Next Article in Journal
How Did COVID-19 Affect Suicidality? Data from a Multicentric Study in Lombardy
Next Article in Special Issue
Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients
Previous Article in Journal
Subcutaneous Bupivacaine Infiltration Is Not Effective to Support Control of Postoperative Pain in Paediatric Patients Undergoing Spinal Surgery
Due to scheduled maintenance work on our core network, there may be short service disruptions on this website between 16:00 and 16:30 CEST on September 25th.
Article

Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR

1
Institute for Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany
2
Institute for Medical Microbiology, University Medical Center Göttingen, 37075 Göttingen, Germany
3
Institute for Medical Microbiology, Virology and Hygiene, University Medicine Rostock, 18057 Rostock, Germany
4
Department of Ophthalmology, University Medical Center Göttingen, 37075 Göttingen, Germany
5
Department of Microbiology and Hospital Hygiene, Bundeswehr Hospital Hamburg, 20359 Hamburg, Germany
*
Author to whom correspondence should be addressed.
Sascha Dierks and Oliver Bader contributed equally to this work.
Hagen Frickmann and Andreas E. Zautner contributed equally to this work.
Academic Editor: Paola Concolino
J. Clin. Med. 2021, 10(11), 2404; https://doi.org/10.3390/jcm10112404
Received: 23 April 2021 / Revised: 21 May 2021 / Accepted: 27 May 2021 / Published: 29 May 2021
(This article belongs to the Special Issue New Diagnostic Assays for COVID-19)
This study was performed as a head-to-head comparison of the performance characteristics of (1) two SARS-CoV-2-specific rapid antigen assays with real-time PCR as gold standard as well as (2) a fully automated high-throughput transcription-mediated amplification (TMA) assay and real-time PCR in a latent class analysis-based test comparison without a gold standard with several hundred samples in a low prevalence “real world” setting. Recorded sensitivity and specificity of the NADAL and the LumiraDx antigen assays and the Hologic Aptima SARS-CoV-2 TMA assay were 0.1429 (0.0194, 0.5835), 0.7644 (0.7016, 0.8174), and 0.7157 (0, 1) as well as 0.4545 (0.2022, 0.7326), 0.9954 (0.9817, 0.9988), and 0.9997 (not estimable), respectively. Agreement kappa between the positive results of the two antigen-based assays was 0.060 (0.002, 0.167) and 0.659 (0.492, 0.825) for TMA and real-time PCR. Samples with low viral load as indicated by cycle threshold (Ct) values > 30 were generally missed by both antigen assays, while 1:10 pooling suggested higher sensitivity of TMA compared to real-time PCR. In conclusion, both sensitivity and specificity speak in favor of the use of the LumiraDx rather than the NADAL antigen assay, while TMA results are comparably as accurate as PCR, when applied in a low prevalence setting. View Full-Text
Keywords: SARS-CoV-2; rapid diagnostic resting; antigen test comparison; transcription-mediated amplification TMA; real-time PCR SARS-CoV-2; rapid diagnostic resting; antigen test comparison; transcription-mediated amplification TMA; real-time PCR
MDPI and ACS Style

Dierks, S.; Bader, O.; Schwanbeck, J.; Groß, U.; Weig, M.S.; Mese, K.; Lugert, R.; Bohne, W.; Hahn, A.; Feltgen, N.; Torkieh, S.; Denker, F.R.; Lauermann, P.; Storch, M.W.; Frickmann, H.; Zautner, A.E. Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR. J. Clin. Med. 2021, 10, 2404. https://doi.org/10.3390/jcm10112404

AMA Style

Dierks S, Bader O, Schwanbeck J, Groß U, Weig MS, Mese K, Lugert R, Bohne W, Hahn A, Feltgen N, Torkieh S, Denker FR, Lauermann P, Storch MW, Frickmann H, Zautner AE. Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR. Journal of Clinical Medicine. 2021; 10(11):2404. https://doi.org/10.3390/jcm10112404

Chicago/Turabian Style

Dierks, Sascha, Oliver Bader, Julian Schwanbeck, Uwe Groß, Michael S. Weig, Kemal Mese, Raimond Lugert, Wolfgang Bohne, Andreas Hahn, Nicolas Feltgen, Setare Torkieh, Fenja R. Denker, Peer Lauermann, Marcus W. Storch, Hagen Frickmann, and Andreas E. Zautner 2021. "Diagnosing SARS-CoV-2 with Antigen Testing, Transcription-Mediated Amplification and Real-Time PCR" Journal of Clinical Medicine 10, no. 11: 2404. https://doi.org/10.3390/jcm10112404

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop