Diagnostic Accuracy of the Quidel Sofia Rapid Influenza Fluorescent Immunoassay in Patients with Influenza-like Illness: A Systematic Review and Meta-analysis

BACKGROUND: Although the Quidel Sofia rapid influenza fluorescent immunoassay (FIA) is widely used to identify influenza A and B, the diagnostic accuracy of this test remains unclear. Thus, the objective of this study was to determine the diagnostic performance of this test compared to reverse transcriptase-polymerase chain reaction. METHODS: A systematic literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register. Pooled sensitivity, specificity, diagnostic odds ratio (DOR), and a hierarchical summary receiver-operating characteristic curve (HSROC) of this test for identifying influenza A and B were determined using meta-analysis. A sensitivity subgroup analysis was performed to identify potential sources of heterogeneity within selected studies. RESULTS: We identified 17 studies involving 8,334 patients. Pooled sensitivity, specificity, and DOR of the Quidel Sofia rapid influenza FIA for identifying influenza A were 0.78 (95% confidence interval [CI], 0.71–0.83), 0.99 (95% CI, 0.98–0.99), and 251.26 (95% CI, 139.39–452.89), respectively. Pooled sensitivity, specificity, and DOR of this test for identifying influenza B were 0.72 (95% CI, 0.60–0.82), 0.98 (95% CI, 0.96–0.99), and 140.20 (95% CI, 55.92–351.54), respectively. The area under the HSROC for this test for identifying influenza A was similar to that for identifying influenza B. Age was considered a probable source of heterogeneity. CONCLUSION: Pooled sensitivities of the Quidel Sofia rapid influenza FIA for identifying influenza A and B did not quite meet the target level (≥80%). Thus, caution is needed when interpreting data of this study due to substantial between-study heterogeneity.