Abstract We compared the performance of five assays for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) detection on nasopharyngeal swab samples: Roche “cobas,” Luminex “ARIES,” MiRXES “Fortitude,” Altona “RealStar,” and Thermo Fisher Scientific “TaqPath.” A total of 94 nasopharyngeal swab samples were obtained from 80 confirmed coronavirus disease 2019 cases in the first 2 weeks of illness (median, 7 days; range, 2–14 days) and 14 healthy controls. After collection, all samples were transported to the hospital clinical laboratory within 24 h. These samples were tested on all five assays within 3 days of sample receipt. Of the 94 samples, 69 yielded the same result on all platforms, resulting in an agreement of 73.4% (69 of 94). Of these, 14 were the healthy control swabs which all tested negative, demonstrating good specificity across all platforms. The ARIES assay had the lowest detection rate (68.8%), followed by Fortitude (85.0%), RealStar (86.3%), cobas (95.0%), and TaqPath (100%). Statistically significant differences were observed for ARIES, Fortitude, and RealStar when compared against the best performing TaqPath using McNemar’s χ 2 test. A consensus result was established based on the results obtained by the cobas, Fortitude, RealStar, and TaqPath. Six discrepancies had failed to reach a consensus and were adjudicated using the Cepheid Xpert Xpress SARS‐CoV‐2. Overall, the TaqPath and cobas assays were the most sensitive at detecting their designated SARS‐CoV‐2 gene targets. On the other hand, the ARIES assay was the least sensitive, thus warranting the need for assay re‐optimization before go‐live at the testing laboratory.
【저자키워드】 COVID‐19, coronavirus, pandemic, SARS‐CoV‐2, molecular diagnostics, 【초록키워드】 coronavirus disease, Coronavirus disease 2019, coronavirus, hospital, severe acute respiratory syndrome Coronavirus, Laboratory, SARS‐CoV‐2, Nasopharyngeal swab, specificity, targets, Swab, Cepheid, respiratory, Roche, detection rate, Nasopharyngeal swab samples, TaqPath, clinical laboratory, followed by, best, Consensus, acute respiratory syndrome, significant difference, acute respiratory syndrome coronavirus, significant differences, acute respiratory syndrome coronavirus 2, healthy controls, discrepancy, Thermo Fisher Scientific, nasopharyngeal swab sample, FIVE, lowest, resulting, tested, median, transported, the healthy, 【제목키워드】 SARS‐CoV‐2, clinical, Applied Biosystem,