STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays.

Abstract

The demand for assays that can rapidly and accurately detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains high. We evaluated the performance of two rapid real-time reverse transcription polymerase chain reaction (RT-qPCR) assays (STANDARD M10 SARS-CoV-2 and Xpert Xpress SARS-CoV-2) against conventional RT-qPCR assays (STANDARD M nCoV and Allplex SARS-CoV-2) for detecting SARS-CoV-2. A total of 225 swab samples were collected and tested using the four assays. The STANDARD M10 SARS-CoV-2 assay showed 97.4% positive percent agreement (PPA) and 100.0% negative percent agreement (NPA) compared to the STANDARD M nCoV assay and Allplex SARS-CoV-2 assay. STANDARD M10 exhibited high performance except in samples with low viral loads (cycle threshold (Ct) > 30). Xpert Xpress showed PPA and NPA of 100.0% compared to the two conventional RT-qPCR assays. The kappa coefficient (Κ) showed nearly almost perfect agreement between each assay and conventional RT-qPCR assays. The correlations of Ct values between the two rapid RT-qPCR and conventional RT-qPCR assays were >0.8, indicating strong correlations. All included assays could detect SARS-CoV-2 variants, such as the Alpha, Beta, and Gamma variants. The recently developed STANDARD M10 has a shorter turnaround time and random-access detection on automated devices, thereby facilitating efficient testing in emergency settings.