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Indication -
Hepatitis B virus (HBV) infection
Hepatitis B surface antigen (HBsAg)
Assay formats
Immunoassay
Status history
First added in 2018
Changed in 2020
Purpose type
Screening
Purpose
To screen blood donations for HBV
Specimen types
Plasma, Serum
WHO prequalified or recommended products
Public reports of WHO prequalified IVDs https://extranet.who.int/pqweb/vitro-diagnostics/prequalification-reports/whopr?field_whopr_category=63
WHO supporting documents
Screening donated blood for transfusion-transmissible infections: recommendations (2009) http://apps.who.int/iris/handle/10665/44202
Technical specifications for procurements
This tool presents technical specifications for 16 IVD tests for HBV. To review the one(s) of your interest, download the file and go to the “Test menu” tab to make your selection. You will find more details in the “Content” tab of this file.
Codes
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.