Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19).
<h4>Objectives</h4>To evaluate the diagnostic accuracy of the Roche SARS-CoV-2 & Flu A/B Rapid Antigen Test at the point of care.<h4>Design</h4>Prospective diagnostic accuracy study.<h4>Setting</h4>17 primary care practices in England.<h4>Participants<...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2025-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0329611 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849228133585125376 |
|---|---|
| author | Thomas R Fanshawe Sharon Tonner Philip J Turner Margaret Głogowska Umasha Ukwatte Cecilia Okusi Jade Cogdale Maria Zambon Brian D Nicholson F D Richard Hobbs Gail N Hayward RAPTOR-C19 Study Group |
| author_facet | Thomas R Fanshawe Sharon Tonner Philip J Turner Margaret Głogowska Umasha Ukwatte Cecilia Okusi Jade Cogdale Maria Zambon Brian D Nicholson F D Richard Hobbs Gail N Hayward RAPTOR-C19 Study Group |
| author_sort | Thomas R Fanshawe |
| collection | DOAJ |
| description | <h4>Objectives</h4>To evaluate the diagnostic accuracy of the Roche SARS-CoV-2 & Flu A/B Rapid Antigen Test at the point of care.<h4>Design</h4>Prospective diagnostic accuracy study.<h4>Setting</h4>17 primary care practices in England.<h4>Participants</h4>500 individuals with symptoms consistent with possible SARS-CoV-2 or influenza infection identified upon presentation to primary care or via medical note review.<h4>Primary and secondary outcome measures</h4>Sensitivity, specificity and predictive values, compared to a laboratory reference standard of real-time reverse transcription PCR, using samples collected using a combined nasal and oropharyngeal swab.<h4>Results</h4>Of 481 participants with available index and reference test results, 5.6% (27/481) were reference standard-positive for SARS-CoV-2, 11.4% (55/481) for Influenza A and 1.9% (9/481) for Influenza B. The sensitivity of the antigen test to detect SARS-CoV-2 was 70.4% (19/27, 95% CI 49.6-86.2%) and specificity was 99.3% (451/454, 95%CI 98.1-99.9%). For Influenza A, sensitivity was 29.1% (16/55, 95% CI 17.6-42.9%) and specificity 98.6% (420/426, 97.0-99.5%), and for Influenza B, sensitivity was 22.2% (2/9, 2.8-60.0%) and specificity 98.1% (463/472, 96.4-99.1%).<h4>Conclusions</h4>In a primary care population of symptomatic individuals, the assay was highly specific and had moderate sensitivity to detect SARS-CoV-2, but did not detect the majority of influenza infections.<h4>Registration</h4>ISRCTN14226970. |
| format | Article |
| id | doaj-art-1bcd596c374a413291146ca1970c738d |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-1bcd596c374a413291146ca1970c738d2025-08-23T05:32:00ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01208e032961110.1371/journal.pone.0329611Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19).Thomas R FanshaweSharon TonnerPhilip J TurnerMargaret GłogowskaUmasha UkwatteCecilia OkusiJade CogdaleMaria ZambonBrian D NicholsonF D Richard HobbsGail N HaywardRAPTOR-C19 Study Group<h4>Objectives</h4>To evaluate the diagnostic accuracy of the Roche SARS-CoV-2 & Flu A/B Rapid Antigen Test at the point of care.<h4>Design</h4>Prospective diagnostic accuracy study.<h4>Setting</h4>17 primary care practices in England.<h4>Participants</h4>500 individuals with symptoms consistent with possible SARS-CoV-2 or influenza infection identified upon presentation to primary care or via medical note review.<h4>Primary and secondary outcome measures</h4>Sensitivity, specificity and predictive values, compared to a laboratory reference standard of real-time reverse transcription PCR, using samples collected using a combined nasal and oropharyngeal swab.<h4>Results</h4>Of 481 participants with available index and reference test results, 5.6% (27/481) were reference standard-positive for SARS-CoV-2, 11.4% (55/481) for Influenza A and 1.9% (9/481) for Influenza B. The sensitivity of the antigen test to detect SARS-CoV-2 was 70.4% (19/27, 95% CI 49.6-86.2%) and specificity was 99.3% (451/454, 95%CI 98.1-99.9%). For Influenza A, sensitivity was 29.1% (16/55, 95% CI 17.6-42.9%) and specificity 98.6% (420/426, 97.0-99.5%), and for Influenza B, sensitivity was 22.2% (2/9, 2.8-60.0%) and specificity 98.1% (463/472, 96.4-99.1%).<h4>Conclusions</h4>In a primary care population of symptomatic individuals, the assay was highly specific and had moderate sensitivity to detect SARS-CoV-2, but did not detect the majority of influenza infections.<h4>Registration</h4>ISRCTN14226970.https://doi.org/10.1371/journal.pone.0329611 |
| spellingShingle | Thomas R Fanshawe Sharon Tonner Philip J Turner Margaret Głogowska Umasha Ukwatte Cecilia Okusi Jade Cogdale Maria Zambon Brian D Nicholson F D Richard Hobbs Gail N Hayward RAPTOR-C19 Study Group Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19). PLoS ONE |
| title | Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19). |
| title_full | Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19). |
| title_fullStr | Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19). |
| title_full_unstemmed | Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19). |
| title_short | Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19). |
| title_sort | diagnostic accuracy evaluation of a point of care antigen test for sars cov 2 and influenza in uk primary care raptor c19 |
| url | https://doi.org/10.1371/journal.pone.0329611 |
| work_keys_str_mv | AT thomasrfanshawe diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT sharontonner diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT philipjturner diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT margaretgłogowska diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT umashaukwatte diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT ceciliaokusi diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT jadecogdale diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT mariazambon diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT briandnicholson diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT fdrichardhobbs diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT gailnhayward diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 AT raptorc19studygroup diagnosticaccuracyevaluationofapointofcareantigentestforsarscov2andinfluenzainukprimarycareraptorc19 |