Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis
Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers....
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-07-01
|
| Series: | Viruses |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4915/14/7/1479 |
| _version_ | 1797433054300471296 |
|---|---|
| author | Jimin Kim Heungsup Sung Hyukmin Lee Jae-Seok Kim Sue Shin Seri Jeong Miyoung Choi Hyeon-Jeong Lee on behalf of the Development Committee and Clinical Evidence Research Team in National Evidence-Based Healthcare Collaborating Agency |
| author_facet | Jimin Kim Heungsup Sung Hyukmin Lee Jae-Seok Kim Sue Shin Seri Jeong Miyoung Choi Hyeon-Jeong Lee on behalf of the Development Committee and Clinical Evidence Research Team in National Evidence-Based Healthcare Collaborating Agency |
| author_sort | Jimin Kim |
| collection | DOAJ |
| description | Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic searches of the available literature and updates were conducted in PubMed, Ovid-MEDLINE, Ovid-EMBASE, CENTRAL, and KMBASE for articles evaluating the accuracy of instrument-free RATs for variants up until 14 March 2022. A bivariate random effects model was utilized to calculate pooled diagnostic values in comparison with real-time reverse transcription-polymerase chain reaction as the reference test. A total of 7562 samples from six studies were available for the meta-analysis. The overall pooled sensitivity and specificity of RATs for variants were 69.7% (95% confidence interval [CI] = 62.5% to 76.1%) and 100.0% (95% CI = 98.8% to 100.0%), respectively. When an additional 2179 samples from seven studies reporting sensitivities only were assessed, the pooled sensitivity dropped to 50.0% (95% CI = 44.0% to 55.0%). These findings suggest reassessment and monitoring of the diagnostic utility of RATs for variants, especially for the sensitivity aspect, to facilitate appropriate diagnosis and management of COVID-19 patients. |
| first_indexed | 2024-03-09T10:10:33Z |
| format | Article |
| id | doaj.art-8e2acadf07fa4f6cbe6eab219937b82d |
| institution | Directory Open Access Journal |
| issn | 1999-4915 |
| language | English |
| last_indexed | 2024-03-09T10:10:33Z |
| publishDate | 2022-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj.art-8e2acadf07fa4f6cbe6eab219937b82d2023-12-01T22:47:11ZengMDPI AGViruses1999-49152022-07-01147147910.3390/v14071479Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-AnalysisJimin Kim0Heungsup Sung1Hyukmin Lee2Jae-Seok Kim3Sue Shin4Seri Jeong5Miyoung Choi6Hyeon-Jeong Lee7on behalf of the Development Committee and Clinical Evidence Research Team in National Evidence-Based Healthcare Collaborating AgencyDivision of Healthcare Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, 400, Neungdong-ro, Gwangjin-gu, Seoul 04933, KoreaDepartments of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, KoreaDepartments of Laboratory Medicine, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 03722, KoreaDepartment of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, 150, Seongan-ro, Gangdong-gu, Seoul 05355, KoreaDepartments of Laboratory Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul 07061, KoreaDepartments of Laboratory Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul 07441, KoreaDivision of Healthcare Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, 400, Neungdong-ro, Gwangjin-gu, Seoul 04933, KoreaDivision of Healthcare Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, 400, Neungdong-ro, Gwangjin-gu, Seoul 04933, KoreaRapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic searches of the available literature and updates were conducted in PubMed, Ovid-MEDLINE, Ovid-EMBASE, CENTRAL, and KMBASE for articles evaluating the accuracy of instrument-free RATs for variants up until 14 March 2022. A bivariate random effects model was utilized to calculate pooled diagnostic values in comparison with real-time reverse transcription-polymerase chain reaction as the reference test. A total of 7562 samples from six studies were available for the meta-analysis. The overall pooled sensitivity and specificity of RATs for variants were 69.7% (95% confidence interval [CI] = 62.5% to 76.1%) and 100.0% (95% CI = 98.8% to 100.0%), respectively. When an additional 2179 samples from seven studies reporting sensitivities only were assessed, the pooled sensitivity dropped to 50.0% (95% CI = 44.0% to 55.0%). These findings suggest reassessment and monitoring of the diagnostic utility of RATs for variants, especially for the sensitivity aspect, to facilitate appropriate diagnosis and management of COVID-19 patients.https://www.mdpi.com/1999-4915/14/7/1479SARS-CoV-2COVID-19variantrapid antigen testperformance |
| spellingShingle | Jimin Kim Heungsup Sung Hyukmin Lee Jae-Seok Kim Sue Shin Seri Jeong Miyoung Choi Hyeon-Jeong Lee on behalf of the Development Committee and Clinical Evidence Research Team in National Evidence-Based Healthcare Collaborating Agency Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis Viruses SARS-CoV-2 COVID-19 variant rapid antigen test performance |
| title | Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis |
| title_full | Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis |
| title_fullStr | Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis |
| title_full_unstemmed | Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis |
| title_short | Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis |
| title_sort | clinical performance of rapid and point of care antigen tests for sars cov 2 variants of concern a living systematic review and meta analysis |
| topic | SARS-CoV-2 COVID-19 variant rapid antigen test performance |
| url | https://www.mdpi.com/1999-4915/14/7/1479 |
| work_keys_str_mv | AT jiminkim clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT heungsupsung clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT hyukminlee clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT jaeseokkim clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT sueshin clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT serijeong clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT miyoungchoi clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT hyeonjeonglee clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis AT onbehalfofthedevelopmentcommitteeandclinicalevidenceresearchteaminnationalevidencebasedhealthcarecollaboratingagency clinicalperformanceofrapidandpointofcareantigentestsforsarscov2variantsofconcernalivingsystematicreviewandmetaanalysis |