Abstract
Introduction: Rapid, 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.
Methods: Nasopharyngeal 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).
Results: In 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.
Conclusions: QIAstat-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.
Keywords: COVID-19; Dianostics; Rapid tests; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, Rapid tests, Dianostics, 【초록키워드】 Treatment, coronavirus disease, SARS-CoV-2, infection control, Coronavirus disease 2019, coronavirus, therapy, Infectious diseases, Multiplex PCR, Diagnosis, Infectious disease, severe acute respiratory syndrome Coronavirus, RT-PCR, global health, Predictive value, Medicine, polymerase chain reaction, SARS-CoV-2 detection, sensitivity, specificity, Positive predictive value, pathogen, nasopharyngeal swabs, Patient, Co-infection, Rapid, Pathogens, Swab, respiratory, diagnose, Negative predictive value, Chain Reaction, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, respiratory pathogen, center, precautions, NPs, polymerase chain, analyzed, evaluate, caused, proportion, diagnosed, evaluated, required, provided, were used, Panel, patients with COVID-19, 【제목키워드】 SARS-CoV-2, Multiplex PCR, respiratory, diagnosis of COVID-19,