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

Abstract

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. We compared the diagnostic performances of this test with reverse transcriptase-polymerase chain reaction.Methods: A systematic literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register. The 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 pooled using meta-analysis. A sensitivity and subgroup analysis was used to identify potential sources of heterogeneity within the selected studies.Results: We identified seventeen studies comprising 8,334 patients. The pooled sensitivity, specificity, and DOR of the Quidel Sofia rapid influenza FIA to identify influenza A were 0.78 (95% CI, 0.71–0.83), 0.99 (95% CI, 0.98–0.99), and 251.26 (95% CI, 139.39–452.89), respectively. The pooled sensitivity, specificity, and diagnostic odds ratio of this test to identify 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 was similar for identification of influenza A and influenza B. Age was considered a probable source of heterogeneity.Conclusions: The pooled sensitivities of the Quidel Sofia rapid influenza FIA did not quite meet the target level (≥80%) for both influenza A and B. The interpretation of data should be carefully considered due to substantial between-study heterogeneity.