Comparative Diagnostic Accuracy of the STANDARD M10 Assay for the Molecular Diagnosis of SARS-CoV-2 in the Point-of-Care and Critical Care Settings

Abstract

Accurate and rapid molecular diagnosis of COVID-19 is a crucial step to tackle the ongoing pandemic. The primary objective of this study was to estimate the real-world performance of the novel RT-PCR STANDARD M10 SARS-CoV-2 assay in a large number of nasopharyngeal (NP) specimens eluted in universal transport medium. The secondary objective was to evaluate the compatibility of this kit in testing NP samples eluted in an inactivated transport medium (essential for point-of-care testing) and lower respiratory tract (LRT) specimens, which are commonly collected in critical care. A total of 591 samples were analyzed. Compared with the standard extraction-based RT-PCR Allplex 2019-nCoV (time-to-result of 270 min), the sensitivities of the STANDARD M10 were 100% (95% CI: 98.1–100%), 95.5% (95% CI: 91.7–97.6%), and 99.5% (95% CI: 97.2–99.9%) for ≥1 gene, the ORF1ab gene, and the E gene, respectively, while the specificity was 100% (95% CI: 98.7–100%). The diagnostic accuracy was 100% in testing both NP samples eluted in an inactivated transport medium and LRT specimens. STANDARD M10 reliably detects SARS-CoV-2 in 60 min, may be used as a POC tool, and is suitable for testing LRT specimens in the critical care setting.

Evaluation of STANDARDTM M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples

“…Two other studies have also evaluated the STANDARD TM M10 SARS-CoV-2 assay for its use at POC sites. The first evaluation study estimated the sensitivity and specificity of the assay for the ORF1ab target at 95.5% (95% CI 91.7% to 97.6%) and 100% (95% CI 98.7% to 100%), respectively [20] . Furthermore, they also confirmed the lower LoD of the STANDARD TM M10 SARS-CoV-2 assay, compared to the reference methods they used.…”

Rapid RT-PCR identification of SARS-CoV-2 in screening donors of fecal microbiota transplantation

“…The latter is a walk-away and random access all-in-one system processing the sample from extraction to results. Recent publications show that the performance of the STANDARD™ M10 SARS-CoV-2 with nasopharyngeal swabs is comparable to that of the main commercially available systems [ [20] , [21] , [22] ], but there isn’t yet no study about its use with stool samples. Given the on-demand nature of the test, its ease of set-up and its speed of execution (60 min), evaluating the performance of STANDARD™ M10 SARS-CoV-2 on fecal samples can greatly improve the detection of SARS-CoV-2 in donor material destined for FMT.…”

High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2

“…For instance, a comparative evaluation of 122 CE-marked Ag-RDTs by Scheiblauer et al [ 15 ] has demonstrated that the sensitivity of these assays may be as low as 0–30%. It is likely that this discrepancy is driven by the fact that the validation studies conceived by manufacturers for regulatory purposes may have low external validity as these evaluations are usually carried out on a limited number of well-characterized samples skewed towards high viral loads [ 17 ].…”