J Infect Chemother . 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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J Infect Chemother


. 2022 Feb 9;S1341-321X(22)00044-7.
doi: 10.1016/j.jiac.2022.02.004. Online ahead of print.
Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19


Masahiro Ishikane ¹ , Hiroyuki Unoki-Kubota ² , Ataru Moriya ³ , Satoshi Kutsuna ⁴ , Honami Ando ³ , Yasushi Kaburagi ² , Tetsuya Suzuki ⁵ , Noriko Iwamoto ⁵ , Moto Kimura ⁶ , Norio Ohmagari ⁵



Affiliations

• PMID: 35184977
• DOI: 10.1016/j.jiac.2022.02.004

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.