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. 2021 Sep;40(9):1975-1981.
doi: 10.1007/s10096-021-04274-7. Epub 2021 May 22.

Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Johannes G M Koeleman  1 , Henk Brand  1 , Stijn J de Man  1 , David S Y Ong  2   3   4
Affiliations

Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Johannes G M Koeleman et al. Eur J Clin Microbiol Infect Dis. 2021 Sep.

Abstract

The RT-qPCR in respiratory specimens is the gold standard for diagnosing acute COVID-19 infections. However, this test takes considerable time before test results become available, thereby delaying patients from being diagnosed, treated, and isolated immediately. Rapid antigen tests could overcome this problem. In the first study, clinical performances of five rapid antigen tests were compared to RT-qPCR in upper respiratory specimens from 40 patients with positive and 40 with negative RTq-PCR results. In the second study, the rapid antigen test with one of the best test characteristics (Romed) was evaluated in a large prospective collection of upper respiratory specimens from 900 different COVID-19-suspected patients (300 emergency room patients, 300 nursing home patients, and 300 health care workers). Test specificities ranged from 87.5 to 100.0%, and test sensitivities from 55.0 to 80.0%. The clinical specificity of the Romed test was 99.8% (95% CI 98.9-100). Overall clinical sensitivity in the study population was 73.3% (95% CI 67.9-78.2), whereas sensitivity in the different patient groups varied from 65.3 to 86.7%. Sensitivity was 83.0 to 86.7% in patients with short duration of symptoms. In a population with a COVID-19 prevalence of 1%, the negative predictive value in all patients was 99.7%. There is a large variability in diagnostic performance between rapid antigen tests. The Romed rapid antigen test showed a good clinical performance in patients with high viral loads (RT-qPCR cycle threshold ≤30), which makes this antigen test suitable for rapid identification of COVID-19-infected health care workers and patients.

Keywords: COVID-19; Lateral flow immunoassay; POC test; Rapid antigen test; SARS-CoV-2.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Correlations of cycle threshold (CT) values of RT-qPCR E gene and the LFA rapid antigen results of throat nasopharyngeal samples with positive and negative results from 225 health care workers (HCW), 150 emergency room patients (ERP), and 225 nursing home residents (NHP). The median CT values and interquartile range are shown in red
Fig. 2
Fig. 2
Distribution of cycle threshold (CT) values of RT-qPCR E genes and duration of symptoms in 150 emergency room patients (ERP). The median CT values and interquartile range are shown in red
Fig. 3
Fig. 3
Association between LFA results (Romed), CT values of RT-qPCR-positive throat nasopharyngeal samples, and duration of symptoms in patients presenting to the emergency department
See this image and copyright information in PMC

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