Bibliographic information
Recommendation
For the diagnosis of chronic HBV infection in adults, adolescents and children (>12 months of age), a serological assay (in either rapid diagnostic tests or laboratory-based immunoassay format) that meets minimum quality, safety and performance standards (with regard to both analytical and clinical sensitivity and specificity) is recommended to detect hepatitis B surface antigen (HBsAg).
- In settings where existing laboratory testing is already available and accessible,
laboratory-based immunoassays are recommended as the preferred assay format.
- In settings where there is limited access to laboratory testing and/or in populations
where access to rapid testing would facilitate linkage to care and treatment, use of rapid diagnostic tests (RDTs) is recommended to improve access.
Recommended in favor
Strong
Certainty of evidence
Low
Notes and Remarks
a A full vaccination schedule including birth dose should be completed in all infants in accordance with the WHO position paper on hepatitis B vaccines from 2017. Testing of exposed infants is problematic within the first six months of life since HBsAg and hepatitis B DNA may be inconsistently detectable in infected infants. Exposed infants should be tested for HBsAg between 6 and 12 months of age to screen for evidence of hepatitis B infection. In all age groups, acute HBV infection can be confirmed by the presence of HBsAg and IgM anti-HBc. CHB is diagnosed if there is persistence of HBsAg for six months or more. b Laboratory-based immunoassays include enzyme immunoassay, chemoluminescence immunoassay, and electrochemiluminescence assay. c Assays should meet minimum acceptance criteria of either WHO prequalification of in vitro diagnostics or a stringent regulato ry review for in vitro diagnostics. All in vitro diagnostics should be used in accordance with manufacturers’ instructions for use and, where possible, at testing sites enrolled in a national or international external quality assessment scheme.
Also Featured In
This recommendation also appears in the following guidelines:
WHO guidelines on hepatitis B and C testing.