Performance evaluation of a new on-demand molecular test for the rapid identification of severe acute respiratory syndrome coronavirus 2 in pediatric and adult patients

Abstract

The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has increased the need to identify additional rapid diagnostic tests for an accurate and early diagnosis of infection. Here, we evaluated the diagnostic performance of the cartridge-based reverse transcription polymerase chain reaction (RT-PCR) test STANDARD M10 SARS-CoV-2 (SD Biosensor Inc., Suwon, South Korea), targeting the ORF1ab and E gene of SARS-CoV-2, and which can process up to eight samples in parallel in 60 min. From January 2022 to March 2022, STANDARD™ M10 assay performance was compared with Xpert® Xpress SARS-CoV-2 (Cepheid, Sunnyvale CA) on 616 nasopharyngeal swabs from consecutive pediatric (N = 533) and adult (N = 83) patients presenting at the “Istituto di Ricovero e Cura a Carattere Scientifico” (IRCCS) Ospedale Pediatrico Bambino Gesù, Roma. The overall performance of STANDARD M10 SARS-CoV-2 was remarkably and consistently comparable to the Xpert® Xpress SARS-CoV-2 with an overall agreement of 98% (604/616 concordant results), and negligible differences in time-to-result (60 min vs. 50 min, respectively). When the Xpert® Xpress SARS-CoV-2 results were considered as the reference, STANDARD™ M10 SARS-CoV-2 had 96.5% sensitivity and 98.4% specificity. STANDARD M10 SARS-CoV-2 can thus be safely included in diagnostic pathways because it rapidly and accurately identifies SARS-CoV-2 present in nasopharyngeal swabs.

Evaluation of analytical performance of the STANDARD TM M10 MPX/OPX assay for the simultaneous DNA detection and clade attribution of Monkeypox virus

“…The M10 assay is rapid, user-friendly, and in the single-test format, which allows to return of a result in less than two hours from sample reception to validation. The STANDARD M10 platform was previously evaluated in the context of SARS-CoV-2 detection, also for differential diagnosis with Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV), proving its reliability in terms of PPA, NPA, short time-to-result, and easy usage and an appropriate diagnostic tool for those scenarios requiring a rapid response [ 22 , 27–30 ]. The present study is the first on the use of STANDARD M10 MPX/OPX: as for respiratory pathogens, the assay showed high-quality performance, with a higher concordance with first results as per RealStar® OPX-1, especially when the operator interpretation was 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.…”