Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the first rapid multiplex PCR commercial assay for SARS-CoV-2 detection.

In the race to contain SARS-CoV-2, efficient detection and triage of infected patients must rely on rapid and reliable testing. In this work we performed the first evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS) for SARS-CoV-2 detection. This assay is the first rapid multiplex PCR (mPCR) assay including SARS-CoV-2 detection, and is fully compatible with a non-PCR trained laboratory or point-of-care (POC) testing.This evaluation was performed using 69 primary clinical samples (66 NPS, 1 BAL and 1 tracheal aspirate and 1 bronchial aspirate) comparing the SARS-CoV-2 detection with the currently WHO recommended RT-PCR (WHO-PCR) workflow. Additionally, a comparative limit of detection (LoD) assessment was performed between QIAstat-SARS and the WHO-PCR using a quantified clinical sample. Compatibility of sample pre-treatment for viral neutralisation or viscous samples with the QIAstat-SARS system were also tested.The QIAstat-Dx Respiratory SARS-CoV-2 Panel demonstrated a comparable sensitivity to the WHO recommended assay with a limit of detection at 1000 copies/mL. The overall percent agreement between QIAstat-Dx SARS and WHO-PCR on 69 clinical samples was 97% with a sensitivity at 100% (40/40) and specificity at 93% (27/29). No cross reaction was encountered for any other respiratory viruses or bacteria included in the panel.The QIAstat-SARS rapid multiplex-PCR panel provides a highly sensitive, robust and accurate assay for rapid detection of SARS-CoV-2. This assay allows rapid decisions even in non-PCR trained laboratory or point-of-care testing, allowing innovative organisation.