PloS one · 2025
Diagnostic accuracy evaluation of a point-of-care antigen test for SARS-CoV-2 and influenza in UK primary care (RAPTOR-C19).
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Fanshawe Thomas R, Tonner Sharon, Turner Philip J, Głogowska Margaret, Ukwatte Umasha, Okusi Cecilia, Cogdale Jade, Zambon Maria, Nicholson Brian D, Hobbs F D Richard, Hayward Gail N, RAPTOR-C19 Study Group
Аннотация
OBJECTIVES: To evaluate the diagnostic accuracy of the Roche SARS-CoV-2 & Flu A/B Rapid Antigen Test at the point of care.
DESIGN: Prospective diagnostic accuracy study.
SETTING: 17 primary care practices in England.
PARTICIPANTS: 500 individuals with symptoms consistent with possible SARS-CoV-2 or influenza infection identified upon presentation to primary care or via medical note review.
PRIMARY AND SECONDARY OUTCOME MEASURES: 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.
RESULTS: 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%).
CONCLUSIONS: 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.
REGISTRATION: ISRCTN14226970.
DESIGN: Prospective diagnostic accuracy study.
SETTING: 17 primary care practices in England.
PARTICIPANTS: 500 individuals with symptoms consistent with possible SARS-CoV-2 or influenza infection identified upon presentation to primary care or via medical note review.
PRIMARY AND SECONDARY OUTCOME MEASURES: 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.
RESULTS: 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%).
CONCLUSIONS: 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.
REGISTRATION: ISRCTN14226970.
Предметные рубрики MeSH
HumansInfluenza, HumanPrimary Health CareCOVID-19SARS-CoV-2Middle AgedFemaleMaleAdultSensitivity and SpecificityAgedProspective StudiesAntigens, ViralAdolescentUnited KingdomPoint-of-Care TestingYoung AdultInfluenza A virusAged, 80 and overInfluenza B virusChildPoint-of-Care SystemsCOVID-19 Serological Testing