Evaluation of the analytical and clinical performance of two RT-PCR based point-of-care tests; Cepheid Xpert® Xpress CoV-2/Flu/RSV plus and SD BioSensor STANDARD™ M10 Flu/RSV/SARS-CoV-2
Journal of Clinical Virology(2024)
摘要
Background
Rapid and accurate detection of viral respiratory infections is important for infection control measures. This study compares the analytical and clinical performance of the Xpert® Xpress CoV-2/Flu/RSV plus test (“Xpert”, Cepheid) and the STANDARD™ M10 Flu/RSV/SARS-CoV-2 test (“M10”, SD Biosensor). Both tests are quadruplex RT-PCR assays for rapid diagnosis of SARS-CoV-2, influenza A/B and RSV.
Study design
Analytical sensitivities were determined by limit of detection for SARS-CoV-2, influenza A, influenza B and RSV, respectively. Additionally, the clinical performance of the Xpert and the M10 tests was evaluated against standard-of-care RT-PCR by testing of 492 clinical specimens.
Results
The analytical sensitivities for Xpert versus M10 test was 10, 50, 50 and 300 versus 300, 200, 800 and 1500 copies/mL for SARS-CoV-2, influenza A, influenza B and RSV, respectively. Clinical sensitivity for the Xpert test was superior across all four pathogens compared to the M10 test. Xpert showed clinical sensitivity of 100% in all Ct-ranges for all four pathogens whereas M10 showed clinical sensitivity of 100% in the 25-30 Ct-range, 84-100% in the 30-35 Ct-range and 47-67% in the ˃35 Ct-range across the four pathogens. Translating into real-life clinical sensitivity, the Xpert would detect 100% of all four pathogens, whereas M10 would detect 92.1, 92.4, 84.8 and 94.7% for SARS-CoV-2, influenza A, influenza B and RSV.
Conclusion
This study demonstrates improved analytical and clinical performance of Xpert Xpress CoV-2/Flu/RSV plus compared to STANDARD M10 Flu/RSV/SARS-CoV-2, which is important for ensuring accuracy of diagnosis at all stages of a respiratory infection.
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关键词
Molecular point-of-care test,GeneXpert,STANDARD M10,SARS-CoV-2,Influenza A/B,RSV
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