Export
Indication -
Hepatitis B virus (HBV) infection
IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc)
Assay formats
Immunoassay
Status history
First added in 2018
Changed in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of acute HBV infection in the context of outbreak investigation
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
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
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.