Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence
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 Pa...
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| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2021-08-01
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| Series: | Infection and Drug Resistance |
| Subjects: | |
| Online Access: | https://www.dovepress.com/clinical-comparison-of-three-sample-to-answer-systems-for-detecting-sa-peer-reviewed-fulltext-article-IDR |
| _version_ | 1818597611684233216 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jian MJ |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-16T11:50:34Z |
| format | Article |
| id | doaj.art-eeb3527d11114348924fb57a11e929da |
| institution | Directory Open Access Journal |
| issn | 1178-6973 |
| language | English |
| last_indexed | 2024-12-16T11:50:34Z |
| publishDate | 2021-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Infection and Drug Resistance |
| spelling | doaj.art-eeb3527d11114348924fb57a11e929da2022-12-21T22:32:44ZengDove Medical PressInfection and Drug Resistance1178-69732021-08-01Volume 143255326167985Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage EmergenceJian MJChung HYChang CKLin JCYeh KMChen CWLi SYHsieh SSLiu MTYang JRTang SHPerng CLChang FYShang HSMing-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 concernhttps://www.dovepress.com/clinical-comparison-of-three-sample-to-answer-systems-for-detecting-sa-peer-reviewed-fulltext-article-IDRcovid-19sars-cov-2point of care testingmolecular diagnosticssample to answervariant of concern |
| spellingShingle | 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 Infection and Drug Resistance covid-19 sars-cov-2 point of care testing molecular diagnostics sample to answer variant of concern |
| title | Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence |
| title_full | Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence |
| title_fullStr | Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence |
| title_full_unstemmed | Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence |
| title_short | Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence |
| title_sort | clinical comparison of three sample to answer systems for detecting sars cov 2 in b 1 1 7 lineage emergence |
| topic | covid-19 sars-cov-2 point of care testing molecular diagnostics sample to answer variant of concern |
| url | https://www.dovepress.com/clinical-comparison-of-three-sample-to-answer-systems-for-detecting-sa-peer-reviewed-fulltext-article-IDR |
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