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Disease/health condition - Hepatitis B virus (HBV) infection, Hepatitis D virus (HDV) infection
Quantitative HDV nucleic acid amplification test
Setting:
2. Laboratory
Tiered Testing Service:
National reference laboratory
Assay format
NAAT
Information History
First added in 2024
Purpose type
Diagnosis
Purpose
To diagnose active HDV infection in patients serologically positive for HDV.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN

48400

Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis D virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

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

W0105020406

HEPATITIS DELTA VIRUS - NA REAGENTS

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
Noting concerns about cost and available evidence, including on performance regarding genotypes, SAGE IVD recommended conditional listing of the quantitative hepatitis D nucleic acid amplification test in 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 a NAAT as assay format;
• using serum and plasma as specimen type;
• to diagnose active HDV infection in patients serologically positive for HDV.
The application proposed a NAT for hepatitis D virus infection. HDV RNA molecular testing is the reference standard for diagnosing active HDV infection. It is mainly used after positive serological testing as a confirmatory measure to monitor treatment response. The test has high diagnostic specificity and sensitivity for active infection detection. Concerns were raised about the test’s cost–effectiveness and its clinical utility. There were also concerns about the risk of bias in the studies reviewed for evidence. A SAGE IVD member noted the need for more data on analytic performance regarding genotypes. It was stressed that the test should be used for patients serologically positive for HDV as part of an algorithm (hepatitis B testing followed by hepatitis D virus antibody and then the nucleic acid test). Some members noted that this test complemented the hepatitis D immunoassay that the Group had earlier recommended for inclusion in the EDL 5. The majority of the SAGE IVD favoured conditional listing of the test.
One systematic review and meta-analysis on HDV RNA performance for diagnosis of active HDV infection was available (Chen 2023 ) which included literature published up to Jun 2022. Ten studies with 1213 patients were included. Eight of these had a case-control design, four of these were judged to be at high risk of bias. Six studies were at high risk of bias for at least one domain. Seven of the included studies used real time polymerase chain reaction, one study (published in 1986) used a hybridization assay, and two used a novel droplet digital PCR. The summary sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio of these various HDV RNA assays combined for HDV diagnosis were 0.92 (95% CI: 0.87–0.95); 0.90 (95% CI: 0.86–0.93); 7.74 (95% CI: 5.31–11.29); 0.10 (95% CI: 0.06–0.18) and 99.90 (95% CI: 47.08–211.99), respectively. Diagnostic performance of HDV RNA is good, but several included studies are at high risk of bias. The sample size is substantial, hence there is limited uncertainty on imprecision surrounding the accuracy estimates. There is no evidence on clinical utility and cost-effectiveness of HDV RNA.
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)