Development and Evaluation of A Rapid Test for SARS-CoV-2 IgM/IgG Detection by Immunochromatography

Authors

  • Panadda Dhepakson Medical Life Science Institute, Department of Medical Sciences
  • Anicha Luengchaichawang Medical Life Science Institute, Department of Medical Sciences
  • Apichai Prachasuphap Medical Life Science Institute, Department of Medical Sciences
  • Sakulrat Soonthornchatrawat Medical Life Science Institute, Department of Medical Sciences
  • Kodcharad Jongpitisub Medical Life Science Institute, Department of Medical Sciences
  • Porntip Chaiya Medical Life Science Institute, Department of Medical Sciences
  • Kaveewan Mongkolsiri Medical Life Science Institute, Department of Medical Sciences
  • Pantida Treeyoung Medical Life Science Institute, Department of Medical Sciences
  • Nalinee Saengtong Medical Life Science Institute, Department of Medical Sciences
  • Parnuphan Panyajai Medical Life Science Institute, Department of Medical Sciences
  • Lapasrada Mungmongkol Medical Life Science Institute, Department of Medical Sciences
  • Kritsamon Sophondilok Medical Life Science Institute, Department of Medical Sciences
  • Archawin Rojanawiwat Medical Life Science Institute, Department of Medical Sciences

Keywords:

SARS-CoV-2, Serological test, N-protein, Antibody detection, COVID-19 IgM/IgG Rapid test

Abstract

        The emerging of new coronavirus, SARS-CoV-2 causing COVID-19, is one of the worst pandemics in human. The viral RNA detection by using RT-PCR can indicate current and use for diagnosis of infection and case finding. Serological test can reveal previous infection and be used in multipurpose. In this study, we developed COVID-19 IgM/IgG rapid test for antibody detection in SARS-CoV-2 infection individuals. The developed test used recombinant N-protein of SARS-CoV-2 expressed in mammalian cells as gold-conjugated protein antigen and was assessed with 132 clinical samples. The results showed its sensitivity of 35.09%, 47.62% and 87.51% at 1-7, 8-14 and ≥ 15 days after onset, respectively and no cross-reactivity with other antibodies in various diseases from tested samples. In addition, the test has high specificity of 99.5%.

References

Gorbalenya AE, Baker SC, Baric RS, de Groot RJ, Drosten C, Gulyaeva AA, et al. Severe acute respiratory syndrome-related coronavirus: the species and its virus – a statement of the Coronavirus Study Group. bioRxiv. [serial online] 2020; [cited 2020 Jun 6]; xx(xx) [20 screens]. Available from: URL: https://www.biorxiv.org/content/biorxiv/early/2020/02/11/2020.02.07.937862.full.pdf.

Chan JFW, Yuan S, Kok KH, To KKW, Chu H, Yang J, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet 2020; 395: 514-23.

Illinois Department of Public Health (IDPH). Coronavirus disease 2019 (COVID-19): frequently asked questions. [online]. 2020; [cited 2020 Jun 6]; [10 screens]. Available from: URL: http://www.dph.illinois.gov/topics-services/diseases-and-conditions/diseases-a-z-list/coronavirus/faq.

Yang CL, Qiu X, Zeng YK, Jiang M, Fan HR, Zhang ZM. Coronavirus disease 2019: a clinical review. Eur Rev Med Pharmacol Sci 2020; 24(8): 4585-96.

World Health Organization. Timeline of WHO’s response to COVID-19. [online]. 2020; [cited 2020 Jun 30]; [32 screens]. Available from: URL: https://www.who.int/news-room/detail/29-06-2020-covidtimeline.

World Health Organization. Coronavirus disease (COVID-19) situation reports-157. [online]. 2020; [cited 2020 Jun 26]; [17 screens]. Available from: URL: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200625-covid-19-sitrep-157.pdf?sfvrsn=423f4a82_2.

To KKW, Tsang OTY, Leung WS, Tam AR, Wu TC, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis 2020; 20(5): 565-74.

Cheng VCC, Lau SKP, Woo PCY, Yuen KY. Severe acute respiratory syndrome coronavirus as an agent of emerging and reemerging infection. Clin Microbiol Rev 2007; 20(4): 660-94.

Chan JFW, Lau SKP, To KKW, Cheng VCC, Woo PCY, Yuen KY. Middle East respiratory syndrome coronavirus: another zoonotic betacoronavirus causing SARS-like disease. Clin Microbiol Rev 2015; 28(2): 465-522.

Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. [serial online]. 2020; [cited 2020 Jun 30]; XX(XX): [22 screens]. Available from: URL: https://doi.org/10.1093/cid/ciaa344.

Guan W, Z, Hu Y, Liang W, Ou C, He J, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020; 382(18): 1708-20.

Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, et al. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature 2020; 579: 270-3.

Du L, He Y, Zhou Y, Liu S, Zheng BJ, Jiang S. The spike protein of SARS-CoV -- a target for vaccine and therapeutic development. Nat Rev Microbiol 2009; 7(3): 226-36.

Kang S, Yang M, Hong Z, Zhang L, Huang Z, Chen X, et al. Crystal structure of SARS-CoV-2 nucleocapsid protein RNA binding domain reveals potential unique drug targeting sites. Acta Pharmaceutica Sinica B. [serial online]. 2020; [cited 2020 Jun 30]; 10(7): [11 screens]. Available from: URL: https://doi.org/10.1016/j.apsb.2020.04.009.

Okba NMA, Muller MA, Li W, Wang C, Geurtsvan-Kessel CH, Corman VM, et al. SARS-CoV-2 specific antibody responses in COVID-19 patients. medRxiv. [serial online]. 2020; [cited 2020 Jun 30]; XX(XX): [18 screens]. Available from: URL: https://doi.org/10.1101/2020.03.18.20038059.

Petherick A. Developing antibody tests for SARS-CoV-2. Lancet 2020; 395: 1101-2.

Huang X, Liu X, Chen J, Bao Y, Hou J, Lu X, et al. Evaluation of blood-based antibody rapid testing for HIV early therapy: a meta-analysis of the evidence. Front Immunol 2018; 9: 1458. (9 pages).

Wu FY, Liao YW, Wu JF, Chen HL, Hsu HY, Chang MH, et al. A simple and rapid test-card method to detect hepatitis B surface antigen and antibody: potential application in young children and infants. Pediatr Neonatol 2016; 57(3): 219-24.

Kim YH, Lee J, Kim YE, Chong CK, Pinchemel Y, Reisdörfer F, et al. Development of a rapid diagnostic test kit to detect IgG/IgM antibody against Zika virus using monoclonal antibodies to the envelope and non-structural protein 1 of the virus. Korean J Parasitol 2018; 56(1): 61-70.

Dhepakson P, Prachasuphap A, Jullaksorn D, Luengchaichaweng A, Soonthornchattrawat S, Chaiya P. Transfection optimization for expression of the recombinant monoclonal antibody against Plasmodium falciparum lactate dehydrogenase in mammalian cells. Bull Dept Med Sci 2016; 58(4): 257-69.

Chong CK, Jeong W, Kim HY, An DJ, Jeoung HY, Ryu JE, et al. Development and clinical evaluation of a rapid serodiagnostic test for toxoplasmosis of cats using recombinant SAG1 antigen. Korean J Parasitol 2011; 49(3): 207-12.

Lee GC, Jeon ES, Le DT, Kim TS, Yoo JH, Kim HY, et al. Development and evaluation of a rapid diagnostic test for Plasmodium falciparum, P. vivax and mixed-species malaria antigens. Am J Trop Med Hyg 2011; 85(6): 989-93.

ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. West Conshohocken, PA: ASTM International; 2016.

Downloads

Published

25-09-2020

How to Cite

1.
Dhepakson P, Luengchaichawang A, Prachasuphap A, Soonthornchatrawat S, Jongpitisub K, Chaiya P, Mongkolsiri K, Treeyoung P, Saengtong N, Panyajai P, Mungmongkol L, Sophondilok K, Rojanawiwat A. Development and Evaluation of A Rapid Test for SARS-CoV-2 IgM/IgG Detection by Immunochromatography. ว กรมวิทย พ [internet]. 2020 Sep. 25 [cited 2026 Mar. 14];62(3):167-78. available from: https://he02.tci-thaijo.org/index.php/dmsc/article/view/245904

Issue

Vol. 62 No. 3 (2020): July - September 2020

Section

Original Articles