Evaluation of the clinical performance of the JETest Influenza A/B Antigen Rapid Test Kit versus real-time reverse transcription-PCR for influenza detection.

BACKGROUND: The JETest Influenza A/B Antigen Rapid Test Kit is an in vitro diagnostic kit for detecting influenza A/B nucleoproteins in nasopharyngeal swab specimens. This study aims to verify the clinical performance of the kit compared with the real-time reverse transcription-PCR approach (the Cepheid Xpert® Xpress Flu/RSV assay kit). METHODS: Clinical specimens were collected using two nasopharyngeal swabs from each participant by healthcare professionals. One specimen was tested using a rapid influenza diagnostic test (RIDT), specifically the JETest Influenza A/B Antigen Rapid Test Kit; meanwhile, the result of the other specimen was confirmed by real-time reverse transcription-PCR (RT-PCR) to verify the true-positive or true-negative status of influenza A/B infection. Thereafter, the positive/negative percent agreements were calculated by comparing the test results of both methods. RESULTS: 118 patients were included in the study. For influenza A virus detection, the JETest demonstrated a positive percent agreement (PPA) of 85.5% (53/62) (95% CI: 74.2% - 93.1%) and a negative percent agreement (NPA) of 98.2% (55/56) (95% CI: 90.5% - 99.9%). For influenza B virus detection, the JETest demonstrated a PPA of 90.3% (28/31) (95% CI: 74.3% - 98.0%) and an NPA of 97.7% (85/87) (95% CI: 91.9% - 99.7%). CONCLUSION: The clinical performance of the JETest influenza A/B Antigen Rapid Test Kit met the U.S. FDA clinical performance criteria for rapid influenza diagnostic tests and can serve as a reliable clinical aid in the diagnosis of influenza.