Akinshina Yulia Aleksandrovna, Mardanly S S, Kiseleva V A
JSC «EKOlab».
State Humanitarian and Technological University.
Klin Lab Diagn. 2020 Dec 4;65(11):688-692. doi: 10.18821/0869-2084-2020-65-11-688-692.
The study presents the results of the creation and evaluation of the diagnostic characteristics of the rapid immunochromatographic test for the qualitative detection and differentiation of IgM/IgG antibodies to SARS-CoV-2 in human serum, plasma, and whole blood "ИХА-COVID-19-IgM / IgG". Have been tested some samples without antibodies to SARS-CoV-2 and a samples with two and one type of specific antibodies. The coincidence of the results of immunochromatographic analysis with the results of the immunochemiluminescent method was 87.2%. Test kit can be use as the rapid diagnostic test in the context of the COVID-19 pandemic and to assess the immune status of convalescents.
该研究展示了用于定性检测和区分人血清、血浆及全血中针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的IgM/IgG抗体的快速免疫层析检测试剂“ИХА-COVID-19-IgM / IgG”的诊断特征的创建及评估结果。已对一些不含SARS-CoV-2抗体的样本以及含有两种和一种特异性抗体的样本进行了检测。免疫层析分析结果与免疫化学发光法结果的一致性为87.2%。该检测试剂盒可在新型冠状病毒肺炎（COVID-19）大流行背景下用作快速诊断检测，并用于评估康复者的免疫状态。
