tetano
Editor, Senior Moderator
J Med Virol
. 2021 Mar 14.
doi: 10.1002/jmv.26940. Online ahead of print.
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
Chun Kiat Lee[SUP] 1 [/SUP], Jason Wei Ming Tham[SUP] 1 [/SUP], Siyu Png[SUP] 1 [/SUP], Chean Nee Chai[SUP] 1 [/SUP], Shu Chi Ng[SUP] 1 [/SUP], Eunice Jia Min Tan[SUP] 1 [/SUP], Li Jie Ng[SUP] 1 [/SUP], Rui Ping Chua[SUP] 1 [/SUP], Musa Sani[SUP] 1 [/SUP], Yiqi Seow[SUP] 2 [/SUP], Gabriel Yan[SUP] 3 [/SUP], Julian Tang[SUP] 4 [/SUP]
Affiliations
Abstract
Objectives: We compared the performance of five assays for SARS-CoV-2 detection on nasopharyngeal swab samples: Roche 'cobas', Luminex 'ARIES', MiRXES 'Fortitude', altona 'RealStar', and Thermo Fisher Scientific 'TaqPath'.
Methods: A total of 94 nasopharyngeal swab samples were obtained from 80 confirmed COVID-19 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 hours. These samples were tested on all five assays within three days of sample receipt.
Results: Of the 94 samples, 69 yielded the same result on all platforms, resulting in an agreement of 73.4% (69/94). 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 the McNemar's chi-squared 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.
Conclusion: 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-optimisation prior to go-live at the testing laboratory. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; SARS-CoV-2; coronavirus; molecular diagnostics; pandemic.
. 2021 Mar 14.
doi: 10.1002/jmv.26940. Online ahead of print.
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
Chun Kiat Lee[SUP] 1 [/SUP], Jason Wei Ming Tham[SUP] 1 [/SUP], Siyu Png[SUP] 1 [/SUP], Chean Nee Chai[SUP] 1 [/SUP], Shu Chi Ng[SUP] 1 [/SUP], Eunice Jia Min Tan[SUP] 1 [/SUP], Li Jie Ng[SUP] 1 [/SUP], Rui Ping Chua[SUP] 1 [/SUP], Musa Sani[SUP] 1 [/SUP], Yiqi Seow[SUP] 2 [/SUP], Gabriel Yan[SUP] 3 [/SUP], Julian Tang[SUP] 4 [/SUP]
Affiliations
- PMID: 33719033
- DOI: 10.1002/jmv.26940
Abstract
Objectives: We compared the performance of five assays for SARS-CoV-2 detection on nasopharyngeal swab samples: Roche 'cobas', Luminex 'ARIES', MiRXES 'Fortitude', altona 'RealStar', and Thermo Fisher Scientific 'TaqPath'.
Methods: A total of 94 nasopharyngeal swab samples were obtained from 80 confirmed COVID-19 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 hours. These samples were tested on all five assays within three days of sample receipt.
Results: Of the 94 samples, 69 yielded the same result on all platforms, resulting in an agreement of 73.4% (69/94). 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 the McNemar's chi-squared 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.
Conclusion: 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-optimisation prior to go-live at the testing laboratory. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; SARS-CoV-2; coronavirus; molecular diagnostics; pandemic.