Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19).
<h4>Background and objective</h4>Point-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed to evaluate the diagnostic accuracy of two point-of-care tests (POCTs) for SARS-CoV-2 i...
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Public Library of Science (PLoS)
2023-01-01
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| author | Brian D Nicholson Philip J Turner Thomas R Fanshawe Alice J Williams Gayatri Amirthalingam Sharon Tonner Maria Zambon Richard Body Kerrie Davies Rafael Perera Simon de Lusignan Gail N Hayward F D Richard Hobbs RAPTOR-C19 Study Group and the CONDOR Steering Committee |
| author_facet | Brian D Nicholson Philip J Turner Thomas R Fanshawe Alice J Williams Gayatri Amirthalingam Sharon Tonner Maria Zambon Richard Body Kerrie Davies Rafael Perera Simon de Lusignan Gail N Hayward F D Richard Hobbs RAPTOR-C19 Study Group and the CONDOR Steering Committee |
| author_sort | Brian D Nicholson |
| collection | DOAJ |
| description | <h4>Background and objective</h4>Point-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed to evaluate the diagnostic accuracy of two point-of-care tests (POCTs) for SARS-CoV-2 in routine community care.<h4>Methods</h4>Adults and children with symptoms consistent with suspected current COVID-19 infection were prospectively recruited from 19 UK general practices and two COVID-19 testing centres between October 2020 and October 2021. Participants were tested by trained healthcare workers using at least one of two index POCTs (Roche-branded SD Biosensor Standard™ Q SARS-CoV-2 Rapid Antigen Test and/or BD Veritor™ System for Rapid Detection of SARS-CoV-2). The reference standard was laboratory triplex reverse transcription quantitative PCR (RT-PCR) using a combined nasal/oropharyngeal swab. Diagnostic accuracy parameters were estimated, with 95% confidence intervals (CIs), overall, in relation to RT-PCR cycle threshold and in pre-specified subgroups.<h4>Results</h4>Of 663 participants included in the primary analysis, 39.2% (260/663, 95% CI 35.5% to 43.0%) had a positive RT-PCR result. The SD Biosensor POCT had sensitivity 84.0% (178/212, 78.3% to 88.6%) and specificity 98.5% (328/333, 96.5% to 99.5%), and the BD Veritor POCT had sensitivity 76.5% (127/166, 69.3% to 82.7%) and specificity 98.8% (249/252, 96.6% to 99.8%) compared with RT-PCR. Sensitivity of both devices dropped substantially at cycle thresholds ≥30 and in participants more than 7 days after onset of symptoms.<h4>Conclusions</h4>Both POCTs assessed exceed the Medicines and Healthcare products Regulatory Agency target product profile's minimum acceptable specificity of 95%. Confidence intervals for both tests include the minimum acceptable sensitivity of 80%. In symptomatic patients, negative results on these two POCTs do not preclude the possibility of infection. Tests should not be expected to reliably detect disease more than a week after symptom onset, when viral load may be reduced.<h4>Registration</h4>ISRCTN142269. |
| format | Article |
| id | doaj-art-a34255c2031643e1a30c238b975c57df |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj-art-a34255c2031643e1a30c238b975c57df2025-02-05T05:32:39ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01187e028861210.1371/journal.pone.0288612Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19).Brian D NicholsonPhilip J TurnerThomas R FanshaweAlice J WilliamsGayatri AmirthalingamSharon TonnerMaria ZambonRichard BodyKerrie DaviesRafael PereraSimon de LusignanGail N HaywardF D Richard HobbsRAPTOR-C19 Study Group and the CONDOR Steering Committee<h4>Background and objective</h4>Point-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed to evaluate the diagnostic accuracy of two point-of-care tests (POCTs) for SARS-CoV-2 in routine community care.<h4>Methods</h4>Adults and children with symptoms consistent with suspected current COVID-19 infection were prospectively recruited from 19 UK general practices and two COVID-19 testing centres between October 2020 and October 2021. Participants were tested by trained healthcare workers using at least one of two index POCTs (Roche-branded SD Biosensor Standard™ Q SARS-CoV-2 Rapid Antigen Test and/or BD Veritor™ System for Rapid Detection of SARS-CoV-2). The reference standard was laboratory triplex reverse transcription quantitative PCR (RT-PCR) using a combined nasal/oropharyngeal swab. Diagnostic accuracy parameters were estimated, with 95% confidence intervals (CIs), overall, in relation to RT-PCR cycle threshold and in pre-specified subgroups.<h4>Results</h4>Of 663 participants included in the primary analysis, 39.2% (260/663, 95% CI 35.5% to 43.0%) had a positive RT-PCR result. The SD Biosensor POCT had sensitivity 84.0% (178/212, 78.3% to 88.6%) and specificity 98.5% (328/333, 96.5% to 99.5%), and the BD Veritor POCT had sensitivity 76.5% (127/166, 69.3% to 82.7%) and specificity 98.8% (249/252, 96.6% to 99.8%) compared with RT-PCR. Sensitivity of both devices dropped substantially at cycle thresholds ≥30 and in participants more than 7 days after onset of symptoms.<h4>Conclusions</h4>Both POCTs assessed exceed the Medicines and Healthcare products Regulatory Agency target product profile's minimum acceptable specificity of 95%. Confidence intervals for both tests include the minimum acceptable sensitivity of 80%. In symptomatic patients, negative results on these two POCTs do not preclude the possibility of infection. Tests should not be expected to reliably detect disease more than a week after symptom onset, when viral load may be reduced.<h4>Registration</h4>ISRCTN142269.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0288612&type=printable |
| spellingShingle | Brian D Nicholson Philip J Turner Thomas R Fanshawe Alice J Williams Gayatri Amirthalingam Sharon Tonner Maria Zambon Richard Body Kerrie Davies Rafael Perera Simon de Lusignan Gail N Hayward F D Richard Hobbs RAPTOR-C19 Study Group and the CONDOR Steering Committee Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19). PLoS ONE |
| title | Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19). |
| title_full | Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19). |
| title_fullStr | Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19). |
| title_full_unstemmed | Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19). |
| title_short | Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19). |
| title_sort | evaluation of the diagnostic accuracy of two point of care tests for covid 19 when used in symptomatic patients in community settings in the uk primary care covid diagnostic accuracy platform trial raptor c19 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0288612&type=printable |
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