Hepatitis C Assays: Operational Characteristics (Phase I). Report 2; 2001 (Sólo inglés)

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 second report presents the findings of the Phase I evaluations of five anti-HCV assays and the assays used as reference tests. The work was conducted between the 4th quarter 2000 and the 1st quarter 2001. The anti-HCV assays evaluated and the reference tests included:

Group 1: Simple/Rapid tests and confirmatory assays: Tables 1-5
· GENEDIA® HCV Rapid (Green Cross Life Science Corp.)
· 4 th Generation HCV TRI-DOT (J. Mitra & Co. Ltd.)
· INNO-LIA™ HCV Ab III update (Innogenetics)
· CHIRON* RIBA* HCV 3.0 SIA (Chiron) (used as reference test)

Group 2: ELISA tests: Tables 6-10
· 3 rd Generation HCV Microlisa (J. Mitra & Co. Ltd)
· Innotest HCV Ab III (Innogenetics)
· Innotest ® HCV Ab IV(Innogenetics)
· Ortho® HCV 3.0/Enhanced SAVe (Ortho-Clinical Diagnostics) (used as reference test)
· Monolisa® anti-HCV PLUS (Bio-Rad) (used as reference test)

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 analysis of the assay evaluations are contained in the tables and figures in section 5. Annex 1, 2 and 3 show respectively, the algorithm for characterization of the WHO HCV panel, the cumulative list of assays evaluated and the addresses of manufacturers of the assays evaluated.

This second report contains Phase I assessments of two simple/rapid tests, 4th Generation HCV TRIDOT and GENEDIA® HCV Rapid, and three enzyme linked immunosorbent assays (ELISA), 3rd Generation HCV Microlisa, Innotest HCV Ab III and Innotest ® HCV Ab IV. Four reference assays were also included in the report for comparative purposes. 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.