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Summary  Early identification of chronic hepatitis  B  is important for optimal disease management and prevention of transmission. Cost and lack of access to commercial hepatitis  B  surface antigen ( HB s A g) immunoassays can compromise the effectiveness of  HBV  screening in resource‐limited settings and among marginalized populations. High‐quality point‐of‐care ( POC ) testing may improve  HBV  diagnosis in these situations. Currently available  POC HB s A g assays are often limited in sensitivity. We evaluated the NanoSign ®   HB s  POC  chromatographic immunoassay for its ability to detect  HB sAg of different genotypes and with substitutions in the ‘a’ determinant. Thirty‐seven serum samples from patients with  HBV  infection, covering  HBV  genotypes A–G, were assessed for  HB sAg titre with the Roche Elecsys  HB sAg  II  quantification assay and with the  POC  assay. The  POC  assay reliably detected  HB sAg at a concentration of at least 50 IU/mL for all genotypes, and at lower concentrations for some genotypes. Eight samples with substitutions in the  HBV  ‘a’ determinant were reliably detected after a 1/100 dilution. The  POC  strips were used to screen serum samples from 297 individuals at risk for  HBV  in local clinical settings (health fairs and outreach events) in parallel with commercial laboratory  HB sAg testing (Quest Diagnostics  EIA ).  POC  testing was 73.7% sensitive and 97.8% specific for detection of  HB sAg. Although the  POC  test demonstrated high sensitivity over a range of genotypes, false negatives were frequent in a clinical setting. Nevertheless, the  POC  assay offers advantages for testing in both developed and resource‐limited countries due to its low cost (0.50$) and immediately available results.

A simple and inexpensive point‐of‐care test for hepatitis B surface antigen detection: serological and molecular evaluation