Diagnostic Accuracy of Novel and Traditional Rapid Tests Compared to Reverse-Transcription Polymerase Chain Reaction for Influenza Infection: A Systematic Review and Meta-Analysis Open Access

Background. Rapid and accurate testing for influenza can positively impact patient care. A 2012 meta-analysis assessing traditional rapid influenza diagnostic tests (RIDT) showed poor sensitivity but high specificity. Two novel classes of rapid tests, antigen detection tests with automated readers (digital immunoassays [DIAs]) and rapid nucleic acid amplification tests (NAATs) are now available, but their accuracy has not yet been systematically reviewed. Thus, we aimed to estimate and compare the pooled accuracy for influenza diagnosis of (1) traditional RIDTs, (2) DIAs, and (3) rapid NAATs.

Methods. We searched PUBMED, EMBASE, SCOPUS, and other databases through August 2015 for relevant diagnostic accuracy studies published as full-text in English, French, or Spanish. Cross-sectional and cohort studies that provided original 2 × 2 tables on the accuracy of commercialized rapid tests, i.e. results in <30 minutes, compared with reverse-transcription polymerase chain reaction as reference standard in children and adults with suspected influenza were included. Two reviewers independently screened citations and extracted data. Study quality and risk of bias were assessed using QUADAS-2. For each of the 3 types of index tests, Bayesian bivariate random effect models were used to calculate separate summary accuracy estimates with their 95% credible intervals (CrIs).

Results. We included 102 articles comprising 141 studies of individual index tests. A total of 124 studies evaluated traditional RIDTs, 12 DIAs (BD Veritor; Quidel Sofia), and 5 rapid NAATs (Alere; Cobas Liat). Pooled sensitivities and specificities for influenza A were as follows: 53.6% (95% CrI, 47.9%–59.2%) and 99.4% (95% CrI, 99.1%–99.4%) for traditional RIDTs, 80.7% (95% CrI, 73.6%–87.0%) and 98.2% (95% CrI, 97.0%–99.0%) for DIAs and 87.5% (95% CrI, 77.2%–94.4%) and 98.9% (95% CrI, 97.0%–99.8%) for rapid NAATs. Pooled sensitivities and specificities for influenza B were as follows: 48.0% (95% CrI, 36.0%–60.4%) and 99.8% (95% CrI, 99.7%–99.9%) for traditional RIDTs, 79.1% (95% CrI, 63.4%–90.0%) and 97.9% (95% CrI, 94.7%–99.2%) for DIAs, and 94.0% (95% CrI, 83.2%–98.7%) and 99.3% (95% CrI, 98.0%–99.9%) for rapid NAATs.

Conclusion. Novel DIAs and rapid NAATs demonstrate markedly higher sensitivities for influenza A and B compared with traditional RIDTs, with equally high specificities.

Disclosures. J. Papenburg, Becton, Dickenson and Co: Investigator, Research grant RPS Diagnostics: Scientific Advisor, n/a AbbVie: Scientific Advisor, n/a

Author notes