Volume 5, Issue 3, September 2020, Page: 131-134
Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus
Sahar Mohammed Khairat, Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Central Public Health Laboratories (CPHL), Ministry of Health, Cairo, Egypt
Nancy EL Guindy, Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Central Public Health Laboratories (CPHL), Ministry of Health, Cairo, Egypt
Mohammad Salah Eldeen Abdel Motaleb, Serology Unit, Central Public Health Laboratories (CPHL), Ministry of Health, Cairo, Egypt
Noha Salah Soliman, Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo, Egypt
Received: Jul. 21, 2020;       Accepted: Aug. 3, 2020;       Published: Aug. 13, 2020
DOI: 10.11648/j.ijmb.20200503.18      View  166      Downloads  788
Abstract
Nucleic acid and antibody detection assays have been utilized in COVID-19 laboratory diagnosis. However, the use of viral antigenic proteins for diagnosis has not been successfully developed. Using viral antigen allows rapid direct viral detection earlier than production of antibodies. The present study was aimed at evaluating the performance of two COVID-19 rapid antigen detection tests, which are BIOCREDIT COVID-19 Ag (RapiGEN Inc., Korea) and Standard Q COVID-19 Ag (SD Biosensor, Korea), in comparison with RT-PCR. These tests were performed on 80 COVID-19 RT-PCR positive respiratory samples and 20 RT-PCR negative control samples. BIOCREDIT COVID-19 Ag and SD Biosensor RAD kits recorded total sensitivities of 52.5% and 68.7% and specificities of 46% and 96%, respectively. In high viral load samples, BIOCREDIT COVID-19 Ag and SD Biosensor RAD kits recorded higher sensitivities of 60% and 77%, compared to 45% and 60% in normal viral load samples, respectively. Sensitivity and specificity of the 2 antigen kits varied significantly with P values of <0.000001 and 0.0135, respectively. The evaluated RAD tests presented promising performance which was relatively better for SD-Biosensor than BIOCREDIT RAD tests, especially in high viral load samples. However, antigen tests are still considered substandard in comparison with RT-PCR in detecting SARS-CoV-2.
Keywords
COVID-19, SARS-CoV-2, Rapid Antigen Detection, RT-PCR
To cite this article
Sahar Mohammed Khairat, Nancy EL Guindy, Mohammad Salah Eldeen Abdel Motaleb, Noha Salah Soliman, Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus, International Journal of Microbiology and Biotechnology. Vol. 5, No. 3, 2020, pp. 131-134. doi: 10.11648/j.ijmb.20200503.18
Copyright
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Reference
[1]
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. (2019). A novel Coronavirus from patients with Pneumonia in China. N Engl J Med, 382: 727-33. 10.1056/NEJMoa2001017.
[2]
Huang C, Wang Y, Li X, et al. (2020). Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet, 395 (10223): 497-506, doi: https://doi.org/10.1016/S0140-6736 (20)30183-5.
[3]
World Health Organization (WHO) (2020). [Accessed 15 April 2020] https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov.
[4]
Xiang F, Xiaorong W, Xinliang H, Zhenghong P, Bohan Y, Jianchu Z, et al. (2020). Antibody detection and dynamic characteristics in patients with COVID-19. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, https://doi.org/10.1093/cid/ciaa461.
[5]
Mertens P, De Vos N, Martiny D, Jassoy C, Mirazimi A, Cuypers L et al. (2020). Development and potential usefulness of the COVID-19 Ag Respi-Strip diagnostic assay in a pandemic context. Front Med (Lausanne), 7: 225. doi: 10.3389/fmed.2020.00225.
[6]
Rubin EJ, Baden LR, Morrissey S. (2020). Audio interview: new research on possible treatments for Covid-19. N Engl J Med, 382: e30. 10.1056/NEJMe2005759.
[7]
Shi Y, Wang Y, Shao C, Huang J, Gan J, Huang X, et al. (2020). COVID-19 infection: the perspectives on immune responses. Cell Death Differ, 27: 1451-54. 10.1038/s41418-020-0530-3.
[8]
Carter L, Linda VG, Jeffrey WS, Yingzhu L, Qiongqiong Z, Catherine JS, Janet MS, et al. Assay Techniques and Test Development for COVID-19 Diagnosis. ACS Central Science 2020, https://doi.org/10.1021/acscentsci.0c00501.
[9]
Tahamtan A, Abdollah A. (2020). Real-Time RT-PCR in COVID-19 detection: issues affecting the results. Expert Review of Molecular Diagnostic, 20 (5): 453-454, https://doi.org/10.1080/14737159.2020.1757437.
[10]
Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A and Rodriguez-Villalobos H. (2020). Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol, 129: 104455.
[11]
Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VYC, et al. (2020) Diagnosing COVID-19: the disease and tools for detection. ACS Nano, 14 (4): 3822-3835, https://doi.org/10.1021/acsnano.0c02624 14, 3822.
[12]
Cassaniti I, Novazzi F, Giardina F, et al. (2020). Performance of VivaDiag COVID-19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID-19 in acute patients referring to emergency room department. J Med Virol, 10.1002/jmv.25800. doi: 10.1002/jmv.25800.
[13]
Food and Drug Administration (FDA). (2020). [Accessed 24 April 2020] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2.
[14]
Clinical and Laboratory Standards Institute (CLSI). (2008). User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standard Institute.
[15]
Foundation of Innovative New Diagnostics (FIND). (2020). [Accessed 24 April 2020] https://www.finddx.org/covid-19/dx-data/.
[16]
Mak GCK, Cheng PKC, Lau SSY, Wong Kky, Lau CS, Lam ETK et al. (2020). Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol, 129: 104500.
Browse journals by subject