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Microbiol Spectr . Assessment of QuantuMDx Q-POC Assay for Rapid Detection of SARS-CoV-2 Using Middle Turbinate Swabs

tetano

Editor, Senior Moderator
Microbiol Spectr


. 2023 Mar 28;e0425622.
doi: 10.1128/spectrum.04256-22. Online ahead of print.
Assessment of QuantuMDx Q-POC Assay for Rapid Detection of SARS-CoV-2 Using Middle Turbinate Swabs


Mariana Fernandez-Pittol[SUP] 1 2 3 [/SUP], Juan Carlos Hurtado[SUP] 1 2 3 [/SUP], Maryam Ali[SUP] 1 [/SUP], Álvar Simarro[SUP] 1 [/SUP], Fadiana Proaño[SUP] 1 [/SUP], Maria Sierra[SUP] 1 [/SUP], Jordi Vila[SUP] 1 2 3 4 [/SUP]



Affiliations

Abstract

Currently, a rapid detection of SARS-CoV-2 in clinical settings such as patients from emergency surgery is needed. The QuantuMDx Q-POC assay is a real-time-PCR test that was created for the rapid detection of SARS-CoV-2 in only 30 min. This study aimed to compare QuantuMDx Q-POC with our standard algorithm with Cobas 6800 for SARS-CoV-2 detection. The samples were run in parallel in both platforms. First, a comparison analysis was carried out. Second, the limit of detection was determinate in both platforms using a serial dilution of SARS-CoV-2 inactivated virus. A total of 234 samples were analyzed. For a Ct <30, the sensitivity and specificity was 100.0% and 92.5%, respectively. Positive predictive value was 86.2% and negative predictive value was 100.0%. Both COBAS 6800 and QuantuMDx Q-POC could detect up to 100 copies/mL. The QuantuMDx Q-POC system it is a reliable option when a rapid detection of SARS-CoV-2 is necessary. IMPORTANCE In different health care settings, such as patients from emergency surgery, rapid detection of SARS-CoV-2 is needed. The QuantuMDx Q-POC is an automatized fast workflow platform based on detection of three genes: two genes encoding structural proteins that can be used to differentiate SARS-CoV-2 from other coronavirus and a third target gene encoding a nonstructural region that is unique for SARS-CoV-2 such as the open reading frame (ORF1). This assay enables a rapid detection of SARS-CoV-2 with a high sensitivity in a short time frame (30 min). Therefore, QuantuMDx is a simple, rapid and easy SARS-CoV-2 detection test from direct middle nasal swabs.

Keywords: RT-PCR; SARS-CoV-2; assay; evaluation.
 
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