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Introduction <p>SARS-CoV-2, influenza&#xa0;A 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.</p> Methods <p>This retrospective validation study included 600 nasopharyngeal swab specimens previously tested using the standard-of-care laboratory-based Allplex Respiratory Panels&#xa0;1–4 and Allplex SARS-CoV-2/FluA/FluB/RSV reference assays. Of these samples, 300 were positive for SARS-CoV-2, influenza&#xa0;A, influenza&#xa0;B, 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.</p> Results <p>Of 600 samples processed in the M10Fast, 590 (98.3%) were fully concordant. Positive percent agreement coefficients were 98.7% for influenza&#xa0;A and 100% for SARS-CoV-2, influenza&#xa0;B, and RSV. Negative percent agreement was 99.2% for influenza&#xa0;A, 99.4% for both SARS-CoV-2 and RSV, and 99.8% for influenza&#xa0;B. 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 189&#xa0;copies/mL for RSV to 541&#xa0;copies/mL for the <i>N</i> gene of SARS-CoV-2.</p> Conclusions <p>The M10Fast, developed for near-patient settings, reliably detects SARS-CoV-2, FluA, FluB, and RSV in 36&#xa0;min and its performance is comparable to standard laboratory-based assays.</p>

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

  • 期刊论文

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  • 发表日期：

    2026年1月3日

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  • Alexander Domnich,
  • Giada Garzillo,
  • Vincenzo Paolozzi,
  • Valentina Ricucci,
  • Andrea Orsi,
  • Giancarlo Icardi

摘要

Introduction

SARS-CoV-2, influenza A 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.

Methods

This retrospective validation study included 600 nasopharyngeal swab specimens previously tested using the standard-of-care laboratory-based Allplex Respiratory Panels 1–4 and Allplex SARS-CoV-2/FluA/FluB/RSV reference assays. Of these samples, 300 were positive for SARS-CoV-2, influenza A, influenza B, 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.

Results

Of 600 samples processed in the M10Fast, 590 (98.3%) were fully concordant. Positive percent agreement coefficients were 98.7% for influenza A and 100% for SARS-CoV-2, influenza B, and RSV. Negative percent agreement was 99.2% for influenza A, 99.4% for both SARS-CoV-2 and RSV, and 99.8% for influenza B. 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 189 copies/mL for RSV to 541 copies/mL for the N gene of SARS-CoV-2.

Conclusions

The M10Fast, developed for near-patient settings, reliably detects SARS-CoV-2, FluA, FluB, and RSV in 36 min and its performance is comparable to standard laboratory-based assays.