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Development of indigenous IgG ELISA for the detection of anti-SARS-CoV-2 IgG.
Indian Journal of Medical Research ( IF 2.7 ) Pub Date : 2020-05-01 , DOI: 10.4103/ijmr.ijmr_2232_20 Gajanan Sapkal 1 , Anita Shete-Aich 2 , Rajlaxmi Jain 2 , Pragya D Yadav 2 , Prasad Sarkale 2 , Rajen Lakra 2 , Srikant Baradkar 2 , Gururaj Rao Deshpande 1 , Deepak Mali 2 , Bipin N Tilekar 1 , Triparna Majumdar 2 , Himanshu Kaushal 3 , Yogesh Gurav 4 , Nivedita Gupta 5 , Sreelekshmy Mohandas 2 , Ketki Deshpande 1 , Ojas Kaduskar 1 , Malvika Salve 2 , Savita Patil 2 , Shivshankar Gaikwad 1 , A P Sugunan 6 , M Ashok 7 , Sidhartha Giri 5 , Jayanthi Shastri 8 , Priya Abraham 9 , Raman R Gangakhedkar 5 ,
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.
中文翻译：
开发用于检测抗 SARS-CoV-2 IgG 的本土 IgG ELISA。
背景和目标：自 2020 年初以来，严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）引起的大流行对人类几乎所有生活领域都产生了不利影响。该病毒属于冠状病毒科β冠状病毒属。 SARS-CoV-2 会引起称为 2019 年冠状病毒病 (COVID-19) 的疾病，伴有轻度至重度呼吸道疾病。目前用于诊断 COVID-19 的诊断工具主要基于分子检测。实时逆转录聚合酶链式反应是世界卫生组织目前推荐的唯一针对 COVID-19 的诊断方法。随着 SARS-CoV-2 的迅速传播，有必要利用其他检测来确定疾病的负担以及疫情的传播。考虑到开发此类筛查测试的需要，我们尝试开发和评估基于 IgG 的 COVID-19 ELISA。
方法：共收集 513 份血液样本（131 份 SARS-CoV-2 阳性，382 份阴性），并通过微量中和试验（MNT）进行检测。 SARS-CoV-2 的抗原储备是通过在 Vero CCL-81 细胞中繁殖病毒来制备的。开发了 IgG 捕获 ELISA，用于血清样本中抗 SARS-CoV-2 IgG 的血清学检测。通过使用受试者工作特征（ROC）曲线确定终点截止值。确定了测定间的变异性。
结果：开发的 ELISA 灵敏度为 92.37%，特异性为 97.9%，稳健且可重复。阳性预测值为94.44%，阴性预测值为98.14%。
解释和结论：这种自主开发的 IgG ELISA 对于检测人血清样本中的抗 SARS-CoV-2 IgG 具有敏感性和特异性。该测定可用于确定暴露于该病毒的人群中 SARS-CoV-2 的血清流行率。
更新日期：2020-06-23
Indian Journal of Medical Research ( IF 2.7 ) Pub Date : 2020-05-01 , DOI: 10.4103/ijmr.ijmr_2232_20 Gajanan Sapkal 1 , Anita Shete-Aich 2 , Rajlaxmi Jain 2 , Pragya D Yadav 2 , Prasad Sarkale 2 , Rajen Lakra 2 , Srikant Baradkar 2 , Gururaj Rao Deshpande 1 , Deepak Mali 2 , Bipin N Tilekar 1 , Triparna Majumdar 2 , Himanshu Kaushal 3 , Yogesh Gurav 4 , Nivedita Gupta 5 , Sreelekshmy Mohandas 2 , Ketki Deshpande 1 , Ojas Kaduskar 1 , Malvika Salve 2 , Savita Patil 2 , Shivshankar Gaikwad 1 , A P Sugunan 6 , M Ashok 7 , Sidhartha Giri 5 , Jayanthi Shastri 8 , Priya Abraham 9 , Raman R Gangakhedkar 5 ,
Affiliation
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.
中文翻译：
开发用于检测抗 SARS-CoV-2 IgG 的本土 IgG ELISA。
背景和目标：自 2020 年初以来，严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）引起的大流行对人类几乎所有生活领域都产生了不利影响。该病毒属于冠状病毒科β冠状病毒属。 SARS-CoV-2 会引起称为 2019 年冠状病毒病 (COVID-19) 的疾病，伴有轻度至重度呼吸道疾病。目前用于诊断 COVID-19 的诊断工具主要基于分子检测。实时逆转录聚合酶链式反应是世界卫生组织目前推荐的唯一针对 COVID-19 的诊断方法。随着 SARS-CoV-2 的迅速传播，有必要利用其他检测来确定疾病的负担以及疫情的传播。考虑到开发此类筛查测试的需要，我们尝试开发和评估基于 IgG 的 COVID-19 ELISA。
方法：共收集 513 份血液样本（131 份 SARS-CoV-2 阳性，382 份阴性），并通过微量中和试验（MNT）进行检测。 SARS-CoV-2 的抗原储备是通过在 Vero CCL-81 细胞中繁殖病毒来制备的。开发了 IgG 捕获 ELISA，用于血清样本中抗 SARS-CoV-2 IgG 的血清学检测。通过使用受试者工作特征（ROC）曲线确定终点截止值。确定了测定间的变异性。
结果：开发的 ELISA 灵敏度为 92.37%，特异性为 97.9%，稳健且可重复。阳性预测值为94.44%，阴性预测值为98.14%。
解释和结论：这种自主开发的 IgG ELISA 对于检测人血清样本中的抗 SARS-CoV-2 IgG 具有敏感性和特异性。该测定可用于确定暴露于该病毒的人群中 SARS-CoV-2 的血清流行率。
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