1. Comparison of two commercial platforms and a laboratory developed test for detection of SARS-CoV-2 RNA
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Maija Lappalainen, Jenni Antikainen, Hannimari Kallio-Kokko, Satu Kurkela, Laura Mannonen, Anu Jääskeläinen, Pia Jokela, Raisa Loginov, Paula Väre, Eliisa Kekäläinen, and Hanna Jarva
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0303 health sciences ,Veterinary medicine ,Coronavirus disease 2019 (COVID-19) ,SARS-CoV-2 ,030306 microbiology ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,COVID-19 ,Regular Article ,Nucleic Acid Testing ,3. Good health ,Test (assessment) ,03 medical and health sciences ,COVID-19 Testing ,0302 clinical medicine ,Humans ,Medicine ,030212 general & internal medicine ,business ,Nucleic Acid Amplification Techniques ,Reference standards - Abstract
Mitigation of the ongoing coronavirus disease 2019 (COVID-19) pandemic requires reliable and accessible laboratory diagnostic services. In this study, the performance of one laboratory-developed test (LDT) and two commercial tests, cobas SARS-CoV-2 (Roche) and Amplidiag COVID-19 (Mobidiag), were evaluated for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory specimens. A total of 183 specimens collected from suspected COVID-19 patients were studied with all three methods to compare their performance. In relation to the reference standard, which was established as the result obtained by two of the three studied methods, the positive percent agreement was highest for the cobas test (100%), followed by the Amplidiag test and the LDT (98.9%). The negative percent agreement was lowest for the cobas test (89.4%), followed by the Amplidiag test (98.8%), and the highest value was obtained for the LDT (100%). The dilution series of positive specimens, however, suggests significantly higher sensitivity for the cobas assay in comparison with the other two assays, and the low negative percent agreement value may be due to the same reason. In general, all tested assays performed adequately. Clinical laboratories need to be prepared for uninterrupted high-throughput testing during the coming months to mitigate the pandemic. To ensure no interruption, it is critical that clinical laboratories maintain several simultaneous platforms in their SARS-CoV-2 nucleic acid testing.
- Published
- 2020
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