key: cord-0891831-zzxvz0gp
authors: Lebourgeois, Samuel; Storto, Alexandre; Gout, Bernard; Le Hingrat, Quentin; Tjader, Gustave Ardila; Cerdan, Maria del Carmen; English, Alistair; Pareja, Josep; Love, Joanna; Houhou-Fidouh, Nadhira; Manissero, Davide; Descamps, Diane; Visseaux, Benoit
title: Performance Evaluation of the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
date: 2021-04-24
journal: Int J Infect Dis
DOI: 10.1016/j.ijid.2021.04.066
sha: 550c5de0d0e565312ddad3762e552939c4bc7e5d
doc_id: 891831
cord_uid: zzxvz0gp

OBJECTIVE: The aim of this study was to evaluate the QIAstat-Dx® Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2), which is a closed, fully automated, multiplex polymerase chain reaction (PCR) assay that detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and 21 other pathogens that cause respiratory disease. METHODS: Nasopharyngeal swabs from patients with, or suspected of having, coronavirus disease 2019 were collected and tested at Bichat-Claude Bernard Hospital, Paris, France. Using the World Heath Organisation-approved real-time-PCR assay developed by the Charité Institute of Virology as the reference, positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. RESULTS: In total, 189 negative and 88 positive samples were analysed. QIAstat-SARS-CoV-2 had a NPA of 90.48% (95% confidence interval (CI), 85.37%, 94.26%) and a PPA of 94.32% (95% CI, 87.24%, 98.13%). Co-infections were detected by QIAstat-SARS-CoV-2 in 4/277 specimens. The methods exhibited comparable failure rates (23/307 [7.5%] vs 6/298 [2.0%] for QIAstat-SARS-CoV-2 and reference methods, respectively). The turnaround time was shorter for QIAstat-SARS-CoV-2 compared with the reference method (difference in mean –14:30 h [standard error, 0:03:23; 95% CI, –14:37, –14:24]; P < 0.001). CONCLUSIONS: QIAstat-SARS-CoV-2 shows good agreement with the reference assay, providing faster and accurate results for the detection of SARS-CoV-2.

Early identification of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enables rapid isolation to prevent transmission (European Centre for Disease Prevention and Control, National Institutes of Health, 2020, The World Health Organization). Symptoms of coronavirus disease 2019 are common to a range of respiratory pathogens; therefore, accurate diagnostics are required for differential diagnosis.

The QIAstat-Dx® Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2) is a closed, fully automated, multiplex assay that detects SARS-CoV-2 and 21 other respiratory pathogens. Prior independent validation studies of the SARS-CoV-2 assay demonstrated comparable performance with a WHO-recommended reversetranscription polymerase chain reaction (RT-PCR) assay . The remaining 21 targets in the panel had been previously validated (Boers et al., 2020) .

The aim of this study was to evaluate the SARS-CoV-2 assay performance characteristics in QIAstat-SARS-CoV-2 against the WHO-recommended reference method (WHO-Charité) (Corman et al., 2020) .

This was an observational, retrospective study of specimens from patients with, or suspected of having, COVID-19. The primary objective was to compare the performance of QIAstat-SARS-CoV-2 with the WHO-Charité reference method (Corman et al., 2020) , which was the standard-of-care test at the investigation site The remaining 277 samples were tested using both QIAstat-SARS-CoV-2 and the reference method. A further 25 results were excluded based on a failed QIAstat-SARS-CoV-2 (n=13) or reference method test (n=12; Figure 1 

The QIAstat-SARS-CoV-2 panel demonstrated PPA and NPA with the WHOrecommended assay greater than 90%, both in this study and in another previous smaller study .

Rapid testing for SARS-CoV-2 enables quick triage and identification of patients requiring isolation (Brendish et al., 2020) . In this study, QIAstat-SARS-CoV-2 was 14.5 h quicker than the reference method and rapid testing with QIAstat-SARS-CoV-2 is consistent with previous results (Brendish et al., 2020 .

Near-patient multiplex tests allow testing of multiple pathogens in a single assay, simplifying testing workflows and assisting in the timely differential diagnosis of infectious diseases. The utility of near-patient multiplex testing using the QIAstat-Dx® Respiratory Panel in reducing time to diagnosis and improving patient management has previously been demonstrated .

In this study, co-infections were identified in four samples, including two samples positive for SARS-CoV-2. Co-infections with SARS-CoV-2, at rates in-line with this study, have previously been reported in the literature (Lai et al., 2020 , Lansbury et al., 2020 .

In conclusion, QIAstat-SARS-CoV-2 produces concordant results with the WHO-Charité reference method, but in a significantly shorter time and in a near-patient setting. 

Multicenter Evaluation of QIAstat-Dx Respiratory Panel V2 for Detection of Viral and Bacterial Respiratory Pathogens

PCR implementation as point-of-care testing in a French emergency department

Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study

Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2; 2020

Co-infections among patients with COVID19: The need for combination therapy with non-anti-SARS-CoV-2 agents?

Co-infections in people with COVID-19: a systematic review and meta-analysis

COVID-19 Treatment Guidelines. Testing for SARS-CoV-2 Infection

Evalua tion of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the First Rapid Multiplex PCR Commercial Assay for SARS-CoV2 Detection

The authors would like to acknowledge Sarah Johnston, MBiolSci, of Ashfield MedComms, an Ashfield Health company, part of UDG Healthcare plc, for medical writing support that was funded by QIAGEN Manchester Ltd., Manchester, UK.J o u r n a l P r e -p r o o f