Analytical Performance of Direct Rapid Nucleic Acid Assay for Detection of SARS-Cov-2

Abstract

Background: A rapid and accurate test to detect SARS-CoV-2 is essential for controlling the transmission of the COVID-19. Rapid diagnostic tests are currently marketed, although it is uncertain how well they perform in actual clinical settings and with relevant subpopulations. We evaluated the clinical performance of the Direct Detect® SARS-CoV-2 Detection Kit (Coyote Bioscience Co., Ltd., Beijing, China) rapid, molecular-based assay. Methods and Results: The clinical laboratory received 707 clinical samples for rapid PCR between December 2021 and March 2022, including confirmed or suspected COVID-19 cases. These samples were tested by the Direct Detect® SARS-CoV-2 Detection Kit and by the LabGun® COVID-19 ExoFast RT-PCR Kit. Of 707 specimens tested, 649(91.79%) were negative and 58(8.20%) were positive. The sensitivity and specificity of the rapid RT-PCR test were 79.31% (95% CI: 66.65% to 88.83%) and 99.54% (95% CI: 98.66% to 99.90%), respectively. Conclusion: The Direct Detect® SARS-CoV-2 Detection Kit evaluated in this study was able to detect SARS-CoV-2 infection with high viral loads but not so for higher loads. To determine strategies for appropriate use, more investigation of the assay's field performance in various conditions is required.

Keywords

• diagnostic testing
• sars-cov-2
• rapid tests