Hepatitis B Surface Antigen Assays: Operational characteristics (Phase I). Report 2; 2004 (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 the detection of Hepatitis B surface antigen (HBsAg). This second report presents the findings of the Phase I evaluations of 5 HBsAg assays conducted between September 2001 and January 2004. The HBsAg assays evaluated included: • Enzygnost HBsAg 5.0 (Dade Behring 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 HBsAg 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. Annexes 1, 2 and 3 show, respectively, the algorithm for characterization of the WHO HBsAg panel, the cumulative list of assays evaluated and the addresses of the manufacturers of the assays evaluated. This report contains Phase I assessments of enzyme linked immunosorbent assays (ELISAs). The previous report, Operational Characteristics Report 1 (WHO/BCT/BTS/01.4) contains the assessments of 10 simple/rapid HBsAg assays. Copies of these reports are available on request from the Department of Essential Health Technologies (EHT), World Health Organization, 1211 Geneva 27, Switzerland. |