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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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<h3>Background</h3> <p>In 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 A...

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Main Authors: Klein, Julian (Author) , Krüger, Lisa (Author) , Tobian, Frank (Author) , Gaeddert, Mary (Author) , Lainati, Federica (Author) , Schnitzler, Paul (Author) , Lindner, Andreas (Author) , Nikolai, Olga (Author) , Knorr, Britta (Author) , Welker, Andreas (Author) , Vos, Margaretha de (Author) , Sacks, Jilian A. (Author) , Escadafal, Camille (Author) , Denkinger, Claudia M. (Author)
Format: Article (Journal) Chapter/Article
Language:English
Published: March 24, 2021
In: medRxiv
Year: 2021, Pages: 1-10
DOI:10.1101/2021.03.17.21253076
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1101/2021.03.17.21253076
Verlag, kostenfrei, Volltext: https://www.medrxiv.org/content/10.1101/2021.03.17.21253076v1
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Author Notes:Julian A. F. Klein, Lisa J. Krüger, Frank Tobian, Mary Gaeddert, Federica Lainati, Paul Schnitzler, Andreas K. Lindner, Olga Nikolai, B. Knorr, A. Welker, Margaretha de Vos, Jilian A. Sacks, Camille Escadafal, Claudia M. Denkinger, for the study team
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Summary:<h3>Background</h3> <p>In 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.</p><h3>Methods</h3> <p>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 (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.</p><h3>Results</h3> <p>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.</p><h3>Conclusion</h3> <p>For 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.</p>
Item Description:Gesehen am 30.04.2021
Physical Description:Online Resource
DOI:10.1101/2021.03.17.21253076

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