Diagnostic Accuracy of a Rapid Influenza Test for Pandemic Influenza A H1N1

BACKGROUND: With the current influenza A H1N1 pandemic (H1N1pdm), it is extremely important that clinicians can quickly and accurately identify influenza cases. METHODOLOGY/PRINCIPAL FINDINGS: To investigate the performance of the QuickVue Influenza A+B rapid test, we conducted a prospective study of the diagnostic accuracy of the QuickVue Influenza A+B test compared to real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A H1N1pdm in Nicaraguan children aged 2 to 14 years. Rapid test sensitivity and specificity compared to real-time RT-PCR were 64.1% (95% CI 53.5, 73.9) and 98.3% (95.0, 99.6), respectively. Agreement between the two tests was 86.4% (95% CI 81.7, 90.3), and kappa was calculated to be 0.67 (95% CI 0.56, 0.76). Performance of the rapid test varied by day of presentation, with a sensitivity of 41.7% (95% CI 22.1, 63.4) for samples from children presenting on the day of symptom onset and a sensitivity of 72.1% (95% CI 59.9, 82.3) for samples from children presenting one or more days post-symptom onset. CONCLUSIONS/SIGNIFICANCE: We found that the rapid test performed with moderate sensitivity and high specificity. Test performance varied by day of onset, with lower sensitivity on the day of symptom onset.