisory staff. People in these categories were tabulated as full-time equivalents and exclusions specified. Tests were counted in uniform formats, specified for each laboratory section, according to Medicare rules for the bundling and unbundling of tests. Ninety-eight participating institutions provided data that showed significant associations between test volumes and staffing for all 4 sections. There was wide variation in productivity based on volume. There was no relationship between testing volume per laboratory section and management span of control. Higher productivity in chemistry/hematology/immunology was associated with a higher fraction of tests coming from nonacute care patients. In both the 2004 and 2010 studies, productivity was inseparably linked to test volume. Higher test volume was associated with higher productivity ratios in chemistry/hematology/immunology and transfusion medicine sections. The impact of various testing services on productivity is section-specific.

  14. Intradermal air pouch leukocytosis as an in vivo test for nanoparticles

    PubMed Central

    Vandooren, Jennifer; Berghmans, Nele; Dillen, Chris; Van Aelst, Ilse; Ronsse, Isabelle; Israel, Liron Limor; Rosenberger, Ina; Kreuter, Jörg; Lellouche, Jean-Paul; Michaeli, Shulamit; Locatelli, Erica; Franchini, Mauro Comes; Aiertza, Miren K; Sánchez-Abella, Laura; Loinaz, Iraida; Edwards, Dylan R; Shenkman, Louis; Opdenakker, Ghislain

    2013-01-01

    The need for test systems for nanoparticle biocompatibility, toxicity, and inflammatory or adaptive immunological responses is paramount. Nanoparticles should be free of microbiological and chemical contaminants, and devoid of toxicity. Nevertheless, in the absence of contamination, these particles may still induce undesired immunological effects in vivo, such as enhanced autoimmunity, hypersensitivity reactions, and fibrosis. Here we show that artificial particles of specific sizes affect immune cell recruitment as tested in a dermal air pouch model in mice. In addition, we demonstrate that the composition of nanoparticles may influence immune cell recruitment in vivo. Aside from biophysical characterizations in terms of hydrodynamic diameter, zeta potential, concentration, and atomic concentration of metals, we show that – after first-line in vitro assays – characterization of cellular and molecular effects by dermal air pouch analysis is straightforward and should be included in the quality control of nanoparticles. We demonstrate this for innate immunological effects such as neutrophil recruitment and the production of immune-modulating matrix metalloproteases such as MMP-9; we propose the use of air pouch leukocytosis analysis as a future standard assay. PMID:24379662

  15. History of Primary Immunodeficiency Diseases in Iran

    PubMed Central

    Aghamohammadi, Asghar; Moin, Mostafa; Rezaei, Nima

    2010-01-01

    Pediatric immunology came into sight in the second half of 20th century, when pediatricians and basic immunologists began to give attention to diagnosis and treatment of children with primary immunodeficiency diseases (PIDs). Understanding the genetic and mechanistic basis of PIDs provides unique insight into the functioning of the immune system. By progress in basic and clinical immunology, many infrastructural organizations and academic centers have been established in many countries worldwide to focus on training and research on the immune system and related disorders. Along with progress in basic and clinical immunology in the world, pediatric immunology had a good progress in Iran during the last 33-year period. Now, patients with PIDs can benefit from multidisciplinary comprehensive care, which is provided by clinical immunologists in collaboration with other specialists. Patients with history of recurrent and/or chronic infections suggestive of PIDs are evaluated by standard and research-based testing and receive appropriate treatment. The progress in PIDs can be described in three periods. Development of training program for clinical fellowship in allergy and immunology, multidisciplinary and international collaborative projects, primary immunodeficiency diseases textbooks, meetings on immunodeficiency disorders, improvement in diagnosis and treatment, and construction of Iranian primary immunodeficiency association, Students' research group for immunodeficiencies, Iranian primary immunodeficiency registry, and the immunological societies and centers were the main activities on PIDs during these years. In this article, we review the growth of modern pediatric immunology and PIDs status in Iran. PMID:23056678

  16. Distinct Cytokine and Chemokine Profiles in Autism Spectrum Disorders

    PubMed Central

    Han, Yvonne M. Y.; Cheung, Winnie K. Y.; Wong, Chun Kwok; Sze, Sophia L.; Cheng, Timmy W. S.; Yeung, Michael K.; Chan, Agnes S.

    2017-01-01

    Previous studies have shown that immunological factors are involved in the pathogenesis of autism spectrum disorders (ASDs). However, this research has been conducted almost exclusively in Western contexts, and only a handful of studies on immune measures have been conducted in Asian populations, such as Chinese populations. The present study examined whether immunological abnormalities are associated with cognitive deficits and problem behaviors in Chinese children with ASD and whether these children show different immunological profiles. Thirteen typically developing (TD) children and 22 children with ASD, aged 6–17 years, participated voluntarily in the study. Executive functions and short-term memory were measured using neuropsychological tests, and behavioral measures were assessed using parent ratings. The children were also assessed on immunological measures, specifically, the levels of cytokines and chemokines in the blood serum. Children with ASD showed greater deficits in cognitive functions, as well as altered levels of immunological measures, including CCL2, CCL5, and CXCL9 levels, compared to TD children, and the cognitive functions and associated behavioral deficits of children with ASD were significantly associated with different immunological measures. The children were further sub-classified into ASD with only autistic features (ASD-only) or ASD comorbid with attention deficit hyperactivity disorder (ASD + ADHD). The comorbidity results showed that there were no differences between the two groups of ASD children in any of the cognitive or behavioral measures. However, the results pertaining to immunological measures showed that the children with ASD-only and ASD + ADHD exhibited distinct cytokine and chemokine profiles and that abnormal immunologic function was associated with cognitive functions and inattention/hyperactivity symptoms. These results support the notion that altered immune functions may play a role in the selective cognitive and behavioral symptoms of ASD. PMID:28167942

  17. 21 CFR 866.5370 - Cohn fraction V immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be...

  18. 21 CFR 866.5370 - Cohn fraction V immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be...

  19. 21 CFR 866.5370 - Cohn fraction V immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be...

  20. 21 CFR 866.5370 - Cohn fraction V immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be...

  1. 21 CFR 866.5370 - Cohn fraction V immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be...

  2. Hematology and immunology studies

    NASA Technical Reports Server (NTRS)

    Kimzey, S. L.; Fischer, C. L.; Johnson, P. C.; Ritzmann, S. E.; Mengel, C. E.

    1975-01-01

    The hematology and immunology program conducted in support of the Apollo missions was designed to acquire specific laboratory data relative to the assessment of the health status of the astronauts prior to their commitment to space flight. A second objective was to detect and identify any alterations in the normal functions of the immunohematologic systems which could be attributed to space flight exposure, and to evaluate the significance of these changes relative to man's continuing participation in space flight missions. Specific changes observed during the Gemini Program formed the basis for the major portion of the hematology-immunology test schedule. Additional measurements were included when their contribution to the overall interpretation of the flight data base became apparent.

  3. Nutritional and immunological correlates of memory and neurocognitive development among HIV infected children living in Kayunga, Uganda

    PubMed Central

    Horacio, Ruiseñor-Escudero; Itziar, Familiar-Lopez; Alla, Sikorskii; Nikita, Jambulingam; Noelline, Nakasujja; Robert, Opoka; Judith, Bass; Michael, Boivin

    2015-01-01

    Objective To identify the nutritional and immunological correlates of memory and neurocognitive development as measured by the Mullen Scales of Early Learning (MSEL) and by the Color Object Association Test (COAT) among children in Uganda. Design This analysis uses baseline data collected between 2008 and 2010 from 119 HIV-infected children ages 1–6 years participating in a randomized controlled trial of an interventional parenting program in Kayunga, Uganda. Methods Peripheral blood draws were performed to determine immunological biomarkers. Unadjusted and adjusted linear regression models were used to relate MSEL and COAT scores to sociodemographic characteristics, weight-for-age Z-scores (WAZ), antiretroviral therapy (ART) status and immunological biomarkers. Results 111 children were included in the final analysis. Lower levels of CD4+ CD38+ T-cells (p=0.04) were associated to higher Immediate and Total Recall scores (p=0.04). Higher levels of CD8+ HLA-DR+ T-cells were associated with higher Total Recall score (p=0.04) of the COAT. Higher CD4+ CD38+ HLA-DR+ T-cells levels were associated with higher Gross Motor scores of the MSEL (p=0.02). WAZ was positively correlated to Visual Reception, Fine Motor, Expressive Language and composite score of the MSEL. Conclusions Overall, WAZ was a stronger predictor of neurocognitive outcomes assessed by the MSEL. CD4+ CD38+ T-cells were more specifically associated with memory-related outcomes. Future research should include immunological markers and standardized neurocognitive tests to further understand this relationship. PMID:26605506

  4. Sensitivity, specificity and comparison of three commercially available immunological tests in the diagnosis of Cryptosporidium species in animals.

    PubMed

    Danišová, Olga; Halánová, Monika; Valenčáková, Alexandra; Luptáková, Lenka

    The study was conducted to compare the specificity of immunological diagnostic methods used for the diagnosis of Cryptosporidium species capable of causing life-threatening infection in both immunosuppressed and immunocompetent patients. For the detection of Cryptosporidium species in 79 animals with diarrhoea, we used three Copro-antigen tests: RIDASCREEN ® Cryptosporidium test, Cryptosporidium 2nd Generation (ELISA) and RIDA ® QUICK Cryptosporidium. For immunoassays we used positive and negative samples detected by means of polymerase chain reaction and validated by sequencing and nested polymerase chain reaction to confirm the presence six different species of Cryptosporidium species. Prevalence of cryptosporidiosis in the entire group determined by enzyme immunoassay, enzyme linked immunosorbent assay, immuno-chromatographic test and polymerase chain reaction was 34.17%, 27.84%, 6.33% and 27.84%, respectively. Sensitivity of animal samples with enzyme immunoassay, enzyme linked immunosorbent assay, and immuno-chromatographic test was 63.6%, 40.9% and 22.7%, resp., when questionable samples were considered positive, whereas specificity of enzyme immunoassay, enzyme linked immunosorbent assay and immuno-chromatographic test was 75.9%, 78.9% and 100%, respectively. Positive predictive values and negative predictive values were different for all the tests. These differences results are controversial and therefore reliability and reproducibility of immunoassays as the only diagnostic method is questionable. The use of various Cryptosporidium species in diagnosis based on immunological testing and different results obtained by individual tests indicate potential differences in Copro-antigens produced by individual Cryptosporidium species. Copyright © 2017 Sociedade Brasileira de Microbiologia. Published by Elsevier Editora Ltda. All rights reserved.

  5. Recommendations regarding the genetic and immunological study of reproductive dysfunction.

    PubMed

    Alonso-Cerezo, María Concepción; Calero Ruiz, Mercedes; Chantada-Abal, Venancio; de la Fuente-Hernández, Luis Alfonso; García-Cobaleda, Inmaculada; García-Ochoa, Carlos; García-Sagredo, José Miguel; Nuñez, Rocío; Oliva, Rafael; Orera-Clemente, María; Pintado-Vera, David; Sanchez-Ramon, Silvia

    2018-04-19

    In this article several members of diverse scientific associations and reproduction experts from Spain have updated different genetic and immunological procedure recommendations in couples affected by reproductive dysfunction with the goal of providing a set of useful guidelines for the clinic. The laboratory test has been considered as highly recommendable for making clinical decisions when the result of the diagnostic test is relevant, moderately recommendable when the results are of limited evidence because they are inconsistent, and low when the benefit of the test is uncertain. It is expected that these recommendations will provide some useful guidelines for the diagnosis, prognosis and treatment of couples presenting reproductive dysfunction. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

  6. The influence of sublingual immunotherapy on several parameters of immunological response in children suffering from atopic asthma and allergic rhinitis depending on asthma features.

    PubMed

    Ciepiela, Olga; Zawadzka-Krajewska, Anna; Kotuła, Iwona; Demkow, Urszula

    2014-01-01

    The clinical efficacy of sublingual immunotherapy (SLIT) has already been proven and is known to be high. Its influence on the immunological system of patients suffering from bronchial asthma was also examined. However, it is still unclear how the polysensitisation, coexistence of other atopic disease and asthma treatment step influence the response to treatment with specific immunotherapy. Herein we evaluate the impact of one-year SLIT on selected markers of immunological response depending on different individual and clinical factors of children suffering from atopic asthma and allergic rhinitis. Twenty-five patients aged 8.1 ± 3.1 years (range 5-15 years), 21 boys and 4 girls, suffering from asthma and allergic rhinitis with polysensitisation to seasonal and non-seasonal allergens, shortlisted for SLIT, were included in the study. Th1 cell and Th2 cell percentages, Bcl-2 expression in T cells, and basophil activation after allergen challenge (house dust mite and/or grass pollen antigen in solution used for skin prick tests) in peripheral blood were measured using flow cytometry. The association between clinical features of asthma and the influence of SLIT on immunological parameters was evaluated with exact Fisher test. No association between the influence of one-year sublingual immunotherapy on immunological system and patients' age, polysensitisation, asthma treatment step, or coexistence of any other atopic diseases was observed. However, an increase of the Th1 percentage in children sensitised against more than three allergens was found more often (at the limit of statistical significance) than in the group of children sensitised against three or less allergens. Based on our results, we cannot point to any subgroup isolated in the study, in which the response of the immunological system to sublingual immunotherapy is more satisfactory than any other. Nevertheless, the increase of Th1 cells may be more specific for polysensitised children.

  7. Skin prick/puncture testing in North America: a call for standards and consistency.

    PubMed

    Fatteh, Shahnaz; Rekkerth, Donna J; Hadley, James A

    2014-01-01

    Skin prick/puncture testing (SPT) is widely accepted as a safe, dependable, convenient, and cost-effective procedure to detect allergen-specific IgE sensitivity. It is, however, prone to influence by a variety of factors that may significantly alter test outcomes, affect the accuracy of diagnosis, and the effectiveness of subsequent immunotherapy regimens. Proficiency in SPT administration is a key variable that can be routinely measured and documented to improve the predictive value of allergy skin testing. Literature surveys were conducted to determine the adherence to repeated calls for development and implementation of proficiency testing standards in the 1990's, the mid-2000's and the 2008 allergy diagnostics practice parameters. Authors publishing clinical research in peer-reviewed journals and conducting workshops at annual scientific meetings have recommended proficiency testing based primarily on its potential to reduce variability, minimize confounding test results, and promote more effective immunotherapeutic treatments. Very few publications of clinical studies, however, appear to report proficiency testing data for SPT performance. Allergen immunotherapy recommendations are updated periodically by the Joint Task Force on Practice Parameters representing the American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), and the Joint Council of Allergy, Asthma and Immunology (JCAAI). Despite consensus that all staff who perform SPT should meet basic quality assurance standards that demonstrate their SPT proficiency, the gap between recommendations and daily practice persists. By embracing standards, the accuracy of SPT and allergy diagnosis can be optimized, ultimately benefiting patients with allergic disease.

  8. Structural and Immunological Activity Characterization of a Polysaccharide Isolated from Meretrix meretrix Linnaeus

    PubMed Central

    Li, Li; Li, Heng; Qian, Jianying; He, Yongfeng; Zheng, Jialin; Lu, Zhenming; Xu, Zhenghong; Shi, Jinsong

    2015-01-01

    Polysaccharides from marine clams perform various biological activities, whereas information on structure is scarce. Here, a water-soluble polysaccharide MMPX-B2 was isolated from Meretrix meretrix Linnaeus. The proposed structure was deduced through characterization and its immunological activity was investigated. MMPX-B2 consisted of d-glucose and d-galctose residues at a molar ratio of 3.51:1.00. The average molecular weight of MMPX-B2 was 510 kDa. This polysaccharide possessed a main chain of (1→4)-linked-α-d-glucopyranosyl residues, partially substituted at the C-6 position by a few terminal β-d-galactose residues or branched chains consisting of (1→3)-linked β-d-galactose residues. Preliminary immunological tests in vitro showed that MMPX-B2 could stimulate the murine macrophages to release various cytokines, and the structure-activity relationship was then established. The present study demonstrated the potential immunological activity of MMPX-B2, and provided references for studying the active ingredients in M. meretrix. PMID:26729136

  9. Relationship between megadose vitamin supplementation and immunological function in a healthy elderly population.

    PubMed Central

    Goodwin, J S; Garry, P J

    1983-01-01

    We studied the immunological effects of 'megadose' vitamin or mineral supplementation by comparing the immunological functions of healthy elderly subjects taking large amounts of specific nutrients to similar subjects not on supplements. There was a non-significant trend for those subjects taking megadoses of vitamin C to have increased cell-mediated immune responses as measured in vivo by skin test reactivity but not by in vitro mitogen responses. In addition, subjects taking megadoses of vitamin E or any of several B vitamins (B1, B2, B6, folate and niacin) had lower absolute circulating lymphocyte counts than did the rest of the population. The relative lack of effect of megadose vitamins on immunological function in this population compared to reports of short term trials of mega nutrients raises the possibility that some of the previously reported immuno-enhancing properties of megadose vitamins may be due to a non-specific adjuvant effect that disappears with time. PMID:6851251

  10. Movement Limitation and Immune Responses of Rhesus Monkeys

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald; Morton, Darla S.; Swiggett, Jeanene P.; Hakenewerth, Anne M.; Fowler, Nina A.

    1993-01-01

    The effects of restraint on immunological parameters was determined in an 18 day ARRT (adult rhesus restraint test). The monkeys were restrained for 18 days in the experimental station for the orbiting primate (ESOP), the chair of choice for Space Shuttle experiments. Several immunological parameters were determined using peripheral blood, bone marrow, and lymph node specimens from the monkeys. The parameters included: response of bone marrow cells to GM-CSF (granulocyte-macrophage colony stimulating factor), leukocyte subset distribution, and production of IFN-alpha (interferon-alpha) and IFN-gamma (interferon-gamma). The only parameter changed after 18 days of restraint was the percentage of CDB+ T cells. No other immunological parameters showed changes due to restraint. Handling and changes in housing prior to the restraint period did apparently result in some restraint-independent immunological changes. Handling must be kept to a minimum and the animals allowed time to recover prior to flight. All experiments must be carefully controlled. Restraint does not appear to be a major issue regarding the effects of space flight on immune responses.

  11. Spaceflight and immune responses of rhesus monkeys

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald; Morton, Darla S.; Swiggett, Jeanene P.; Hakenewerth, Anne M.; Fowler, Nina A.

    1995-01-01

    The effects of restraint on immunological parameters was determined in an 18 day ARRT (adult rhesus restraint test). The monkeys were restrained for 18 days in the experimental station for the orbiting primate (ESOP), the chair of choice for Space Shuttle experiments. Several immunological parameters were determined using peripheral blood, bone marrow, and lymph node specimens from the monkeys. The parameters included: response of bone marrow cells to GM-CSF (granulocyte-macrophage colony stimulating factor), leukocyte subset distribution, and production of IFN-a (interferon-alpha) and IFN-gamma (interferon-gamma). The only parameter changed after 18 days of restraint was the percentage of CD8+ T cells. No other immunological parameters showed changes due to restraint. Handling and changes in housing prior to the restraint period did apparently result in some restraint-independent immunological changes. Handling must be kept to a minimum and the animals allowed time to recover prior to flight. All experiments must be carefully controlled. Restraint does not appear to be a major issue regarding the effects of space flight on immune responses.

  12. Engineering antigen-specific immunological tolerance.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kontos, Stephan; Grimm, Alizee J.; Hubbell, Jeffrey A.

    2015-05-01

    Unwanted immunity develops in response to many protein drugs, in autoimmunity, in allergy, and in transplantation. Approaches to induce immunological tolerance aim to either prevent these responses or reverse them after they have already taken place. We present here recent developments in approaches, based on engineered peptides, proteins and biomaterials, that harness mechanisms of peripheral tolerance both prophylactically and therapeutically to induce antigenspecific immunological tolerance. These mechanisms are based on responses of B and T lymphocytes to other cells in their immune environment that result in cellular deletion or ignorance to particular antigens, or in development of active immune regulatorymore » responses. Several of these approaches are moving toward clinical development, and some are already in early stages of clinical testing.« less

  13. [Methods of testing inactivated antirabies vaccines].

    PubMed

    Nedosekov, V V; Vishniakov, I F; Gruzdev, K N

    2001-01-01

    Methods for evaluating the potency of inactivated rabies vaccines are reviewed. Shortcomings of the traditional NIH method and advantages of modern rapid immunological in vitro methods (antibody binding test, radial immunodiffusion test, enzyme linked immunoadsorbent assay) for estimation of antigenic activity of vaccines are discussed.

  14. HLA-typing analysis following allogeneic bone grafting for sinus lifting.

    PubMed

    Piaia, Marcelo; Bub, Carolina Bonet; Succi, Guilherme de Menezes; Torres, Margareth; Costa, Thiago Henrique; Pinheiro, Fabricio Costa; Napimoga, Marcelo Henrique

    2017-03-01

    According to the Brazilian Association of Organ Transplants, in 2015, 19,408 bone transplants were performed in Brazil, over 90% by Dental Surgeons. The surgical technique itself has a respectable number of reports regarding its clinical efficacy, as measured by long-term survival of dental implants in grafted areas. Uncertainty remains, however, as to whether fresh frozen grafts from human bone donors remain immunologically innocuous in the body of the host. Six male with no previous medical history of note, including systemic diseases, surgery or blood transfusion were selected. These patients underwent reconstructive procedures (sinus lifting) using fresh frozen human bone from a tissue bank. All patients had venous blood samples collected prior to surgery and 6 months after the procedure. Anti-HLA analysis for the detection of HLA (human leukocyte antigen) antibodies was performed using methods such as the LABScreen PRA Class I and Class II, LABScreen Single Antigen Class I and Class II, Luminex Platform. Reactive individuals to the screening tests (LABScreen PRA) were further investigated to determine the specificity of the antibodies detected (LABScreen Single Antigen) with a cutoff value of median fluorescence intensity ≥500. As a result, it was observed that two patients (33%) were positive in screening tests, one presenting with anti-HLA Class I and II sensitization and the other with anti-HLA class II. The specificity analysis showed that the patients sensitized to HLA class II presented 4 specificities, 3 of which immunologically relevant. In the second individual, 23 specificities were identified, 6 of which immunologically important for HLA class I and 4 specificities for HLA class II, 3 of these were immunologically important. All specificities detected had average fluorescence. These findings are suggestive that sinus-lifting procedures with allogeneic bone can induce immunological sensitization.

  15. Practices to improve identification of Adult Antiretroviral Therapy failure at the Lighthouse Trust clinic in Lilongwe, Malawi

    PubMed Central

    Vorkas, Charles Kyriakos; Tweya, Hannock; Mzinganjira, Dalitso; Dickie, George; Weigel, Ralf; Phiri, Sam; Hosseinipour, Mina C.

    2011-01-01

    Summary Background Evaluating treatment failure is critical when deciding to modify antiretroviral therapy (ART). Virologic Assessment Forms (VAFs) were implemented in July 2008 as a prerequisite for ordering viral load. The form requires assessment of clinical and immunologic status. Methods Using the Electronic Medical Record (EMR), we retrospectively evaluated patients who met 2006 WHO guidelines for immunologic failure (≥15 years old; on ART ≥6 months; CD4 count 50% drop from peak OR CD4 persistently <100 cells) at the Lighthouse Trust clinic from 12/2007–12/2009. We compared virologic screening, VAF implementation and ART modification during the same period using Fisher’s exact tests and unpaired t-tests as appropriate. Results Of 7,000 enrolled ART patients ≥ 15 years old with at least two CD4 counts, 10% had immunologic failure with a median follow-up time on ART of 1.4 years (IQR: 0.8–2.3). Forty (6%) viral loads were ordered: 14 (35%) were detectable (>400 HIV RNA copies/mL) and 1 (7%) patient was switched to second-line therapy. Overall, 259 VAFs were completed: 67% for immunologic failure and 33% for WHO Stage 4 condition. Before VAF implementation, 1% of patients had viral loads drawn during routine care, whereas afterwards, 8% did (p<0.0001; 95% CI 0.03–0.08). Conclusions Clinicians did not identify a large proportion of immunologic failure patients for screening. Implementation of VAFs produced little improvement in virologic screening during routine care. Better training and monitoring systems are needed. PMID:22039960

  16. Trypsin pre-treatment corrects SRID over-estimation of immunologically active, pre-fusion HA caused by mixed immunoprecipitin rings.

    PubMed

    Wen, Yingxia; Palladino, Giuseppe; Xie, Yuhong; Ferrari, Annette; Ma, Xiuwen; Han, Liqun; Dormitzer, Philip R; Settembre, Ethan C

    2016-06-17

    Influenza vaccines are the primary intervention to prevent the substantial health burden of seasonal and pandemic influenza. Subunit and split influenza vaccines are formulated, released for clinical use, and tested for stability based on their content of immunologically active (capable of eliciting functional antibodies) hemagglutinin (HA). Single-radial immunodiffusion (SRID), the standard in vitro potency assay in the field, is believed to specifically detect immunologically active HA. We confirmed that, with conformationally homogeneous HA preparations, SRID specifically detected native, pre-fusion HA, which elicited influenza neutralizing and hemagglutination inhibiting (HI) antibodies in mice, and it did not detect low-pH stressed, post-fusion HA, which was selectively removed from the SRID gel during a blotting step and was significantly less immunologically active. This selective detection was due to the SRID format, not a conformational specificity of the sheep antiserum used in the SRID, as the same antiserum detected non-stressed and low-pH stressed HA similarly when used in an ELISA format. However, when low-pH stressed HA was mixed with non-stressed HA, SRID detected both forms in mixed immunoprecipitin rings, leading to over-quantification of pre-fusion HA. We previously reported that trypsin digestion of antigen samples selectively degrade stressed HA, so that an otherwise conformationally insensitive biophysical quantification technique, reversed-phase high pressure liquid chromatography (RP-HPLC), can specifically quantify trypsin-resistant, immunologically active, pre-fusion HA. Here, we report that trypsin digestion can also improve the specificity of SRID so that it can quantify immunologically active, pre-fusion HA when it is mixed with less immunologically active, post-fusion HA. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Predictors of immunological failure of antiretroviral therapy among HIV infected patients in Ethiopia: a matched case-control study.

    PubMed

    Teshome, Wondu; Asefa, Anteneh; Assefa, Anteneh

    2014-01-01

    In resource constrained settings, immunological assessment through CD4 count is used to assess response to first line Highly Active Antiretroviral Therapy (HAART). In this study, we aim to investigate factors associated with immunological treatment failure. A matched case-control study design was used. Cases were subjects who already experienced immunological treatment failure and controls were those without immunological failure after an exactly or approximately equivalent duration of first line treatment with cases. Data were analyzed using SPSS v16.0. Conditional logistic regression was carried out. A total of 134 cases and 134 controls were included in the study. At baseline, the mean age ± 1 SD of cases was 37.5 ± 9.7 years whereas it was 36.9 ± 9.2 years among controls. The median baseline CD4 counts of cases and controls were 121.0 cells/µl (IQR: 47-183 cells/µl) and 122.0 cells/µl (IQR: 80.0-189.8 cells/µl), respectively. The median rate of CD4 cells increase was comparable for the two groups in the first six months of commencing HAART (P = 0.442). However, the median rate of CD4 increase was significantly different for the two groups in the next 6 months period (M6 to M12). The rate of increment was 8.8 (IQR: 0.5, 14.6) and 1.8 (IQR: 8.8, 11.3) cells/µl/month for controls and cases, respectively (Mann-Whitney U test, P = 0.003). In conditional logistic regressions grouped baseline CD4 count (P = 0.028), old age group and higher educational status (P<0.001) were significant predictors of immunological treatment failure. Subjects with immunological treatment failure have an optimal rate of immunological recovery in the first 6 months of treatment with first line HAART, but relative to the non-failing group the rate declines at a later period, notably between 6 and 12 months. Low baseline CD4 count, old age and higher educational status were associated with immunological treatment failure.

  18. Immunological strain specificity within type 1 poliovirus*

    PubMed Central

    Gard, Sven

    1960-01-01

    The demonstration of immunological differences between poliovirus strains of any one type is a valuable procedure in epidemiological research as it may allow a virus strain to be identified as derived from or unrelated to a given possible source of infection. It is obviously of particular importance in connexion with live poliovirus vaccination campaigns. Both kinetic tests and conventional neutralization and complement-fixation techniques have been used to this end, the former involving a more complicated test procedure and the latter demanding greater nicety in the pre-standardization of reagents. The present paper reports on attempts to establish a simplified technique. Neutralization titres of sera obtained by immunization of guinea-pigs with three strains of type 1 poliovirus (including one isolated from a patient in the 1958-59 epidemic in Léopoldville described in the two preceding papers) indicated a degree of strain specificity sufficient to permit the design of a simple screening method for the purpose of a rough immunological classification. Preliminary observations on isolates from persons fed attenuated virus indicate that antigenic changes may occur in the course of multiplication of the virus in the human intestinal tract. PMID:13826481

  19. Laboratory tests for identification or exclusion of heparin induced thrombocytopenia: HIT or miss?

    PubMed

    Favaloro, Emmanuel J

    2018-02-01

    Heparin induced thrombocytopenia (HIT) is a potentially fatal condition that arises subsequent to formation of antibodies against complexes containing heparin, usually platelet-factor 4-heparin ("anti-PF4-heparin"). Assessment for HIT involves both clinical evaluation and, if indicated, laboratory testing for confirmation or exclusion, typically using an initial immunological assay ("screening"), and only if positive, a secondary functional assay for confirmation. Many different immunological and functional assays have been developed. The most common contemporary immunological assays comprise enzyme-linked immunosorbent assay [ELISA], chemiluminescence, lateral flow, and particle gel techniques. The most common functional assays measure platelet aggregation or platelet activation events (e.g., serotonin release assay; heparin-induced platelet activation (HIPA); flow cytometry). All assays have some sensitivity and specificity to HIT antibodies, but differ in terms of relative sensitivity and specificity for pathological HIT, as well as false negative and false positive error rate. This brief article overviews the different available laboratory methods, as well as providing a suggested approach to diagnosis or exclusion of HIT. © 2017 Wiley Periodicals, Inc.

  20. Immunologic changes in children with egg allergy ingesting extensively heated egg.

    PubMed

    Lemon-Mulé, Heather; Sampson, Hugh A; Sicherer, Scott H; Shreffler, Wayne G; Noone, Sally; Nowak-Wegrzyn, Anna

    2008-11-01

    Prior studies have suggested that heated egg might be tolerated by some children with egg allergy. We sought to confirm tolerance of heated egg in a subset of children with egg allergy, to evaluate clinical and immunologic predictors of heated egg tolerance, to characterize immunologic changes associated with continued ingestion of heated egg, and to determine whether a diet incorporating heated egg is well tolerated. Subjects with documented IgE-mediated egg allergy underwent physician-supervised oral food challenges to extensively heated egg (in the form of a muffin and a waffle), with tolerant subjects also undergoing regular egg challenges (in a form of scrambled egg or French toast). Heated egg-tolerant subjects incorporated heated egg into their diets. Skin prick test wheal diameters and egg white, ovalbumin, and ovomucoid IgE levels, as well as ovalbumin and ovomucoid IgG4 levels, were measured at baseline for all subjects and at 3, 6, and 12 months for those tolerant of heated egg. Sixty-four of 117 subjects tolerated heated egg, 23 tolerated regular egg, and 27 reacted to heated egg. Heated egg-reactive subjects had larger skin test wheals and greater egg white-specific, ovalbumin-specific, and ovomucoid-specific IgE levels compared with heated egg- and egg-tolerant subjects. Continued ingestion of heated egg was associated with decreased skin test wheal diameters and ovalbumin-specific IgE levels and increased ovalbumin-specific and ovomucoid-specific IgG4 levels. The majority of subjects with egg allergy were tolerant of heated egg. Continued ingestion of heated egg was well tolerated and associated with immunologic changes that paralleled the changes observed with the development of clinical tolerance to regular egg.

  1. [Husband to wife kidney transplantation in five multiparous women: sensitization or tolerance after pregnancy?].

    PubMed

    Ortiz-Arroyo, Víctor M; Granados, Julio; Uribe-Uribe, Norma; de Leo, Claudia; Castelán, Natalia; González, Norma; López, Mayra; Alberú, Josefina

    2004-01-01

    Pregnancy is a known cause of immunological sensitization and it has been reported graft survival to be lower in husband to wife kidney transplantation if the wife had been pregnant (mutual children) as compare to those cases without pregnancies. Previous exposure to husband HLA antigens during pregnancies may lead to specific sensitization to subsequent allografts. To communicate the fate of kidney allograft in husband to wife transplantation when the recipient had been pregnant. From 682 renal transplants performed at INCMNSZ 5 corresponded to husband to wife transplants. All the recipients were multiparous and had received multiple blood transfusions. Pretransplantation lymphocytotoxic cross-match testing were performed by complement dependent citotoxicity with antihuman globulin added (AHG-CDC), being negative in all cases for T and B cells. All the patients received triple-drug immunosuppressive therapy, additionally, anti-IL2R monoclonal antibodies were used in two cases. Two patients developed: accelerated acute rejection (case 1), and acute humoral rejection (case 5), respectively. Graft in these patients were loss to rejection and transplant nephrectomy accomplished. The remaining three patients (cases 2, 3, and 4) has not had any rejection episode, and have had excellent graft outcome at 34, 30, and 21 months posttransplant, respectively. Why under similar conditions some husband to wife kidney transplant recipients developed an adverse humoral immunological events while others maintain excellent long-term graft outcome? Is it possible to speculate that for some women pregnancy is in fact a sensitizing event, while in others it promotes "immunological acceptance"? At present there is no a test that characterized one and other group. Even though pretransplantation cross-match testing by flow cytometry is more sensitive than AHG-CDC, its negative result is by no means an absolute guarantee that an adverse anamnestic immunological event will not occur.

  2. Granulocyte-associated IgG in neutropenic disorders

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cines, D.B.; Passero, F.; Guerry, D. IV

    We applied a radiolabeled antiglobulin test to a study of patients with a variety of neutropenic disorders. After defining the nature of the interaction of radiolabeled anti-IgG with the neutrophil, we studied 16 patients with neutropenia of uncertain etiology and adequate bone marrow granulocyte precursors. Twelve of these 16 patients had increased neutrophil-associated IgG (PMN-IgG). Patients with the highest levels of PMN-IgG had the lowest neutrophil counts. The majority of patients with neutropenia and increased PMN-IgG had an underlying immunologic disorder that included immune thrombocytopenic purpura in 5 patients and autoimmune hemolytic anemia in 1 patient. In some patients, elevatedmore » PMN-IgG preceded other evidence for immunologic disease. The direct antiglobulin test helped to distinguish neutropenic patients with increased PMN-IgG both from patients with neutropenia due to a known nonimmune disorder and from noneutropenic patients with rheumatoid arthritis or systemic lupus erythematosis. Each of four patients with increased neutrophil-associated IgG treated with systemic corticosteroids responded clinically with an associated fall in neutrophil IgG and a rise in the circulating neutrophil count. The radiolabeled antiglobulin test appears useful in defining a subpopulation of patients with neutropenia due to an underlying immunologic disorder.« less

  3. Granulocyte-associated IgG in neutropenic disorders

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cines, D.B.; Passero, F.; Guerry, D.

    We applied a radiolabeled antiglobulin test to a study of patients with a variety of neutropenic disorders. After defining the nature of the interaction of radiolabeled anti-IgG with the neutrophil, we studied 16 patients with neutropenia of uncertain etiology and adequate bone marrow granulocyte precursors. Twelve of these 16 patients had increased neutrophil-associated IgG (PMN-IgG). Patients with the highest levels of PMN-IgG had the lowest neutrophil counts. The majority of patients with neutropenia and increased PMN-IgG had an underlying immunologic disorder that included immune thrombocytopenic purpura in 5 patients and autoimmune hemolytic anemia in 1 patient. In some patients, elevatedmore » PMN-IgG preceded other evidence for immunologic disease. The direct antiglobulin test helped to distinguish neutropenic patients with increased PMN-IgG both from patients with neutropenia due to a known nonimmune disorder and from nonneutropenic patients with rheumatoid arthritis or systemic lupus erythematosis. Each of four patients with increased neutrophil-associated IgG treated with systemic corticosteroids responded clinically with an associated fall in neutrophil IgG and a rise in the circulating neutrophil count. The radiolabeled antiglobulin test appears useful in defining a subpopulation of patients with neutropenia due to an underlying immunologic disorder.« less

  4. How safe is the use of chlorpyrifos: Revelations through its effect on layer birds.

    PubMed

    Singh, P P; Kumar, Ashok; Chauhan, R S; Pankaj, P K

    2016-07-01

    The present study was aimed to investigate the immunological competence of chlorpyrifos (CPF) insecticide after oral administration in layer chickens. A total of 20 White Leghorn birds were given CPF in drinking water at 0.3 ppm/bird/day (no observable effect level dose) for a period of 3-month. Immune competence status of layer birds and chicks hatched from CPF-treated birds were estimated at 15 days interval in layer birds and monthly interval in chicks using immunological and biochemical parameters. There was a significant decrease in values of total leukocytes count, absolute lymphocyte count, absolute heterophil count, total serum protein, serum albumin, serum globulin, and serum gamma globulin in the birds treated with CPF as compared to control. Similarly, immune competence tests such as lymphocyte stimulation test, oxidative burst assay, and enzyme-linked immunosorbent assay tests indicated lower immunity in birds treated with CPF as compared to control. Subsequently, chicks produced from CPF-treated birds were also examined for immune competence, but no significant difference was observed between chicks of both the groups. The exposure to CPF produced hemo-biochemical and other changes that could be correlated with changes in the immunological profile of layer chickens suggesting total stoppage of using CPF in poultry sheds.

  5. 21 CFR 866.6050 - Ovarian adnexal mass assessment score test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ovarian adnexal mass assessment score test system... immunological Test Systems § 866.6050 Ovarian adnexal mass assessment score test system. (a) Identification. An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or...

  6. Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force.

    PubMed

    Cox, Linda; Williams, Brock; Sicherer, Scott; Oppenheimer, John; Sher, Larry; Hamilton, Robert; Golden, David

    2008-12-01

    The intended purpose of this monograph is to provide a general overview of allergy diagnostics for health care professionals who care for patients with allergic disease. For a more comprehensive review of allergy diagnostic testing, readers can refer to the Allergy Diagnostic Practice Parameters. A key message is that a positive allergy test result (skin or blood) indicates only the presence of allergen specific IgE (called sensitization). It does not necessarily mean clinical allergy (ie, allergic symptoms with exposure). It is important for this reason that the allergy evaluation be based on the patient's history and directed by a health care professional with sufficient understanding of allergy diagnostic testing to use the information obtained from his/her evaluation of the patient to determine (1) what allergy diagnostic tests to order, (2) how to interpret the allergy diagnostic test results, and (3) how to use the information obtained from the allergy evaluation to develop an appropriate therapeutic treatment plan.

  7. Problem-Solving Test: Submitochondrial Localization of Proteins

    ERIC Educational Resources Information Center

    Szeberenyi, Jozsef

    2011-01-01

    Mitochondria are surrounded by two membranes (outer and inner mitochondrial membrane) that separate two mitochondrial compartments (intermembrane space and matrix). Hundreds of proteins are distributed among these submitochondrial components. A simple biochemical/immunological procedure is described in this test to determine the localization of…

  8. A UK national survey of investigations for beta-lactam hypersensitivity - heterogeneity in practice and a need for national guidelines - on behalf of British Society for Allergy and Clinical Immunology (BSACI).

    PubMed

    Richter, A G; Nasser, S M; Krishna, M T

    2013-08-01

    Beta lactams (BL) are the most widely prescribed antibiotics in the UK and the commonest cause of hypersensitivity reactions. There are no UK guidelines for BL testing and the most relevant guidelines were devised by the European Network for Drug Allergy (ENDA) on behalf of the European Academy of Allergy and Clinical Immunology. Delivery of allergy services differs across Europe, so this survey was designed to investigate how closely UK practice adhered to these guidelines. An online survey, using surveymonkey.com software, was sent to all consultants offering an allergy service in the UK and who were members of either BSACI or 'Travellers' (Immunology consultant group). The response rate was 48% (n=81/165) and BL allergy testing was undertaken by 78% of respondents. All responders requested SsIgE, although four responders stated they rarely requested. Skin testing was undertaken by 87% of respondents who perform beta lactam testing with 17% undertaking skin prick testing (SPT) only, 77% SPT followed by intra-dermal testing (IDT) if the former were negative or indeterminate and 6% SPT and IDT in all cases. The drugs, doses and protocols for skin testing varied considerably. Drug provocation testing was undertaken by 87% of respondents who undertake beta lactam testing with significant heterogeneity in protocols. Respondents that investigated ≤ 20 patients per year demonstrated lower adherence to ENDA recommendations compared to those who saw > 20. Following positive testing, 79% advised avoidance of all penicillins only and the remainder advised additional drug avoidance. This survey revealed variation in the investigation and management of BL hypersensitivity in the UK with some centres reporting procedures that could potentially put patients at risk of anaphylaxis if allergy was falsely excluded. This survey highlights an urgent need for evidence based national guidelines and standardisation of practice. © 2013 John Wiley & Sons Ltd.

  9. [Pseudoallergies].

    PubMed

    Bernardini, R; Novembre, E; Lombardi, E; Monaco, M G; Monte, M T; Pucci, N; Rossi, M E; Vierucci, A

    2001-01-01

    Pseudo-allergic-reactions (PAR) are clinical manifestations including urticaria, angioedema, conjunctivitis, rhinitis, asthma, and anaphylaxis. The prevalence of PAR ranges from 0.1% to 75% according to various studies. The pathogenetic mechanism of these diseases is not immunologically mediated. Food, additives, and drugs are the main responsibilities for PAR. The diagnosis of PAR is characterized by the absence of specific IgE for the suspected products. The absence of immunological mechanisms is confirmed by in vitro and in vivo tests. The treatment of PAR is similar to that of allergic diseases (antihistamine drugs, steroids, B2 agonists, epinephrine).

  10. Practical Management of Antibiotic Hypersensitivity in 2017.

    PubMed

    Macy, Eric; Romano, Antonino; Khan, David

    Antibiotics are the most common class of medications that individuals report allergy or intolerance to. Adverse reactions are reported at a predictable rate with all antibiotic use that vary by antibiotic. Antibiotic allergy incidence rates are sex dependent, higher in females than in males. Most of these events are not reproducible or immunologically mediated. Antibiotic allergy prevalence increases with increasing age and is more common in hospitalized populations and in populations that use more antibiotics. Determining potential mechanisms for the observed symptoms of the adverse reactions is the starting point for effective management of antibiotic hypersensitivity. Skin testing and direct challenges are the primary tools used to determine acute tolerance in 2017. Commercially available in vitro testing is not currently clinically useful in determining antibiotic hypersensitivity, with rare exceptions. Desensitization can be used when acute-onset immunologically mediated hypersensitivity is confirmed to safely administer a needed antibiotic. Desensitization is not possible when clinically significant T-cell-mediated delayed-type hypersensitivity is present. Effective management of antibiotic allergy is an important part of a comprehensive antibiotic stewardship program. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  11. [Isolation and immunology identification of spermagglutinating antibodies from human serum].

    PubMed

    Cibulka, J; Ulcova-Gallová, Z; Balvín, M; Bibková, K; Micanová, Z

    2009-06-01

    Isolation of spermagglutinating antibodies and their assesment. Retrospective study. Special consulting for reptoduction immunology, Department of Obstetrics and Gynecology, Charles University and Faculty Hospital, Plzen. Fractionation of serum samples by liquid exclusion chromatography, examination of full sera and their chromatographic fractions by Friberg teste (Tray Agglutination Test--TAT), indirect antiimmunoglobulin reaction test (i-MAR test) and by supplementar radial immunodiffusiona (RID). Isolation of spermagglutinating fractions of antisperm antibodies positive sera preserved spermagglutinating aktivity and confirmed great spermagglutinating potential of IgM. According to assesment of the presence of IgG and IgG we reported possible states of immunisation: actual immunisation with IgM activity, perpetual stimulation (IgG and IgM) and, finaly, anamnestic titres in IgG. These findings can help us to choose an optimal way of treatment. Excluding gel chromatography is suitable method for serum proteins fractionation, but not their identification--presence of antisperm antibodies does not affect the chromatographic spectrum, nor the RID patterns.

  12. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  13. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  14. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  15. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  16. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  17. A baseline metabolomic signature is associated with immunological CD4+ T-cell recovery after 36 months of antiretroviral therapy in HIV-infected patients.

    PubMed

    Rodríguez-Gallego, Esther; Gómez, Josep; Pacheco, Yolanda M; Peraire, Joaquim; Viladés, Consuelo; Beltrán-Debón, Raúl; Mallol, Roger; López-Dupla, Miguel; Veloso, Sergi; Alba, Verónica; Blanco, Julià; Cañellas, Nicolau; Rull, Anna; Leal, Manuel; Correig, Xavier; Domingo, Pere; Vidal, Francesc

    2018-03-13

    Poor immunological recovery in treated HIV-infected patients is associated with greater morbidity and mortality. To date, predictive biomarkers of this incomplete immune reconstitution have not been established. We aimed to identify a baseline metabolomic signature associated with a poor immunological recovery after antiretroviral therapy (ART) to envisage the underlying mechanistic pathways that influence the treatment response. This was a multicentre, prospective cohort study in ART-naive and a pre-ART low nadir (<200 cells/μl) HIV-infected patients (n = 64). We obtained clinical data and metabolomic profiles for each individual, in which low molecular weight metabolites, lipids and lipoproteins (including particle concentrations and sizes) were measured by NMR spectroscopy. Immunological recovery was defined as reaching CD4 T-cell count at least 250 cells/μl after 36 months of virologically successful ART. We used univariate comparisons, Random Forest test and receiver-operating characteristic curves to identify and evaluate the predictive factors of immunological recovery after treatment. HIV-infected patients with a baseline metabolic pattern characterized by high levels of large high density lipoprotein (HDL) particles, HDL cholesterol and larger sizes of low density lipoprotein particles had a better immunological recovery after treatment. Conversely, patients with high ratios of non-HDL lipoprotein particles did not experience this full recovery. Medium very-low-density lipoprotein particles and glucose increased the classification power of the multivariate model despite not showing any significant differences between the two groups. In HIV-infected patients, a baseline healthier metabolomic profile is related to a better response to ART where the lipoprotein profile, mainly large HDL particles, may play a key role.

  18. An Investigation of Immunological Tolerance Based on Chimaera Analysis

    PubMed Central

    Michie, Donald; Woodruff, M. F. A.; Zeiss, Irmgard M.

    1961-01-01

    Newborn mice of strain A were injected intravenously at birth with 9–15 million spleen cells from adult CBA donors. The recipients exhibited splenomegaly and other signs of graft-versus-host reaction during the first 3 weeks of life. Adult survivors were uniformly tolerant of CBA skin. They showed no sign of a continuing graft-versus-host reaction. The spleens of the treated mice were tested for the presence of immunologically competent donor and host cells by Simonsen's discriminant spleen assay. From the age of 7 days onwards the spleens were found to contain a small percentage of donor cells which were immunologically active against antigens of a third strain. In spleens from adult survivors activity, attributable to the host component, against third-party antigens was undiminished as compared with that of untreated A-strain mice. But activity against the CBA donor strain was absent. PMID:14473459

  19. Cellular Profile and Expression of Immunologic Markers in Chronic Apical Periodontitis from HIV-infected Patients Undergoing Highly Active Antiretroviral Therapy.

    PubMed

    Gama, Túlio Gustavo Veiga; Pires, Fabio Ramoa; Armada, Luciana; Gonçalves, Lucio Souza

    2016-06-01

    This study tested the hypothesis that the inflammatory cell profile (CD3-, CD4-, CD8-, CD20-, and CD68-positive cells) and the expression of immunologic markers (tumor necrosis factor α, interferon-γ, interleukin-6, and interleukin-18) in chronic apical periodontitis are the same between non-HIV-infected patients and HIV-infected patients undergoing highly active antiretroviral therapy (HAART). Thirty-four surgically excised chronic apical periodontitis lesions were sampled from 34 patients (17 HIV-infected and 17 non-HIV-infected). The lesions were extracted from teeth with no previous endodontic treatment. All HIV-infected patients were undergoing HAART. The specimens were submitted to histopathologic and immunohistochemical analyses by using an optical microscope. Immunoexpression was graded into 2 levels, focal to weak and moderate to strong. The χ(2), Fisher exact, and Mann-Whitney tests were used to analyze all significant differences between groups. Periapical cysts represented 70.6% and 52.9% of the lesions in the HIV-infected and non-HIV-infected groups, respectively; however, no statistically significant difference was observed (P = .481). There were no statistically significant differences between groups for the inflammatory cell profile and for any of the immunologic markers (P > .05). There are no statistically significant differences of the cellular profile and expression of immunologic markers in chronic apical periodontitis between non-HIV-infected patients and HIV-infected patients undergoing HAART. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  20. 21 CFR 866.5100 - Antinuclear antibody immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). (b) Classification...

  1. 21 CFR 866.5100 - Antinuclear antibody immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). (b) Classification...

  2. 21 CFR 866.5340 - Ferritin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. (b... that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron...

  3. 21 CFR 866.5340 - Ferritin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. (b... that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron...

  4. 21 CFR 866.5340 - Ferritin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. (b... that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron...

  5. 21 CFR 866.5340 - Ferritin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. (b... that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron...

  6. [Pulmonary involvement in systemic sclerosis. Alveolitis, fibrosis and pulmonar arterial hypertension].

    PubMed

    Navarro, Carmen

    2006-11-01

    Pulmonary involvement in systemic sclerosis. Alveolitis, fibrosis and pulmonar arterial hypertension Lung disease is present in most of the patients with systemic sclerosis and is now the most important cause of mortality. Interstitial lung disease and pulmonary hypertension are, so far, the main disorders found and both are difficult to detect at the earliest stages. However, diagnostic tools such as immunological test, lung function test, high resolution CT, bronchoalveolar lavage, echocardiography, right-side cardiac catheterization, or lung biopsy are necessary to accurately evaluate the clinical status and allow to improve the management organ-specific ad hoc. Progress in immunological and vascular therapies as well as other emergence drugs offer new expectations to scleroderma patients. Copyright © 2006 Elsevier España S.L. Barcelona. Published by Elsevier Espana. All rights reserved.

  7. German guideline for the management of adverse reactions to ingested histamine: Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the German Society for Pediatric Allergology and Environmental Medicine (GPA), the German Association of Allergologists (AeDA), and the Swiss Society for Allergology and Immunology (SGAI).

    PubMed

    Reese, Imke; Ballmer-Weber, Barbara; Beyer, Kirsten; Fuchs, Thomas; Kleine-Tebbe, Jörg; Klimek, Ludger; Lepp, Ute; Niggemann, Bodo; Saloga, Joachim; Schäfer, Christiane; Werfel, Thomas; Zuberbier, Torsten; Worm, Margitta

    2017-01-01

    Adverse food reactions are far more often perceived than objectively verified. In our scientific knowledge on non-allergic adverse reactions including the so called histamine intolerance, there are large deficits. Due to the fact that this disorder is increasingly discussed in the media and the internet, more and more people suspect it to be the trigger of their symptoms. The scientific evidence to support the postulated link between ingestion of histamine and adverse reactions is limited, and a reliable laboratory test for objective diagnosis is lacking. This position paper by the "Food Allergy" Working Group of the German Society for Allergology and Clinical Immunology (DGAKI) in collaboration with the German Association of Allergologists (AeDA), the Society for Pediatric Allergology and Environmental Medicine (GPA), and the Swiss Society for Allergology and Immunology (SGAI) reviews the data on the clinical picture of adverse reactions to ingested histamine, summarizes important aspects and their consequences, and proposes a practical diagnostic and therapeutic approach.

  8. 21 CFR 866.1640 - Antimicrobial susceptibility test powder.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Antimicrobial susceptibility test powder. 866.1640 Section 866.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1640 Antimicrobial...

  9. 21 CFR 866.1620 - Antimicrobial susceptibility test disc.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antimicrobial susceptibility test disc. 866.1620 Section 866.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1620 Antimicrobial...

  10. 21 CFR 866.3290 - Gonococcal antibody test (GAT).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Gonococcal antibody test (GAT). 866.3290 Section 866.3290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3290 Gonococcal...

  11. 21 CFR 866.1620 - Antimicrobial susceptibility test disc.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antimicrobial susceptibility test disc. 866.1620 Section 866.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1620 Antimicrobial...

  12. 21 CFR 866.1620 - Antimicrobial susceptibility test disc.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Antimicrobial susceptibility test disc. 866.1620 Section 866.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1620 Antimicrobial...

  13. 21 CFR 866.1620 - Antimicrobial susceptibility test disc.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Antimicrobial susceptibility test disc. 866.1620 Section 866.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1620 Antimicrobial...

  14. 21 CFR 866.1620 - Antimicrobial susceptibility test disc.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Antimicrobial susceptibility test disc. 866.1620 Section 866.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1620 Antimicrobial...

  15. 21 CFR 866.1640 - Antimicrobial susceptibility test powder.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Antimicrobial susceptibility test powder. 866.1640 Section 866.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1640 Antimicrobial...

  16. 21 CFR 866.3290 - Gonococcal antibody test (GAT).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Gonococcal antibody test (GAT). 866.3290 Section 866.3290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3290 Gonococcal...

  17. 21 CFR 866.1640 - Antimicrobial susceptibility test powder.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antimicrobial susceptibility test powder. 866.1640 Section 866.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1640 Antimicrobial...

  18. 21 CFR 866.1640 - Antimicrobial susceptibility test powder.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Antimicrobial susceptibility test powder. 866.1640 Section 866.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1640 Antimicrobial...

  19. 21 CFR 866.3290 - Gonococcal antibody test (GAT).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Gonococcal antibody test (GAT). 866.3290 Section 866.3290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3290 Gonococcal...

  20. 21 CFR 866.3290 - Gonococcal antibody test (GAT).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Gonococcal antibody test (GAT). 866.3290 Section 866.3290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3290 Gonococcal...

  1. 21 CFR 866.1640 - Antimicrobial susceptibility test powder.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Antimicrobial susceptibility test powder. 866.1640 Section 866.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1640 Antimicrobial...

  2. 21 CFR 866.3290 - Gonococcal antibody test (GAT).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gonococcal antibody test (GAT). 866.3290 Section 866.3290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3290 Gonococcal...

  3. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  4. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  5. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  6. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  7. Recommendations for Competency in Allergy Training for Undergraduates Qualifying as Medical Practitioners: A Position Paper of the World Allergy Organization

    PubMed Central

    2009-01-01

    The Council acknowledges specific comments from: The American Academy of Allergy, Asthma and Immunology (AAAAI) (Amal H Assa'ad); The American College of Allergy, Asthma and Immunology (ACAAI) (Mark Dykewicz, D. Betty Lew, Bryan L. Martin); The Argentine Association of Allergy and Immunology (Ledit RF Ardusso); The Argentine Society of Allergy and Immunopathology (Estrella Asayag); The Australasian Society of Clinical Immunology and Allergy (ASCIA) (Jill Smith); The British Society for Allergy and Clinical Immunology (Stephen Durham); The Brazilian Society of Allergy and Immunopathology (Nelson Rosario); The Bulgarian Society of Allergology (Vasil Dimitrov); The Canadian Society of Allergy and Clinical Immunology (CSACI) (Richard Warrington); The Chilean Society of Allergy and Immunology (Jessica Salinas); The Chinese Society of Allergology (Zhang Hongyu, Yin Jia); The Czech Society of Allergology and Clinical Immunology (Jiri Litzman); The Danish Society of Allergology (Lone Winther, Peter Plaschke); The Egyptian Society of Allergy and Clinical Immunology (Kamal Maurice Hanna); The Egyptian Society of Pediatric Allergy and Immunology (Yehia El-Gamal); The German Society for Allergy and Clinical Immunology (Thilo Jakob, Claus Bachert, Bernhard Przybilla); The Hungarian Society of Allergology and Clinical Immunology (Kristof Nekam); The Icelandic Society of Allergy and Clinical Immunology (Björn R. Lúðvíksson); The Italian Association of Territorial and Hospital Allergists (Riccardo Asero); The Italian Society of Allergy and Clinical Immunology (Luigi Fontana); The Japanese Society of Allergology (Sankei Nishima); The Korean Academy of Asthma Allergy and Clinical Immunology (Joon Sung Lee, Hae-Sim Park); The Latvian Association of Allergists (Ieva Cirule); The Lebanese Society of Allergy & Immunology (Fares Zaitoun); The Mongolian Society of Allergology (S. Munkhbayarlakh); The Allergy and Clinical Immunology Society (Singapore) (Chng Hiok Hee); The Allergy Society of South Africa (Sharon Kling); The Spanish Society of Allergy and Clinical Immunology (Tomás Chivato); The Swiss Society for Allergology and Immunology (SSAI-SGAI) (Beat A. Imhof, Andreas Bircher); The Allergy and Immunology Society of Thailand (Pakit Vichyanond); The Turkish National Society of Allergy and Clinical Immunology (Omer Kalayci); and The Venezuelan Society of Allergy, Asthma and Immunology (Luis F Sarmiento). PMID:23283109

  8. The PHA Test Reflects Acquired T-Cell Mediated Immunocompetence in Birds

    PubMed Central

    Tella, José L.; Lemus, Jesús A.; Carrete, Martina; Blanco, Guillermo

    2008-01-01

    Background cological immunology requires techniques to reliably measure immunocompetence in wild vertebrates. The PHA-skin test, involving subcutaneous injection of a mitogen (phytohemagglutinin, PHA) and measurement of subsequent swelling as a surrogate of T-cell mediated immunocompetence, has been the test of choice due to its practicality and ease of use in the field. However, mechanisms involved in local immunological and inflammatory processes provoked by PHA are poorly known, and its use and interpretation as an acquired immune response is currently debated. Methodology Here, we present experimental work using a variety of parrot species, to ascertain whether PHA exposure produces larger secondary than primary responses as expected if the test reflects acquired immunocompetence. Moreover, we simultaneously quantified T-lymphocyte subsets (CD4+, CD5+ and CD8+) and plasma proteins circulating in the bloodstream, potentially involved in the immunological and inflammatory processes, through flow cytometry and electrophoresis. Principal Findings Our results showed stronger responses after a second PHA injection, independent of species, time elapsed and changes in body mass of birds between first and second injections, thus supporting the adaptive nature of this immune response. Furthermore, the concomitant changes in the plasma concentrations of T-lymphocyte subsets and globulins indicate a causal link between the activation of the T-cell mediated immune system and local tissue swelling. Conclusions/Significance These findings justify the widespread use of the PHA-skin test as a reliable evaluator of acquired T-cell mediated immunocompetence in diverse biological disciplines. Further experimental research should be aimed at evaluating the relative role of innate immunocompetence in wild conditions, where the access to dietary proteins varies more than in captivity, and to ascertain how PHA responses relate to particular host-parasite interactions. PMID:18820730

  9. Comparison of techniques of detecting immunoglobulin-binding protein reactivity to immunoglobulin produced by different avian and mammalian species.

    PubMed

    Justiz-Vaillant, A A; Akpaka, P E; McFarlane-Anderson, N; Smikle, M F

    2013-01-01

    The rationale of this study was to use several immunological assays to investigate the reactivity of immunoglobulin binding protein (IBP) to immunoglobulins from various avian and mammalian species. The IBP studied were Staphylococcal protein A (SpA), Streptococcal protein G (SpG), Peptostreptococcal protein L (SpL) and recombinant protein LA (SpLA). The various immunological techniques used were double immunodiffusion (Ouchterlony technique) that tested positive high protein reactivities, direct and competitive enzyme-linked immunosorbent assays (ELISAs) that tested moderate and low positive protein binding capacities, respectively. In addition to sandwich ELISAs, immunoblot analyses and Ig-purification by SpA-affinity chromatography, which were sensitive tests and helpful in the screening and confirmatory tests were also used. The Ouchterlony technique showed that compared to the other proteins, SpLA had the highest range of reactivity with animal sera and purified immunoglobulins while SpL was least reactive. With the direct ELISA, SpL reacted with the raccoon sera, rabbit IgG and with IgY from bantam hens and pigeons. While with the direct ELISA, SpA reacted with sera from skunk, coyote, raccoon, mule, donkey and human. The sandwich ELISA revealed high reactivity of both SpG and SpLA with mammalian sera titres ranging from 1:32 (raccoon serum) to 1:1024 (mule and donkey sera). These results suggest that IBP can be used for the detection of immunoglobulin using various immunological assays and this is important for the diagnosis of infectious diseases in animal and bird populations studied and in the purification of immunoglobulins.

  10. 21 CFR 866.1700 - Culture medium for antimicrobial susceptibility tests.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Culture medium for antimicrobial susceptibility tests. 866.1700 Section 866.1700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866...

  11. 21 CFR 866.3390 - Neisseria spp. direct serological test reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Neisseria spp. direct serological test reagents. 866.3390 Section 866.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3390...

  12. 21 CFR 866.3830 - Treponema pallidum tre-ponemal test reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Treponema pallidum tre-ponemal test reagents. 866.3830 Section 866.3830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3830...

  13. 21 CFR 866.1700 - Culture medium for antimicrobial susceptibility tests.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Culture medium for antimicrobial susceptibility tests. 866.1700 Section 866.1700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866...

  14. 21 CFR 866.3390 - Neisseria spp. direct serological test reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Neisseria spp. direct serological test reagents. 866.3390 Section 866.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3390...

  15. 21 CFR 866.1700 - Culture medium for antimicrobial susceptibility tests.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Culture medium for antimicrobial susceptibility tests. 866.1700 Section 866.1700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866...

  16. 21 CFR 866.3830 - Treponema pallidum tre-ponemal test reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Treponema pallidum tre-ponemal test reagents. 866.3830 Section 866.3830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3830...

  17. 21 CFR 866.3820 - Treponema pallidum non-treponemal test reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Treponema pallidum non-treponemal test reagents. 866.3820 Section 866.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3820...

  18. 21 CFR 866.3820 - Treponema pallidum non-treponemal test reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Treponema pallidum non-treponemal test reagents. 866.3820 Section 866.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3820...

  19. 21 CFR 866.1700 - Culture medium for antimicrobial susceptibility tests.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Culture medium for antimicrobial susceptibility tests. 866.1700 Section 866.1700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866...

  20. 21 CFR 866.3830 - Treponema pallidum tre-ponemal test reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Treponema pallidum tre-ponemal test reagents. 866.3830 Section 866.3830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3830...

  1. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Oxidase screening test for gonorrhea. 866.2420 Section 866.2420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2420 Oxidase...

  2. 21 CFR 866.3390 - Neisseria spp. direct serological test reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Neisseria spp. direct serological test reagents. 866.3390 Section 866.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3390...

  3. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oxidase screening test for gonorrhea. 866.2420 Section 866.2420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2420 Oxidase...

  4. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxidase screening test for gonorrhea. 866.2420 Section 866.2420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2420 Oxidase...

  5. 21 CFR 866.3390 - Neisseria spp. direct serological test reagents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Neisseria spp. direct serological test reagents. 866.3390 Section 866.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3390...

  6. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Oxidase screening test for gonorrhea. 866.2420 Section 866.2420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2420 Oxidase...

  7. 21 CFR 866.3820 - Treponema pallidum non-treponemal test reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Treponema pallidum non-treponemal test reagents. 866.3820 Section 866.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3820...

  8. 21 CFR 866.3820 - Treponema pallidum non-treponemal test reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Treponema pallidum non-treponemal test reagents. 866.3820 Section 866.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3820...

  9. 21 CFR 866.3830 - Treponema pallidum tre-ponemal test reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Treponema pallidum tre-ponemal test reagents. 866.3830 Section 866.3830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3830...

  10. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oxidase screening test for gonorrhea. 866.2420 Section 866.2420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2420 Oxidase...

  11. 21 CFR 866.3820 - Treponema pallidum non-treponemal test reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Treponema pallidum non-treponemal test reagents. 866.3820 Section 866.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3820...

  12. 21 CFR 866.3390 - Neisseria spp. direct serological test reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Neisseria spp. direct serological test reagents. 866.3390 Section 866.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3390...

  13. 21 CFR 866.1700 - Culture medium for antimicrobial susceptibility tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Culture medium for antimicrobial susceptibility tests. 866.1700 Section 866.1700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866...

  14. 21 CFR 866.3830 - Treponema pallidum tre-ponemal test reagents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Treponema pallidum tre-ponemal test reagents. 866.3830 Section 866.3830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3830...

  15. 21 CFR 866.5080 - Alpha-1-antichymotrypsin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection...

  16. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo... span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt...

  17. 21 CFR 866.5100 - Antinuclear antibody immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). (b) Classification...

  18. 21 CFR 866.5100 - Antinuclear antibody immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). (b) Classification...

  19. Long-term antibody response and immunologic memory in children immunized with hepatitis B vaccine at birth.

    PubMed

    Saffar, M J; Rezai, M S

    2004-12-01

    Four hundred and fifty three healthy children immunized with a course of hepatitis B vaccine beginning at birth were tested at 10-11 years of age for persistence of anti-hepatitis B-S antigen antibody (anti-HBs); and responses of children without protective antibody to different doses of hepatitis B vaccine booster were evaluated. Although nearly 42% of them were not seroprotected, but most of boosted subjects (87.3%) retained robust immunologic memory and rapidly retained a protective anti-HBs antibody titer of at least 10 IU/L after booster vaccination.

  20. Immunologic and clinical responses to "Monday morning miseries" antigens.

    PubMed

    Cernelc, S; Stropnik, Z

    1987-01-01

    Authors analysed 96 workers exposed to air conditioning system (Group A), and 71 workers (Group B) breathing normal ambient air. 38 workers in group A had a positive clinical history of "Monday morning miseries". Eight cases with the diagnosis hypersensitivity pneumonitis, acute and chronic form was based on environmental history, clinical investigations, physical examination, Chest-X-ray examination, immunological test "in vivo" and "in vitro" with common allergens and antigen "Monday morning miseries", ELISA, spirometry and PEFR (Peak Expiratory Flow-Rate) measurements. Exposure to contaminated air may be responsible for morbidity and reduced performance of workers.

  1. 21 CFR 866.5520 - Immunoglobulin G (Fab fragment specific) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues). (b...

  2. 21 CFR 866.5520 - Immunoglobulin G (Fab fragment specific) immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues). (b...

  3. 21 CFR 866.5520 - Immunoglobulin G (Fab fragment specific) immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues). (b...

  4. 21 CFR 866.5520 - Immunoglobulin G (Fab fragment specific) immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues). (b...

  5. 21 CFR 866.5820 - Systemic lupus erythema-tosus immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the...

  6. 21 CFR 866.5820 - Systemic lupus erythema-tosus immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the...

  7. 21 CFR 866.5820 - Systemic lupus erythema-tosus immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the...

  8. 21 CFR 866.5820 - Systemic lupus erythema-tosus immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the...

  9. 21 CFR 866.5320 - Properdin factor B immuno-logical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermititis...

  10. 21 CFR 866.5570 - Lactoferrin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron... fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of...

  11. 21 CFR 866.5570 - Lactoferrin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron... fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of...

  12. 21 CFR 866.5570 - Lactoferrin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron... fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of...

  13. 21 CFR 866.5570 - Lactoferrin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron... fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of...

  14. 21 CFR 866.5180 - Fecal calprotectin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel...

  15. 21 CFR 866.5180 - Fecal calprotectin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel...

  16. 21 CFR 866.5180 - Fecal calprotectin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel...

  17. 21 CFR 866.5320 - Properdin factor B immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem...

  18. 21 CFR 866.5425 - Alpha-2-glycoproteins immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to... some cancers and genetically inherited deficiencies of these plasma proteins. (b) Classification. Class...

  19. 21 CFR 866.5425 - Alpha-2-glycoproteins immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to... some cancers and genetically inherited deficiencies of these plasma proteins. (b) Classification. Class...

  20. 21 CFR 866.5425 - Alpha-2-glycoproteins immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to... some cancers and genetically inherited deficiencies of these plasma proteins. (b) Classification. Class...

  1. 21 CFR 866.5425 - Alpha-2-glycoproteins immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to... some cancers and genetically inherited deficiencies of these plasma proteins. (b) Classification. Class...

  2. 21 CFR 866.5425 - Alpha-2-glycoproteins immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to... some cancers and genetically inherited deficiencies of these plasma proteins. (b) Classification. Class...

  3. Anxiolytic Effect of Aromatherapy Massage in Patients with Breast Cancer

    PubMed Central

    Kuriyama, Hiroko; Shigemori, Ichiro; Watanabe, Satoko; Aihara, Yuka; Kita, Masakazu; Sawai, Kiyoshi; Nakajima, Hiroo; Yoshida, Noriko; Kunisawa, Masahiro; Kawase, Masanori; Fukui, Kenji

    2009-01-01

    We examined how aromatherapy massage influenced psychologic and immunologic parameters in 12 breast cancer patients in an open semi-comparative trial. We compared the results 1 month before aromatherapy massage as a waiting control period with those during aromatherapy massage treatment and 1 month after the completion of aromatherapy sessions. The patients received a 30 min aromatherapy massage twice a week for 4 weeks (eight times in total). The results showed that anxiety was reduced in one 30 min aromatherapy massage in State-Trait Anxiety Inventory (STAI) test and also reduced in eight sequential aromatherapy massage sessions in the Hospital Anxiety and Depression Scale (HADS) test. Our results further suggested that aromatherapy massage ameliorated the immunologic state. Further investigations are required to confirm the anxiolytic effect of aromatherapy in breast cancer patients. PMID:18955225

  4. Immunologic and tissue biocompatibility of flexible/stretchable electronics and optoelectronics.

    PubMed

    Park, Gayoung; Chung, Hyun-Joong; Kim, Kwanghee; Lim, Seon Ah; Kim, Jiyoung; Kim, Yun-Soung; Liu, Yuhao; Yeo, Woon-Hong; Kim, Rak-Hwan; Kim, Stanley S; Kim, Jong-Seon; Jung, Yei Hwan; Kim, Tae-Il; Yee, Cassian; Rogers, John A; Lee, Kyung-Mi

    2014-04-01

    Recent development of flexible/stretchable integrated electronic sensors and stimulation systems has the potential to establish an important paradigm for implantable electronic devices, where shapes and mechanical properties are matched to those of biological tissues and organs. Demonstrations of tissue and immune biocompatibility are fundamental requirements for application of such kinds of electronics for long-term use in the body. Here, a comprehensive set of experiments studies biocompatibility on four representative flexible/stretchable device platforms, selected on the basis of their versatility and relevance in clinical usage. The devices include flexible silicon field effect transistors (FETs) on polyimide and stretchable silicon FETs, InGaN light-emitting diodes (LEDs), and AlInGaPAs LEDs, each on low modulus silicone substrates. Direct cytotoxicity measured by exposure of a surrogate fibroblast line and leachable toxicity by minimum essential medium extraction testing reveal that all of these devices are non-cytotoxic. In vivo immunologic and tissue biocompatibility testing in mice indicate no local inflammation or systemic immunologic responses after four weeks of subcutaneous implantation. The results show that these new classes of flexible implantable devices are suitable for introduction into clinical studies as long-term implantable electronics. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  5. Virological and immunological response to antiretroviral regimens containing maraviroc in HIV type 1-infected patients in clinical practice: role of different tropism testing results and of concomitant treatments.

    PubMed

    Rossetti, Barbara; Bianco, Claudia; Bellazzi, Lara Ines; Bruzzone, Bianca; Colao, Grazia; Corsi, Paola; Monno, Laura; Pagano, Gabriella; Paolucci, Stefania; Punzi, Grazia; Setti, Maurizio; Zazzi, Maurizio; De Luca, Andrea

    2014-01-01

    We assessed the immunovirological response to antiretroviral regimens containing maraviroc in HIV-infected viremic patients with viral tropism predicted by different assays. We selected antiretroviral treatment-experienced HIV-1-infected patients initiating regimens containing maraviroc after different phenotypic or genotypic viral tropism assays, with at least one HIV-1 RNA determination during follow-up. Survival analysis was employed to assess the virological response as time to HIV-1 RNA <50 copies/ml and immunological response as time to a CD4 cell count increase of ≥ 100/μl from baseline. Predictors of these outcomes were analyzed by multivariate Cox regression models. In 191 treatments with maraviroc, virological response was achieved in 65.4% and the response was modestly influenced by the baseline viral load and concomitant drug activity but not influenced by the type of tropism assay employed. Immunological response was achieved in 58.1%; independent predictors were baseline HIV-1 RNA (per log10 higher: HR 1.29, 95% CI 1.05-1.60) and concomitant therapy with enfuvirtide (HR 2.05, 0.96-4.39) but not tropism assay results. Of 17 patients with baseline R5-tropic virus and available tropism results while viremic during follow-up on maraviroc, seven (41%) showed a tropism switch to non-R5 virus. A significant proportion of experienced patients treated with regimens containing maraviroc achieved virological response. The tropism test type used was not associated with immunovirological response and concomitant treatment with enfuvirtide increased the chance of immunological response. More than half of virological failures with maraviroc were not accompanied by tropism switch.

  6. Increased levels of immunological markers in the respiratory tract but not in serum correlate with active pulmonary mycobacterial infection in mice.

    PubMed

    Arko-Mensah, J; Rahman, M J; Julián, E; Horner, G; Singh, M; Fernández, C

    2009-08-01

    Immunological tests for the diagnosis of tuberculosis (TB) have relied mostly on detection of immune markers in serum or release of cytokines by mononuclear cells in vitro. These tests, although useful, sometimes fail to discriminate between active infection and contact with mycobacteria or vaccination. TB is primarily a disease of the lung, and therefore identification of immunological markers in the respiratory tract will be more likely to reflect the infection status or disease activity. In this study, it is demonstrated that active infection of mice with Mycobacterium bovis bacille Calmette-Guérin (BCG), but not exposure to heat-killed BCG, induced production of interleukin-12 (IL-12), interferon-gamma (IFN-gamma) or soluble tumour necrosis factor receptors (sTNFRs) locally in the lungs, as detected in bronchoalveolar lavage (BAL) fluid. There was a strong correlation between bacterial growth in the lung and levels of sTNFRs, and to some extent IL-12 and IFN-gamma, in BAL fluid. Furthermore, sTNFR levels increased significantly in BAL fluid after reactivation of controlled infection with dexamethasone, and this correlated with increased bacterial growth in the lungs. Finally, infection, but not exposure to non-replicating mycobacteria, induced specific IgG and IgA in BAL fluid. Elevated levels of all biomarkers measured were also detected in the serum, but correlation with infection was not as clear as in the case of BAL fluid. Taken together, the detection of sTNFRs and mycobacterium-specific antibodies, especially IgA, locally in the lungs could be used as immunological markers for the diagnosis of TB.

  7. Immunology for rheumatology residents: working toward a Canadian national curriculum consensus.

    PubMed

    Chow, Shirley L; Herman-Kideckel, Sari; Mahendira, Dharini; McDonald-Blumer, Heather

    2015-01-01

    Immunologic mechanisms play an integral role in understanding the pathogenesis and management of rheumatic conditions. Currently, there is limited access to formal instruction in immunology for rheumatology trainees across Canada. The aims of this study were (1) to describe current immunology curricula among adult rheumatology training programs across Canada and (2) to compare the perceived learning needs of rheumatology trainees from the perspective of program directors and trainees to help develop a focused nationwide immunology curriculum. Rheumatology trainees and program directors from adult rheumatology programs across Canada completed an online questionnaire and were asked to rank a comprehensive list of immunology topics. A modified Delphi approach was implemented to obtain consensus on immunology topics. Only 42% of program directors and 31% of trainees felt the current method of teaching immunology was effective. Results illustrate concordance between program directors and trainees for the highest-ranked immunology topics including innate immunity, adaptive immunity, and cells and tissues of the immune system. However, there was discordance among other topics, such as diagnostic laboratory immunology and therapeutics. There is a need to improve immunology teaching in rheumatology training programs. Results show high concordance between the basic immunology topics. This study provides the groundwork for development of future immunology curricula.

  8. Endosafe(R)-Portable Test System (PTS)

    NASA Technical Reports Server (NTRS)

    Maule, Jake; Wainwright, Norm; Burbank, Dan

    2005-01-01

    The Portable Test System (PTS) is a hand-held device for monitoring the presence of potentially hazardous bacteria in the environment. It uses an immunological method derived from the horseshoe crab (Limulus polyphemus) to detect bacterial cell membranes and other molecular components of a cell. Further modifications of the PTS will allow detection of individual hazardous species of bacteria. This study was a follow-up of previous PTS and other immunological tests performed on the KC-135 during 2002-2003 (Maule et al., 2003, J. Gravit. Physiol.) and in the underwater habitat Aquarius during NEEMO 5 (Maule et al., 2005, Appl. Environ. Microbiol in prep.). The experiments described here were part of a final testing phase prior to use of the PTS on the International Space Station (ISS), scheduled for launch on 12A.1 on February 9th 2006. The specific aspects of PTS operation studied were those involving a fluid component: pumping, mixing, incubations and pipetting into the instrument. The PTS uses a stepper motor to move fluid along small channels, which may be affected by reduced gravity.

  9. Diagnostic accuracy of HLA-B*57:01 screening for the prediction of abacavir hypersensitivity and clinical utility of the test: a meta-analytic review.

    PubMed

    Cargnin, Sarah; Jommi, Claudio; Canonico, Pier Luigi; Genazzani, Armando A; Terrazzino, Salvatore

    2014-05-01

    To determine diagnostic accuracy of HLA-B*57:01 testing for prediction of abacavir-induced hypersensitivity and to quantify the clinical benefit of pretreatment screening through a meta-analytic review of published studies. A comprehensive search was performed up to June 2013. The methodological quality of relevant studies was assessed by the QUADAS-2 tool. The pooled diagnostic estimates were calculated using a random effect model. Despite the presence of heterogeneity in sensitivity or specificity estimates, the pooled diagnostic odds ratio to detect abacavir-induced hypersensitivity on the basis of clinical criteria was 33.07 (95% CI: 22.33-48.97, I(2): 13.9%), while diagnostic odds ratio for detection of immunologically confirmed abacavir hypersensitivity was 1141 (95% CI: 409-3181, I(2): 0%). Pooled analysis of risk ratio showed that prospective HLA-B*57:01 testing significantly reduced the incidence of abacavir-induced hypersensitivity. This meta-analysis demonstrates an excellent diagnostic accuracy of HLA-B*57:01 testing to detect immunologically confirmed abacavir hypersensitivity and corroborates existing recommendations.

  10. Health surveillance for occupational asthma.

    PubMed

    Fishwick, David; Forman, Steve

    2018-04-01

    The outcome for workers with occupational asthma is improved for those with an earlier diagnosis. Health surveillance at work is in principle designed to identify such cases, so that the risks to the individual worker, and coworkers, can be reduced. There is recent evidence to suggest that the uptake and quality of such surveillance could be improved. This review has assessed current approaches to health surveillance for occupational asthma. The article covers a review of the utility of questionnaires, lung function testing, immunological investigations, and other tests, including exhaled nitric oxide, sputum eosinophilia, and exhaled breath condensate specifically in the context of workplace-based health surveillance. Questionnaires remain a key component of respiratory health surveillance, although maybe limited by both sensitivity and specificity for early occupational asthma. The role of lung function testing is debated, although is recommended for higher level health surveillance. Various examples of immunological testing in health surveillance are discussed, but more evidence is needed in many specific areas before more general recommendations can be made. Evidence is discussed in relation to the utility of newer approaches such as exhaled nitric oxide, sputum eosinophilia, and exhaled breath condensate.

  11. Precision medicine in patients with allergic diseases: Airway diseases and atopic dermatitis-PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology.

    PubMed

    Muraro, Antonella; Lemanske, Robert F; Hellings, Peter W; Akdis, Cezmi A; Bieber, Thomas; Casale, Thomas B; Jutel, Marek; Ong, Peck Y; Poulsen, Lars K; Schmid-Grendelmeier, Peter; Simon, Hans-Uwe; Seys, Sven F; Agache, Ioana

    2016-05-01

    In this consensus document we summarize the current knowledge on major asthma, rhinitis, and atopic dermatitis endotypes under the auspices of the PRACTALL collaboration platform. PRACTALL is an initiative of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology aiming to harmonize the European and American approaches to best allergy practice and science. Precision medicine is of broad relevance for the management of asthma, rhinitis, and atopic dermatitis in the context of a better selection of treatment responders, risk prediction, and design of disease-modifying strategies. Progress has been made in profiling the type 2 immune response-driven asthma. The endotype driven approach for non-type 2 immune response asthma, rhinitis, and atopic dermatitis is lagging behind. Validation and qualification of biomarkers are needed to facilitate their translation into pathway-specific diagnostic tests. Wide consensus between academia, governmental regulators, and industry for further development and application of precision medicine in management of allergic diseases is of utmost importance. Improved knowledge of disease pathogenesis together with defining validated and qualified biomarkers are key approaches to precision medicine. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Prevalence and Predictors of Immunological Failure among HIV Patients on HAART in Southern Ethiopia.

    PubMed

    Yirdaw, Kesetebirhan Delele; Hattingh, Susan

    2015-01-01

    Immunological monitoring is part of the standard of care for patients on antiretroviral treatment. Yet, little is known about the routine implementation of immunological laboratory monitoring and utilization in clinical care in Ethiopia. This study assessed the pattern of immunological monitoring, immunological response, level of immunological treatment failure and factors related to it among patients on antiretroviral therapy in selected hospitals in southern Ethiopia. A retrospective longitudinal analytic study was conducted using documents of patients started on antiretroviral therapy. Adequacy of timely immunological monitoring was assessed every six months the first year and every one year thereafter. Immunological response was assessed every six months at cohort level. Immunological failure was based on the criteria: fall of follow-up CD4 cell count to baseline (or below), or CD4 levels persisting below 100 cells/mm3, or 50% fall from on-treatment peak value. A total of 1,321 documents of patients reviewed revealed timely immunological monitoring were inadequate. There was adequate immunological response, with pediatric patients, females, those with less advanced illness (baseline WHO Stage I or II) and those with higher baseline CD4 cell count found to have better immunological recovery. Thirty-nine patients (3%) were not evaluated for immunological failure because they had frequent treatment interruption. Despite overall adequate immunological response at group level, the prevalence of those who ever experienced immunological failure was 17.6% (n=226), while after subsequent re-evaluation it dropped to 11.5% (n=147). Having WHO Stage III/IV of the disease or a higher CD4 cell count at baseline was identified as a risk for immunological failure. Few patients with confirmed failure were switched to second line therapy. These findings highlight the magnitude of the problem of immunological failure and the gap in management. Prioritizing care for high risk patients may help in effective utilization of meager resources.

  13. Prevalence and Predictors of Immunological Failure among HIV Patients on HAART in Southern Ethiopia

    PubMed Central

    2015-01-01

    Immunological monitoring is part of the standard of care for patients on antiretroviral treatment. Yet, little is known about the routine implementation of immunological laboratory monitoring and utilization in clinical care in Ethiopia. This study assessed the pattern of immunological monitoring, immunological response, level of immunological treatment failure and factors related to it among patients on antiretroviral therapy in selected hospitals in southern Ethiopia. A retrospective longitudinal analytic study was conducted using documents of patients started on antiretroviral therapy. Adequacy of timely immunological monitoring was assessed every six months the first year and every one year thereafter. Immunological response was assessed every six months at cohort level. Immunological failure was based on the criteria: fall of follow-up CD4 cell count to baseline (or below), or CD4 levels persisting below 100 cells/mm3, or 50% fall from on-treatment peak value. A total of 1,321 documents of patients reviewed revealed timely immunological monitoring were inadequate. There was adequate immunological response, with pediatric patients, females, those with less advanced illness (baseline WHO Stage I or II) and those with higher baseline CD4 cell count found to have better immunological recovery. Thirty-nine patients (3%) were not evaluated for immunological failure because they had frequent treatment interruption. Despite overall adequate immunological response at group level, the prevalence of those who ever experienced immunological failure was 17.6% (n=226), while after subsequent re-evaluation it dropped to 11.5% (n=147). Having WHO Stage III/IV of the disease or a higher CD4 cell count at baseline was identified as a risk for immunological failure. Few patients with confirmed failure were switched to second line therapy. These findings highlight the magnitude of the problem of immunological failure and the gap in management. Prioritizing care for high risk patients may help in effective utilization of meager resources. PMID:25961732

  14. Leukocyte Agglomeration Reaction in Diagnosis of Allergy Reactions from Antibiotics,

    DTIC Science & Technology

    tested in a clinic on 80 patients with serious allergic anamnesis . The results of the studies indicate that the leukocyte agglomeration reaction is a highly sensitive immunological indicator of hypersensitivity to antibiotics.

  15. 21 CFR 866.5320 - Properdin factor B immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... involvement of the alternative to the classical pathway of activation of complement (a group of plasma... the skin). Other diseases in which the alternate pathway of complement activation has been implicated...

  16. 21 CFR 866.5320 - Properdin factor B immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... involvement of the alternative to the classical pathway of activation of complement (a group of plasma... the skin). Other diseases in which the alternate pathway of complement activation has been implicated...

  17. 21 CFR 866.5320 - Properdin factor B immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... involvement of the alternative to the classical pathway of activation of complement (a group of plasma... the skin). Other diseases in which the alternate pathway of complement activation has been implicated...

  18. Harnessing an RNA-mediated chaperone for the assembly of influenza hemagglutinin in an immunologically relevant conformation.

    PubMed

    Yang, Seung Won; Jang, Yo Han; Kwon, Soon Bin; Lee, Yoon Jae; Chae, Wonil; Byun, Young Ho; Kim, Paul; Park, Chan; Lee, Young Jae; Kim, Choon Kang; Kim, Young Seok; Choi, Seong Il; Seong, Baik Lin

    2018-05-01

    A novel protein-folding function of RNA has been recognized, which can outperform previously known molecular chaperone proteins. The RNA as a molecular chaperone (chaperna) activity is intrinsic to some ribozymes and is operational during viral infections. Our purpose was to test whether influenza hemagglutinin (HA) can be assembled in a soluble, trimeric, and immunologically activating conformation by means of an RNA molecular chaperone (chaperna) activity. An RNA-interacting domain (RID) from the host being immunized was selected as a docking tag for RNA binding, which served as a transducer for the chaperna function for de novo folding and trimeric assembly of RID-HA1. Mutations that affect tRNA binding greatly increased the soluble aggregation defective in trimer assembly, suggesting that RNA interaction critically controls the kinetic network in the folding/assembly pathway. Immunization of mice resulted in strong hemagglutination inhibition and high titers of a neutralizing antibody, providing sterile protection against a lethal challenge and confirming the immunologically relevant HA conformation. The results may be translated into a rapid response to a new influenza pandemic. The harnessing of the novel chaperna described herein with immunologically tailored antigen-folding functions should serve as a robust prophylactic and diagnostic tool for viral infections.-Yang, S. W., Jang, Y. H., Kwon, S. B., Lee, Y. J., Chae, W., Byun, Y. H., Kim, P., Park, C., Lee, Y. J., Kim, C. K., Kim, Y. S., Choi, S. I., Seong, B. L. Harnessing an RNA-mediated chaperone for the assembly of influenza hemagglutinin in an immunologically relevant conformation.

  19. Immunologically active biomaterials for cancer therapy.

    PubMed

    Ali, Omar A; Mooney, David J

    2011-01-01

    Our understanding of immunological regulation has progressed tremendously alongside the development of materials science, and at their intersection emerges the possibility to employ immunologically active biomaterials for cancer immunotherapy. Strong and sustained anticancer, immune responses are required to clear large tumor burdens in patients, but current approaches for immunotherapy are formulated as products for delivery in bolus, which may be indiscriminate and/or shortlived. Multifunctional biomaterial particles are now being developed to target and sustain antigen and adjuvant delivery to dendritic cells in vivo, and these have the potential to direct and prolong antigen-specific T cell responses. Three-dimensional immune cell niches are also being developed to regulate the recruitment, activation and deployment of immune cells in situ to promote potent antitumor responses. Recent studies demonstrate that materials with immune targeting and stimulatory capabilities can enhance the magnitude and duration of immune responses to cancer antigens, and preclinical results utilizing material-based immunotherapy in tumor models show a strong therapeutic benefit, justifying translation to and future testing in the clinic.

  20. Congenital toxoplasmosis transmitted from an immunologically competent mother infected before conception.

    PubMed

    Vogel, N; Kirisits, M; Michael, E; Bach, H; Hostetter, M; Boyer, K; Simpson, R; Holfels, E; Hopkins, J; Mack, D; Mets, M B; Swisher, C N; Patel, D; Roizen, N; Stein, L; Stein, M; Withers, S; Mui, E; Egwuagu, C; Remington, J; Dorfman, R; McLeod, R

    1996-11-01

    Congenital transmission of Toxoplasma gondii from a mother who was apparently immunologically competent and who had toxoplasmic lymphadenitis 2 months before conception is described. Since no T. gondii-specific serological data were available for this mother from the time her lymph node biopsy specimen was obtained, the specimen was studied by polymerase chain reaction (PCR) to determine whether the T. gondii B1 gene was present. The predictive diagnostic value of histologic findings previously considered to be classic signs of T. gondii lymphadenitis also was studied. This was done by correlation of serological tests diagnostic of acute acquired T. gondii infection and presence of characteristic findings in biopsy specimens from persons without known immunocompromise. Both PCR and review of the characteristic features of her lymph node biopsy specimen confirmed the diagnosis of preconceptual infection in the mother. We also discuss two other cases in which apparently immunologically competent mothers with preconceptually acquired infection transmitted this parasite to their fetuses.

  1. Design Considerations for a Web-based Database System of ELISpot Assay in Immunological Research

    PubMed Central

    Ma, Jingming; Mosmann, Tim; Wu, Hulin

    2005-01-01

    The enzyme-linked immunospot (ELISpot) assay has been a primary means in immunological researches (such as HIV-specific T cell response). Due to huge amount of data involved in ELISpot assay testing, the database system is needed for efficient data entry, easy retrieval, secure storage, and convenient data process. Besides, the NIH has recently issued a policy to promote the sharing of research data (see http://grants.nih.gov/grants/policy/data_sharing). The Web-based database system will be definitely benefit to data sharing among broad research communities. Here are some considerations for a database system of ELISpot assay (DBSEA). PMID:16779326

  2. Cross-reactivity of stimulants found in sports drug testing by two fluorescence polarization immunoassays.

    PubMed

    de la Torre, R; Badia, R; Gonzàlez, G; García, M; Pretel, M J; Farré, M; Segura, J

    1996-01-01

    We investigated the usefulness of immunological methods for presumptive detection of stimulants found in sports drug testing. The ingestion of substances that show no cross-reactivity in tests commercially available for the detection of amphetamines can produce positive results in the urine. Human metabolism contributes to the positive results of some urine samples when the parent compound does not cross-react with the antibodies of the assay. Urine samples from healthy volunteers given stimulants were tested by chromatographic methods and by two different fluorescence polarization immunoassays (FPIA) from Abbott Laboratories for the analysis of amphetamines. According to the results obtained, we classified stimulants into four groups: detectable stimulants that gave rise to amphetamine by human metabolism (group 1); detectable ephedrines and related compounds, appearing in the urine either as parent compounds or originated by metabolism (group 2); detectable stimulants that displayed actual cross-reactivity with amphetamine tests (group 3); and stimulants not detected by FPIA (group 4). Most of the true doping cases due to the ingestion of stimulants may be detected by FPIA. The specificity of the results may be increased by combining immunological assays with different antibodies.

  3. Food avoidance and restriction in adults: a cross-sectional pilot study comparing patients from an immunology clinic to a general practice.

    PubMed

    Fitzgerald, Michael; Frankum, Brad

    2017-01-01

    With the introduction of avoidant/restrictive food intake disorder (ARFID) in the Diagnostic and Statistical Manual - fifth edition, there is an increased need to understand the prevalence and pattern of food avoidance and restriction in adults. High rates of food allergy and intolerance in immunology clinic populations, and subsequent high rates of elimination diets, place these individuals at a greater risk of developing pathological eating behaviours. This descriptive cross sectional pilot study aims to provide preliminary data on the prevalence and nature of food avoidance and restriction in an adult population, and to explore the reasons for this behaviour. A self-administered questionnaire was designed and distributed to adults presenting to an immunology clinic and a general practice over the course of 6 months to describe the prevalence and nature of avoidant and restrictive eating behaviours in this population. Pearson's chi square test was used to examine the strength of a potential link to a formal diagnosis of avoidant restrictive food intake disorder in these patients. A total of 102 completed questionnaires were used for data analysis. Food avoidance or restriction was detected in 81 respondents (79%), with rates not significantly higher in the immunology clinic group compared to the general practice group ( p  = .242). Food allergy and intolerance were the most common reasons for disturbed eating patterns. Life impact secondary to food avoidance and restriction was reported by 26% of respondents, with significantly higher rates observed in the immunology clinic cohort compared to the general practice ( p  = .011). Eating disturbances similar to those characteristic of ARFID are very common in adults. Food avoidance and restriction due to perceived food allergy and intolerance are significant reasons for such disordered eating patterns, particularly in an immunology clinic population. Further investigation is needed to determine if such eating behaviours are pathological and whether they qualify for a diagnosis of ARFID.

  4. [Human trypanosomiasis focus of Vavoua (Ivory Coast). A clinical, parasitological and sero-immunological survey (author's transl)].

    PubMed

    Duvallet, G; Stanghellini, A; Saccharin, C; Vivant, J F

    1979-01-01

    Vavoua human trypanosomiasis focus, located 60 km north of Daloa (Ivory Coast Republic) is facing a period of hyperactivity. A medical survey has been conducted in 9 villages of this focus: 7.424 persons have been examined and 128 new cases diagnosed in the field after clinical and parasitological examinations. Indirect Fluorescence Antibody Test applied to dried blood blots, in the laboratory, revealed 266 immunological suspects to be reexamined. 185 suspects were reexamined, 104 of whom were diagnosed after tyrpanosomes had been found in blood or/and in gland juice. The microhaematocrit centrifuge technique gave good results. Most of the 232 new cases were in the classical first period (unaltered CSF). Authors are insisting on the importance of survey prospections allowing an early diagnosis of sleeping sickness and on the interest of an immunodiagnostic test in addition to classical techniques to diagnose asymptomatical forms.

  5. Blood: Tests Used to Assess the Physiological and Immunological Properties of Blood

    ERIC Educational Resources Information Center

    Quinn, J. G.; Tansey, E. A.; Johnson, C. D.; Roe, S. M.; Montgomery, L. E. A.

    2016-01-01

    The properties of blood and the relative ease of access to which it can be retrieved make it an ideal source to gauge different aspects of homeostasis within an individual, form an accurate diagnosis, and formulate an appropriate treatment regime. Tests used to determine blood parameters such as the erythrocyte sedimentation rate, hemoglobin…

  6. Immunodiagnostic Techniques for Bacterial Infections

    DTIC Science & Technology

    1981-01-01

    specificity that specific immune sera (the immune response) provides. The early use of immunological diagnosis was to demonstrate circulating antibodies to...testing requirements. 4. Carefully remove punched plugs by suction. 5. Fill the central well with immune serum and the surrounding wells with test...capsulatuni Serum Actinomvcesr israeli Serum Aspergillus fumiqatus Serum Protozoan: Trvnanosoma cruzi Serum Entameaba histolvtica Serum Trichinella sviralis

  7. 21 CFR 866.5260 - Complement C3b inactivator immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the...

  8. 21 CFR 866.5260 - Complement C3b inactivator immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the...

  9. 21 CFR 866.5260 - Complement C3b inactivator immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the...

  10. 21 CFR 866.5260 - Complement C3b inactivator immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the...

  11. 21 CFR 866.5250 - Complement C2 inhibitor (inactivator) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1...

  12. 21 CFR 866.5250 - Complement C2 inhibitor (inactivator) immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1...

  13. 21 CFR 866.5250 - Complement C2 inhibitor (inactivator) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1...

  14. 21 CFR 866.5250 - Complement C 2 inhibitor (inactivator) immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1...

  15. 21 CFR 866.5250 - Complement C 2 inhibitor (inactivator) immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1...

  16. Laparoscopic surgery contributes more to nutritional and immunologic recovery than fast-track care in colorectal cancer.

    PubMed

    Xu, Dong; Li, Jun; Song, Yongmao; Zhou, Jiaojiao; Sun, Fangfang; Wang, Jianwei; Duan, Yin; Hu, Yeting; Liu, Yue; Wang, Xiaochen; Sun, Lifeng; Wu, Linshan; Ding, Kefeng

    2015-02-04

    Many clinical trials had repeatedly shown that fast-track perioperative care and laparoscopic surgery are both preferred in the treatment of colorectal cancer. But few studies were designed to explore the diverse biochemical impacts of the two counterparts on human immunologic and nutritional status. Ninety-two cases of colorectal cancer patients meeting the inclusion criteria were randomized to four groups: laparoscopy with fast-track treatment (LAFT); open surgery with fast-track treatment (OSFT); laparoscopy with conventional treatment (LAC); open surgery with conventional treatment (OSC). Peripheral blood tests including nutritional factors (albumin, prealbumin, and transferrin), humoral immunologic factors (IgG, IgM, and IgA), and cellular immunologic factors (T and NK cells) were evaluated. Blood samples were collected preoperatively (baseline) and 12 and 96 h after surgery (indicated as POH12 and POH96, respectively). Albumin, transferrin, prealbumin, and IgG levels were the highest in the LAFT group for both POH12 and POH96 time intervals. Repeated measures (two-way ANOVA) indicated that the difference of albumin, transferrin, and IgG level were attributed to surgery type (P < 0.05) and not perioperative treatment (P > 0.05). Only in the laparoscopy-included groups, the relative albumin and IgG levels of POH96 were obviously higher than that of POH12. Laparoscopic surgery accelerated postoperative nutrition and immune levels rising again while fast-track treatment retarded the drop of postoperative nutrition and immune levels. Laparoscopic surgery might play a more important role than fast-track treatment in the earlier postoperative recovery of nutritional and immunologic status. Combined laparoscopic surgery with fast-track treatment provided best postoperative recovery of nutrition and immune status. These results should be further compared with the clinical outcomes of our FTMDT trial (clinicaltrials.gov: NCT01080547).

  17. International Consensus on drug allergy.

    PubMed

    Demoly, P; Adkinson, N F; Brockow, K; Castells, M; Chiriac, A M; Greenberger, P A; Khan, D A; Lang, D M; Park, H-S; Pichler, W; Sanchez-Borges, M; Shiohara, T; Thong, B Y- H

    2014-04-01

    When drug reactions resembling allergy occur, they are called drug hypersensitivity reactions (DHRs) before showing the evidence of either drug-specific antibodies or T cells. DHRs may be allergic or nonallergic in nature, with drug allergies being immunologically mediated DHRs. These reactions are typically unpredictable. They can be life-threatening, may require or prolong hospitalization, and may necessitate changes in subsequent therapy. Both underdiagnosis (due to under-reporting) and overdiagnosis (due to an overuse of the term ‘allergy’) are common. A definitive diagnosis of such reactions is required in order to institute adequate treatment options and proper preventive measures. Misclassification based solely on the DHR history without further testing may affect treatment options, result in adverse consequences, and lead to the use of more-expensive or less-effective drugs, in contrast to patients who had undergone a complete drug allergy workup. Several guidelines and/or consensus documents on general or specific drug class-induced DHRs are available to support the medical decision process. The use of standardized systematic approaches for the diagnosis and management of DHRs carries the potential to improve outcomes and should thus be disseminated and implemented. Consequently, the International Collaboration in Asthma, Allergy and Immunology (iCAALL), formed by the European Academy of Allergy and Clinical Immunology (EAACI), the American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), and the World Allergy Organization (WAO), has decided to issue an International CONsensus (ICON) on drug allergy. The purpose of this document is to highlight the key messages that are common to many of the existing guidelines, while critically reviewing and commenting on any differences and deficiencies of evidence, thus providing a comprehensive reference document for the diagnosis and management of DHRs.

  18. Environmental conditions, immunologic phenotypes, atopy, and asthma: new evidence of how the hygiene hypothesis operates in Latin America.

    PubMed

    Figueiredo, Camila Alexandrina; Amorim, Leila D; Alcantara-Neves, Neuza M; Matos, Sheila M A; Cooper, Philip J; Rodrigues, Laura C; Barreto, Mauricio L

    2013-04-01

    It has been proposed that improved hygiene and reduced experience of infections in childhood influences the development of allergic diseases. The mechanisms by which the hygiene operates are not well established but are underpinned by two apparently incompatible immunologic paradigms, the balance of TH1 versus TH2 cytokines and IL-10-mediated regulation of TH2 cytokines. This study defined immunologic phenotypes with the use of latent class analysis and investigated their associations with environmental factors, markers of allergy and asthma, in a Latin American population. We studied 1127 children living in urban Brazil. Data on wheeze and environmental exposures were collected with standardized questionnaires. Atopy was measured by specific IgE in serum and skin prick test reactivity to aeroallergens. Cytokines were measured in culture after the stimulation of peripheral blood leukocytes with mitogen. Infections with pathogens were assessed by serology and stool examinations. Children were classified as having high or low burden of infection. Latent class analysis was used to identify immune phenotypes on the basis of cytokine production. Logistic regression was used to evaluate the adjusted effects of environment and burden of infection on the immunologic phenotypes and the effect of the phenotypes on atopy and asthma. Three phenotypes were identified, labeled underresponsive, intermediate, and responsive. Children of more educated mothers, living in improved environmental conditions, and with a low burden of infection were significantly more likely to have the responsive phenotype. The responsive phenotype was significantly associated with an increased prevalence of atopy but not asthma. Our findings contribute to a better understanding of the immune mechanisms by which the hygiene hypothesis operates in urban Latin America. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  19. Tumor Necrosis Factor Is a Therapeutic Target for Immunological Unbalance and Cardiac Abnormalities in Chronic Experimental Chagas' Heart Disease

    PubMed Central

    Pereira, Isabela Resende; Vilar-Pereira, Glaucia; Silva, Andrea Alice; Moreira, Otacilio Cruz; Britto, Constança; Sarmento, Ellen Diana Marinho

    2014-01-01

    Background. Chagas disease (CD) is characterized by parasite persistence and immunological unbalance favoring systemic inflammatory profile. Chronic chagasic cardiomyopathy, the main manifestation of CD, occurs in a TNF-enriched milieu and frequently progresses to heart failure. Aim of the Study. To challenge the hypothesis that TNF plays a key role in Trypanosoma cruzi-induced immune deregulation and cardiac abnormalities, we tested the effect of the anti-TNF antibody Infliximab in chronically T. cruzi-infected C57BL/6 mice, a model with immunological, electrical, and histopathological abnormalities resembling Chagas' heart disease. Results. Infliximab therapy did not reactivate parasite but reshaped the immune response as reduced TNF mRNA expression in the cardiac tissue and plasma TNF and IFNγ levels; diminished the frequency of IL-17A+ but increased IL-10+ CD4+ T-cells; reduced TNF+ but augmented IL-10+ Ly6C+ and F4/80+ cells. Further, anti-TNF therapy decreased cytotoxic activity but preserved IFNγ-producing VNHRFTLV-specific CD8+ T-cells in spleen and reduced the number of perforin+ cells infiltrating the myocardium. Importantly, Infliximab reduced the frequency of mice afflicted by arrhythmias and second degree atrioventricular blocks and decreased fibronectin deposition in the cardiac tissue. Conclusions. Our data support that TNF is a crucial player in the pathogenesis of Chagas' heart disease fueling immunological unbalance which contributes to cardiac abnormalities. PMID:25140115

  20. The effect of Corynebacterium parvum on the humoral and cellular immune systems in patients with breast cancer.

    PubMed Central

    Minton, J P; Rossio, J L; Dixon, B; Dodd, M C

    1976-01-01

    Corynebacterium parvum, a Gram-positive anaerobic bacillus thought to be a strong immunological stimulant, has been shown to decrease tumour growth and prolong survival in patients with metastatic disease. Study of the effect of a single injection of a strain of C. parvum (CN. 6134) in six patients with stage IV metastatic breast cancer is reported. Results of laboratory tests to judge the physical and immunological effects of the drug infusion 24 hr post-treatment and weekly thereafter for 3 weeks are evaluated. Within 24 hr after C. parvum administration, most patients experienced fever and nausea. Blood counts and differential counts exhibited increased values 24 hr after treatment with a strong shift to the left. Lymphocyte and monocyte counts were greatly depressed at 24 hr. T-cell numbers in peripheral blood did not appear to be altered, but the picture with regard to B cells was less clear. Normal count was recovered by day 8. It appears that intravenous administration of C. parvum produces a temporary marked immunological depression which returns to essentially normal values in 8 days. The return to normal may be accompanied by resolution of the endotoxin-like syndrome of side-effects. Further study of patients receiving this therapeutic agent is important to detect enhancement of the anti-tumour immunological response precipitated. PMID:1084821

  1. Buffalo's Center for Immunology: A New Answer to an Old Dilemma

    ERIC Educational Resources Information Center

    Rose, Noel R.; Bogazzi, Pierluigi E.

    1972-01-01

    The Center for Immunology at the University of Buffalo provides a viable resource for educating medical students in immunology until a department of immunology can be developed within the medical school. (HS)

  2. [Effects of radiotherapy on lymphocyte populations in lung cancer].

    PubMed

    Gava, A; Moro, L; De Angeli, S; Coghetto, F; Marazzato, G; Fantin, P; Patrese, P

    1988-11-01

    The authors report on the results of the immune monitoring of a study population of 31 patients with lung cancer who were treated with radiotherapy. A synthetic thymic pentapeptide, thymopentin, was employed whose effect was evaluated on the immunological parameters analyzed. After radiotherapy, a considerable and homogeneous decrement was observed in several lymphocytic subsets (less sensible in activated T-cells), together with a progressive decrement in the helper/suppressor ratio, in the long run. Monocytes and null cells showed more radioresistance. Thymopentin had no influence on the tested immunological parameters up to 6 months after radiotherapy; later on, a slightly more balanced helper/suppressor ratio could be noticed in the surviving patients who had been treated with thymopentin.

  3. Immunological hurdles of ageing: indispensable research of the human model.

    PubMed

    Vallejo, Abbe N

    2011-07-01

    Census reports of many countries indicate continuing trends for the graying of their populations. For the United States alone, persons aged ≥65 years are projected to comprise over 20% of the population by the year 2050. In view of the special medical needs of elders, scientific investigation into the biological aspects of ageing is key towards the improvement of geriatric care for the coming decades. This special issue of Ageing Research Reviews focuses on advances in research on the immunology of human ageing. Herein are nine articles about the age-related alterations in both the innate and adaptive arms of the immune system, and about continuing hurdles in vaccinology. These articles point to a common theme that the immunological milieu in old age is substantially different from that seen in the young. This suggests that new development and/or innovation of immune-based clinical interventions for the elderly may need to be customized for their age group, rather than the mere adoption of therapies that have been designed for and/or tested for younger persons. Copyright © 2011 Elsevier B.V. All rights reserved.

  4. Immunological hurdles of ageing: Indispensable research of the human model

    PubMed Central

    Vallejo, Abbe N.

    2011-01-01

    Census reports of many countries indicate continuing trends for the graying of their populations. For the United States alone, persons aged ≥65 years are projected to comprise over 20% of the population by the year 2050. In view of the special medical needs of elders, scientific investigation into the biological aspects of aging is key towards the improvement of geriatric care for the coming decades. This special issue of Ageing Research Reviews focuses on advances in research on the immunology of human ageing. Herein are nine articles about the age-related alterations in both the innate and adaptive arms of the immune system, and about continuing hurdles in vaccinology. These articles point to a common theme that the immunological milieu in old age is substantially different from that seen in the young. This suggests that new development and/or innovation of immune-based clinical interventions for the elderly may need to be customized for their age group, rather than the mere adoption of therapies that have been designed for and/or tested for younger persons. PMID:21315185

  5. Immunological relatedness among Candida albicans and other pathogenic Candida species.

    PubMed Central

    Hector, R F; Lyon, F L; Domer, J E

    1981-01-01

    Membrane-mitochondrial (butanol-hot phosphate-buffered saline) and cytosol (soluble cytoplasmic substances) extracts from seven pathogenic species of Candida were used in in vivo and in vitro immunological assays to study antigenic similarities among the strains with respect to C. albicans. Mice were sensitized with C. albicans serotype A for footpad testing or to provide cells for lymphocyte stimulation assays, and guinea pigs were immunized with whole cells or butanol-hot phosphate-buffered saline extracts of C. albicans to obtain antisera for immunodiffusion assays. When extracts from each of the seven species were used in the assays, they consistently segregated, as determined by statistical or subjective analyses, into three groups. Extracts of C. albicans serotype A or B and C. stellatoidea were the most immunologically reactive in all assays, indicating close similarities between those two species, whereas extracts of C. tropicalis and C. parapsilosis elicited only moderate responses. Extracts from C. krusei, C. guilliermondii, and C. pseudotropicalis were hypo- or nonreactive in the assays, indicating a low level of antigenic relatedness to C. albicans. Images PMID:7037643

  6. Effects of an immuno-enhanced diet containing antioxidants in esophageal cancer surgery following neoadjuvant therapy.

    PubMed

    Aiko, S; Kumano, I; Yamanaka, N; Tsujimoto, H; Takahata, R; Maehara, T

    2012-02-01

    Neoadjuvant therapy-induced immunological deterioration may be a key factor in postoperative morbidity in patients with esophageal cancer. This study aimed to determine the effects of perioperative feeding with an immuno-enhanced diet on immune competence in patients treated with neoadjuvant therapy followed by surgery. Because an immuno-enhanced diet that contained several antioxidants was used, perioperative oxidative stress and the effects of the immuno-enhanced diet on this stress were also investigated. Of 39 patients with esophageal cancer who underwent similar surgical procedures, 26 patients who received chemotherapy or chemoradiation therapy before surgery were randomly divided into two groups: group 1 (n= 14) was given an immuno-enhanced diet for 5 days before surgery, and group 2 (n= 12) received no enteral feeding products before surgery. Group 3 (n= 13) consisted of patients that did not receive neoadjuvant therapy and received no enteral feeding products before surgery. Several markers for coagulation and fibrinolysis were determined and immunological assessments were performed for each patient. To measure reactive oxygen metabolites and the total antioxidant capacity, diacron-reactive oxygen metabolites (d-ROMs) and OXY-adsorbent tests were performed using a free radical elective evaluator. Significant depression in lymphocyte numbers was observed in groups 1 and 2 before and early after surgery as compared to group 3. Numbers of B cells, CD4/CD8 ratio, and phytohemagglutinin-induced lymphocyte transformation tests were also significantly decreased in groups 1 and 2 on postoperative day 1. Fibrin and fibrinogen degradation products were significantly elevated in group 2 compared to group 1. d-ROMs and OXY-adsorbent test values were elevated before surgery and were decreased transiently early after surgery. Compared to groups 2 and 3, d-ROMs values were significantly lower in group 1 patients throughout the postoperative period, while OXY-adsorbent test values were significantly higher in group 2 patients. Oxidative index was significantly suppressed in group 1 compared to group 3. No significant intergroup differences were observed with regard to morbidity after surgery. Although the baseline levels of immunological function might have been different because of less-advanced cancer stages in group 3, neoadjuvant therapy significantly affected several immunological parameters. Preoperative administration of an immuno-enhanced diet did not significantly prevent neoadjuvant therapy-induced immunological deterioration prior to esophageal cancer surgery. Patients with esophageal cancer had elevated levels of oxidant and antioxidant activities before surgery, which were transiently decreased early after surgery. Although the underlying mechanisms for these perioperative changes are unclear, this study showed that an immuno-enhanced diet containing several antioxidants may reduce oxidative stress following esophageal cancer surgery. After these mechanisms are studied further, oxidative stress control may become another tool for perioperative management to reduce morbidity after esophageal cancer surgery. © 2011 Copyright the Authors. Journal compilation © 2011, Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

  7. Cattle temperament influences metabolism: 1. Metabolic response to a glucose tolerance test in beef steers

    USDA-ARS?s Scientific Manuscript database

    Temperamental cattle are behaviorally, physiologically, and immunologically different in comparison to calm cattle. Recently, the metabolic differences between temperamental and calm cattle have begun to be explored; temperamental cattle maintain greater circulating concentrations of non-esterified ...

  8. Workload Impact of Medical Subspecialties in the Teaching Hospital

    ERIC Educational Resources Information Center

    Van Peenen, Hubert J.

    1973-01-01

    This paper documents, using a single test as a model, the significant increase in clinical laboratory workload which occurred in a university hospital when strong sections of nephrology, hematology-oncology, and immunology-rheumatology were added to the department of medicine. (Author)

  9. 21 CFR 864.1860 - Immunohistochemistry reagents and kits.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Immunohistochemistry reagents and kits. (a) Identification. Immunohistochemistry test systems (IHC's) are in vitro... performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for...

  10. 21 CFR 864.1860 - Immunohistochemistry reagents and kits.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Immunohistochemistry reagents and kits. (a) Identification. Immunohistochemistry test systems (IHC's) are in vitro... performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for...

  11. A trial of patient-oriented problem-solving system for immunology teaching in China: a comparison with dialectic lectures

    PubMed Central

    2013-01-01

    Background The most common teaching method used in China is lecturing, but recently, efforts have been widely undertaken to promote the transition from teacher-centered to student-centered education. The patient-oriented problem-solving (POPS) system is an innovative teaching-learning method that permits students to work in small groups to solve clinical problems, promotes self-learning, encourages clinical reasoning and develops long-lasting memory. To our best knowledge, however, POPS has never been applied in teaching immunology in China. The aim of this study was to develop POPS in teaching immunology and assess students’ and teachers’ perception to POPS. Methods 321 second-year medical students were divided into two groups: I and II. Group I, comprising 110 students, was taught by POPS, and 16 immunology teachers witnessed the whole teaching process. Group II including the remaining 211 students was taught through traditional lectures. The results of the pre- and post-test of both groups were compared. Group I students and teachers then completed a self-structured feedback questionnaire for analysis before a discussion meeting attended only by the teachers was held. Results Significant improvement in the mean difference between the pre- and post-test scores of those in Groups I and II was seen, demonstrating the effectiveness of POPS teaching. Most students responded that POPS facilitates self-learning, helps them to understand topics and creates interest, and 88.12% of students favored POPS over simple lectures. Moreover, while they responded that POPS facilitated student learning better than lectures, teachers pointed out that limited teaching resources would make it difficult for wide POPS application in China. Conclusions While POPS can break up the monotony of dialectic lectures and serve as a better teaching method, it may not be feasible for the current educational environment in China. The main reason for this is the relative shortage of teaching resources such as space, library facilities and well-trained teachers. PMID:23356717

  12. A trial of patient-oriented problem-solving system for immunology teaching in China: a comparison with dialectic lectures.

    PubMed

    Zhang, Zhiren; Liu, Wei; Han, Junfeng; Guo, Sheng; Wu, Yuzhang

    2013-01-28

    The most common teaching method used in China is lecturing, but recently, efforts have been widely undertaken to promote the transition from teacher-centered to student-centered education. The patient-oriented problem-solving (POPS) system is an innovative teaching-learning method that permits students to work in small groups to solve clinical problems, promotes self-learning, encourages clinical reasoning and develops long-lasting memory. To our best knowledge, however, POPS has never been applied in teaching immunology in China. The aim of this study was to develop POPS in teaching immunology and assess students' and teachers' perception to POPS. 321 second-year medical students were divided into two groups: I and II. Group I, comprising 110 students, was taught by POPS, and 16 immunology teachers witnessed the whole teaching process. Group II including the remaining 211 students was taught through traditional lectures. The results of the pre- and post-test of both groups were compared. Group I students and teachers then completed a self-structured feedback questionnaire for analysis before a discussion meeting attended only by the teachers was held. Significant improvement in the mean difference between the pre- and post-test scores of those in Groups I and II was seen, demonstrating the effectiveness of POPS teaching. Most students responded that POPS facilitates self-learning, helps them to understand topics and creates interest, and 88.12% of students favored POPS over simple lectures. Moreover, while they responded that POPS facilitated student learning better than lectures, teachers pointed out that limited teaching resources would make it difficult for wide POPS application in China. While POPS can break up the monotony of dialectic lectures and serve as a better teaching method, it may not be feasible for the current educational environment in China. The main reason for this is the relative shortage of teaching resources such as space, library facilities and well-trained teachers.

  13. IT-25DEVELOPMENTALLY REGULATED ANTIGENS FOR IMMUNOLOGIC TARGETING OF MEDULLOBLASTOMA SUBTYPES

    PubMed Central

    Pham, Christina; Flores, Catherine; Pei, Yanxin; Wechsler-Reya, Robert; Mitchell, Duane

    2014-01-01

    INTRODUCTION: Medulloblastoma (MB) remains incurable in one third of patients despite aggressive multi-modality standard therapies. Immunotherapy presents a promising alternative by specifically targeting cancer cells. To date, there have been no successful immunologic applications targeting MB. Emerging evidence from integrated genomic studies has suggested MB variants arise from deregulation of pathways affecting proliferation of progenitor cell populations within the developing cerebellum. Using total embryonic RNA as a source of tumor rejection antigens is attractive because it can be delivered as a single vaccine, target both known and unknown fetal proteins, and can be refined to preferentially treat distinct MB subtypes. METHODS: We have created two transplantable, syngeneic animal MB models recapitulating human SHH and Group 3 variants to investigate the immunologic targeting of different MB subtypes. We generated T cells specific to the developing mouse cerebellum (P5) and tested their reactivity to target cells pulsed with total RNA from two MB subtypes and the normal brain. Immune responses were evaluated by measuring cytokine secretion following re-stimulation of activated T cells with both normal and tumor cell targets. In vivo antitumor efficacy was also tested in survival studies of intracranial tumor-bearing animals. RESULTS: We generated T cells specific to the developing cerebellum in vitro, confirming the immunogenicity of developmentally regulated antigens. Additionally, we have shown that developmental antigen-specific T cells produce high levels of Th1-type cytokines in response to tumor cells of two immunologically distinct subtypes of MB. Interestingly, developmental antigen specific T cells do not show cross reactivity with the normal brain or subsequent stages of the developing brain after P5. Targeting developmental antigens also conferred a significant survival benefit in a treatment model of Group 3 tumor bearing animals. CONCLUSIONS: Developmental antigens can safely target multiple MB subtypes with equal effectiveness compared to previously established total tumor strategies.

  14. Study on the immunological safety of universal plasma in the Chinese population in vitro.

    PubMed

    Chen, Guanyi; Zhu, Liguo; Wang, Shufang; Zhuang, Yuan; Yu, Yang; Wang, Deqing

    2017-04-01

    The prepared procedure for universal plasma in the Chinese population has been developed. However, the immunological safety with the level of antibodies, soluble immune complexes and complements is necessary to investigate. The universal plasma was pooled at the optimal ratio of A:B:AB=6:2.5:1.5 at 22°C for 1 hour. The titer of IgM antibodies was detected by saline agglutination, and the titer of IgG antibodies was detected by a Polybrene test after IgM destroyed by 2-mereaptoethanol. The hemolysis extent of RBC was investigated by an extracorporal hemolysis test, and the concentration of free-hemoglobin was determined by the ortho-tolidine method. The levels of CIC-C1q, C3b and TCC (C5-9) were tested using an enzyme linked immunosorbent assay (ELISA). The titer of IgM and IgG in universal plasma was lower than 2 and 4, respectively. The hemolysis of the universal plasma with A, B and AB group RBCs was negative with values of 5.5, 6.8 and 5.7, respectively. The level of CIC-C1q and TCC (C5-9) in universal plasma was comparable to that in A or B type pooled plasma, but CIC-C1q was lower than that and TCC (C5-9) was higher than that in AB type pooled plasma. The level of complement C3b was comparable to that in A type pooled plasma, but lower than that in B type pooled plasma and higher than that in AB type pooled plasma. The results of this study demonstrated that the immunological levels were within an acceptable range and confirmed the safety in vitro. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Effect of gamma irradiation on mistletoe (Viscum album) lectin-mediated toxicity and immunomodulatory activity☆

    PubMed Central

    Sung, Nak-Yun; Byun, Eui-Baek; Song, Du-Sup; Jin, Yeung-Bae; Kim, Jae-Kyung; Park, Jong-Heum; Song, Beom-Seok; Jung, Pil-Mun; Byun, Myung-Woo; Lee, Ju-Woon; Park, Sang-Hyun; Kim, Jae-Hun

    2013-01-01

    This study evaluated the effect of gamma irradiation on the reduction of the toxicity of mistletoe lectin using both in vitro and in vivo models. To extract the lectin from mistletoe, an (NH4)2SO4 precipitation method was employed and the precipitant purified using a Sepharose 4B column to obtain the pure lectin fraction. Purified lectin was then gamma-irradiated at doses of 0, 5, 10, 15, and 20 kGy, or heated at 100 °C for 30 min. Toxic effects of non-irradiated, irradiated, and heat-treated lectins were tested using hemagglutination assays, cytotoxicity assays, hepatotoxicity, and a mouse survival test and immunological response was tested using cytokine production activity. Hemagglutination of lectin was remarkably decreased (P < 0.05) by irradiation at doses exceeding 10 kGy and with heat treatment. However, lectin irradiated with 5 kGy maintained its hemagglutination activity. The cytotoxicity of lectin was decreased by irradiation at doses over 5 kGy and with heat treatment. In experiments using mouse model, glutamate oxaloacetate transaminase (GOT) and glutamic pyruvic transaminase (GPT) levels were decreased in the group treated with the 5 kGy irradiated and heat-treated lectins as compared to the intact lectin, and it was also shown that 5 kGy irradiated and heat-treated lectins did not cause damage in liver tissue or mortality. In the result of immunological response, tumor necrosis factor (TNF-α) and interleukin (IL-6) levels were significantly (P < 0.05) increased in the 5 kGy gamma-irradiated lectin treated group. These results indicate that 5 kGy irradiated lectin still maintained the immunological response with reduction of toxicity. Therefore, gamma-irradiation may be an effective method for reducing the toxicity of lectin maintaining the immune response. PMID:23847758

  16. Virtual immunology: software for teaching basic immunology.

    PubMed

    Berçot, Filipe Faria; Fidalgo-Neto, Antônio Augusto; Lopes, Renato Matos; Faggioni, Thais; Alves, Luiz Anastácio

    2013-01-01

    As immunology continues to evolve, many educational methods have found difficulty in conveying the degree of complexity inherent in its basic principles. Today, the teaching-learning process in such areas has been improved with tools such as educational software. This article introduces "Virtual Immunology," a software program available free of charge in Portuguese and English, which can be used by teachers and students in physiology, immunology, and cellular biology classes. We discuss the development of the initial two modules: "Organs and Lymphoid Tissues" and "Inflammation" and the use of interactive activities to provide microscopic and macroscopic understanding in immunology. Students, both graduate and undergraduate, were questioned along with university level professors about the quality of the software and intuitiveness of use, facility of navigation, and aesthetic organization using a Likert scale. An overwhelmingly satisfactory result was obtained with both students and immunology teachers. Programs such as "Virtual Immunology" are offering more interactive, multimedia approaches to complex scientific principles that increase student motivation, interest, and comprehension. © 2013 by The International Union of Biochemistry and Molecular Biology.

  17. Consortium biology in immunology: the perspective from the Immunological Genome Project.

    PubMed

    Benoist, Christophe; Lanier, Lewis; Merad, Miriam; Mathis, Diane

    2012-10-01

    Although the field has a long collaborative tradition, immunology has made less use than genetics of 'consortium biology', wherein groups of investigators together tackle large integrated questions or problems. However, immunology is naturally suited to large-scale integrative and systems-level approaches, owing to the multicellular and adaptive nature of the cells it encompasses. Here, we discuss the value and drawbacks of this organization of research, in the context of the long-running 'big science' debate, and consider the opportunities that may exist for the immunology community. We position this analysis in light of our own experience, both positive and negative, as participants of the Immunological Genome Project.

  18. Virtual Immunology: Software for Teaching Basic Immunology

    ERIC Educational Resources Information Center

    Berçot, Filipe Faria; Fidalgo-Neto, Antônio Augusto; Lopes, Renato Matos; Faggioni, Thais; Alves, Luiz Anastácio

    2013-01-01

    As immunology continues to evolve, many educational methods have found difficulty in conveying the degree of complexity inherent in its basic principles. Today, the teaching-learning process in such areas has been improved with tools such as educational software. This article introduces "Virtual Immunology," a software program available…

  19. Need for immunologic stimulators during immunosuppression produced by major cancer surgery.

    PubMed Central

    Cole, W H; Humphrey, L

    1985-01-01

    Although surgery, radiology, and anticancer chemicals have been effective in the treatment of cancer, the immunologic phase of therapy deserves more effort and thought, because the possibilities are considerable. However, the immunologic phase is so complicated that, without the advances made during the past few years, little could be expected from immunology. The focus of this paper is on the immunosuppression produced by major cancer operations, at which time the patient needs immunologic help. PMID:3893336

  20. Immunologic Regulation in Pregnancy: From Mechanism to Therapeutic Strategy for Immunomodulation

    PubMed Central

    Chen, Shyi-Jou; Liu, Yung-Liang; Sytwu, Huey-Kang

    2012-01-01

    The immunologic interaction between the fetus and the mother is a paradoxical communication that is regulated by fetal antigen presentation and/or by recognition of and reaction to these antigens by the maternal immune system. There have been significant advances in understanding of abnormalities in the maternal-fetal immunologic relationship in the placental bed that can lead to pregnancy disorders. Moreover, immunologic recognition of pregnancy is vital for the maintenance of gestation, and inadequate recognition of fetal antigens may cause abortion. In this paper, we illustrate the complex immunologic aspects of human reproduction in terms of the role of human leukocyte antigen (HLA), immune cells, cytokines and chemokines, and the balance of immunity in pregnancy. In addition, we review the immunologic processes of human reproduction and the current immunologic therapeutic strategies for pathological disorders of pregnancy. PMID:22110530

  1. Identification of micro-organisms

    NASA Technical Reports Server (NTRS)

    Taylor, G. R.; Zaloguev, S. N.

    1979-01-01

    Manual presents detailed laboratory procedures for identifying aerobic or microaerobic bacteria, yeast or yeastible organisms, and filamentous fungi and conducting other microbiological or immunological evaluations of samples taken from human subjects. Standardized procedures should be useful to researchers and clinicians in laboratories, hospitals and other biological test facilities.

  2. LABELING WITH 14C AMINO ACIDS OF ALBUMIN-LIKE PROTEIN BY RAT LIVER RIBONUCLEOPROTEIN PARTICLES

    PubMed Central

    von der Decken, Alexandra

    1963-01-01

    Ribonucleoprotein particles were prepared by treatment of rat liver microsomes with detergents and high concentrations of KCl. They were active in incorporating 14C amino acids into protein when incubated with cell sap together with ATP, GTP, and a system to regenerate the triphosphates. The albumin of the incubation mixture, soluble at 105,000 g, and that of the fraction released by ultrasonication of the particles were studied by immunoelectrophoresis in agar gel. When the ribonucleoprotein particles were incubated with cell sap the immunological precipitation lines formed with antiserum to rat serum albumin were highly radioactive as tested by autoradiography. After zone electrophoresis on cellulose acetate, two immunologically reactive albumins were obtained which differed in their electrophoretic mobility from rat serum albumin. Labeled albumin, when purified on DEAE-cellulose columns, retained its radioactivity as tested by autoradiography following immunoelectrophoresis. On cellulose acetate this purified albumin showed an electrophoretic mobility higher than that of rat serum albumin. PMID:14026307

  3. Concise review: humanized models of tumor immunology in the 21st century: convergence of cancer research and tissue engineering.

    PubMed

    Holzapfel, Boris Michael; Wagner, Ferdinand; Thibaudeau, Laure; Levesque, Jean-Pierre; Hutmacher, Dietmar Werner

    2015-06-01

    Despite positive testing in animal studies, more than 80% of novel drug candidates fail to proof their efficacy when tested in humans. This is primarily due to the use of preclinical models that are not able to recapitulate the physiological or pathological processes in humans. Hence, one of the key challenges in the field of translational medicine is to "make the model organism mouse more human." To get answers to questions that would be prognostic of outcomes in human medicine, the mouse's genome can be altered in order to create a more permissive host that allows the engraftment of human cell systems. It has been shown in the past that these strategies can improve our understanding of tumor immunology. However, the translational benefits of these platforms have still to be proven. In the 21st century, several research groups and consortia around the world take up the challenge to improve our understanding of how to humanize the animal's genetic code, its cells and, based on tissue engineering principles, its extracellular microenvironment, its tissues, or entire organs with the ultimate goal to foster the translation of new therapeutic strategies from bench to bedside. This article provides an overview of the state of the art of humanized models of tumor immunology and highlights future developments in the field such as the application of tissue engineering and regenerative medicine strategies to further enhance humanized murine model systems. © 2015 AlphaMed Press.

  4. Morbidity study of extruder personnel with potential exposure to brominated dioxins and furans. I. Results of blood monitoring and immunological tests.

    PubMed Central

    Zober, M A; Ott, M G; Päpke, O; Senft, K; Germann, C

    1992-01-01

    The potential for exposure of employees to polybrominated dibenzofurans (PBDFs) and dibenzo-p-dioxins (PBDDs) during extrusion blending of resins containing decabromodiphenyl ether was established through previous air monitoring (area samples) and biomonitoring studies. The findings presented herein are further biomonitoring results for 42 employees and immunological tests for exposed and referent employees. Among potentially exposed men, 2,3,7,8-TBDF and 2,3,7,8-TBDD concentrations in blood lipid ranged from non-detectable to 112 parts per trillion (ppt) and from non-detectable to 478 ppt respectively. Biomonitoring results correlated well with assignments in the extruder work area when adjusted for process changes and engineering improvements and provided biological half life estimates of between 1.1 and 1.9 years for 2,3,7,8-TBDF and between 2.9 and 10.8 years for 2,3,7,8-TBDD. Results for 16 measures of the immune system were examined in relation to exposure (exposed v referent group) and in relation to the biomonitoring data. Some individual trends in immunological parameters with exposure and covariates such as age and cigarette smoking were found (for example, an increase in complement C4 with increasing concentrations of PBDFs and PBDDs, increased lymphocyte subpopulation counts with cigarette smoking); however, the overall clinical assessment was that the immune system of exposed employees was not adversely impacted at these burdens of PBDFs and PBDDs. PMID:1515345

  5. Morbidity study of extruder personnel with potential exposure to brominated dioxins and furans. I. Results of blood monitoring and immunological tests.

    PubMed

    Zober, M A; Ott, M G; Päpke, O; Senft, K; Germann, C

    1992-08-01

    The potential for exposure of employees to polybrominated dibenzofurans (PBDFs) and dibenzo-p-dioxins (PBDDs) during extrusion blending of resins containing decabromodiphenyl ether was established through previous air monitoring (area samples) and biomonitoring studies. The findings presented herein are further biomonitoring results for 42 employees and immunological tests for exposed and referent employees. Among potentially exposed men, 2,3,7,8-TBDF and 2,3,7,8-TBDD concentrations in blood lipid ranged from non-detectable to 112 parts per trillion (ppt) and from non-detectable to 478 ppt respectively. Biomonitoring results correlated well with assignments in the extruder work area when adjusted for process changes and engineering improvements and provided biological half life estimates of between 1.1 and 1.9 years for 2,3,7,8-TBDF and between 2.9 and 10.8 years for 2,3,7,8-TBDD. Results for 16 measures of the immune system were examined in relation to exposure (exposed v referent group) and in relation to the biomonitoring data. Some individual trends in immunological parameters with exposure and covariates such as age and cigarette smoking were found (for example, an increase in complement C4 with increasing concentrations of PBDFs and PBDDs, increased lymphocyte subpopulation counts with cigarette smoking); however, the overall clinical assessment was that the immune system of exposed employees was not adversely impacted at these burdens of PBDFs and PBDDs.

  6. 42 CFR 493.1208 - Condition: General immunology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: General immunology. 493.1208 Section 493....1208 Condition: General immunology. If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493...

  7. 42 CFR 493.1208 - Condition: General immunology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: General immunology. 493.1208 Section 493....1208 Condition: General immunology. If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493...

  8. Graduate Students' Interest in Immunology as a Discipline

    ERIC Educational Resources Information Center

    Kwarteng, Alexander; Frimpong, Michael; Sylverken, Augustina Angelina; Arthur, Yarhands D.; Ahuno, Samuel T.; Owusu-Dabo, Ellis

    2017-01-01

    Interest and motivation significantly influence achievement; however, interest in immunology remains to be determined. Using a structured questionnaire, the current study assessed for the first time interest in immunology among biomedical graduate students in Ghana after a one-week introduction to immunology course. Our results revealed that…

  9. 42 CFR 493.1208 - Condition: General immunology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Condition: General immunology. 493.1208 Section 493....1208 Condition: General immunology. If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493...

  10. 42 CFR 493.1208 - Condition: General immunology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Condition: General immunology. 493.1208 Section 493....1208 Condition: General immunology. If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493...

  11. SPECIAL ISSUE VETERINARY IMMUNOLOGY IMMUNOPATHOLOGY: PROCEEDINGS 8TH INTERNATIONAL VETERINARY IMMUNOLOGY SYMPOSIUM

    USDA-ARS?s Scientific Manuscript database

    This is the Special Issue of Vet. Immunol. Immunopathol. that summarizes the 8th International Veterinary Immunology Symposium (8 th IVIS) held August 15th-19th, 2007, in Ouro Preto, Brazil. The 8 th IVIS highlighted the importance of veterinary immunology for animal health, vaccinology, reproducti...

  12. 42 CFR 493.1208 - Condition: General immunology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Condition: General immunology. 493.1208 Section 493....1208 Condition: General immunology. If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in §§ 493.1230 through 493.1256, and §§ 493...

  13. Effects of microgravity on the immune system

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald; Taylor, Gerald R.

    1991-01-01

    Changes in resistance to bacterial and viral infections in Apollo crew members has stimulated interest in the study of immunity and space flight. Results of studies from several laboratories in both humans and rodents have indicated alterations after space flight that include the following immunological parameters: thymus size, lymphocyte blastogenesis, interferon and interleukin production, natural killer cell activity, cytotoxic T-cell activity, leukocyte subset population distribution, response of bone marrow cells to colony stimulating factors, and delayed hypersensitivity skin test reactivity. The interactions of the immune system with other physiological systems, including muscle, bone, and the nervous system, may play a major role in the development of these immunological parameters during and after flight. There may also be direct effects of space flight on immune responses.

  14. Psychological, immunological and physiological effects of a Laughing Qigong Program (LQP) on adolescents.

    PubMed

    Chang, Chueh; Tsai, Grace; Hsieh, Chia-Jung

    2013-12-01

    One objective of this study was to assess the effects of laughter on the psychological, immunological and physiological systems of the body. Another objective was to introduce the Laughing Qigong Program (LQP), as a method of standardization for simulated laughter interventions. A randomized, prospective, experimental study of the LQP was conducted in a group of adolescents (n=67) in Taiwan. During study-hall sessions, experimental subjects (n=34) attended the LQP for eight-weeks. Simultaneously, control subjects (n=33) read or did their homework. All subjects were tested before and after the intervention on the following: Rosenberg Self-Esteem scale (RSE), Chinese Humor Scale (CHS) and Face Scale (FS) as psychological markers; saliva cortisol (CS) as an immunological marker; blood pressure (BP), heart rate (HR), and heart rate variability (HRV) as physiological markers of the body's response to stress. Mood states (FS) were measured before/after each LQP session. Mood states (p=.00) and humor (p=.004; p=.003) improved in the experimental group; no significant changes were found in the controls (p=69; p=60). The immunological marker of stress, cortisol levels, decreased significantly for those who participated in the LQP (p=.001), suggesting lower levels of stress after completion of the program. The LQP is a non-pharmacological and cost-effective means to help adolescents mitigate stresses in their everyday life. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Spaceflight and Development of Immune Responses

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald

    1996-01-01

    Evidence from both human and rodent studies has indicated that alterations in immunological parameters occur after space flight. The number of flight experiments has been small, and the full breadth of immunological alterations occurring after space flight remains to be established. Among the major effects on immune responses after space flight that have been reported are: alterations in lymphocyte blastogenesis and natural killer cell activity, alterations in production of cytokines, changes in leukocyte sub-population distribution, and decreases in the ability of bone marrow cells to respond to colony stimulating factors. Changes have been reported in immunological parameters of both humans and rodents. The significance of these alterations in relation to resistance to infection remains to be established. The objective of the studies contained in this project was to determine the effects of space flight on immune responses of pregnant rats and their offspring. The hypothesis was that space flight and the attendant period of microgravity will result in alteration of immunological parameters of both the pregnant rats as well as their offspring carried in utero during the flight. The parameters tested included: production of cytokines, composition of leukocyte sub- populations, response of bone marrow/liver cells to granulocyte/monocyte colony stimulating factor, and leukocyte blastogenesis. Changes in immune responses that could yield alterations in resistance to infection were determined. This yielded useful information for planning studies that could contribute to crew health. Additional information that could eventually prove useful to determine the potential for establishment of a permanent colony in space was obtained.

  16. Delayed complications of sulfur mustard poisoning in the skin and the immune system of Iranian veterans 16-20 years after exposure.

    PubMed

    Hefazi, Mehrdad; Maleki, Masoud; Mahmoudi, Mahmoud; Tabatabaee, Abbas; Balali-Mood, Mahdi

    2006-09-01

    Extensive cutaneous burns caused by alkylating chemical warfare agent sulfur mustard (SM) have been associated with the severe suppression of the immune system in humans. We aimed to study the association between late cutaneous and immunological complications of SM poisoning. Skin examination was performed on all SM-poisoned Iranian veterans in the province of Khorasan, Iran, who had significant clinical complications, and their SM intoxication was confirmed by toxicological analysis. Light microscopy was performed on eight skin biopsies. Blood cell counts, serum immunoglobulin and complement factor, as well as flow cytometric, analyses were performed on all the patients. The severity of cutaneous complications were classified into four grades and compared with hematological and immunological parameters, using Spearman's rank correlation test. Forty male subjects, confirmed with SM poisoning 16-20 years earlier, were studied. The main objective findings were hyperpigmentation (55%), dry skin (40%), multiple cherry angiomas (37.5%), atrophy (27.5%), and hypopigmentation (25%). Histopathologic findings were nonspecific and compatible with hyperpigmented old atrophic scars. Except for the hematocrit and C4 levels, hematological and immunological parameters revealed no significant correlation with the severity grades of cutaneous complications. Sulfur mustard is an alkylating agent with prolonged adverse effects on both the skin and the immune system. Although skin is a major transporting system for SM's systemic absorption, there is probably no correlation between the severity of late cutaneous and immunological complications of SM poisoning.

  17. Haemophilus influenzae type B in an immunocompetent, fully vaccinated ALL survivor.

    PubMed

    Nevin, John; Kanter Washko, Julie; Arnold, John

    2013-05-01

    A 7-year-old boy with a history of recurrent acute lymphoblastic leukemia (ALL), in remission, presented to primary care clinic after 2 days of progressive right hip pain with weight-bearing activities. He was otherwise asymptomatic at the time of presentation. Blood cultures revealed Gram-negative diplococci, which prompted an MRI that was significant for a hip joint effusion and femoral head bone marrow edema. The patient had no sick contacts and no significant past medical history other than ALL. The patient had been given all recommended childhood vaccinations. Arthrocentesis and needle biopsy of the femoral neck were not diagnostic for malignancy and revealed only mild hip joint inflammation, leading to a diagnosis of osteomyelitis. The organism in the original blood culture was identified as Haemophilus influenzae type b, β-lactamase negative. Review of the patient's medical records showed a history of complete immunization to Haemophilus influenzae type b. An immunologic evaluation was made to determine if the patient retained immunity from his other vaccinations. Pathogen-specific antibody testing revealed detectable antibodies to polio but not measles, mumps, rubella, varicella-zoster virus, tetanus, diphtheria, pertussis, or hepatitis B. This loss of immunologic memory appears to be a rarely described side effect of ALL chemotherapy. There is currently no protocol to evaluate the immunologic memory of patients who underwent chemotherapy for ALL or to revaccinate them after their treatment. It is unclear whether the loss of immunologic memory is genuinely rare or is underdiagnosed because affected patients are protected by herd immunity.

  18. A prescription for clinical immunology: the pills are available and ready for testing. A review.

    PubMed

    Parker, William; Perkins, Sarah E; Harker, Matthew; Muehlenbein, Michael P

    2012-07-01

    Modern immunology has been extremely successful in elucidating many features of the immune system, but not in stemming pandemics of non-infectious, immune-related disease associated with industrialized populations. These pandemics involve a broad range of allergic, autoimmune, and inflammatory diseases, potentially including neuroinflammatory-associated disorders. It is the purpose of this review to outline the literature pointing toward the causes and potential treatments of these problems. A wide range of evidence from the fields of clinical medicine, biomedical research, evolutionary biology, anthropology, epidemiology, immunology, and ecology point to the conclusion that pandemics of non-infectious, immune-related conditions arise from consequences of industrialization. Primary among these consequences is the loss of helminths from the ecosystem of the human body, the 'human biome'. In this view, helminths comprise a 'keystone species' of the human biome, and their loss is profoundly felt as pandemics of non-infectious, immune-related disease. Fortunately, evidence indicates that the consequences of industrialization that cause immune disease, such as helminth depletion, can be effectively avoided. Using this approach, it is expected that further pandemics of immune disease may be prevented, although it remains to be established whether prophylaxis rather than treatment of disease is required for some disorders. Thus, it is predicted that those who will succeed in curing and preventing immune-related disease will focus on addressing 'evolutionary mismatches' rather than simply on the molecular and genetic underpinnings of immunological disorders.

  19. Immunological Demyelination Triggers Macrophage/Microglial Cells Activation without Inducing Astrogliosis

    PubMed Central

    Sears-Kraxberger, Ilse; Keirstead, Hans S.

    2013-01-01

    The glial scar formed by reactive astrocytes and axon growth inhibitors associated with myelin play important roles in the failure of axonal regeneration following central nervous system (CNS) injury. Our laboratory has previously demonstrated that immunological demyelination of the CNS facilitates regeneration of severed axons following spinal cord injury. In the present study, we evaluate whether immunological demyelination is accompanied with astrogliosis. We compared the astrogliosis and macrophage/microglial cell responses 7 days after either immunological demyelination or a stab injury to the dorsal funiculus. Both lesions induced a strong activated macrophage/microglial cells response which was significantly higher within regions of immunological demyelination. However, immunological demyelination regions were not accompanied by astrogliosis compared to stab injury that induced astrogliosis which extended several millimeters above and below the lesions, evidenced by astroglial hypertrophy, formation of a glial scar, and upregulation of intermediate filaments glial fibrillary acidic protein (GFAP). Moreover, a stab or a hemisection lesion directly within immunological demyelination regions did not induced astrogliosis within the immunological demyelination region. These results suggest that immunological demyelination creates a unique environment in which astrocytes do not form a glial scar and provides a unique model to understand the putative interaction between astrocytes and activated macrophage/microglial cells. PMID:24319469

  20. 21 CFR 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Immunomagnetic circulating cancer cell selection... Associated Antigen immunological Test Systems § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system. (a) Identification. An immunomagnetic circulating cancer cell selection and enumeration...

  1. 21 CFR 866.5660 - Multiple autoantibodies immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... 866.5660 Section 866.5660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when...

  2. 21 CFR 866.5660 - Multiple autoantibodies immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... 866.5660 Section 866.5660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when...

  3. 21 CFR 866.5660 - Multiple autoantibodies immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    .... 866.5660 Section 866.5660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when...

  4. 21 CFR 866.5660 - Multiple autoantibodies immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    .... 866.5660 Section 866.5660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when...

  5. 21 CFR 866.5735 - Prothrombin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  6. 21 CFR 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Immunomagnetic circulating cancer cell selection... Associated Antigen immunological Test Systems § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system. (a) Identification. An immunomagnetic circulating cancer cell selection and enumeration...

  7. 21 CFR 866.5150 - Bence-Jones proteins immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of... disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody... plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination...

  8. 21 CFR 866.5150 - Bence-Jones proteins immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of... disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody... plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination...

  9. 21 CFR 866.5150 - Bence-Jones proteins immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of... disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody... plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination...

  10. 21 CFR 866.5150 - Bence-Jones proteins immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of... disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody... plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination...

  11. 21 CFR 866.5150 - Bence-Jones proteins immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of... disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody... plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination...

  12. 21 CFR 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Immunomagnetic circulating cancer cell selection... Associated Antigen immunological Test Systems § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system. (a) Identification. An immunomagnetic circulating cancer cell selection and enumeration...

  13. 21 CFR 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Immunomagnetic circulating cancer cell selection... Associated Antigen immunological Test Systems § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system. (a) Identification. An immunomagnetic circulating cancer cell selection and enumeration...

  14. 21 CFR 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Immunomagnetic circulating cancer cell selection... Associated Antigen immunological Test Systems § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system. (a) Identification. An immunomagnetic circulating cancer cell selection and enumeration...

  15. Tests for sensitisation in occupational medicine practice--the soy bean example.

    PubMed

    Roodt, L; Rees, D

    1995-06-01

    To determine the prevalence of sensitisation to soy bean measured by specific IgE and skin prick tests (SPTs) and to examine the association between evidence of sensitisation to soy bean allergens and symptoms of allergic disease. Cross-sectional study. Questionnaire survey. A venous blood sample was taken for specific IgE testing, and SPTs for common allergens and soy bean dust were performed. Soy bean mill. A volunteer sample of 22 workers exposed to soy bean dust; the first 20 non-exposed workers presenting to the National Centre for Occupational Health clinic formed the control group. Immunological tests for sensitisation and symptoms of respiratory and allergic disease. Eight of the exposed workers had positive skin reactions to either full-fat or defatted soy bean. None of the controls was SPT-positive. Eight of the exposed workers had increased levels of soy-specific IgE of whom only 4 were SPT-positive and had an increased level of soy-specific IgE. One of the control workers had an increased level of soy-specific IgE. Workers with an increased specific IgE or SPT positive to soy bean did not have more symptoms than workers with negative tests. However, work-related breathlessness was significantly higher in the exposed group (P < 0.05). The data suggest that the immunological tests for sensitisation were not useful in identifying workers with soy bean-related disease but that tests for sensitisation were linked to exposure.

  16. Clinical trial tests first-in-class bifunctional immunotherapy drug in HPV-associated cancers | Center for Cancer Research

    Cancer.gov

    HPV-associated cancers that spread or do not respond to treatment are often incurable. Julius Strauss, M.D., of the Laboratory of Tumor Immunology and Biology is testing a first-in-class bifunctional immunotherapy to see if it can control the growth of HPV-associated tumors by restoring and improving the immune system’s ability to kill cancer cells.

  17. Implantation in assisted reproduction: a look at endometrial receptivity.

    PubMed

    Fatemi, H M; Popovic-Todorovic, B

    2013-11-01

    Implantation failure in assisted reproduction is thought to be mainly due to impaired uterine receptivity. With normal uterine anatomy, changes in endocrine profile during ovarian stimulation and medical conditions of the mother (i.e. thrombophilia and abnormal immunological response) could result in a non-receptive endometrium. High oestradiol concentrations during ovarian stimulation lead to premature progesterone elevation, causing endometrial advancement and hampering implantation, which can be overcome by a freeze-all approach and embryo transfer in natural cycles or by milder stimulation protocols. Patients with recurrent implantation failure (RIF) should be tested for inherited and acquired thrombophilias. Each patient should be individually assessed and counselled regarding therapy with low-molecular-weight heparin (LMWH). Empirical treatment with LMWH, aspirin or corticosteroids is not effective for women with RIF who have negative thrombophilic tests. If thrombophilic tests are normal, patients should be tested for immunological causes. If human leukocyte antigen dissimilarity is proven, treatment with intravenous immunoglobulin might be beneficial. Preliminary observational studies using intralipid infusion in the presence of increased natural killer cytotoxic activity are interesting but the proposed rationale is controversial and randomized controlled trials are needed. Hysteroscopy and/or endometrial scratching in the cycle preceding ovarian stimulation should become standard for patients with RIF. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  18. Immunodiagnosis of sheep infections with Echinococcus granulosus: in 35 years where have we come?

    PubMed

    McManus, D P

    2014-03-01

    W. K. Yong and D. D. Heath published in 1979 a seminal paper in the first issue of Parasite immunology describing their efforts to determine whether the arc 5 precipitin band, formed when test human serum is reacted against electrophoresed hydatid cyst fluid antigen, would be a suitable immunodiagnostic test for the identification of sheep infected with Echinococcus granulosus. Although they found antibodies to arc 5 in the sera of hydatid-infected sheep, the sera of some sheep harbouring Taenia ovis and T. hydatigena also precipitated the hydatid cyst fluid arc 5 antigen, so they concluded arc 5 antibodies were not suitable for the specific immunodiagnosis of E. granulosus infection in sheep in New Zealand. Subsequent work has shown that the existence of multiple infections with different taeniid species, antigenic cross-reactivity between these related parasites and the low level of specific antibody response to infection continue to hinder efforts to improve the diagnosis of hydatid infection in sheep and other natural intermediate hosts, thereby preventing the development of any practical test. In particular, the poor antibody response of ruminants to naturally acquired hydatid infection may prove an insurmountable barrier in future efforts to develop a reliable and accurate immunological test. © 2013 John Wiley & Sons Ltd.

  19. Laboratory diagnosis of ophthalmic sarcoidosis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Weinreb, R.N.; Tessler, H.

    Because the eye is involved in about 25% of patients with active sarcoid, the ophthalmologist is often the first physician to see these patients. Although clinical findings may suggest sarcoid, laboratory tests (e.g., x-ray, skin tests, blood chemistries, etc.) may be normal or inconclusive. Thus, it is important that the ophthalmologist be aware of the availability and limitations of the various biochemical, immunological, radiological, and histopathological tests that contribute to the early diagnosis of sarcoidosis. The authors review diagnostic procedures and present a flowchart detailing indications for each.

  20. Medical immunology: two-way bridge connecting bench and bedside.

    PubMed

    Rijkers, Ger T; Damoiseaux, Jan G M C; Hooijkaas, Herbert

    2014-12-01

    Medical immunology in The Netherlands is a laboratory specialism dealing with immunological analyses as well as pre- and post-analytical consultation to clinicians (clinical immunologists and other specialists) involved in patients with immune mediated diseases. The scope of medical immunology includes immunodeficiencies, autoimmune diseases, allergy, transfusion and transplantation immunology, and lymphoproliferative disorders plus the monitoring of these patients. The training, professional criteria, quality control of procedures and laboratories is well organized. As examples of the bridge function of medical immunology between laboratory (bench) and patient (bedside) the contribution of medical immunologists to diagnosis and treatment of primary immunodeficiency diseases (in particular: humoral immunodeficiencies) as well as autoantibodies (anti-citrullinated proteins in rheumatoid arthritis) are given. Copyright © 2014 Elsevier B.V. All rights reserved.

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