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Disease/health condition - Hepatitis B virus (HBV) infection, Hepatitis D virus (HDV) infection
Antibodies to hepatitis D virus (anti-HDV)
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Immunoassay
Information History
First added in 2024
Purpose type
Screening, Aid to diagnosis
Purpose
To screen for HDV infection and to aid in the diagnosis of acute and chronic hepatitis D infection only among people who are also HBsAg positive
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN

48397

Hepatitis D virus total antibody IVD, kit, enzyme immunoassay (EIA)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis D virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0105020403

HEPATITIS DELTA ANTIBODY (TOTAL)

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2024)‎. Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection. World Health Organization. https://iris.who.int/handle/10665/376353
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended fully listing the total antibodies to hepatitis D virus in the EDL 5:
• as a disease-specific IVD for use in health care facilities with clinical laboratories (Section II.b. Hepatitis D virus (HDV) infection and Hepatitis B virus (HBV) infection);
• using an immunoassay as say format;
• using serum and plasma as specimen type;
• to screen for HDV infection and to aid in the diagnosis of acute and chronic hepatitis D infection only among people who are also HBsAg positive.
The application proposed a test for detection of total anti-hepatitis D virus (HDV) antibodies. HDV is a co-infection with hepatitis B virus (HBV), which significantly increases the risk of liver disease, including cirrhosis and liver cancer. About 12 million people are affected globally, but accessing testing is a challenge. Anti-HDV serological tests are vital for initial screening. WHO guidelines recommend universal HDV testing for HBV-positive individuals. The test has high sensitivity (~98%) so can reliably detect HDV cases. Its specificity (~71%) indicates some risk of false positives but this is adequate for public health use. Concerns raised by the SAGE IVD included: lack of data on clinical utility and cost–effectiveness of the test; the need for additional pricing information and an access strategy for low-income countries; and concern about premature listing without available therapies for HDV in some regions. However, it was noted that including the test could lead to better understanding of the HDV burden and guide public health interventions and could prompt the inclusion of related treatments in the essential medicines lists. It also aligns with WHO’s strategy which aims to reduce new hepatitis infections by 90% and deaths by 65% between 2016 and 2030. All SAGE IVD members voted for either full or conditional listing of the test with an equal split between the two. However, one member then elected to change to full listing. Literature cited in the discussion: Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection. Geneva: World Health Organization; 2024. Available at https://iris.who.int/handle/10665/376353 (accessed 5 January 2025).
Diagnostic accuracy of total anti-HDV for hepatitis D virus revealed very high sensitivity, with reasonable specificity. IgM or IgG showed slightly lower sensitivity, while providing increased specificity. There was considerable heterogeneity between studies, with some uncertainty surrounding the point estimates. Included studies were at moderate risk of bias. There is no evidence on clinical utility and cost-effectiveness of the test.
The selection and use of essential in vitro diagnostics: report of the fifth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2024. World Health Organization. (To be published)