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

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

doi:10.2147/IDR.S328327

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.

Authors

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.

^# Contributed equally.

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 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; molecular diagnostics; point of care testing; sample to answer; variant of concern.

Grants and funding

This study was supported by the Tri-Service General Hospital, Taipei, Taiwan, ROC, (grant number TSGH-D-110100). The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.