Disease condition and impact on patients: Seasonal influenza causes disease all year, globally. Illness ranges in severity: most people recover within 1 week without requiring medical attention, but influenza can lead to hospitalization and death. Does the test meet a medical need? Molecular tests for Influenza are rapid, automated IVD tests for qualitative detection of influenza A and B in nasal or nasopharyngeal swabs or washes eluted in viral transport medium. A molecular amplification technique, e.g. PCR or isothermal amplification, is used to target and detect conserved regions of the influenza virus in the nucleic acid hybridization reaction. A test result is obtained within 10–15 min, allowing physicians and nurses to diagnose influenza and decide on treatment at a single patient visit. The performance is far more reliable than that of RDTs, but the tests are more expensive. Although the best results are obtained from a nasopharyngeal swab, which is uncomfortable to obtain from patients, molecular tests also perform well with nasal swabs, which are much easier to obtain, especially from small children. How the test is used: PCR-based influenza tests are typically used at or close to points of care as a single test in patients with suspected seasonal influenza. Some manufacturers provide multiplex PCR tests for both influenza A and B and respiratory syncytial virus A and B in the same reaction.

Prevalence: Worldwide, influenza epidemics are estimated to result in 3–5 million cases of severe illness and about 290 000–650 000 deaths from respiratory conditions. The US Centers for Disease Control and Prevention estimated that influenza has caused 9.3–49.0 million cases of illness, 140 000–960 000 hospitalizations and 12 000–79 000 deaths annually in the USA since 2010. WHO states that the estimated national influenza burden determines influenza prevention and control programmes; however, reliable data are not available for LMICs. Socioeconomic impact: The WHO project on the burden of influenza, in partnership with the Pandemic Influenza Preparedness framework, is improving understanding of the burden of influenza (1).

The WHO guideline is from 2010 and should be updated. Laboratory confirmation of influenza virus from throat, nasal and nasopharyngeal secretions or tracheal aspirate or washings is commonly done by direct antigen detection, virus isolation or detection of influenza-specific RNA by RT-PCR.

Several studies have shown that molecular tests are more accurate than RDTs; however, no recent studies were found that showed that molecular assays that give results within 15–20 min improve clinical outcomes or antimicrobial stewardship.

Only one study was found of the cost–effectiveness of rapid molecular testing for influenza (2). A decision analytical model was used to simulate the outcomes of a hypothetical cohort of elderly patients presenting with influenza-like illness at outpatient clinics in Hong Kong (China) during the peak influenza season, with rapid PCR and with clinical judgement alone. The outcome measures included direct medical cost, hospitalization rate, mortality rate, QALY loss and incremental cost per QALY saved. PCR was cost–effective in 60.6% and 99.4% of 10 000 Monte Carlo simulations of willingness to pay threshold one and three times the gross domestic product per capita, respectively. Whereas RDTs cost about US$ 15 per test, rapid molecular influenza tests cost about US$ 25 per test, and up to US$ 45 per test if they include respiratory syncytial virus.

Consent is required to obtain a sample. Like RDTs, rapid molecular tests for influenza are accessible for use in any outpatient setting, owing to their ease of use. The typical price of US$ 25 per test may limit access in LMICs.