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

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(R) HQ SARS-CoV-2 and GENECUBE(R) 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(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 with GENECUBE(R) 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(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.