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

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

doi:10.3389/fmicb.2022.999783

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

Front Microbiol. 2022 Nov 3:13:999783. doi: 10.3389/fmicb.2022.999783. eCollection 2022.

Authors

Luna Colagrossi¹, Valentino Costabile¹, Rossana Scutari^{1

2}, Valeria Cento^{3

4}, Luana Coltella¹, Antonino Reale⁵, Martina Scilipoti⁵, Alberto Villani⁵, Claudia Alteri^{1

2}, Carlo Federico Perno¹, Cristina Russo¹

Affiliations

¹ Unit of Diagnostic Microbiology and Immunology and Multimodal Medicine Area, Department of Laboratories, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
² Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
³ Department of Biomedical Sciences, Humanitas University, Milan, Italy.
⁴ IRCCS Humanitas Research Hospital, Milan, Italy.
⁵ General Pediatrics Unit, Department of Emergency and General Pediatrics, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.

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.

Keywords: COVID-19; RT-PCR testing; SARS-CoV-2; comparative diagnostic accuracy; molecular diagnosis.