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Disease/health condition -
Influenza A and B infection
Influenza A and B nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2019
Changed in 2024
Purpose type
Diagnosis
Purpose
To diagnose influenza in patients with suspected severe influenza virus infection.
Specimen types
Upper respiratory specimens (e.g., Nasal swab, Nasopharyngeal swab, Nasopharyngeal aspirate or wash)
WHO prequalified or recommended products
N/A
GMDN
47277
Influenza A/B 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 nucleic acid from influenza A virus and/or influenza B virus 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 2005-2024EMDN
W0105040504
INFLUENZA & PARA INFLUENZA - 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/emdnWHO supporting publications
World Health Organization. (2024). Clinical practice guidelines for influenza. World Health Organization. https://iris.who.int/handle/10665/378872
Technical specifications
N/A
Related Medical Devices in MeDevIS
The SAGE IVD recommended inclusion on the EDL of the PCR test for influenza, noting that it is the most sensitive rapid influenza test for both clinical management and surveillance. They further recommended that point-of-care tests could be used in the primary care settings as well as in district hospitals and in secondary and tertiary care facilities.
Clinical diagnosis of influenza is difficult because the manifestations are often nonspecific. PCR for influenza is the most sensitive rapid test and is widely held to be the reference standard for detection of influenza-specific RNA, with high sensitivity and high specificity. PCR is also necessary for surveillance in national hospitals and reference laboratories. Their uptake in LMICs is, however, limited by economic factors and lack of infrastructure and training.
There is strong evidence for the high accuracy of nucleic acid amplification tests (NAATs). In a meta-analysis of 13 studies of NAATs, the estimated sensitivity for detecting influenza A was 91.6% (84.9 ; 95.9), and that for detecting influenza B was 95.4% (87.3% ; 98.7%). The pooled specificity was about 99% (3).
World Health Organization. (2019). The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (including the second WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/329527