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 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 log 10 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. Supplementary Information The online version contains supplementary material available at 10.1007/s00430-021-00710-9.
【저자키워드】 COVID-19, SARS-CoV-2, Self-sampling, Nasal sampling, Antigen-detecting rapid diagnostic test, Head-to-head comparison, 【초록키워드】 SARS-COV-2 infection, nasal, RT-PCR, diagnostics, lateral flow, polymerase chain reaction, sensitivity, Viral, Sensitivity and specificity, Viral load, RNA copies, nasopharyngeal, clinical, sampling, WHO, reverse transcription, SARS-CoV-2 RNA, Swab, NP swab, Ag-RDT, reference standard, RDTs, Abbott, comparability, Health Organization, Chain Reaction, Abbott), World Health Organization, supplementary material, head, PCR positive, high viral load, Ag-RDTs, participant, positive, PanBio, polymerase chain, log, diagnosed, conducted, calculated, comparable, 【제목키워드】 nasal, Nasopharyngeal swab, Rapid diagnostic test,