TY - JOUR
T1 - Diagnostic Performance of Rapid Antigen Testing for SARS-CoV-2
T2 - The COVid-19 AntiGen (COVAG) study
AU - Wertenauer, Christoph
AU - Brenner Michael, Geovana
AU - Dressel, Alexander
AU - Pfeifer, Caroline
AU - Hauser, Ulrike
AU - Wieland, Eberhard
AU - Mayer, Christian
AU - Mutschmann, Caren
AU - Roskos, Martin
AU - Wertenauer, Hans Jörg
AU - Moissl, Angela P.
AU - Lorkowski, Stefan
AU - März, Winfried
N1 - Funding Information:
We thank the participants for joining in free of remuneration. Katja Pöhl, CEO, SYNLAB MVZ Leinfelden-Echterdingen and Christoph Mahnke, CEO SYNLAB Holding Deutschland GmbH, supported the study. We thank Madeline Beckers, Alexander Ignatenko, Anna Süßmuth, Annika Saile, Berfin Cicek, Brigitte Schwandt, Carolin Meixner, Christian Lang, Felix Eisenmann, Jacques Pfander, Katerina Triantafillidi, Lars Banzhaf, Leo Rahmig, Miriam Berner, Robin Bohn, Susanne Kunz, Tim Fröschle, Verena Lebherz, and Jacob Göhring for carrying out the RDTs and documenting the participants at the Corona Test Center Cannstatter Wasen, Stuttgart. The content of this manuscript has previously appeared online on the preprint-server medRxiv (39).
Publisher Copyright:
Copyright © 2022 Wertenauer, Brenner Michael, Dressel, Pfeifer, Hauser, Wieland, Mayer, Mutschmann, Roskos, Wertenauer, Moissl, Lorkowski and März.
PY - 2022/3
Y1 - 2022/3
N2 - Background: Rapid diagnostic testing for SARS-Cov-2 antigens is used to combat the ongoing pandemic. In this study we aimed to compare two RDTs, the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche) and the Panbio COVID-19 Ag Rapid Test (Abbott), against rRT-PCR. Methods: We included 2,215 all-comers at a diagnostic center between February 1 and March 31, 2021. rRT-PCR-positive samples were examined for SARS-CoV-2 variants. Findings: Three hundred and thirty eight participants (15%) were rRT-PCR-positive for SARS-CoV-2. The sensitivities of Roche-RDT and Abbott-RDT were 60.4 and 56.8% (P < 0.0001) and specificities 99.7% and 99.8% (P = 0.076). Sensitivity inversely correlated with rRT-PCR-Ct values. The RDTs had higher sensitivities in individuals referred by treating physicians (79.5%, 78.7%) than in those referred by health departments (49.5%, 44.3%) or tested for other reasons (50%, 45.8%), in persons without any comorbidities (74.4%, 71%) compared to those with comorbidities (38.2%, 34.4%), in individuals with COVID-19 symptoms (75.2%, 74.3%) compared to those without (31.9%, 23.3%), and in the absence of SARS-CoV-2 variants (87.7%, 84%) compared to Alpha variant carriers (77.1%, 72.3%). If 10,000 symptomatic individuals are tested of which 500 are truly positive, the RDTs would generate 38 false-positive and 124 false-negative results. If 10,000 asymptomatic individuals are tested, including 50 true positives, 18 false-positives and 34 false-negatives would be generated. Interpretation: The sensitivities of the two RDTs for asymptomatic SARS-CoV-2 carriers are unsatisfactory. Their widespread use may not be effective in the ongoing SARS-CoV-2 pandemic. The virus genotype influences the sensitivity of the two RDTs. RDTs should be evaluated for different SARS-CoV-2 variants.
AB - Background: Rapid diagnostic testing for SARS-Cov-2 antigens is used to combat the ongoing pandemic. In this study we aimed to compare two RDTs, the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche) and the Panbio COVID-19 Ag Rapid Test (Abbott), against rRT-PCR. Methods: We included 2,215 all-comers at a diagnostic center between February 1 and March 31, 2021. rRT-PCR-positive samples were examined for SARS-CoV-2 variants. Findings: Three hundred and thirty eight participants (15%) were rRT-PCR-positive for SARS-CoV-2. The sensitivities of Roche-RDT and Abbott-RDT were 60.4 and 56.8% (P < 0.0001) and specificities 99.7% and 99.8% (P = 0.076). Sensitivity inversely correlated with rRT-PCR-Ct values. The RDTs had higher sensitivities in individuals referred by treating physicians (79.5%, 78.7%) than in those referred by health departments (49.5%, 44.3%) or tested for other reasons (50%, 45.8%), in persons without any comorbidities (74.4%, 71%) compared to those with comorbidities (38.2%, 34.4%), in individuals with COVID-19 symptoms (75.2%, 74.3%) compared to those without (31.9%, 23.3%), and in the absence of SARS-CoV-2 variants (87.7%, 84%) compared to Alpha variant carriers (77.1%, 72.3%). If 10,000 symptomatic individuals are tested of which 500 are truly positive, the RDTs would generate 38 false-positive and 124 false-negative results. If 10,000 asymptomatic individuals are tested, including 50 true positives, 18 false-positives and 34 false-negatives would be generated. Interpretation: The sensitivities of the two RDTs for asymptomatic SARS-CoV-2 carriers are unsatisfactory. Their widespread use may not be effective in the ongoing SARS-CoV-2 pandemic. The virus genotype influences the sensitivity of the two RDTs. RDTs should be evaluated for different SARS-CoV-2 variants.
KW - antigen testing
KW - COVID-19
KW - diagnostic performance
KW - rapid detection
KW - SARS-CoV-2
KW - sensitivity
KW - variants
UR - https://www.scopus.com/pages/publications/85128104823
U2 - 10.3389/fmed.2022.774550
DO - 10.3389/fmed.2022.774550
M3 - Article
AN - SCOPUS:85128104823
SN - 2296-858X
VL - 9
JO - Frontiers in Medicine
JF - Frontiers in Medicine
M1 - 774550
ER -