Indication - Hepatitis B virus (HBV) infection
Quantitative HBV nucleic acid test
First added in 2018
Changed in 2020
To stage chronic HBV infection, to determine the need for treatment, (including use of antivirals in mother to prevent mother-to- child transmission) and to monitor response to treatment.
WHO prequalified or recommended products
WHO supporting documents
Guidelines on hepatitis B and C testing (February 2017) http://apps.who.int/iris/handle/10665/254621 ; https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
ICD11 code: 1E51.0Z
Summary of SAGE IVD recommendation
The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.