Abstract
Rapid and widespread diagnostic testing is critical to providing timely patient care and reducing transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Recently, the Visby Medical COVID-19 point of care (POC) test was granted emergency use authorization (EUA) for qualitative detection of SARS-CoV-2 nucleic acid at the point of care. We evaluated its performance characteristics using residual specimens (n = 100) collected from Mayo Clinic patients using nasopharyngeal (NP) swabs and placed in viral transport media (VTM). The same specimen was tested using both the laboratory reference method (RT-qPCR) and Visby test. The reference methods utilized included a laboratory developed test with EUA (Mayo Clinic Laboratories, Rochester, MN) using the TaqMan assay on a Roche Light Cycler 480 or a commercially available EUA platform (cobas® SARS-CoV-2; Roche Diagnostics, Indianapolis, IN). Positive, negative, and overall percent agreement between the Visby COVID-19 test and the reference method were calculated. Additionally, the limit of detection (LoD) claimed by the manufacturer (1112 copies/mL) was verified with serial dilutions of heat inactivated virus. The Visby COVID-19 test correctly identified 29/30 positive samples and 69/70 negative samples, resulting in an overall concordance of 98.0%, positive percent agreement of 96.7%, and negative percent agreement of 98.6%. The abbreviated LoD experiment showed that the analytical sensitivity of the method is as low as or lower than 500 copies/mL. Our study demonstrated that Visby COVID-19 is well-suited to address rapid SARS-CoV-2 testing needs. It has high concordance with central laboratory-based RT-qPCR methods, a low rate of invalid results, and superior analytical sensitivity to some other EUA POC devices.
【저자키워드】 severe acute respiratory syndrome coronavirus 2, Emergency use authorization, Food and Drug Administration, point-of-care, nasopharyngeal, limit of detection, nucleic acid amplification test, horseradish peroxidase, institutional review board, SARS-CoV-2severe acute respiratory syndrome coronavirus 2, WHOWorld Health Organization, World Health Organization, FDAFood and Drug Administration, CIconfidence interval, confidence interval, EUAemergency use authorization, POCpoint-of-care, LoDlimit of detection, NPnasopharyngeal, Cpcrossing point, crossing point, HRPhorseradish peroxidase, IRBinstitutional review board, NAATnucleic acid amplification test, NPAnegative percent agreement, negative percent agreement, PPApositive percent agreement, positive percent agreement, RT-qPCRreverse transcription quantitative polymerase chain reaction, reverse transcription quantitative polymerase chain reaction, VTMviral transfer media, viral transfer media, 【초록키워드】 COVID-19, SARS-CoV-2, coronavirus, POC, point of care, diagnostic, Transmission, virus, EUA, Laboratory, RT-qPCR, Concordance, Characteristics, Transport media, VTM, Patient, Rapid, Swab, experiment, Roche, Critical, platform, inactivated, analytical sensitivity, COVID-19 test, LIGHT, Patient care, acute respiratory syndrome, Mayo Clinic, specimen, SARS-CoV-2 nucleic acid, rapid SARS-CoV-2 testing, positive, reference method, Roche Diagnostics, TaqMan, qualitative detection, positive sample, overall concordance, widespread, serial dilution, resulting, collected, evaluated, calculated, in viral, reducing, demonstrated, claimed, Visby, was tested, 【제목키워드】 COVID-19, point of care, nucleic acid amplification, Visby,