... 3. Avoid microbial contamination of specimens, reagents and water used for washing. ... be shipped ambient, refrigerated (2 to 8�C) on wet ice, or ...
Center for Biologics Evaluation and Research (CBER)
... 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 ...
Page 1. ABBOTT PRISM � HCV Summary of Basis for Approval Product Trade Name(s) ABBOTT PRISM � HCV Proper ...
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 ...
PubMed
... Product Correction: Hepatitis B Surface Antigen AUSAB EIA-Abbott Laboratories. DATE NOTIFICATION INITIATED: April 21, 2008. ... Hepatitis B Surface Antigen AUSAB EIA ...
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 ...
PubMed Central
HIVAB HIV-1/HIV-2 (rDNA) EIA is an in vitro enzyme immunoassay for the qualitative detection of antibodies to human immunodeficiency viruses ...
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 ...
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 ...
... 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: ...
... requested to submit samples of each future master lot of the product with protocols consisting of a summary of essential manufacturing data inclusive of all ...
... in compliance with applicable federal and international ... in blood donors throughout the United States has been ... US Department of Labor, Occupational Safety and ...
... In vitro qualitative enzyme immunoassay for the detection of antibodies to human T-lymphotropic virus types I and II in human serum or plasma. -. ...
Most hepatitis C testing in Uganda is performed using commercial rapid strip assays (RSA) to detect antibodies to hepatitis C virus (anti-HCV), rather than enzyme immunoassays (EIA). The prevalence of hepatitis C antibodies in a Ugandan hospital population was determined using both methods to test their accuracy using nucleic acid testing (NAT) as a ...
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 ...
Hepatitis E is a classic water-borne disease in developing countries. Detection of anti-HEV IgM and IgG antibodies, in addition to HEV RNA are useful epidemiological markers in diagnosis of hepatitis E. This study was conducted to investigate an outbreak of acute viral hepatitis in South-Pakistan. Anti-HEV IgM and IgG were assessed comparatively with serological kits manufactured by ...
An enzyme immunoassay (EIA) which utilizes a solid phase coated with a recombinant antigen (c100-3) derived from the hepatitis C virus (HCV) genome was evaluated for efficacy in the detection of antibodies to HCV (anti-HCV). The sensitivity of the antibody test was demonstrated by the detection of ...
AimsVertical transmission of HCV is increased among HIV-1/HCV coinfected women and is related to HCV viral load. In this study we assessed clinical and demographic factors associated with HCV viremia in a cohort of young pregnant and non-pregnant mothers coinfected with HIV-1.DesignA cross-sectional clinic-based ...
A commercially developed IFA system (Electro Nucleonics, Inc.) was compared to EIA (Abbott Laboratories) and WB (Bio-Rad, Inc.) for detection of HIV-1 antibodies. Of 91 EIA negative sera tested, 76 (83.5%) were negative, and 15 (16.5%) were equivocal by IFA on initial testing. Of 156 EIA positive sera tested, 18 ...
Serial carcinoembryonic antigen (CEA) levels were determined by both the Roche RIA and Abbott EIA methods in 11 patients with pancreatic cancer (9 with extrahepatic biliary obstruction); 7 with benign extrahepatic obstruction; 26 with colonic cancer without biliary obstruction; and 12 normal, non-smoking controls. The Roche/Abbott CEA ...
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 ...
... Nos. 95-012012 I & 95-O I30 LICENSING REVIEW COMMITTEE Elliot P. Cowan. Ph.D., Chairperson Sheila M. Buck, Member LLL s r, Reza Sadaie, Ph.D., Member ...
Two nonradioisotopic methods were evaluated for the determination of HCG and TSH. Two EIA TSH assays (Abbott, Hybritech) and one FEI assay (Dade) were compared to each other and an immunoradiometric (IRMA) assay. The FEI assay performed better than the EI...
National Technical Information Service (NTIS)
An enzyme immunoassay (EIA) for serum immunoglobulin M (IgM) antibodies to rubella virus based on enzyme labeling of viral antigen was developed. The sensitivity of the EIA for the detection of recent rubella virus infection was evaluated by using 115 rubella-IgM-antibody-positive serum specimens, which were confirmed as positive by Rubazyme M ...
Estrogen receptor determinations have been performed on 241 cytosols from 160 breast cancer tumors using both radioactive ligands ((/sup 3/H)-estradiol, (3H)R2858) and monoclonal antibodies (Abbott ER-EIA Kit) to compare the two methods and to evaluate the clinical usefulness of the new immunological, simplified assay. Intra- and interassay reproducibility ...
Energy Citations Database
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 ...
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, ...
Assays for human choriogonadotropin (HCG) and thyroid stimulating hormone (TSH) have typically been performed using radioisotopic procedures. Two newer, nonradioisotopic approaches, enzyme immunoassay (EIA) and fluorometric enzyme immunoassay (FEI), were evaluated for the determination of HCG and TSH. Two TSH EIA assays (Abbott, ...
Objectives. Between April and September of 2009 we evaluated the accuracy of the OraQuick hepatitis C virus (HCV) rapid antibody test and assessed its feasibility for use by community-based organizations (CBOs) serving populations at high risk for HCV in New York City. Methods. We compared the results of screening by OraQuick (oral swab) and enzyme ...
Determination of estrogen receptor content in 82 breast cancer specimens with immunocytochemical estrogen receptor assay (ER-EIA) (Abbott) was compared with our routinely used binding assay using /sup 125/I-estradiol as radioligand with Scatchard plot analysis of the binding data. Although the estrogen receptor content measured with the ...
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 ...
Following a laboratory audit, a significant number of Treponema pallidum particle agglutination assay (TPPA)-negative sera were identified when TPPA was used as a confirmatory assay of syphilis enzyme immunoassay (EIA) screening-reactive sera (SSRS). Sera giving such discrepant results were further characterized to assess their significance. A panel of 226 sera was tested by ...
Carcinoembryonic antigen (CEA) and nonspecific cross-reacting antigen (NCA) levels in draining tumour blood were compared with concentrations of these antigens in peripheral blood of patients with gastric and colonic malignancies. The controls were cases with gastric and duodenal ulcers. The results obtained by radioimmunoassay (RIA) were compared with enzyme immunoassay ...
BackgroundIn 1992-1993, the prevalence of anti-HCV among U.S. blood donors was 0.36 percent, but contemporary data on antibody and RNA prevalence are lacking.MethodsWe performed a large, cross-sectional study of blood donors at six U.S. blood centers in 2006-2007. Anti-HCV was measured by EIA followed by immunoblot, and ...
