Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test
Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test
BackgroundIn 2020, the World Health Organization (WHO) recommended two SARS-CoV-2 lateral flow antigen detecting rapid diagnostics tests (Ag-RDTs), both initially with nasopharyngeal (NP) sample collection. Independent head-to-head studies demonstrated for SARS-CoV-2 Ag-RDTs nasal sampling to be a comparable and reliable alternative for nasopharyngeal (NP) sampling. MethodsWe conducted a head-to-head comparison study of a supervised, self-collected nasal mid-turbinate (NMT) swab and a professional-collected NP swab, using the Panbio Ag-RDT (the second WHO-listed SARS-CoV-2 Ag-RDT, distributed by Abbott). We calculated positive and negative percent agreement and, compared to the reference standard reverse transcription polymerase chain reaction (RT-PCR), sensitivity and specificity for both sampling techniques. ResultsA SARS-CoV-2 infection could be diagnosed by RT-PCR in 45 of 290 participants (15.5%). Comparing the NMT and NP sampling the positive percent agreement of the Ag-RDT was 88.1% (37/42 PCR positives detected; CI 75.0% - 94.8%). The negative percent agreement was 98.8% (245/248; CI 96.5% - 99.6%). The overall sensitivity of Panbio with NMT sampling was 84.4% (38/45; CI 71.2% - 92.3%) and 88.9% (40/45; CI 76.5% - 95.5%) with NP sampling. Specificity was 99.2% (243/245; CI 97.1% - 99.8%) for both, NP and NMT sampling. The sensitivity of the Panbio test in participants with high viral load (> 7 log10 SARS-CoV-2 RNA copies/mL) was 96.3% (CI 81.7% - 99.8%) for both, NMT and NP sampling. ConclusionFor the Panbio Ag-RDT supervised NMT self-sampling yields to results comparable to NP sampling. This suggests that nasal self-sampling could be used for scale-up population testing.
Klein Julian A.F.、Gaeddert Mary、Lainati Federica、Sacks Jilian A.、Escadafal Camille、for the study team、Kr¨1ger Lisa J.、Knorr B.、Welker A.、de Vos Margaretha、Schnitzler Paul、Denkinger Claudia M.、Lindner Andreas K.、Nikolai Olga、Tobian Frank
Division of Clinical Tropical Medicine, Centre of Infectious Diseases, Heidelberg University HospitalDivision of Clinical Tropical Medicine, Centre of Infectious Diseases, Heidelberg University HospitalDivision of Clinical Tropical Medicine, Centre of Infectious Diseases, Heidelberg University HospitalFoundation for Innovative New DiagnosticsFoundation for Innovative New DiagnosticsDivision of Clinical Tropical Medicine, Centre of Infectious Diseases, Heidelberg University HospitalLocal Health Authority of Heidelberg and Rhein-Neckar-RegionLocal Health Authority of Heidelberg and Rhein-Neckar-RegionFoundation for Innovative New DiagnosticsDepartment of Virology, Centre of Infectious Diseases, Heidelberg University HospitalDivision of Clinical Tropical Medicine, Centre of Infectious Diseases, Heidelberg University HospitalCharit¨| ¨C Universit?tsmedizin Berlin, corporate member of Freie Universit?t Berlin, Humboldt-Universit?t zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International HealthCharit¨| ¨C Universit?tsmedizin Berlin, corporate member of Freie Universit?t Berlin, Humboldt-Universit?t zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International HealthDivision of Clinical Tropical Medicine, Centre of Infectious Diseases, Heidelberg University Hospital
医学研究方法耳鼻咽喉科学预防医学
SARS-CoV-2COVID-19nasal samplingantigen-detecting rapid diagnostic testself-samplinghead-to-head comparison
Klein Julian A.F.,Gaeddert Mary,Lainati Federica,Sacks Jilian A.,Escadafal Camille,for the study team,Kr¨1ger Lisa J.,Knorr B.,Welker A.,de Vos Margaretha,Schnitzler Paul,Denkinger Claudia M.,Lindner Andreas K.,Nikolai Olga,Tobian Frank.Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test[EB/OL].(2025-03-28)[2025-08-02].https://www.medrxiv.org/content/10.1101/2021.03.17.21253076.点此复制
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