A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B

Kiyasu, Yoshihiko; Akashi, Yusaku; Sugiyama, Akio; Takeuchi, Yuto; Notake, Shigeyuki; Naito, Asami; Nakamura, Koji; Ishikawa, Hiroichi; Suzuki, Hiromichi

BACKGROUND: Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. OBJECTIVE: This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B. METHOD: This prospective study was conducted between 14 December 2020 and 9 January 2021 at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE(®) system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared. RESULT: Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE(®) HQ SARS-CoV-2 and the reference RT-PCR; the total, positive, and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive with GENECUBE(®) HQ SARS-CoV-2 and negative with the reference RT-PCR. SARS-CoV-2 was detected in all three samples using another molecular assay for SARS-CoV-2. For GENECUBE(®) FLU A/B, the total, positive, and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%. CONCLUSION: The GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40291-021-00535-5.