• Media type: E-Article
  • Title: 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
  • Contributor: 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]
  • Published: March 24, 2021
  • Published in: medRxiv ; (2021), Artikel-ID 2021.03.17.21253076, Seite 1-10
  • Language: English
  • DOI: 10.1101/2021.03.17.21253076
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  • Footnote:
  • Description: <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>
  • Access State: Open Access