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A single-center experience on long-term clinical performance of a rapid SARS-CoV-2 Antigen Detection Test, STANDARD Q COVID-19 Ag Test
DC Field | Value | Language |
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dc.contributor.author | 김도균 | - |
dc.contributor.author | 박용정 | - |
dc.contributor.author | 정석훈 | - |
dc.date.accessioned | 2024-01-03T01:37:10Z | - |
dc.date.available | 2024-01-03T01:37:10Z | - |
dc.date.issued | 2023-11 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/197617 | - |
dc.description.abstract | The COVID-19 pandemic in Korea has dynamically changed with the occurrence of more easily transmissible variants. A rapid and reliable diagnostic tool for detection of SARS-CoV-2 is needed. While RT-PCR is currently the gold standard for detecting SARS-CoV-2, the procedure is time-consuming and requires expert technicians. The rapid antigen detection test (RADT) was approved as a confirmatory test on 14 March 2022 due to rapid dissemination of the Omicron variant. The benefits of the RADT are speed, simplicity, and point-of-care feasibility. The aim of our study was to evaluate the clinical performance of RADT compared to RT-PCR in a single center over 15 months, fully covering the SARS-CoV-2 'Variants of Concern (VOC).' A total of 14,194 cases was simultaneously tested by RT-PCR and RADT from January 2021 to March 2022 in Gangnam Severance Hospital and were retrospectively reviewed. PowerChek SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit, and STANDARD Q COVID-19 Ag Test were used. Positive rates, sensitivities, specificities, positive predictive values (PPV), and negative predictive values (NPV) were estimated for five periods (3 months/period). Receiver operator characteristic curve (ROC) analysis was performed, and Spearman's rank test assessed the correlation between RT-PCR Ct values and semi-quantitative RADT results. The overall positive rate of RT-PCR was 4.64%. The overall sensitivity and specificity were 0.577 [95% confidence interval (CI) 0.539-0.614] and 0.991 [95% CI 0.989-0.993], respectively. ROC analysis resulted in an area under the curve of 0.786 (P < 0.0001, Yuden's index = 0.568). The PCR positive rates were estimated as 0.11%, 0.71%, 4.51%, 2.02%, and 13.72%, and PPV was estimated as 0.045, 0.421, 0.951, 0.720, and 0.798 in Periods 1, 2, 3, 4, and 5, respectively. A significant and moderate negative correlation between PCR Ct values and semi-quantitative RADT results was observed (Spearman's ρ = - 0.646, P < 0.0001). The RADT exhibited good performance in specimens with low Ct values (Ct ≤ 25.00) by RT-PCR. The PPV was significantly higher in Periods 3 and 5, which corresponds to rapid dissemination of the Delta and Omicron variants. The high PPV implies that individuals with a positive RADT result are very likely infected with SARS-CoV-2 and would require prompt quarantine rather than additional RT-PCR testing. The sensitivity of 0.577 indicates that RADT should not replace RT-PCR. Nonetheless, given the high PPV and the ability to track infected persons through rapid results, our findings suggest that RADT could play a significant role in control strategies for further SARS-CoV-2 variants. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Nature Publishing Group | - |
dc.relation.isPartOf | SCIENTIFIC REPORTS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | COVID-19* / diagnosis | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Pandemics | - |
dc.subject.MESH | Real-Time Polymerase Chain Reaction | - |
dc.subject.MESH | Retrospective Studies | - |
dc.subject.MESH | SARS-CoV-2* / genetics | - |
dc.subject.MESH | Sensitivity and Specificity | - |
dc.title | A single-center experience on long-term clinical performance of a rapid SARS-CoV-2 Antigen Detection Test, STANDARD Q COVID-19 Ag Test | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Laboratory Medicine (진단검사의학교실) | - |
dc.contributor.googleauthor | Seo Wan Kim | - |
dc.contributor.googleauthor | Yongjung Park | - |
dc.contributor.googleauthor | Dokyun Kim | - |
dc.contributor.googleauthor | Seok Hoon Jeong | - |
dc.identifier.doi | 10.1038/s41598-023-48194-2 | - |
dc.contributor.localId | A04891 | - |
dc.contributor.localId | A01582 | - |
dc.contributor.localId | A03619 | - |
dc.relation.journalcode | J02646 | - |
dc.identifier.eissn | 2045-2322 | - |
dc.identifier.pmid | 38012319 | - |
dc.contributor.alternativeName | Kim, Dokyun | - |
dc.contributor.affiliatedAuthor | 김도균 | - |
dc.contributor.affiliatedAuthor | 박용정 | - |
dc.contributor.affiliatedAuthor | 정석훈 | - |
dc.citation.volume | 13 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 20777 | - |
dc.identifier.bibliographicCitation | SCIENTIFIC REPORTS, Vol.13(1) : 20777, 2023-11 | - |
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