Comparative Diagnostic Performance of the 36-Minute STANDARD M10 Fast Assay for Molecular Diagnosis of SARS-CoV-2, InfluenzaA and B, and Respiratory Syncytial Virus in Near-Patient Settings.

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SARS-CoV-2, influenzaA and B, and respiratory syncytial virus (RSV) are the major seasonal viruses that can cause severe illness. Rapid and accurate diagnosis of these viruses may improve patient management and surveillance efforts. Here, we assessed the diagnostic performance of the STANDARD M10 Flu/RSV/SARS-CoV-2 Fast (M10Fast) real-time polymerase chain reaction assay for near-patient diagnosis of the four viruses. This retrospective validation study included 600 nasopharyngeal swab specimens previously tested using the standard-of-care laboratory-based Allplex Respiratory Panels1-4 and Allplex SARS-CoV-2/FluA/FluB/RSV reference assays. Of these samples, 300 were positive for SARS-CoV-2, influenzaA, influenzaB, or RSV, while the remaining 300 samples were negative for the four viruses. Positive and negative percent agreements between the M10Fast index and reference tests were the primary endpoints. Additionally, analytical sensitivity of the M10Fast in terms of 95% limit of detection was estimated via serial dilutions of a positive reference material. Of 600 samples processed in the M10Fast, 590 (98.3%) were fully concordant. Positive percent agreement coefficients were 98.7% for influenzaA and 100% for SARS-CoV-2, influenzaB, and RSV. Negative percent agreement was 99.2% for influenzaA, 99.4% for both SARS-CoV-2 and RSV, and 99.8% for influenzaB. Discordant results were characterized by low viral loads with cycle threshold values of 38 or greater. The rate of invalid M10Fast runs was low (1.2%). Limit of detection of the M10Fast varied from 189copies/mL for RSV to 541copies/mL for the N gene of SARS-CoV-2. The M10Fast, developed for near-patient settings, reliably detects SARS-CoV-2, FluA, FluB, and RSV in 36min and its performance is comparable to standard laboratory-based assays.