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内部研发的新型冠状病毒肺炎IgG/IgM抗体快速诊断试剂盒的性能评估

Performance evaluation of in-house developed Covid-19 IgG/IgM antibody rapid diagnostic kit.

作者信息

G Vinaya Chandu Vidya Sagar, Reddy P V Janardhan, Suravajhala Prashanth, Suravajhala Renuka, V Uday Kiran, Pb Kavi Kishor, Tc Venkateswarulu, Polavarapu Rathnagiri

机构信息

Genomix CARL Pvt. Ltd, Pulivendula, Andhra Pradesh, 516 390, India.

Department of Biotechnology, Vignan's Foundation for Science, Technology & Research Deemed to be University, Vadlamudi, Guntur, Andhra Pradesh, 522 213, India.

出版信息

AMB Express. 2023 Oct 17;13(1):116. doi: 10.1186/s13568-023-01620-0.

DOI:10.1186/s13568-023-01620-0
PMID:37848586
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10581998/
Abstract

In the interest of preventing the Coronavirus Disease 2019 (COVID-19) pandemic from spreading, it is crucial to promptly identify and confine afflicted patients. Serological antibody testing is a significant diagnostic technique that is increasingly employed in clinics, however its clinical use is still being investigated. The present study was carried out to scrutinize how well Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibody testing using in-house developed rapid antibody assay worked against the chemiluminescence (CLIA) assay. Either IgG positive (IgG + IgM-) or IgM positive (IgM + IgG-); both IgG and IgM positive (IgM + IgG+); and negatives (IgM- IgG-) have been evaluated. A total of 300 samples with diverse age and sexual identity data were included. The combined sensitivities for IgG + IgM+, IgM + IgG-, IgG + IgM- and IgG-IgM- were evaluated. More accurate diagnostic results may be obtained using molecular diagnostic tools. The Antibody Rapid Diagnostic kit's (in-house developed) performance was satisfactory for determining the presence of Covid-19 infection with IgG and IgM positivity. The IgG and IgM positivity helped evaluate the immune response in the individual for the COVID-19 infection. These results lend support to the additional utilisation of serological antibody tests in the COVID-19 diagnosis.

摘要

为防止2019冠状病毒病(COVID-19)大流行蔓延,迅速识别和隔离患病患者至关重要。血清学抗体检测是一种重要的诊断技术,在临床上的应用越来越广泛,但其临床应用仍在研究中。本研究旨在审视使用自行研发的快速抗体检测法检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)抗体与化学发光免疫分析法(CLIA)相比的效果如何。对IgG阳性(IgG+IgM-)、IgM阳性(IgM+IgG-)、IgG和IgM均阳性(IgM+IgG+)以及阴性(IgM-IgG-)情况进行了评估。共纳入300份具有不同年龄和性别数据的样本。评估了IgM+IgG+、IgM+IgG-、IgG+IgM-和IgG-IgM-的综合敏感性。使用分子诊断工具可能会获得更准确的诊断结果。抗体快速诊断试剂盒(自行研发)在确定COVID-19感染的IgG和IgM阳性情况方面表现令人满意。IgG和IgM阳性有助于评估个体对COVID-19感染的免疫反应。这些结果支持在COVID-19诊断中更多地使用血清学抗体检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/36cb78bd5346/13568_2023_1620_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/416d01cf9003/13568_2023_1620_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/fef867ec8724/13568_2023_1620_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/36cb78bd5346/13568_2023_1620_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/416d01cf9003/13568_2023_1620_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/50d1bb7c1da5/13568_2023_1620_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/9e58255e40a9/13568_2023_1620_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/fef867ec8724/13568_2023_1620_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad1/10581998/36cb78bd5346/13568_2023_1620_Fig5_HTML.jpg

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