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

Julian A F Klein,Andreas K Lindner,B Knorr,For The Study Team ,Mary Gaeddert,Jilian A Sacks,Lisa J Krüger,A Welker,Federica Lainati,Margaretha De Vos,Camille Escadafal,Olga Nikolai,Frank Tobian,Claudia M Denkinger,Paul Schnitzler

doi:10.1007/s00430-021-00710-9

Abstract

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 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.

Highlights

The use of antigen-detecting rapid diagnostic tests (AgRDTs) for SARS-CoV-2 has increased within the last months and has an important role in pandemic management
After exclusion of two participants, 290 participants were included in the analysis
SARSCoV-2 infection was detected by reverse transcription polymerase chain reaction (RT-PCR) in 15.5% (45/290) of the study population (Table 1), with eight infections being among asymptomatic participants

Summary

Introduction

The use of antigen-detecting rapid diagnostic tests (AgRDTs) for SARS-CoV-2 has increased within the last months and has an important role in pandemic management. In 2020, the World Health Organization (WHO) recommended two lateral flow AgRDTs ((SD Biosensor, Inc. Gyeonggi-do, Korea, distributed by Roche, Germany, called Standard Q; and Abbott PanbioTM (Rapid Diagnostics, Jena, Germany; called Panbio))), both initially with nasopharyngeal (NP) sample collection [1, 2]. Independent head-to-head studies demonstrated that nasal sampling (including self-sampling) assessed against NP sampling leads to comparable performance using the SARS-CoV-2 Ag-RDT SD STANDARD Q [3,4,5]. For Panbio, only one study to date assessed professional nasal mid-turbinate (NMT) sampling and showed 82.1% sensitivity and 99.1% specificity in comparison to reverse transcription polymerase chain reaction (RT-PCR). A head-to-head comparison with NP sampling has not been performed to date [6]

Methods

Results

Conclusion