1. Virus variant–specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022
- Author
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Isabell Wagenhäuser, Kerstin Knies, Daniela Hofmann, Vera Rauschenberger, Michael Eisenmann, Julia Reusch, Alexander Gabel, Sven Flemming, Oliver Andres, Nils Petri, Max S. Topp, Michael Papsdorf, Miriam McDonogh, Raoul Verma-Führing, Agmal Scherzad, Daniel Zeller, Hartmut Böhm, Anja Gesierich, Anna K. Seitz, Michael Kiderlen, Micha Gawlik, Regina Taurines, Thomas Wurmb, Ralf-Ingo Ernestus, Johannes Forster, Dirk Weismann, Benedikt Weißbrich, Lars Dölken, Johannes Liese, Lars Kaderali, Oliver Kurzai, Ulrich Vogel, and Manuel Krone
- Subjects
Microbiology (medical) ,Infectious Diseases ,General Medicine - Abstract
Antigen rapid diagnostic tests (RDTs) for SARS coronavirus 2 (SARS-CoV-2) are quick, widely available, and inexpensive. Consequently, RDTs have been established as an alternative and additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable clinical and large-scale performance data specific to a SARS-CoV-2 virus variant of concern (VOC) are limited, especially for the Omicron VOC. The aim of this study was to compare RDT performance among different VOCs.This single-centre prospective performance assessment compared RDTs from three manufacturers (NADAL, Panbio, MEDsan) with RT-qPCR including deduced standardized viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022.Among 35 479 RDT/RT-qPCR tandems taken from 26 940 individuals, 164 of the 426 SARS-CoV-2 positive samples tested true positive with an RDT corresponding to an RDT sensitivity of 38.50% (95% CI, 34.00-43.20%), with an overall specificity of 99.67% (95% CI, 99.60-99.72%). RDT sensitivity depended on viral load, with decreasing sensitivity accompanied by descending viral load. VOC-dependent sensitivity assessment showed a sensitivity of 42.86% (95% CI, 32.82-53.52%) for the wild-type SARS-CoV-2, 43.42% (95% CI, 32.86-54.61%) for the Alpha VOC, 37.67% (95% CI, 30.22-45.75%) for the Delta VOC, and 33.67% (95% CI, 25.09-43.49%) for the Omicron VOC. Sensitivity in samples with high viral loads of ≥10RDT sensitivity for detection of the Omicron VOC is reduced in individuals infected with a high viral load, which curtails the effectiveness of RDTs. This aspect furthert: limits the use of RDTs, although RDTs are still an irreplaceable diagnostic tool for rapid, economic point-of-care and extensive SARS-CoV-2 screening.
- Published
- 2023