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1
ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory

... Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) Tradename: ABBOTT PRISM HBsAg ...

Center for Biologics Evaluation and Research (CBER)

2
PRODUCT CORRECTION: ABBOTT PRISM Reaction Trays

... time (DT) error codes when using ABBOTT PRISM HBsAg (List Number 06D19) and ABBOTT PRISM HIV O Plus (List Number 03L68) assays and the ABBOTT PRISM Reaction ...

Center for Biologics Evaluation and Research (CBER)

3
July 18, 2006 Approval Letter - ABBOTT PRISM HBsAg; ABBOTT PRISM ...

... We have approved your biologics license application for Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) and Antibody to Hepatitis B Surface ...

Center for Biologics Evaluation and Research (CBER)

4
ABBOTT PRISM@ HBsAg

... Confinnatory, BL 103766 Ver 1.1 Page 3. d. 3 Bottles (l0.4 mL each) Positive Calibrator (Human). Recalcified, inactivated plasma ...

Center for Biologics Evaluation and Research (CBER)

5
ABBOTT PRISM HBcore

... ABBOTT PRISM HBcore. Proper Name: Hepatitis B Virus Core Antigen (E.coli, Recombinant) Tradename: ABBOTT PRISM HBcore Manufacturer ...

Center for Biologics Evaluation and Research (CBER)

6
Abbott Prism Positive Run Control Kit - label

Page 1. 1 ABBOTT PRISM� Positive Run Control Kit List No. 3E60-11 34-3827/R7 ABBOTT PRISM Positive Run Control Kit Customer Service ...

Center for Biologics Evaluation and Research (CBER)

7
Abbott Prism Run Control Kit - label

Page 1. ABBOTT PRISM Run Control Kit 1 ABBOTT LABORATORIES List No. 3E60-10 Diagnostics Division Printed in USA Abbott Park, Illinois 60064 ...

Center for Biologics Evaluation and Research (CBER)

8
Summary Basis of Approval: Hepatitis C Virus Encoded ...

Page 1. ABBOTT PRISM � HCV Summary of Basis for Approval Product Trade Name(s) ABBOTT PRISM � HCV Proper ...

Center for Biologics Evaluation and Research (CBER)

9
ABBOTT PRISM HTLV-I/HTLV-II

The ABBOTT PRISM HTLV-I/HTLV-II assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to ...

Center for Biologics Evaluation and Research (CBER)

10
Hepatitis B

... Biologics Evaluation and Research. -. Hepatitis B. -. Antibody to Hepatitis B Surface Antigen (HBsAg Assay). Auszyme Monoclonal Abbott Laboratories; ...

Center for Biologics Evaluation and Research (CBER)

11
April 30, 2010 Approval Letter - Abbott Prism Chagas

... Our STN: BL 125361/0 Abbott Laboratories Attention: Ms. Susan Sanborn Diagnostics Division, D-49C/AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-6092. ...

Center for Biologics Evaluation and Research (CBER)

12
Recall of Abbott Prism HIV O Plus

... REASON: Abbott has seen an increase in customer complaints for calibration failures when PRISM-HIV-1 Group O Positive Assay Control (2) (Symbol: OPC) is out of ...

Center for Biologics Evaluation and Research (CBER)

13
July 11, 2007 Approval Letter - Abbott PRISM HCV

... July 11, 2007. Our STN: BL 103762/0. Abbott Laboratories Attention: Susan Sanborn D-49C, AP6C/2 100 Abbott Park Road Chicago, IL 60064. Dear Ms. Sanborn: ...

Center for Biologics Evaluation and Research (CBER)

14
Sensitivities of Four New Commercial Hepatitis B Virus Surface Antigen (HBsAg) Assays in Detection of HBsAg Mutant Forms
2006-07-01

Mutations in hepatitis B virus surface antigen (HBsAg) involving amino acid substitution within the immunodominant �a� determinant may affect the performance of commercial HBsAg assays. The performances of four HBsAg assays that recently received Conformit� Europ�ene marking, Advia Centaur HBsAg (Bayer), ...

PubMed Central

15
Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants.
2007-09-21

In a multicenter study a new, fully automated Roche Diagnostics Elecsys HBsAg II screening assay with improved sensitivity to HBsAg mutant detection was compared to well-established HBsAg tests: AxSYM HBsAg V2 (Abbott), Architect HBsAg (Abbott), Advia ...

PubMed

16
Abbott Prism Positive Run Control Kit - label

... Customer Service United States: 1-877-4ABBOTT ... in accordance with local, state, and federal regulations.7,8 ... BIBLIOGRAPHY 1. US Department of Labor, Occupational ...

Center for Biologics Evaluation and Research (CBER)

17
September 18, 2009 Approval Letter - ABBOTT PRISM HIV O ...

... BLA) for Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide effective this date. ...

Center for Biologics Evaluation and Research (CBER)

18
Hepatitis C Virus Encoded Antigens (Recombinant c100-3 ...

... signal is generated by addition of an alkaline hydrogen peroxide solution. ... to the ABBOTT PRISM Operations Manual, Section 3. REAGENTS NOTE ...

Center for Biologics Evaluation and Research (CBER)

19
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal ...

... by your firm as well as the one found on your website for the ABBOTT PRISM HBcore promote the indication, sample types, reactivity and sensitivity ...

Center for Biologics Evaluation and Research (CBER)

20
Antibody to Hepatitis B Surface Antigen (Human); ABBOTT PRISM ...

... These azides may explode upon percussion, such as hammering. ... Solutions required for instrument cleaning and maintenance are described in detail in the ...

Center for Biologics Evaluation and Research (CBER)

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21
Abbott Prism Run Control Kit - label

... Sodium azide has been reported to form lead or copper azide in laboratory plumbing. These azides may explode upon percussion, such as hammering. ...

Center for Biologics Evaluation and Research (CBER)

22
Abbott Prism Chagas

... Resources for You. Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay); Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases. -. ...

Center for Biologics Evaluation and Research (CBER)

23
ABBOTT PRISM HTLV-I/HTLV-II Package Insert

... Avoid microbial and chemical contamination of samples, reagents, and equipment. ... Hjelle B, Mills R, Swenson S, et al. ...

Center for Biologics Evaluation and Research (CBER)

24
BioLife Plasma Services Experience with HBV NAT Testing

... Genetic Systems TM. 5,435,228, 27, 1 in 232,451. Abbott PRISM TM. 10,222,462, 8, 1 in 1,277,808. Abbott PRISM has reduced the NAT only yield by 5.5-fold. 5. ...

Center for Biologics Evaluation and Research (CBER)

25
January 16, 2008 Approval Letter - ABBOTT PRISM HTLV-1/HTLV-II

... of release from the Director, Center for Biologics Evaluation and Research (CBER). ... testing, packaging or labeling of Human T-Lymphotropic Virus Types I and II ...

Center for Biologics Evaluation and Research (CBER)

26
Hepatitis B Virus Core Antigen (E.coli, Recombinant) ABBOTT PRISM ...

... No. PLA# 98-0297 and ELA# 98-0365) ... off the blood cell, on the blood cell and on ... triglycerides, bilirubin, hemoglobin, protein and red blood cells), 4) assay ...

Center for Biologics Evaluation and Research (CBER)

27
ABBOTT PRISM HTLV-I/HTLV-II Package Insert

... Virus Types I and II ... in specific immunoassays.65,66 Tests based on reactivities to HTLV-I and HTLV-II type specific proteins may enable viral typing. ...

Center for Biologics Evaluation and Research (CBER)

28
ABBOTT PRISM HIV O Plus

... For the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma ...

Center for Biologics Evaluation and Research (CBER)

29
Correlation of serum hepatitis B surface antigen level with response to entecavir in na�ve patients with chronic hepatitis B.
2011-07-01

Recent studies have suggested that quantifying the serum HBsAg levels can predict the response to pegylated interferon. We aimed to determine the change in serum HBsAg levels during entecavir (ETV) treatment and the correlation with treatment response in chronic HBeAg-positive and HBeAg-negative hepatitis B patients. Serial HBsAg ...

PubMed

30
Serum hepatitis B surface antigen monitoring in long-term lamivudine-treated hepatitis B virus patients.
2011-06-01

Summary.? Serum hepatitis B virus surface antigen (HBsAg) levels have been suggested to predict interferon response in chronic hepatitis B. A few data are available on the role of HBsAg measurement in nucleos(t)ide analogues (NA) treatment. We retrospectively investigated the relation between HBsAg changes and main treatment outcomes ...

PubMed

31
The diagnosis of acute viral hepatitis A or B by microparticle enzyme immunoassay.
1991-10-01

The traditional approach to the diagnosis of viral hepatitis has been to collect a serum sample and to test it for the presence of hepatitis B surface antigen (HBsAg), IgM to the core of HBV (anti-HBc IgM) and IgM to HAV (anti-HAV IgM) by solid phase radio- or enzyme immunoassays. Microparticle enzyme immunoassay technology (IMx-Abbott Laboratories) has ...

PubMed

32
The prevalence of hepatitis B virus markers in a cohort of students in Bangui, Central African Republic
2010-07-29

BackgroundHepatitis B virus (HBV) is the major cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma. The global epidemiological scenario of HBV infection has been changing rapidly over the last two decades due to an effective immunization programme initiated by the World Health Organization. The objective of this study is to estimate the prevalence of HBV in apparently healthy young ...

PubMed Central

33
Prism Ground Experiment.
1995-03-01

... Title : Prism Ground Experiment. ... Abstract : The 3-D Imaging performance of the PRISM Demonstration System is reported. ...

DTIC Science & Technology

34
PRISM Validation
1994-06-13

... Title : PRISM Validation. ... At distances beyond the decorrelation length, PRISM performs as well as ICED and other climatological models. ...

DTIC Science & Technology

35
Industrial Advisory Board
2011-06-23

'95-'96 Roger Gordon Industrial Advisory Board Abbott Laboratories Dr. Jonathan Miller Principal Scientist Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064...

Science.gov Websites

36
Seroprevalence of hepatitis B and hepatitis C markers among children and adolescents in the south Brazilian region: metropolitan area of Florian�polis, Santa Catarina.

Hepatitis B and C are important causes of morbidity and mortality worldwide. In Brazil, according to the Ministry of Health, about 15% of population is infected by hepatitis B virus (HBV) and less than 1% by hepatitis C virus (HCV). Nevertheless, the age-specific prevalence of HBV and HCV markers remains unknown. This study aimed to determine the seroprevalence of HBV and HCV markers of infection ...

PubMed

37
Seroprevalence of hepatitis B and hepatitis C markers in adolescents in Southern Brazil.
2011-04-01

This study was carried out to determine the prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) markers among adolescents aged between 10 and 16 years old, who are elementary school students in the city of Chapec�, Santa Catarina State, Brazil. The study involved a cross-sectional survey that included 418 volunteers, from March to July, 2008. Serology comprised ...

PubMed

38
Ausab test: a radioimmunoassay in the solid phase for the detection of antibodies against HBsAg
1974-01-01

The suitability of a newly developed RIA (Ausab test, Abbott Laboratories) for the detection of antibodies against the Hepatitis B (surface) antigen (HBsAg) has been tested on 1,968 sera of blood donors. Reproducibility test and specificity test were included. During the examination the technique of the Ausab test was changed from the original ...

Energy Citations Database

40
Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime ...

... Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit. Proper ...

Center for Biologics Evaluation and Research (CBER)

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41
506003b HBsAg 3.0.fm

... which is a known reproductive toxin, photosensitizer and ... with the Ortho Summit� System Additional specificity ... performed with the Genetic Systems� HBsAg EIA ...

Center for Biologics Evaluation and Research (CBER)

42
Comparison of the technical and clinical performance of the Elecsys HBsAg II assay with the Architect, AxSym, and Advia Centaur HBsAg screening assays.
2010-05-01

South East Asia has some of the highest prevalence rates of hepatitis B virus (HBV) infection (>or=8%) in the world, and the emergence of hepatitis B surface antigen (HBsAg) mutant strains is a growing problem. Assays with the highest levels of sensitivity, including mutant detection, should be used for routine HBsAg screening. In this large multicenter ...

PubMed

43
The Utility of Strategic Nuclear Forces Through the Prism of ...
2011-05-13

... THE UTILITY OF STRATEGIC NUCLEAR FORCES THROUGH THE PRISM ... forces through the prism of Clausewitz's observations on war. The ...

DTIC Science & Technology

44
Retroreflective Phase Retardation Prisms.
1981-06-01

... of phase retardation is a function of the refractive index of the prism, the refractive ... Two phase retardation prisms have been made and evaluated. ...

DTIC Science & Technology

45
PRISM SHUTTER WITH PERIODIC OPENINGS (PRYZMOVYI ...
1967-09-21

... The construction allows precise adjustment of the rotating prism relative to the ruby crystal of the laser and relative to the other prisms. ...

DTIC Science & Technology

46
Optical Properties of Lithium Niobate Waveguides, and Prism ...
1995-04-25

... an alternative model of prism coupling based upon a ... PROPERTIES, *WAVEGUIDES, *LITHIUM NIOBATES, *PRISMS(OPTICS), MEASUREMENT ...

DTIC Science & Technology

47
Modifications and Improvements to the PRISM and PIM ...
1998-06-15

... Title : Modifications and Improvements to the PRISM and PIM Ionospheric Models. ... PRISM 2 will also have an improved data assimilation algorithm. ...

DTIC Science & Technology

48
MAGNETOSTATIC PRISM FOR ADJUSTING OF ELECTRON ...
1965-05-05

... Abstract : A magnetostatic prism is proposed for adjusting an ... Descriptors : *PRISMS(OPTICS), ELECTRON MICROSCOPES, MAGNETS, OPTICS ...

DTIC Science & Technology

49
Laying Errors Caused by Prism Mislevelment.
1973-06-01

... 3) orientation and placement of the prism and theodolite ... SIGHTS, ERRORS), GUIDED MISSILE COMPONENTS, PRISMS(OPTICS), THEODOLITES ...

DTIC Science & Technology

50
Improvements to the PRISM and PIM Ionospheric Models
1999-08-26

... related to the validation of PRISM using data from a ... MODELS, ALGORITHMS, VALIDATION, SPECIFICATIONS, ASSIMILATION, PRISMS(OPTICS). ...

DTIC Science & Technology

51
Implementation of a Constraint Machine for Prism - A Parallel ...

... Title : Implementation of a Constraint Machine for Prism - A Parallel Problem Solver. ... The constraint machine is a fourth class of machine for PRISM. ...

DTIC Science & Technology

52
DEFORMATIONS ASSOCIATED WITH THE STATE OF ...

... Descriptors : (*ROTATING PRISM CAMERAS, PRISMS(OPTICS)), (*PRISMS(OPTICS), DEFORMATION), ROTATION, STRESSES, PRISMATIC ...

DTIC Science & Technology

53
Color, Refraction - NASA

Discovering Color With a Prism ... a prism. The student will experiment with white light that is composed of a ... glass prism and observed the white light spectrum ...

NASA Website

54
Characterization of Deflagrating Munitions by Rotating Prism ...
1992-08-01

... Copy Page 3. Characterization of Deflagrating Munitions by Rotating Prism High ... Characterization of Deflagrating Munitions by Rotating Prism High ...

DTIC Science & Technology

55
An Improved Prism for Use in Laser Resonators
1981-08-01

... Performance advantages resulting from the use of these prisms include higher ... independence of performance on the refractive index of the prism. ...

DTIC Science & Technology

56
An Assessment of the Crossed Porro Prism Resonator
1980-08-01

... selection of the optical materials for fabrication of the porro prisms is influenced ... provided then the extinction ratio is limited by the porro prism as we ...

DTIC Science & Technology

57
An Assessment of the Crossed Porro Prism Resonator
1980-08-01

... Abstract : Lasers with Crossed Porro Prism Resonators are in ... Descriptors : *MIRRORS, *RESONATORS, *PRISMS(OPTICS), *LASER TARGET ...

DTIC Science & Technology

58
A Description and Analysis of the Wollaston Prism Schlieren ...
1970-07-01

... image, which is characteristic of a Wollaston prism, and its ... DESIGN), (*SUPERSONIC FLOW, VISUAL PERCEPTION), PRISMS(OPTICS), LASERS ...

DTIC Science & Technology

59
Fluid gap Glan-laser prism
1976-09-28

A Glan-laser prism polarizer is described in which spaced prisms are surrounded with an index of refraction matching fluid and the gap between the prisms is also filled with the fluid.

Energy Citations Database

60
Decreasing Levels of HBsAg Predict HBsAg Seroclearance in Patients with Inactive Chronic Hepatitis B Virus Infection.
2011-09-01

BACKGROUND & AIMS: Serum levels of hepatitis B surface antigen (HBsAg) decrease gradually during chronic hepatitis B virus (HBV) infection. We investigated the association between levels of HBsAg and HBsAg seroclearance. METHODS: We studied data from 46 patients who underwent spontaneous seroclearance of HBsAg ...

PubMed

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61
The Epidemiology of the HBsAg Carrier State.
1976-01-01

Contents: Prevalence and incidence of HBsAg in a sample of 128,000 volunteer blood donors; Questionnaire survey of HBsAg positives, anti-HBs positives and controls; A comparison of HBsAg carriers and control donors; Antigenic subspecificities testing; Pre...

National Technical Information Service (NTIS)

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