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Disease/health condition -
Hepatitis E virus (HEV) infection
IgM antibodies to hepatitis E virus (anti-HEV IgM)
Assay format
Lateral flow RDT
Information History
First added in 2022
Purpose type
Aid to diagnosis, Surveillance
Purpose
To aid in the diagnosis and surveillance of hepatitis E virus infection.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN
65766
Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin M (IgM) antibodies to the hepatitis E virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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* lateral flow test
EMDN
W0105090299
HEPATITIS VIRUSES - RT & POC - OTHER
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/emdnWHO supporting publications
World Health Organization. (2014). Waterbone outbreaks of hepatitis E: recognition, investigation and control: technical report. World Health Organization. https://iris.who.int/handle/10665/129448
Technical specifications
N/A
SAGE IVD recommended conditionally including the hepatitis E virus IgM antibody RDT category in EDL 4
• as a disease-specific IVD for use in community settings and health facilities without laboratories (EDL 4, Section I.b);
• using an RDT format;
• using capillary whole blood as specimen type;
• to aid in the diagnosis and surveillance of hepatitis E virus infection; pending the submission of more comprehensive data on performance and a clearer clinical algorithm. SAGE IVD recommended adding a note to the listing table specifying serum and plasma for laboratory settings.
• as a disease-specific IVD for use in community settings and health facilities without laboratories (EDL 4, Section I.b);
• using an RDT format;
• using capillary whole blood as specimen type;
• to aid in the diagnosis and surveillance of hepatitis E virus infection; pending the submission of more comprehensive data on performance and a clearer clinical algorithm. SAGE IVD recommended adding a note to the listing table specifying serum and plasma for laboratory settings.
Hepatitis E is an acute viral hepatitis caused by HEV infection. Most affected people recover. However, a small proportion – generally less than 5% but much higher in pregnant women – develop acute liver failure. Hepatitis E should always be considered in outbreaks of acute jaundice syndrome, which have occurred more recently across sub-Saharan Africa, and particularly in the context of internally displaced person camps.
Definitive diagnosis of hepatitis E is challenging, as causes of acute jaundice are many and include yellow fever, hepatitis A and leptospirosis. For countries experiencing outbreaks, the problem of differential diagnoses is exacerbated by lack of access to hepatitis E assays.
SAGE IVD noted the utility of the HEV IgM RDT both for surveillance and outbreaks. But the group noted that performance for RDTs for hepatitis E are generally poor. One SAGE member stressed that RDTs need to be done in combination with a system where referral-level ELISAs and NATs are available to confirm outbreaks.
The HEV IgM RDT is one of three hepatitis E assays submitted as new additions to EDL 4. The assays are all part of the clinical guidelines beyond WHO and are also mentioned in the EASL guidelines. WHO is currently updating its guidance on hepatitis E, including a performance review of hepatitis E RDTs.
Because the RDT has the advantage of solving an access issue, SAGE IVD agreed to list the test conditionally, pending additional information on performance, and guidance and consolidated algorithms from WHO.
Literature cited in the discussion:
European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis E virus infection. J Hepatol. 2018;68:1256–71 (https://www.journal- of-hepatology.eu/article/S0168-8278(18)30155-7/fulltext, accessed 14 December 2022).
HEV poses a significant clinical challenge, with a medium-high burden of disease. The diagnostic accuracy of commercially available RDTs was evaluated based on the five studies provided. Study sample sizes are often limited (< 100), and methodological quality is variable (no blinding, selection of cases and controls as opposed to cohort). The diagnostic accuracy of the RDTs, however, is high in general. There are no studies assessing the impact of the test on clinical utility or cost–effectiveness (which is not uncommon for diagnostic tests). Based on the body and quality of evidence available, it is necessary to request more high-quality studies on (indirect) effectiveness of this diagnostic test.
World Health Organization. (2023). The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/373322