AUTHOR=Colagrossi Luna , Costabile Valentino , Scutari Rossana , Cento Valeria , Coltella Luana , Reale Antonino , Scilipoti Martina , Villani Alberto , Alteri Claudia , Perno Carlo Federico , Russo Cristina 

TITLE=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

JOURNAL=Frontiers in Microbiology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.999783

DOI=10.3389/fmicb.2022.999783

ISSN=1664-302X

ABSTRACT=The rapid spread of 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 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 able to process up to 8 samples in parallel in 60 minutes. 
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 IRCCS Ospedale Pediatrico Bambino Gesù, Roma.
The overall performance of STANDARDTM 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 of and 98.4% specificity. 
 STANDARD M10 SARS-CoV-2 can thus be safely included in diagnostic pathways since providing a rapid and accurate identification of SARS-CoV-2 in nasopharyngeal swabs.