Diagnostic microbiology and infectious disease · 2026
Evaluation of the clinical performance of the JETest Influenza A/B Antigen Rapid Test Kit versus real-time reverse transcription-PCR for influenza detection.
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Chen Yu-Tung, Chen Ming-Hao, Chin Kuan-Chen, Chien Chiang-Ting, Shen Thomas Yen-Shih, Hung Chung-Chih, Yu Ping-Hsun
Аннотация
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.
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.