A prospective evaluation of the analytical performance of GENECUBE(R) HQ SARS-CoV-2 and GENECUBE(R) FLU A/B

Kiyasu, Y.; Akashi, Y.; Sugiyama, A.; Takeuchi, Y.; Notake, S.; Naito, A.; Nakamura, K.; Ishikawa, H.; Suzuki, H.

Background: Molecular tests are the mainstay for 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. This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE(R) HQ SARS-CoV-2 and the GENECUBE(R) FLU A/B. Method: This prospective study was conducted between December 14, 2020, and January 9, 2021, at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE(R) 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(R) 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 for GENECUBE(R) HQ SARS-CoV-2 and negative for the reference RT-PCR. SARS-CoV-2 was detected from all three samples by another molecular assay for SARS-CoV-2. For the GENECUBE(R) 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(R) HQ SARS-CoV-2 and GENECUBE(R) FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B.