Clinical performance of a semi-quantitative assay for SARS-CoV2 IgG and SARS-CoV2 IgM antibodies.
Clinical performance of a semi-quantitative assay for SARS-CoV2 IgG and SARS-CoV2 IgM antibodies.
复制标题
DOI：
10.1016/j.cca.2020.09.023
复制
发表时间：
2020-11
期刊：
影响因子：
--
通讯作者：
Devaraj S
中科院分区：
文献类型：
--
作者：
Jung J;Garnett E;Jariwala P;Pham H;Huang R;Benzi E;Issaq N;Matzuk M;Singh I;Devaraj S
作为正交试验的一部分，我们评价了Ansh Labs SARS CoV-2 IgG和IgM ELISA。IgG和IgM ELISA测定显示出可接受的性能。与RT-PCR的一致性为100% >症状发作后6天。虽然SARS-CoV-2感染的诊断主要基于病毒RNA的检测，但SARS-CoV-2抗体的检测可用于评估该疾病的既往流行情况，并在挑战性病例中证实当前感染。灵敏和特异的免疫测定提供了识别SARS-CoV-2暴露、确定血清转化、确认恢复期血浆捐赠资格的能力，并在流行病学研究中发挥重要作用。我们报告了Ansh Laboratories SARS-CoV-2 IgG和SARS-CoV-2 IgM ELISA免疫测定的验证。作为CDC推荐的正交试验算法的一部分，对这些检测方法进行了评价，以检测抗SARS-CoV-2 IgG和IgM抗体，供我院临床使用。使用经RT-PCR确认为COVID-19阴性或阳性的样本测试IgG和IgM ELISA检测的诊断特异性和灵敏度。我们还评价了精密度、分析干扰和与已知其他病毒感染病例的交叉反应性。此外，我们验证了与分子和其他血清学检测的一致性，并评估了我们患者人群的血清转换。IgG和IgM ELISA检测试剂盒显示出可接受的精密度，对分析干扰具有耐用性，且与常见呼吸道病毒阳性标本无交叉反应性。两种检测方法与本机构使用的初筛血清学检测方法以及参考实验室半定量方法的一致率均为95%。与RT-PCR的一致性在症状发作后> 6天非常好（100%）。Ansh SARS-CoV-2 ELISA检测方法具有良好的分析性能，适合临床应用。
We evaluated Ansh Labs SARS CoV-2 IgG and IgM ELISA’s as part of orthogonal testing. The IgG and IgM ELISA assays showed acceptable performance. Concordance with RT-PCR was 100% > 6 days after symptom onset. While the diagnosis of SARS-CoV-2 infection is primarily based on detection of viral RNA, the detection of SARS-CoV-2 antibodies is useful for assessing past prevalence of the disease, and in corroborating a current infection in challenging cases. Sensitive and specific immunoassays provide the ability to identify exposure to SARS-CoV-2, to determine seroconversion, to confirm eligibility for donation of convalescent plasma as well as play an essential part in epidemiological studies. We report on the validation of the Ansh Laboratories SARS-CoV-2 IgG and SARS-CoV-2 IgM ELISA immunoassays. These assays were evaluated for detection of anti-SARS-CoV-2 IgG and IgM antibodies for clinical use in our hospital as part of an orthogonal testing algorithm recommended by the CDC. Diagnostic specificity and sensitivity of the IgG and IgM ELISA assays were tested using samples confirmed to be negative or positive for COVID-19 by RT-PCR. We also evaluated precision, analytical interference, and cross-reactivity with known cases of infection with other viruses. Additionally, we validated concordance with molecular and other serological testing and evaluated seroconversion in our patient population. The IgG and IgM ELISA assays showed acceptable precision, were robust to analytical interference and did not exhibit cross reactivity with specimens positive for common respiratory viruses. Both assays exhibited 95% agreement with a primary screening serological assay utilized at our institution as well as with a reference laboratory semi-quantitative method. Concordance with RT-PCR was excellent > 6 days after symptom onset (100%). The Ansh SARS-CoV-2 ELISA assays have good analytical performance suitable for clinical use.
登录
查看更多内容
影响因子：
64.5
作者：
Walls, Alexandra C.;Park, Young-Jun;Veesler, David
通讯作者：
Veesler, David
影响因子：
19
作者：
Zhao, Bo;Liu, Qianqian;Wu, Hao Bin
通讯作者：
Wu, Hao Bin
影响因子：
11.8
作者：
Guo, Li;Ren, Lili;Wang, Jianwei
通讯作者：
Wang, Jianwei
影响因子：
9.4
作者：
Bryan, Andrew;Pepper, Gregory;Greninger, Alexander L.
通讯作者：
Greninger, Alexander L.
影响因子：
8.8
作者：
Weidner, Lisa;Gaensdorfer, Simon;Jungbauer, Christof
通讯作者：
Jungbauer, Christof