Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus

Sahar Mohammed Khairat; Nancy EL Guindy; Mohammad Salah Eldeen Abdel Motaleb; Noha Salah Soliman

doi:doi:10.11648/j.ijmb.20200503.18

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Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus

Sahar Mohammed Khairat, Nancy EL Guindy, Mohammad Salah Eldeen Abdel Motaleb, Noha Salah Soliman

Published in International Journal of Microbiology and Biotechnology (Volume 5, Issue 3)

Received: 21 July 2020 Accepted: 3 August 2020 Published: 13 August 2020

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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.

Published in	International Journal of Microbiology and Biotechnology (Volume 5, Issue 3)
DOI	10.11648/j.ijmb.20200503.18
Page(s)	131-134
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

COVID-19, SARS-CoV-2, Rapid Antigen Detection, RT-PCR

References

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[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.
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APA Style

Sahar Mohammed Khairat, Nancy EL Guindy, Mohammad Salah Eldeen Abdel Motaleb, Noha Salah Soliman. (2020). Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus. International Journal of Microbiology and Biotechnology, 5(3), 131-134. https://doi.org/10.11648/j.ijmb.20200503.18

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ACS Style

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. Int. J. Microbiol. Biotechnol. 2020, 5(3), 131-134. doi: 10.11648/j.ijmb.20200503.18

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AMA Style

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. Int J Microbiol Biotechnol. 2020;5(3):131-134. doi: 10.11648/j.ijmb.20200503.18

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@article{10.11648/j.ijmb.20200503.18,
  author = {Sahar Mohammed Khairat and Nancy EL Guindy and Mohammad Salah Eldeen Abdel Motaleb and Noha Salah Soliman},
  title = {Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus},
  journal = {International Journal of Microbiology and Biotechnology},
  volume = {5},
  number = {3},
  pages = {131-134},
  doi = {10.11648/j.ijmb.20200503.18},
  url = {https://doi.org/10.11648/j.ijmb.20200503.18},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijmb.20200503.18},
  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.},
 year = {2020}
}

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TY  - JOUR
T1  - Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus
AU  - Sahar Mohammed Khairat
AU  - Nancy EL Guindy
AU  - Mohammad Salah Eldeen Abdel Motaleb
AU  - Noha Salah Soliman
Y1  - 2020/08/13
PY  - 2020
N1  - https://doi.org/10.11648/j.ijmb.20200503.18
DO  - 10.11648/j.ijmb.20200503.18
T2  - International Journal of Microbiology and Biotechnology
JF  - International Journal of Microbiology and Biotechnology
JO  - International Journal of Microbiology and Biotechnology
SP  - 131
EP  - 134
PB  - Science Publishing Group
SN  - 2578-9686
UR  - https://doi.org/10.11648/j.ijmb.20200503.18
AB  - 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.
VL  - 5
IS  - 3
ER  -

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Author Information

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

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APA Style

Sahar Mohammed Khairat, Nancy EL Guindy, Mohammad Salah Eldeen Abdel Motaleb, Noha Salah Soliman. (2020). Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus. International Journal of Microbiology and Biotechnology, 5(3), 131-134. https://doi.org/10.11648/j.ijmb.20200503.18

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ACS Style

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. Int. J. Microbiol. Biotechnol. 2020, 5(3), 131-134. doi: 10.11648/j.ijmb.20200503.18

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AMA Style

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. Int J Microbiol Biotechnol. 2020;5(3):131-134. doi: 10.11648/j.ijmb.20200503.18

Copy | Download

@article{10.11648/j.ijmb.20200503.18,
  author = {Sahar Mohammed Khairat and Nancy EL Guindy and Mohammad Salah Eldeen Abdel Motaleb and Noha Salah Soliman},
  title = {Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus},
  journal = {International Journal of Microbiology and Biotechnology},
  volume = {5},
  number = {3},
  pages = {131-134},
  doi = {10.11648/j.ijmb.20200503.18},
  url = {https://doi.org/10.11648/j.ijmb.20200503.18},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijmb.20200503.18},
  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.},
 year = {2020}
}

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TY  - JOUR
T1  - Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus
AU  - Sahar Mohammed Khairat
AU  - Nancy EL Guindy
AU  - Mohammad Salah Eldeen Abdel Motaleb
AU  - Noha Salah Soliman
Y1  - 2020/08/13
PY  - 2020
N1  - https://doi.org/10.11648/j.ijmb.20200503.18
DO  - 10.11648/j.ijmb.20200503.18
T2  - International Journal of Microbiology and Biotechnology
JF  - International Journal of Microbiology and Biotechnology
JO  - International Journal of Microbiology and Biotechnology
SP  - 131
EP  - 134
PB  - Science Publishing Group
SN  - 2578-9686
UR  - https://doi.org/10.11648/j.ijmb.20200503.18
AB  - 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.
VL  - 5
IS  - 3
ER  -

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