Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2
Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2
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DOI：
10.1007/s10096-020-04010-7
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发表时间：
2020-08-17
影响因子：
4.5
通讯作者：
Garcia-Rodriguez, Julio
中科院分区：
文献类型：
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作者：
Guedez-Lopez, Gladys Virginia;Alguacil-Guillen, Marina;Garcia-Rodriguez, Julio
为了应对这一流行病，开发了用于快速检测不同人体样本中针对 SARS-CoV-2 的特异性抗体（IgM 和 IgG）的侧流免疫测定法 (LFIA)。本研究的目的是评估三种免疫色谱法（Sienna (R)、Wondfo (R) 和 Prometheus (R)）用于检测血清样本中 SARS-CoV-2 抗体，并以 RT-qPCR 作为参考。共收集了 145 名临床疑似 COVID-19 患者的 145 份血清样本：所有样本均使用 Sienna (R) 进行检测，117 份样本使用 Wondfo (R) 进行检测，89 份样本使用 Prometheus (R) 进行检测。获得的敏感性、特异性、阳性预测值和阴性预测值的总体结果如下：Sienna(R)为64.4%、75%、85.5%和47.8%； Wondfo (R) 为 45.2%、81.8%、80.5% 和 47.4%，Prometheus (R) 为 75.5%、12.5%、51.4% 和 29.4%。 Sienna (R)、Wondfo (R) 和 Prometheus (R) 的测试准确率分别为 67.6%、59% 和 47.2%，COVID-19 患病率分别为 69.7%、62.4% 和 55.1%。三个测试（分别为Sienna（R）、Wondfo（R）和Prometheus（R））在三个不同阶段的敏感度在早期（第一周）分别为36.6%、18.8%和68.6%；中期（第二周）分别为81.3%、74.1%、90.9%，后期（第三周）分别为100%、83.3%、100%。结果表明，尽管 Prometheus (R) 具有较高的灵敏度，但特异性明显低于其他两种测试。 Sienna (R) 在灵敏度和特异性之间表现出最大的反差，达到了最好的准确性，其次是 Wondfo (R)。三种 ICT 检测的敏感性在疾病晚期较高。
Lateral flow immunoassays (LFIA) for rapid detection of specific antibodies (IgM and IgG) against SARS-CoV-2 in different human specimens have been developed in response to the pandemic. The aim of this study is to evaluate three immunocromathographic assays (Sienna (R), Wondfo (R) and Prometheus (R)) for detection of antibodies against SARS-CoV-2 in serum samples, considering RT-qPCR as a reference. A total of 145 serum samples from 145 patients with clinical suspicion of COVID-19 were collected: all of the samples were tested with Sienna (R), 117 with Wondfo (R) and 89 with Prometheus (R). The overall results of sensitivity, specificity, positive predictive value and negative predictive value obtained were as follows: 64.4%, 75%, 85.5% and 47.8% with Sienna (R); 45.2%, 81.8%, 80.5% and 47.4% with Wondfo (R) and 75.5%, 12.5%, 51.4% and 29.4% with Prometheus (R). The accuracy of the test for Sienna (R), Wondfo (R) and Prometheus (R) was 67.6%, 59% and 47.2%, with a prevalence of COVID-19 of 69.7%, 62.4% and 55.1% respectively. Sensitivity of the three tests (Sienna (R), Wondfo (R) and Prometheus (R) respectively) along the three different stages was 36.6%, 18.8% and 68.6% in the early stage (first week); 81.3%, 74.1% and 90.9% in the intermediate stage (second week) and 100%, 83.3% and 100% in the late stage (third week). The results demonstrate that even though Prometheus (R) presented a high sensitivity, the specificity was notably lower than the other two tests. Sienna (R) showed the greatest contrast between sensitivity and specificity, achieving the best accuracy, followed by Wondfo (R). The sensitivity of the three ICT assays was higher in late stages of the disease.