Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel,a rapid multiplex PCR method for the diagnosis of COVID-19 |
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Affiliation: | 1. Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan;2. Department of Diabetic Complications, Diabetes Research Center, Research Institute, National Center for Global Health and Medicine, Tokyo, Japan;3. Clinical Laboratory, National Center for Global Health and Medicine, Tokyo, Japan;4. Department of Infection Control, Graduate School of Medicine, Osaka University, Japan;5. Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan |
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Abstract: | IntroductionRapid, simple, and accurate methods are required to diagnose coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the performance of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2), a rapid multiplex PCR assay for SARS-CoV-2 detection.MethodsNasopharyngeal swabs (NPS) that were obtained from patients with COVID-19 who were diagnosed at the National Center for Global Health and Medicine were used in this study. When the NPS samples were found to be negative for SARS-CoV-2 after treatment, they were used as negative samples. We evaluated the performance of the QIAstat-SARS-CoV-2 comparing SARS-CoV-2 detection with the National Institute of Infectious Diseases in Japan-recommended real-time polymerase chain reaction (RT-PCR) method (NIID-RT-PCR).ResultsIn total, 45 NPS samples were analyzed. The proportion of overall agreement between QIAstat-SARS-CoV-2 and NIID-RT-PCR on 45 samples was 91.0% with a sensitivity of 84.0% (21/25), specificity at 100% (20/20), negative predictive value at 83.3% (20/24), and positive predictive value at 100% (21/21). There were no patients with co-infections with pathogens other than SARS-CoV-2.ConclusionsQIAstat-SARS-CoV-2 showed a high agreement in comparison with the NIID-RT-PCR for the detection of SARS-CoV-2. The QIAstat-SARS-CoV-2 also provided a rapid and accurate diagnosis for COVID-19, even when the concurrent detection of other respiratory pathogens was desired, and therefore, has the potential to direct appropriate therapy and infection control precautions. |
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Keywords: | COVID-19 SARS-CoV-2 Dianostics Rapid tests |
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