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. 2021 Jun 24;10(13):2774.
doi: 10.3390/jcm10132774.

Evaluation of Two Rapid Antigenic Tests for the Detection of SARS-CoV-2 in Nasopharyngeal Swabs

Ysaline Seynaeve  1 , Justine Heylen  1 , Corentin Fontaine  1 , François Maclot  1 , Cécile Meex  1 , Anh Nguyet Diep  2 , Anne-Françoise Donneau  2 , Marie-Pierre Hayette  1 , Julie Descy  1
Affiliations

Evaluation of Two Rapid Antigenic Tests for the Detection of SARS-CoV-2 in Nasopharyngeal Swabs

Ysaline Seynaeve et al. J Clin Med. .

Abstract

(1) Background: In the current context of the COVID-19 crisis, there is a need for fast, easy-to-use, and sensitive diagnostic tools in addition to molecular methods. We have therefore decided to evaluate the performance of newly available antigen detection kits in "real-life" laboratory conditions. (2) Methods: The sensitivity and specificity of two rapid diagnostic tests (RDT)-the COVID-19 Ag Respi-Strip from Coris Bioconcept, Belgium (CoRDT), and the coronavirus antigen rapid test cassette from Healgen Scientific, LLC, USA (HeRDT)-were evaluated on 193 nasopharyngeal samples using RT-PCR as the gold standard. (3) Results: The sensitivity obtained for HeRDT was 88% for all collected samples and 91.1% for samples with Ct ≤ 31. For the CoRDT test, the sensitivity obtained was 62% for all collected samples and 68.9% for samples with Ct ≤ 31. (4) Conclusions: Despite the excellent specificity obtained for both kits, the poor sensitivity of the CoRDT did not allow for its use in the rapid diagnosis of COVID-19. HeRDT satisfied the World Health Organization's performance criteria for rapid antigen detection tests. Its high sensitivity, quick response, and ease of use allowed for the implementation of HeRDT at the laboratory of the University Hospital of Liège.

Keywords: COVID-19; SARS-CoV-2; antigen detection; rapid diagnostic test.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
HeRDT and CoRDT results according to the viral load (Ct).
See this image and copyright information in PMC

References

    1. Zhu N., Zhang D., Wang W., Li X., Yang B., Song J., Zhao X., Huang B., Shi W., Lu R., et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N. Engl. J. Med. 2020;382:727–733. doi: 10.1056/NEJMoa2001017. - DOI - PMC - PubMed
    1. Zheng J. SARS-CoV-2: An Emerging Coronavirus that Causes a Global Threat. Int. J. Biol. Sci. 2020;16:1678–1685. doi: 10.7150/ijbs.45053. - DOI - PMC - PubMed
    1. WHO (World Health Organization) Coronavirus Disease (COVID-2019) Situation Report–51. [(accessed on 22 March 2021)];2020 Mar 11; Available online: https://www.who.int/docs/default-source/coronaviruse/situation-reports/2....
    1. WHO (World Health Organization) Coronavirus (COVID-19) Dashboard. [(accessed on 3 June 2021)]; Available online: https://covid19.who.int.
    1. WHO (World Health Organization) Laboratory Testing Strategy Recommendations for COVID-19. Interim Guidance. [(accessed on 27 November 2020)];2020 Mar 21; Available online: https://apps.who.int/iris/bitstream/handle/10665/331509/WHO-COVID-19-lab....

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