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Development of indigenous IgG ELISA for the detection of anti-SARS-CoV-2 IgG.
Indian J Med Res. 2020 May; 151(5):444-449.IJ

Abstract

Background & objectives

Since the beginning of the year 2020, the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) impacted humankind adversely in almost all spheres of life. The virus belongs to the genus Betacoronavirus of the family Coronaviridae. SARS-CoV-2 causes the disease known as coronavirus disease 2019 (COVID-19) with mild-to-severe respiratory illness. The currently available diagnostic tools for the diagnosis of COVID-19 are mainly based on molecular assays. Real-time reverse transcription-polymerase chain reaction is the only diagnostic method currently recommended by the World Health Organization for COVID-19. With the rapid spread of SARS-CoV-2, it is necessary to utilize other tests, which would determine the burden of the disease as well as the spread of the outbreak. Considering the need for the development of such a screening test, an attempt was made to develop and evaluate an IgG-based ELISA for COVID-19.

Methods

A total of 513 blood samples (131 positive, 382 negative for SARS-CoV-2) were collected and tested by microneutralization test (MNT). Antigen stock of SARS-CoV-2 was prepared by propagating the virus in Vero CCL-81 cells. An IgG capture ELISA was developed for serological detection of anti-SARS-CoV-2 IgG in serum samples. The end point cut-off values were determined by using receiver operating characteristic (ROC) curve. Inter-assay variability was determined.

Results

The developed ELISA was found to be 92.37 per cent sensitive, 97.9 per cent specific, robust and reproducible. The positive and negative predictive values were 94.44 and 98.14 per cent, respectively.

Interpretation & conclusions

This indigenously developed IgG ELISA was found to be sensitive and specific for the detection of anti-SARS-CoV-2 IgG in human serum samples. This assay may be used for determining seroprevalence of SARS-CoV-2 in a population exposed to the virus.

Authors+Show Affiliations

Diagnostic Virology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Diagnostic Virology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Diagnostic Virology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Human Influenza Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Epidemiology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Diagnostic Virology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Diagnostic Virology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Maximum Containment Laboratory, ICMR-National Institute of Virology, Pune, Maharashtra, India.Diagnostic Virology Group, ICMR-National Institute of Virology, Pune, Maharashtra, India.ICMR-National Institute of Virology, Kerala Unit, Alappuzha, Kerala, India.ICMR-National Institute of Virology, Bangalore Unit, Bengaluru, Karnataka, India.Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.Department of Microbiology, Kasturba Hospital for Infectious Diseases, Mumbai, Maharashtra, India.ICMR-National Institute of Virology, Pune, Maharashtra, India.Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32611915

Citation

Sapkal, Gajanan, et al. "Development of Indigenous IgG ELISA for the Detection of anti-SARS-CoV-2 IgG." The Indian Journal of Medical Research, vol. 151, no. 5, 2020, pp. 444-449.
Sapkal G, Shete-Aich A, Jain R, et al. Development of indigenous IgG ELISA for the detection of anti-SARS-CoV-2 IgG. Indian J Med Res. 2020;151(5):444-449.
Sapkal, G., Shete-Aich, A., Jain, R., Yadav, P. D., Sarkale, P., Lakra, R., Baradkar, S., Deshpande, G. R., Mali, D., Tilekar, B. N., Majumdar, T., Kaushal, H., Gurav, Y., Gupta, N., Mohandas, S., Deshpande, K., Kaduskar, O., Salve, M., Patil, S., ... Gangakhedkar, R. R. (2020). Development of indigenous IgG ELISA for the detection of anti-SARS-CoV-2 IgG. The Indian Journal of Medical Research, 151(5), 444-449. https://doi.org/10.4103/ijmr.IJMR_2232_20
Sapkal G, et al. Development of Indigenous IgG ELISA for the Detection of anti-SARS-CoV-2 IgG. Indian J Med Res. 2020;151(5):444-449. PubMed PMID: 32611915.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of indigenous IgG ELISA for the detection of anti-SARS-CoV-2 IgG. AU - Sapkal,Gajanan, AU - Shete-Aich,Anita, AU - Jain,Rajlaxmi, AU - Yadav,Pragya D, AU - Sarkale,Prasad, AU - Lakra,Rajen, AU - Baradkar,Srikant, AU - Deshpande,Gururaj Rao, AU - Mali,Deepak, AU - Tilekar,Bipin N, AU - Majumdar,Triparna, AU - Kaushal,Himanshu, AU - Gurav,Yogesh, AU - Gupta,Nivedita, AU - Mohandas,Sreelekshmy, AU - Deshpande,Ketki, AU - Kaduskar,Ojas, AU - Salve,Malvika, AU - Patil,Savita, AU - Gaikwad,Shivshankar, AU - Sugunan,A P, AU - Ashok,M, AU - Giri,Sidhartha, AU - Shastri,Jayanthi, AU - Abraham,Priya, AU - Gangakhedkar,Raman R, AU - ,, PY - 2020/7/3/entrez PY - 2020/7/3/pubmed PY - 2020/7/14/medline KW - COVID-19 - diagnosis - ELISA - human - IgG antibodies - microneutralization test - SARS-CoV-2 - standardization SP - 444 EP - 449 JF - The Indian journal of medical research JO - Indian J Med Res VL - 151 IS - 5 N2 - Background & objectives: Since the beginning of the year 2020, the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) impacted humankind adversely in almost all spheres of life. The virus belongs to the genus Betacoronavirus of the family Coronaviridae. SARS-CoV-2 causes the disease known as coronavirus disease 2019 (COVID-19) with mild-to-severe respiratory illness. The currently available diagnostic tools for the diagnosis of COVID-19 are mainly based on molecular assays. Real-time reverse transcription-polymerase chain reaction is the only diagnostic method currently recommended by the World Health Organization for COVID-19. With the rapid spread of SARS-CoV-2, it is necessary to utilize other tests, which would determine the burden of the disease as well as the spread of the outbreak. Considering the need for the development of such a screening test, an attempt was made to develop and evaluate an IgG-based ELISA for COVID-19. Methods: A total of 513 blood samples (131 positive, 382 negative for SARS-CoV-2) were collected and tested by microneutralization test (MNT). Antigen stock of SARS-CoV-2 was prepared by propagating the virus in Vero CCL-81 cells. An IgG capture ELISA was developed for serological detection of anti-SARS-CoV-2 IgG in serum samples. The end point cut-off values were determined by using receiver operating characteristic (ROC) curve. Inter-assay variability was determined. Results: The developed ELISA was found to be 92.37 per cent sensitive, 97.9 per cent specific, robust and reproducible. The positive and negative predictive values were 94.44 and 98.14 per cent, respectively. Interpretation & conclusions: This indigenously developed IgG ELISA was found to be sensitive and specific for the detection of anti-SARS-CoV-2 IgG in human serum samples. This assay may be used for determining seroprevalence of SARS-CoV-2 in a population exposed to the virus. SN - 0971-5916 UR - https://www.unboundmedicine.com/medline/citation/32611915/Development_of_indigenous_IgG_ELISA_for_the_detection_of_anti_SARS_CoV_2_IgG_ L2 - http://www.ijmr.org.in/article.asp?issn=0971-5916;year=2020;volume=151;issue=5;spage=444;epage=449;aulast=Sapkal DB - PRIME DP - Unbound Medicine ER -