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Clinical performance of Roche cobas 6800, Luminex ARIES, MiRXES Fortitude Kit 2.1, Altona RealStar, and Applied Biosystems TaqPath for SARS-CoV-2 detection in nasopharyngeal swabs.
Lee, Chun Kiat; Tham, Jason Wei Ming; Png, Siyu; Chai, Chean Nee; Ng, Shu Chi; Tan, Eunice Jia Min; Ng, Li Jie; Chua, Rui Ping; Sani, Musa; Seow, Yiqi; Yan, Gabriel; Tang, Julian.
  • Lee CK; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Tham JWM; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Png S; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Chai CN; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Ng SC; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Tan EJM; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Ng LJ; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Chua RP; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Sani M; Department of Laboratory Medicine, National University Health System, Singapore, Singapore.
  • Seow Y; Institute of Bioengineering and Nanotechnology, Agency for Science, Technology and Research, Singapore, Singapore.
  • Yan G; Department of Medicine, National University Health System, Singapore, Singapore.
  • Tang J; Department of Respiratory Sciences, University of Leicester, Leicester, UK.
J Med Virol ; 93(7): 4603-4607, 2021 07.
Article in English | MEDLINE | ID: covidwho-1263098
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 χ2 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Nucleic Acid Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: J Med Virol Year: 2021 Document Type: Article Affiliation country: Jmv.26940

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Nucleic Acid Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: J Med Virol Year: 2021 Document Type: Article Affiliation country: Jmv.26940