Clinical usefulness of the “GeneSoC® SARS-CoV-2 N2 Detection Kit”

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.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.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