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
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Published:2021-05-24
Issue:4
Volume:210
Page:181-186
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ISSN:0300-8584
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Container-title:Medical Microbiology and Immunology
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language:en
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Short-container-title:Med Microbiol Immunol
Author:
Klein Julian A. F., Krüger Lisa J., Tobian Frank, Gaeddert Mary, Lainati Federica, Schnitzler Paul, Lindner Andreas K., Nikolai Olga, Knorr B., Welker A., de Vos Margaretha, Sacks Jilian A., Escadafal Camille, Denkinger Claudia M.ORCID,
Abstract
AbstractIn 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 are necessary for SARS-CoV-2 Ag-RDT nasal sampling to demonstrate comparability of performance with nasopharyngeal (NP) sampling. We 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 (distributed by Abbott). We calculated positive and negative percent agreement between the sampling methods as well as sensitivity and specificity for both sampling techniques compared to the reference standard reverse transcription polymerase chain reaction (RT-PCR). A 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. For the Panbio supervised NMT self-sampling yields comparable results to NP sampling. This suggests that nasal self-sampling could be used for to enable scaled-up population testing.Clinical Trial DRKS00021220.
Funder
Unitaid World Health Organization Universitätsklinikum Heidelberg Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg Foundation of innovative new diagnostics DFID
Publisher
Springer Science and Business Media LLC
Subject
Microbiology (medical),Immunology,General Medicine,Immunology and Allergy
Reference17 articles.
1. World Health Organization (2020) Global partnership to make available 120 million affordable, quality COVID-19 rapid tests for low- and middle-income countries. http://www.who.int/news-room/detail/28-09-2020-global-partnership-to-make-available-120-million-affordable-quality-covid-19-rapid-tests-for-low--and-middle-income-countries. Accessed 24 Feb 2021 2. World Health Organization (2021) WHO Emergency Use Assessment Coronavirus disease (COVID-19) IVDsPUBLIC REPORT, Product: Panbio COVID-19 Ag Rapid Test Device (NASAL). https://extranet.who.int/pqweb/key-resources/documents/who-eul-public-report-abbott-panbio-covid-19-ag-rapid-test-device-nasal-eul. Accessed 24 Feb 2021 3. Lindner AK, Nikolai O, Kausch F, Wintel M, Hommes F, Gertler M, Kruger LJ, Gaeddert M, Tobian F, Lainati F, Koppel L, Seybold J, Corman VM, Drosten C, Hofmann J, Sacks JA, Mockenhaupt FP, Denkinger CM (2021) Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab. Eur Respir J. https://doi.org/10.1183/13993003.03961-2020 4. Lindner AK, Nikolai O, Rohardt C, Burock S, Hulso C, Bolke A, Gertler M, Kruger LJ, Gaeddert M, Tobian F, Lainati F, Seybold J, Jones TC, Hofmann J, Sacks JA, Mockenhaupt FP, Denkinger CM (2021) Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with professional-collected nasal versus nasopharyngeal swab. Eur Respir J. https://doi.org/10.1183/13993003.04430-2020 5. Nikolai O, Rohardt C, Tobian F, Junge A, Corman VM, Jones TC, Gaeddert M, Lainati F, Sacks JA, Seybold J, Mockenhaupt FP, Denkinger CM, Lindner AK (2021) Anterior nasal versus nasal mid-turbinate sampling for a SARS-CoV-2 antigen-detecting rapid test: does localisation or professional collection matter? medRxiv. https://doi.org/10.1101/2021.02.09.21251274
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