Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19)
<p><strong>Objectives</strong> Limited evidence exists for the diagnostic performance of point-of-care tests for SARS-CoV-2 and influenza in community healthcare. We carried out a prospective diagnostic accuracy study of the LumiraDx™ SARS-CoV-2 and influenza A or B assay in primar...
| Main Authors: | , , , , , , , , , , , , , |
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| Other Authors: | |
| Format: | Journal article |
| Language: | English |
| Published: |
Elsevier
2023
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| _version_ | 1811139940987174912 |
|---|---|
| author | Fanshawe, TR Tonner, S Turner, PJ Cogdale, J Glogowska, M De Lusignan, S Okusi, C Perera, R Sebastianpillai, P Williams, A Zambon, M Nicholson, Bd Hobbs, FDR Hayward, GN |
| author2 | RAPTOR-C19 Study Group |
| author_facet | RAPTOR-C19 Study Group Fanshawe, TR Tonner, S Turner, PJ Cogdale, J Glogowska, M De Lusignan, S Okusi, C Perera, R Sebastianpillai, P Williams, A Zambon, M Nicholson, Bd Hobbs, FDR Hayward, GN |
| author_sort | Fanshawe, TR |
| collection | OXFORD |
| description | <p><strong>Objectives</strong>
Limited evidence exists for the diagnostic performance of point-of-care tests for SARS-CoV-2 and influenza in community healthcare. We carried out a prospective diagnostic accuracy study of the LumiraDx™ SARS-CoV-2 and influenza A or B assay in primary care.</p>
<p><strong>Methods</strong>
Total of 913 adults and children with symptoms of current SARS-CoV-2 infection were recruited from 18 UK primary care practices during a period when Omicron was the predominant COVID variant of concern (June 2022 to December 2022). Trained health care staff performed the index test, with diagnostic accuracy parameters estimated for SARS-CoV-2 and influenza against real-time reverse-transcription PCR (rtRT-PCR).</p>
<p><strong>Results</strong>
151/887 participants were SARS-CoV-2 rtRT-PCR positive, 109 positive for Influenza A, 6 for Influenza B. Index test sensitivity for SARS-CoV-2 was 80.8% (122 of the 151, 95% CI, 73.6–86.7%) and specificity 98.9% (728 of the 736, 95% CI, 97.9–99.5%). For influenza A, sensitivity was 61.5% (67 of the 109, 95% CI, 51.7–70.6%) and specificity 99.4% (771 of the 776, 95% CI, 98.5–99.8%). Sensitivity to detect SARS-CoV-2 and influenza dropped sharply at rtRT-PCR cycle thresholds (Ct) > 30.</p>
<p><strong>Discussions</strong>
The LumiraDx™ SARS-CoV-2 and influenza A/B assay had moderate sensitivity for SARS-CoV-2 in symptomatic patients in primary care, with lower performance with high rtRT-PCR Ct. Negative results in this patient group cannot definitively rule out SARS-CoV-2 or influenza.</p> |
| first_indexed | 2024-03-07T08:17:20Z |
| format | Journal article |
| id | oxford-uuid:87f69f76-def9-4a24-9543-b1b4117f1712 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-09-25T04:14:05Z |
| publishDate | 2023 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:87f69f76-def9-4a24-9543-b1b4117f17122024-07-12T09:14:48ZDiagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:87f69f76-def9-4a24-9543-b1b4117f1712EnglishSymplectic ElementsElsevier2023Fanshawe, TRTonner, STurner, PJCogdale, JGlogowska, MDe Lusignan, SOkusi, CPerera, RSebastianpillai, PWilliams, AZambon, MNicholson, BdHobbs, FDRHayward, GNRAPTOR-C19 Study Group<p><strong>Objectives</strong> Limited evidence exists for the diagnostic performance of point-of-care tests for SARS-CoV-2 and influenza in community healthcare. We carried out a prospective diagnostic accuracy study of the LumiraDx™ SARS-CoV-2 and influenza A or B assay in primary care.</p> <p><strong>Methods</strong> Total of 913 adults and children with symptoms of current SARS-CoV-2 infection were recruited from 18 UK primary care practices during a period when Omicron was the predominant COVID variant of concern (June 2022 to December 2022). Trained health care staff performed the index test, with diagnostic accuracy parameters estimated for SARS-CoV-2 and influenza against real-time reverse-transcription PCR (rtRT-PCR).</p> <p><strong>Results</strong> 151/887 participants were SARS-CoV-2 rtRT-PCR positive, 109 positive for Influenza A, 6 for Influenza B. Index test sensitivity for SARS-CoV-2 was 80.8% (122 of the 151, 95% CI, 73.6–86.7%) and specificity 98.9% (728 of the 736, 95% CI, 97.9–99.5%). For influenza A, sensitivity was 61.5% (67 of the 109, 95% CI, 51.7–70.6%) and specificity 99.4% (771 of the 776, 95% CI, 98.5–99.8%). Sensitivity to detect SARS-CoV-2 and influenza dropped sharply at rtRT-PCR cycle thresholds (Ct) > 30.</p> <p><strong>Discussions</strong> The LumiraDx™ SARS-CoV-2 and influenza A/B assay had moderate sensitivity for SARS-CoV-2 in symptomatic patients in primary care, with lower performance with high rtRT-PCR Ct. Negative results in this patient group cannot definitively rule out SARS-CoV-2 or influenza.</p> |
| spellingShingle | Fanshawe, TR Tonner, S Turner, PJ Cogdale, J Glogowska, M De Lusignan, S Okusi, C Perera, R Sebastianpillai, P Williams, A Zambon, M Nicholson, Bd Hobbs, FDR Hayward, GN Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19) |
| title | Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19) |
| title_full | Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19) |
| title_fullStr | Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19) |
| title_full_unstemmed | Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19) |
| title_short | Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19) |
| title_sort | diagnostic accuracy of a point of care antigen test for sars cov 2 and influenza in a primary care population raptor c19 |
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