Rapid Tests for Influenza, Respiratory Syncytial Virus, and Other Respiratory Viruses: A Systematic Review and Meta-analysis

Abstract

Rapid diagnosis of respiratory virus infections contributes to patient care. This systematic review evaluates the diagnostic accuracy of rapid tests for the detection of respiratory viruses. We searched Medline and EMBASE for studies evaluating these tests against polymerase chain reaction as the reference standard. Of 179 studies included, 134 evaluated rapid tests for influenza viruses, 32 for respiratory syncytial virus (RSV), and 13 for other respiratory viruses. We used the bivariate random effects model for quantitative meta-analysis of the results. Most tests detected only influenza viruses or RSV. Summary sensitivity and specificity estimates of tests for influenza were 61.1% and 98.9%. For RSV, summary sensitivity was 75.3%, and specificity, 98.7%. We assessed the quality of studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) checklist. Because of incomplete reporting, the risk of bias was often unclear. Despite their intended use at the point of care, 26.3% of tests were evaluated in a laboratory setting. Although newly developed tests seem more sensitive, high-quality evaluations of these tests are lacking.

Burden of influenza among hospitalized febrile children in Ghana

“…The use of rapid diagnostic influenza tests in the study setting would help to distinguish influenza from other febrile infections and would identify the causative agent for the substantial number of hospitalized SARI cases, which otherwise remain undiagnosed. However, rapid diagnostic influenza tests have shown low sensitivities in a recently published meta‐analysis and therefore must be interpreted with caution …”

Evaluation of a two-stage testing algorithm for the diagnosis of respiratory viral infections

“…Because patients testing positive by Sofia® did not undergo further testing, we could not determine the true sensitivity and specificity of this test compared to FilmArray®. Previous studies have shown Sofia® specificity to be high, with a recent meta-analysis reporting a pooled specificity of 95.3% but sensitivity of only 75.3% for influenza A & B, and pooled specificity of 97.8% and sensitivity of 80% for RSV (Bruning et al, 2017;Gomez et al, 2015;Hazelton et al, 2015;Noh et al, 2015). Similarly, we assumed that all patients testing negative by PCR were true negatives; it is possible that some of these patients could have had false negative tests, i.e.…”

“…The Sofia® Fluorescent Immunoassay is a rapid, relatively inexpensive lateral flow assay for influenza A and B. It is reported to have a high specificity (94-98.3%) but low sensitivity (72.4-74%) compared to molecular assays (Bruning et al, 2017;Gomez et al, 2015;Hazelton et al, 2015;Noh et al, 2015). It requires less than 5 minutes hands-on setup time and has a 10-15 minute run-time.…”

“…Older diagnostic modalities such as serology, viral cultures, enzyme immunoassay and immunofluorescence tests are fraught with problems like poor sensitivity and slow turn-around time (Caliendo, 2011). Many institutions have relied on rapid antigen immunoassay tests, which are specific and can produce a result in a clinically useful timeframe, but lack sensitivity and are unable to detect other pathogens, limiting their utility in times of low influenza prevalence (Bruning et al, 2017). The revolution in the development, commercialization and dissemination of molecular multiplex assays for the rapid and accurate detection of respiratory viruses over the last decade has been a major step forward and has led to a greater appreciation of their ubiquity and contribution to many disease states (Gaydos, 2013;Gelfer et al, 2015;Varkey and Varkey, 2008).…”

Performance evaluation of the Panther Fusion® respiratory tract panel

“…Amplification curves were re-evaluated and all exhibited low-fluorescence, which could result in ambiguous interpretation. It is not uncommon that multiplex syndromic PCR panels are less sensitive compared to well-established LDT assays [17,18]. These syndromic panels often are dependent on uniformed nucleic acid isolation and PCR procedures, which are a trade-off between sensitivity and consolidation.…”