Hepatitis C Assays: Operational Characteristics (Phase I). Report 1; 2001 (Sólo inglés)
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In 1998, WHO implemented a programme for the evaluation of performance and major operational characteristics of commercially available assays for detection of antibodies to Hepatitis C (HCV). This first report presents the findings of the Phase I evaluations of five anti-HCV assays conducted between September and November, 1999. The anti-HCV assays evaluated included: · Advanced Quality‰ One Step HCV Test (Bionike Inc.) Section 2 of this report provides background information on the evaluations and the intended use of the evaluation results. Sections 3 and 4 present the laboratory aspects of HCV testing and describe the way in which the evaluations were conducted and the results analysed. The results and outcomes of the analyses of the assay evaluations are contained in the tables and figures in section 5. Annex 1 shows the anti-HCV confirmatory testing algorithm used to characterize the WHO HCV evaluation panel. Annexes 2 and 3 show respectively, the list of evaluated HCV assays and addresses of manufacturers for the assays evaluated. This first report contains Phase I assessments of simple/rapid tests only. Subsequent reports will be issued on a regular basis and will include results on enzyme linked immunosorbent assays (ELISA) and assays using other technologies. Copies of this report are available on request from the Blood Transfusion Safety Team, Department of Blood Safety and Clinical Technology, World Health Organization, 1211 Geneva 27, Switzerland. |