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. 2021 Apr:137:104782.
doi: 10.1016/j.jcv.2021.104782. Epub 2021 Mar 3.

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Flaminia Olearo  1 , Dominik Nörz  1 , Fabian Heinrich  1 , Jan Peter Sutter  2 , Kevin Roedl  3 , Alexander Schultze  4 , Julian Schulze Zur Wiesch  2 , Platon Braun  5 , Lisa Oestereich  6 , Benno Kreuels  7 , Dominic Wichmann  3 , Martin Aepfelbacher  1 , Susanne Pfefferle  8 , Marc Lütgehetmann  9
Affiliations

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Flaminia Olearo et al. J Clin Virol. 2021 Apr.

Abstract

Background: SARS-CoV-2 molecular diagnostics is facing material shortages and long turnaround times due to exponential increase of testing demand.

Objective: We evaluated the analytic performance and handling of four rapid Antigen Point of Care Tests (AgPOCTs) I-IV (Distributors: (I) Roche, (II) Abbott, (III) MEDsan and (IV) Siemens).

Methods: 100 RT-PCR negative and 84 RT-PCR positive oropharyngeal swabs were prospectively collected and used to determine performance and accuracy of these AgPOCTs. Handling was evaluated by 10 healthcare workers/users through a questionnaire.

Results: The median duration from symptom onset to sampling was 6 days (IQR 2-12 days). The overall respective sensitivity were 49.4 % (CI95 %: 38.9-59.9), 44.6 % (CI95 %: 34.3-55.3), 45.8 % (CI95 %: 35.5-56.5) and 54.9 % (CI95 %: 43.4-65.9) for tests I, II, III and IV, respectively. In the high viral load subgroup (containing >106 copies of SARS-CoV-2 /swab, n = 26), AgPOCTs reached sensitivities of 92.3 % or more (range 92.3 %-100 %). Specificity was 100 % for tests I, II (CI95 %: 96.3-100 for both tests) and IV (CI95 %: 96.3-100) and 97 % (CI95 %: 91.5-98.9) for test III. Regarding handling, test I obtained the overall highest scores, while test II was considered to have the most convenient components. Of note, users considered all assays, with the exception of test I, to pose a significant risk for contamination by drips or spills.

Discussion: Besides some differences in sensitivity and handling, all four AgPOCTs showed acceptable performance in high viral load samples. However, due to the significantly lower sensitivity compared to RT-qPCR, a careful consideration of pro and cons of AgPOCT has to be taken into account before clinical implementation.

Keywords: Accuracy; Handling; Rapid antigen test AgPOCT; SARS-CoV-2.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
AgPOCT results in relation to SARS-CoV-2 RNA copies/swab. Purple fields represent positive and blue fields negative AgPOCT results. Blank fields correspond to cases where samples were not tested for the corresponding assay (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article).
Fig. 2
Fig. 2
Evaluation of the handling of four AgPOCTs. Scores vary from 1 (“do not agree at all”) to 5 (“absolutely agree”).
See this image and copyright information in PMC

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