Clinical usefulness of the “GeneSoC® SARS-CoV-2 N2 Detection Kit”
Author:
Sato Yuki12ORCID, Kondo Takashi1, Katayama Yuki1, Narumi Natsuki12ORCID, Togashi Atsuo3, Fujiya Yoshihiro2, Kuronuma Koji4, Takahashi Satoshi12
Affiliation:
1. Division of Laboratory Medicine , Sapporo Medical University Hospital , Sapporo , Japan 2. Department of Infection Control and Laboratory Medicine , Sapporo Medical University School of Medicine , Sapporo , Japan 3. Department of Pediatrics , Sapporo Medical University School of Medicine , Sapporo , Japan 4. Department of Respiratory Medicine and Allergology , Sapporo Medical University School of Medicine , Sapporo , Japan
Abstract
Abstract
Objectives
The GeneSoC® that launched recently enables the quantitative detection of target genes (in approximately 15 min) using microfluidic thermal cycling technology. Here, we compared the diagnostic performance of the “GeneSoC® SARS-CoV-2 N2 Detection Kit” (Kyorin assay) and conventional severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection assays to verify the clinical usefulness of the Kyorin assay.
Methods
Two hundred samples (100 nasopharyngeal and 100 saliva specimens) were collected from patients with suspected SARS-CoV-2 infection between May 2020 and August 2021. Conventional SARS-CoV-2 detection assays were performed using the Japanese National Institute of Infectious Diseases (NIID) assay, Ampdirect™ 2019-nCoV Detection Kit (SHIMADZU assay), and Lumipulse Presto SARS-CoV-2 Ag (FUJIREBIO assay), according to each manufacturer’s instructions.
Results
Using the NIID and SHIMADZU assays as references, the positive and negative concordance rates and the kappa coefficient in the Kyorin assay were 96.9–97.9 %, 99.0–100.0 %, and 0.96–0.98, respectively. The positivity rate of the FUJIREBIO assay was slightly lower than that of the reference assay (p<0.05).
Conclusions
The Kyorin assay showed a favorable concordance rate with conventional SARS-CoV-2 detection assays, making it a useful, rapid, and high-performance assay for detecting SARS-CoV-2, which may lead to early diagnosis and appropriate treatment.
Funder
Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan
Publisher
Walter de Gruyter GmbH
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