评估十种（10）种 SARS-CoV-2 快速血清学检测试剂在西非布基纳法索与万泰 SARS-CoV-2 ab ELISA 的比较。
Evaluation of ten (10) SARS-CoV-2 rapid serological tests in comparison with WANTAI SARS-CoV-2 ab ELISA in Burkina Faso, West Africa.
机构信息
Biomedical Research Laboratory (LaReBio)/Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Centre National de la Recherche Scientifique et Technologique (CNRST), 03 BP 7047, Ouagadougou, Burkina Faso.
Unité de Formation et de Recherche en Sciences de la Santé (UFR-SDS), Université Joseph Ki-Zerbo, Ouagadougou, Burkina Faso.
出版信息
Virol J. 2023 Mar 30;20(1):57. doi: 10.1186/s12985-023-02011-4.
BACKGROUND
The aim of this study was to evaluate the performance of ten (10) SARS-CoV-2 serological rapid diagnostic tests in comparison with the WANTAI SARS-CoV-2 Ab ELISA test in a laboratory setting.
MATERIALS AND METHODS
Ten (10) SARS-CoV-2 serological rapid diagnostic tests (RDTs) for SARS-CoV-2 IgG/IgM were evaluated with two (2) groups of plasma tested positive for one and negative for the other with the WANTAI SARS-CoV-2 Ab ELISA. The diagnostic performance of the SARS-CoV-2 serological RDTs and their agreement with the reference test were calculated with their 95% confidence intervals.
RESULTS
The sensitivity of serological RDTs ranged from 27.39 to 61.67% and the specificity from 93.33 to 100% compared to WANTAI SARS-CoV-2 Ab ELISA test. Of all the tests, two tests (STANDARD Q COVID-19 IgM/IgG Combo SD BIOSENSOR and COVID-19 IgG/IgM Rapid Test (Zhejiang Orient Gene Biotech Co., Ltd)) had a sensitivity greater than 50%. In addition, all ten tests had specificity greater than or equal to 93.33% each. The concordance between RDTs and WANTAI SARS-CoV-2 Ab ELISA test ranged from 0.25 to 0.61.
CONCLUSION
The SARS-CoV-2 serological RDTs evaluated show low and variable sensitivities compared to the WANTAI SARS-CoV-2 Ab ELISA test, with however a good specificity. These finding may have implications for the interpretation and comparison of COVID-19 seroprevalence studies depending on the type of test used.
背景
本研究旨在评估十种（10）种 SARS-CoV-2 血清学快速诊断检测试剂（RDT）与 WANTAI SARS-CoV-2 Ab ELISA 检测试剂在实验室环境中的性能。
材料和方法
用两种（2）组血浆对十种（10）种 SARS-CoV-2 血清学 RDT 进行评估，一组血浆对 WANTAI SARS-CoV-2 Ab ELISA 检测试剂检测结果为阳性，另一组为阴性。用 95%置信区间计算 SARS-CoV-2 血清学 RDT 的诊断性能及其与参考检测试剂的一致性。
结果
与 WANTAI SARS-CoV-2 Ab ELISA 检测试剂相比，血清学 RDT 的敏感性范围为 27.39%至 61.67%，特异性范围为 93.33%至 100%。在所有检测试剂中，有两种检测试剂（STANDARD Q COVID-19 IgM/IgG Combo SD BIOSENSOR 和 COVID-19 IgG/IgM Rapid Test（浙江东方基因生物制品股份有限公司））的敏感性大于 50%。此外，所有十种检测试剂的特异性均大于或等于 93.33%。RDT 与 WANTAI SARS-CoV-2 Ab ELISA 检测试剂的一致性范围为 0.25 至 0.61。
结论
与 WANTAI SARS-CoV-2 Ab ELISA 检测试剂相比，评估的 SARS-CoV-2 血清学 RDT 的敏感性较低且差异较大，但特异性较好。这些发现可能会影响 COVID-19 血清流行率研究的解释和比较，具体取决于使用的检测试剂类型。
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