Journal Article

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)

Turner, Philip J., Hobbs, F.D. Richard, Zambon, Maria, Tonner, Sharon, Nicholson, Brian D., Williams, Alice J., Amirthalingam, Gayatri, Fanshawe, Thomas R., Hayward, Gail N., Body, Richard, Perera, Rafael, de Lusignan, Simon, Davies, Kerrie

2023

Overview

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. 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. 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. 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. ISRCTN142269.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Accuracy / Adult / Antigens / Biology and life sciences / Biosensors / Child / Community health care / Consent / COVID-19 / COVID-19 - diagnosis / COVID-19 Testing / Detectors / Diagnostic systems / Disease transmission / Engineering and Technology / Evaluation / Family medicine / Health aspects / Health care / Humans / Independent regulatory commissions / Infection / Infections / Laboratories / Medical diagnosis / Medical personnel / Medical research / Medical tests / Medicine and Health Sciences / Medicine, Experimental / Parameter estimation / Patients / Pharmaceutical industry / Point of care testing / Polymerase chain reaction / Primary care / Primary Health Care / Quality control / Research and Analysis Methods / Reverse transcription / SARS-CoV-2 / Sensitivity / Sensitivity and Specificity / Severe acute respiratory syndrome coronavirus 2 / Signs and symptoms / Subgroups / United Kingdom / Viral diseases