Abstract
Background and ObjectivesThis study was conducted by the International Consortium for Blood Safety (ICBS) to identify high-quality test kits for detection of hepatitis B virus (HBV) surface antigen (HBsAg) for the benefit of developing countries.Materials and MethodsThe 70 HBsAg test kits from around the world were evaluated comparatively for their clinical sensitivity, analytical sensitivity, sensitivity to HBV genotypes and HBsAg subtypes, and specificity using 394 (146 clinical, 48 analytical and 200 negative) ICBS Master Panel members of diverse geographical origin comprising the major HBV genotypes A-F and the HBsAg subtypes adw2,4, adr and ayw1-4.ResultsSeventeen HBsAg enzyme immunoassay (EIA) kits had high analytical sensitivity <0·13 IU/ml, showed 100% diagnostic sensitivity, and were even sensitive for the various HBV variants tested. An additional six test kits had high sensitivity (<0·13 IU/ml) but missed HBsAg mutants and/or showed reduced sensitivity to certain HBV genotypes. Twenty HBsAg EIA kits were in the sensitivity range of 0·13–1 IU/ml. The other eight EIAs and the 19 rapid assays had analytical sensitivities of 1 to >4 IU/ml. These assays were falsely negative for 1–4 clinical samples and 17 of these test kits showed genotype dependent sensitivity reduction. Analytical sensitivities for HBsAg of >1 IU/ml significantly reduce the length of the HBsAg positive period which renders them less reliable for detecting HBsAg in asymptomatic HBV infections. Reduced sensitivity for HBsAg with genetic diversity of HBV occurred with genotypes/subtypes D/ayw3, E/ayw4, F/adw4 and by S gene mutants. Specificity of the HBsAg assays was ≥99·5% in 57 test kits and 96·4–99·0% in the remaining test kits.ConclusionDiagnostic efficacy of the evaluated HBsAg test kits differed substantially. Laboratories should therefore be aware of the analytical sensitivity for HBsAg and check for the relevant HBV variants circulating in the relevant population.
Highlights
Hepatitis B virus (HBV) is the most common, chronic viral infection globally
Hepatitis B surface antigen (HBsAg) is a key marker for screening and laboratory diagnosis of hepatitis B virus (HBV) infection and the first serological marker to appear during the course of HBV infection
Genotypes A and D have global distribution, genotypes B and C predominate in East and Southeast Asia, genotype E is in West Africa, genotype F is found in the indigenous population of Central and South America, genotype G has been found in France and USA [20], and genotype H is restricted to Central and South America [15,21]
Summary
Hepatitis B virus (HBV) is the most common, chronic viral infection globally. Approximately two billion people worldwide are affected and about 350 million have active chronic HBV infection [1,2]. Laboratories testing blood samples for HBV are increasingly required to recognize the different HBV genotypes and subtypes and to detect very low levels of hepatitis B surface antigen. It has been recommended that Regulatory Authorities devise panels for kit evaluation that include HBsAg-reactive specimens with subtypes and genotypes from their local regions [22]. To meet these needs, the International Consortium for Blood Safety (ICBS). This study was conducted by the International Consortium for Blood Safety (ICBS) to identify high-quality test kits for detection of hepatitis B virus (HBV) surface antigen (HBsAg) for the benefit of developing countries
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