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5 Publications visible to you, out of a total of 5
SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic and the impact of COVID-19 vaccination.

Abstract (Expand)

BACKGROUND: SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference. METHODS: In a prospective … performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital, the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL(R), Panbio, MEDsan(R)) were compared to RT-qPCR as reference standard among patients, accompanying persons and staff aged >/= six month in large-scale, clinical screening use. Regression models were used to assess influencing factors on RDT performance (secondary endpoints). FINDINGS: Among 78,798 paired RDT/RT-qPCR results analysed, overall RDT sensitivity was 34.5% (695/2016; 95% CI 32.4-36.6%), specificity 99.6% (76,503/76,782; 95% CI 99.6-99.7%). Over the pandemic course, sensitivity decreased in line with a lower rate of individuals showing typical COVID-19 symptoms. The lasso regression model showed that a higher viral load and typical COVID-19 symptoms were directly significantly correlated with the likelihood of a positive RDT result in SARS-CoV-2 infection, whereas age, sex, vaccination status, and the Omicron VOC were not. INTERPRETATION: The decline in RDT sensitivity throughout the pandemic can primarily be attributed to the reduced prevalence of symptomatic infections among vaccinated individuals and individuals infected with Omicron VOC. RDTs remain valuable for detecting SARS-CoV-2 in symptomatic individuals and offer potential for detecting other respiratory pathogens in the post-pandemic era, underscoring their importance in infection control efforts. FUNDING: German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care.

Authors: I. Wagenhauser, K. Knies, T. Pscheidl, M. Eisenmann, S. Flemming, N. Petri, M. McDonogh, A. Scherzad, D. Zeller, A. Gesierich, A. K. Seitz, R. Taurines, R. I. Ernestus, J. Forster, D. Weismann, B. Weissbrich, J. Liese, C. Hartel, O. Kurzai, L. Dolken, A. Gabel, M. Krone

Date Published: 9th Oct 2024

Publication Type: Journal

The Sensitivity of Rapid Tests for SARS-CoV-2 Antigen.

Abstract

Not specified

Authors: K. Knies, I. Wagenhauser, D. Hofmann, V. Rauschenberger, M. Eisenmann, J. Reusch, S. Flemming, O. Andres, N. Petri, M. S. Topp, M. Papsdorf, M. McDonogh, R. Verma-Fuhring, A. Scherzad, D. Zeller, H. Bohm, A. Gesierich, A. K. Seitz, M. Kiderlen, M. Gawlik, R. Taurines, T. Wurmb, R. I. Ernestus, J. Forster, D. Weismann, B. Weissbrich, J. Liese, U. Vogel, O. Kurzai, L. Dolken, A. Gabel, M. Krone

Date Published: 10th Nov 2023

Publication Type: Journal

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents.

Abstract

Not specified

Authors: M. Krone, I. Wagenhauser, K. Knies, D. Hofmann, G. Engels, R. Taurines, M. McDonogh, S. Flemming, T. Meyer, H. Bohm, A. Scherzad, M. Eisenmann, V. Rauschenberger, A. Gabel, N. Petri, J. Reusch, J. Forster, B. Weissbrich, L. Dolken, O. Kurzai, U. Vogel, C. Hartel, J. Liese, O. Andres

Date Published: 25th Dec 2022

Publication Type: Journal

Virus variant-specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022.

Abstract (Expand)

OBJECTIVES: 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. METHODS: 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. RESULTS: 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 >/=10(6) SARS-CoV-2 RNA copies per mL was significantly lower in the Omicron VOC (50.00%; 95% CI, 36.12-63.88%) than in the wild-type SARS-CoV-2 (79.31%; 95% CI, 61.61-90.15%; p 0.015). DISCUSSION: RDT 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.

Authors: I. Wagenhauser, K. Knies, D. Hofmann, V. Rauschenberger, M. Eisenmann, J. Reusch, A. Gabel, S. Flemming, O. Andres, N. Petri, M. S. Topp, M. Papsdorf, M. McDonogh, R. Verma-Fuhring, A. Scherzad, D. Zeller, H. Bohm, A. Gesierich, A. K. Seitz, M. Kiderlen, M. Gawlik, R. Taurines, T. Wurmb, R. I. Ernestus, J. Forster, D. Weismann, B. Weissbrich, L. Dolken, J. Liese, L. Kaderali, O. Kurzai, U. Vogel, M. Krone

Date Published: 27th Aug 2022

Publication Type: Journal

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.

Abstract (Expand)

BACKGROUND: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse. METHODS: … In a prospective performance evaluation study, RDT from three manufacturers (NADAL(R), Panbio, MEDsan(R), conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C(t)) values. The data collection period ranged from November 12, 2020 to February 28, 2021. FINDINGS: The sensitivity of RDT compared to RT-qPCR was 42.57% (95% CI 33.38%-52.31%). The specificity was 99.68% (95% CI 99.48%-99.80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of >/=10(8) SARS-CoV-2 RNA copies per ml to 8.82% in samples with a viral load lower than 10(4) SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98.84%; the PPV in persons with typical COVID-19 symptoms was 97.37%, and 28.57% in persons without or with atypical symptoms. INTERPRETATION: RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available. FUNDING: German Federal Ministry for Education and Science (BMBF), Free State of Bavaria.

Authors: I. Wagenhauser, K. Knies, V. Rauschenberger, M. Eisenmann, M. McDonogh, N. Petri, O. Andres, S. Flemming, M. Gawlik, M. Papsdorf, R. Taurines, H. Bohm, J. Forster, D. Weismann, B. Weissbrich, L. Dolken, J. Liese, O. Kurzai, U. Vogel, M. Krone

Date Published: 30th Jun 2021

Publication Type: Journal

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