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Ming-Jr Jian,1,* Hsing-Yi Chung,1,* Chih-Kai Chang,1 Jung-Chung Lin,2 Kuo-Ming Yeh,2 Chien-Wen Chen,3 Shih-Yi Li,1 Shan-Shan Hsieh,1 Ming-Tsan Liu,4 Ji-Rong Yang,4 Sheng-Hui Tang,1 Cherng-Lih Perng,1 Feng-Yee Chang,2 Hung-Sheng Shang1 1Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China; 2Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China; 3Division of Pulmonary and Critical Care Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China; 4Centers for Disease Control, Taipei, Taiwan, Republic of China*These authors contributed equally to this workCorrespondence: Hung-Sheng Shang; Feng-Yee Chang Email iamkeith001@gmail.com; fychang@mail.ndmctsgh.edu.twPurpose: Accurate molecular diagnostic assays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, are needed for epidemiology studies and to support infection-control measures. We evaluated the analytical sensitivity and clinical performance of three sample-to-answer molecular-diagnostics systems for detecting SARS-CoV-2 using 325 nasopharyngeal swab clinical samples from symptomatic patients.Methods: The BioFire Respiratory Panel 2.1 (RP2.1), cobas Liat SARS-CoV-2 and Influenza A/B, and Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV platforms, which have been granted emergency-use authorization by the US FDA, were tested and compared.Results: The positive percent agreement, negative percent agreement, and overall percent agreement among the three point of care testing systems were 98– 100%, including for the wild-type SARS-CoV-2 (non-B.1.1.7) and a variant of concern (B.1.1.7). Notably, the BioFire RP2.1 may fail to detect the SARS-CoV-2 S gene in the B.1.1.7 lineage because of the spike protein mutation.Conclusion: All three point of care testing platforms provided highly sensitive, robust, and almost accurate results for rapidly detecting SARS-CoV-2. These automated molecular diagnostic assays can increase the effectiveness of control and prevention measures for infectious diseases.Keywords: COVID-19, SARS-CoV-2, point of care testing, molecular diagnostics, sample to answer, variant of concern |
