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Jian MJ, Chung HY, Chang CK, et al. Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence. Infect Drug Resist. 2021;14:3255-3261doi: 10.2147/IDR.S328327.
Jian, M. J., Chung, H. Y., Chang, C. K., Lin, J. C., Yeh, K. M., Chen, C. W., Li, S. Y., Hsieh, S. S., Liu, M. T., Yang, J. R., Tang, S. H., Perng, C. L., Chang, F. Y., & Shang, H. S. (2021). Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence. Infection and drug resistance, 143255-3261. https://doi.org/10.2147/IDR.S328327
Jian, Ming-Jr, et al. "Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence." Infection and drug resistance vol. 14 (2021): 3255-3261. doi: https://doi.org/10.2147/IDR.S328327
Jian MJ, Chung HY, Chang CK, Lin JC, Yeh KM, Chen CW, Li SY, Hsieh SS, Liu MT, Yang JR, Tang SH, Perng CL, Chang FY, Shang HS. Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence. Infect Drug Resist. 2021 Aug 17;14:3255-3261. doi: 10.2147/IDR.S328327. eCollection 2021. PMID: 34429623; PMCID: PMC8380303.
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Infect Drug Resist. 2021 Aug 17;14:3255-3261. doi: 10.2147/IDR.S328327. eCollection 2021.

Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence.

Infection and drug resistance

Ming-Jr Jian, Hsing-Yi Chung, Chih-Kai Chang, Jung-Chung Lin, Kuo-Ming Yeh, Chien-Wen Chen, Shih-Yi Li, Shan-Shan Hsieh, Ming-Tsan Liu, Ji-Rong Yang, Sheng-Hui Tang, Cherng-Lih Perng, Feng-Yee Chang, Hung-Sheng Shang

Affiliations

  1. Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.
  2. Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.
  3. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.
  4. Centers for Disease Control, Taipei, Taiwan, Republic of China.

PMID: 34429623 PMCID: PMC8380303 DOI: 10.2147/IDR.S328327

Abstract

PURPOSE: 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

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.

© 2021 Jian et al.

Keywords: COVID-19; SARS-CoV-2; molecular diagnostics; point of care testing; sample to answer; variant of concern

Conflict of interest statement

The authors declare no conflicts of interest for this work.

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