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. 2020 Aug:129:104500.
doi: 10.1016/j.jcv.2020.104500. Epub 2020 Jun 8.

Evaluation of rapid antigen test for detection of SARS-CoV-2 virus

Gannon Ck Mak  1 , Peter Kc Cheng  2 , Stephen Sy Lau  2 , Kitty Ky Wong  2 , C S Lau  2 , Edman Tk Lam  2 , Rickjason Cw Chan  2 , Dominic Nc Tsang  2
Affiliations

Evaluation of rapid antigen test for detection of SARS-CoV-2 virus

Gannon Ck Mak et al. J Clin Virol. 2020 Aug.

Abstract

Background: The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests.

Objective: To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test.

Results: The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 103 fold less sensitive than viral culture while RAD was 105 fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients.

Conclusions: This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.

Keywords: 2019 novel coronavirus; COVID-19; RT-PCR; Rapid antigen detection; SARS-CoV-2; Viral culture.

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Conflict of interest statement

Declaration of Competing Interest None.

Figures

Fig. 1
Fig. 1
The results of the 160 respiratory samples tested for rapid antigen detection test and the corresponding Ct values of SARS-CoV-2 virus–specific RT-PCR.
See this image and copyright information in PMC

References

    1. WHO . 2020. Coronavirus Disease (COVID-2019) Situation Report – 51.https://www.who.int/docs/default-source/coronaviruse/situation-reports/2... 11 March.Available from:
    1. WHO . 2020. Laboratory Testing for Coronavirus Disease 2019 (COVID-19) in Suspected Human Cases: Interim Guidance, 2 March.https://apps.who.int/iris/handle/10665/331329 Available from:
    1. WHO . 2020. Laboratory Testing Strategy Recommendations for COVID-19: Interim Guidance.https://apps.who.int/iris/handle/10665/331509 21 March. Available from:
    1. WHO . 2020. WHO Reference Laboratories Providing Confirmatory Testing for COVID-19.https://www.who.int/who-documents-detail/who-reference-laboratories-prov... (last updated: 29 April 2020). Available from:
    1. Scohy A., Anantharajah A., Bodéus M., Kabamba-Mukadi B., Verroken A., Rodriguez-Villalobos H. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J. Clin. Virol. 2020;(May):21. 2020 published online ahead of print. - PMC - PubMed

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