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)
... 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: ...
... ABBOTT PRISM HBcore. Proper Name: Hepatitis B Virus Core Antigen (E.coli, Recombinant) Tradename: ABBOTT PRISM HBcore Manufacturer ...
... 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 ...
Page 1. 1 ABBOTT PRISM� Positive Run Control Kit List No. 3E60-11 34-3827/R7 ABBOTT PRISM Positive Run Control Kit Customer Service ...
... Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) Tradename: ABBOTT PRISM HBsAg ...
Page 1. ABBOTT PRISM Run Control Kit 1 ABBOTT LABORATORIES List No. 3E60-10 Diagnostics Division Printed in USA Abbott Park, Illinois 60064 ...
The ABBOTT PRISM HTLV-I/HTLV-II assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to ...
... 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. ...
... 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 ...
... We have approved your biologics license application for Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) and Antibody to Hepatitis B Surface ...
The duration of hepatitis C virus (HCV) infection and the response to the standard therapy is strongly related to the HCV genotypes. In addition, the geographical distribution of HCV genotypes is important for the epidemiological studies in terms of distribution and possible risk groups. The aim of this retrospective study was to ...
PubMed
... 3. Avoid microbial contamination of specimens, reagents and water used for washing. ... be shipped ambient, refrigerated (2 to 8�C) on wet ice, or ...
... Customer Service United States: 1-877-4ABBOTT ... in accordance with local, state, and federal regulations.7,8 ... BIBLIOGRAPHY 1. US Department of Labor, Occupational ...
... BLA) for Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide effective this date. ...
... signal is generated by addition of an alkaline hydrogen peroxide solution. ... to the ABBOTT PRISM Operations Manual, Section 3. REAGENTS NOTE ...
... 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 ...
... These azides may explode upon percussion, such as hammering. ... Solutions required for instrument cleaning and maintenance are described in detail in the ...
... Sodium azide has been reported to form lead or copper azide in laboratory plumbing. These azides may explode upon percussion, such as hammering. ...
... Resources for You. Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay); Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases. -. ...
... Avoid microbial and chemical contamination of samples, reagents, and equipment. ... Hjelle B, Mills R, Swenson S, et al. ...
Early detection of hepatitis C virus (HCV) is an important step in preventing progression to cirrhosis and hepatocellular carcinoma. Serologic assays for anti-hepatitis C (anti-HCV) antibody are valuable first-line tests in the screening and diagnosis of HCV infection. The aim of this multicenter study was to compare the Elecsys(�) ...
HCV is a global healthcare problem. Diagnosis of HCV infection is mainly based on the detection of anti-HCV antibodies as a screening test on sera samples. Recombinant immunoblot assays are used as supplemental tests and in the final detection and quantification of HCV RNA in confirmatory tests. In this study, we ...
... 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. ...
... of the Positive and Negative Controls (PN) must ... Assay Inter-Assay Inter-Lot Control N OD ... II. Experimental transmission, putative virus agents and markers, and ...
... 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 ...
... 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 ...
... Confinnatory, BL 103766 Ver 1.1 Page 3. d. 3 Bottles (l0.4 mL each) Positive Calibrator (Human). Recalcified, inactivated plasma ...
... 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. ...
... 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 ...
Hepatitis C virus (HCV) infection is a serious global health problem. Interferon-alpha (IFN-alpha) and ribavirin have demonstrated efficacy in the treatment of HCV infection; however, these therapies display many side effects. To screen the anti-HCV compounds from plants, we established an in vitro model for inoculation of ...
Detection of specific antibodies against hepatitis C virus (HCV) is the most widely available test for viral diagnosis and monitoring of HCV infections. However, narrowing the serologic window of anti-HCV detection by enhancing anti-HCV IgM detection has remained to be a problem. Herein, we used LD5, a novel ...
PubMed Central
The clinical diagnosis of hepatitis C virus (HCV) infection is important to direct an accurate course of therapy. Previous studies have reported a correlation between the signal-to-cutoff (S/CO) ratios of the anti-HCV screening test and confirm HCV infections for American anti-HCV screening kits as well as for ...
The prevalence of hepatitis C virus (HCV) infection among the patients of a hemodialysis unit in Taiwan was determined by an immunoblot and reverse transcriptase-polymerase chain reaction algorithm to be 58.8% (67 of 114 patients) after serological surveys with two advanced-generation enzyme-linked immunosorbent assays (ELISAs) for anti-HCV and a C 100-3 ...
BackgroundThe anti-HCV antibody response has not been well characterized during the early phase of HCV infection and little is known about its relationship to the clinical course during this period.MethodsWe analyzed serial anti-HCV antibodies longitudinally obtained from a prospective cohort of 65 patients with acute ...
Mouse-human chimeric antibodies (cAbs) against hepatitis C virus (HCV) core, NS3 (nonstructural), NS4, and NS5 antigens were developed as quality control (QC) reagents to replace the use of human sera/plasma for Abbott HCV immunoassays. The cAb retains the mouse monoclonal antibody (MAb) specificity and affinity but still reacts in the ...
Abstract Background: Diagnostic laboratories need automation that facilitates efficient processing and workflow management to meet today's challenges for expanding services and reducing cost, yet maintaining the highest levels of quality. Methods: Processing efficiency of two commercially available automated systems for quantifying HIV-1 and HCV RNA, ...
OBJECTIVE: The aim of this study was to assess whether measurement of hepatitis C virus RNA (HCV-RNA) at 12 weeks post-treatment could predict sustained virological response (SVR) to antiviral therapy for chronic hepatitis C (pegylated interferon alfa-2a and ribavirin) in HIV-co-infected patients. PATIENTS AND METHODS: HIV-HCV co-infected patients were ...
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 ...
Because many persons with chronic hepatitis C virus (HCV) infection are asymptomatic, population based serologic studies are needed to estimate the prevalence of infection and to develop and evaluate prevention efforts. A sample of 1422 individuals was included in the study by using multistage sampling technique. Their age ranged from 4-78 years with a mean age (34.7 +/- ...
