Institute for Interdisciplinary Health Research (I2HR), European University at St. Petersburg, St. Petersburg, Russia.
NN Petrov National Research Medical Center of Oncology, St. Petersburg, Russia.
J Med Virol. 2021 Oct;93(10):5846-5852. doi: 10.1002/jmv.27126. Epub 2021 Jun 12.
Geographical variation in severe acute respiratory syndrome coronavirus 2 (SARS--CoV--2) spread requires seroprevalence studies based on local tests, but robust validation is needed. We summarize an evaluation of antibody tests used in a serological study of SARS--CoV--2 in Saint Petersburg, Russia. We validated three different antibody assays: chemiluminescent microparticle immunoassay (CMIA) Abbott Architect SARS--CoV--2 immunoglobulin G (IgG), enzyme- linked immunosorbent assay (ELISA) CoronaPass total antibodies test, and ELISA SARS--CoV--2--IgG--EIA--BEST. Clinical sensitivity was estimated with the SARS--CoV--2 polymerase chain reaction (PCR) test as the gold standard using manufacturer recommended cutoff. Specificity was estimated using pre-pandemic sera samples. The median time between positive PCR test results and antibody tests was 21 weeks. Measures of concordance were calculated against the microneutralization test (MNA).Sensitivity was equal to 91.1% (95% confidence intervbal [CI]: 78.8-97.5), 90% (95% CI: 76.4-96.4), and 63.1% (95% CI [50.2-74.7]) for ELISA Coronapass, ELISA Vector-Best, and CMIA Abbott, respectively. Specificity was equal to 100% for all the tests. Comparison of receiver operating characteristics has shown lower AUC for CMIA Abbott. The cut-off SC/O ratio of 0.28 for CMIA Abbott resulted in a sensitivity of 80% at the same level of specificity. Less than 33% of the participants with positive antibody test results had neutralizing antibodies in titers 1:80 and above. Antibody assays results and MNA correlated moderately. This study encourages the use of local antibody tests and sets the reference for seroprevalence correction. Available tests' sensitivity allows detecting antibodies within the majority of PCR- positive individuals. The Abbott assay sensitivity can be improved by incorporating a new cut-off. Manufacturers' test characteristics may introduce bias into the study results.
地理变异严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的传播需要基于当地检测的血清阳性率研究，但需要进行稳健的验证。我们总结了在俄罗斯圣彼得堡进行的 SARS-CoV-2 血清学研究中使用的抗体检测的评估。我们验证了三种不同的抗体检测：化学发光微粒子免疫分析（CMIA）雅培 Architect SARS-CoV-2 免疫球蛋白 G（IgG）、酶联免疫吸附试验（ELISA）CoronaPass 总抗体试验和 ELISA SARS-CoV-2-IgG-EIA-BEST。使用制造商推荐的截止值，以 SARS-CoV-2 聚合酶链反应（PCR）检测作为金标准来估计临床灵敏度。使用大流行前的血清样本估计特异性。阳性 PCR 检测结果与抗体检测之间的中位数时间为 21 周。针对微量中和试验（MNA）计算了一致性测量值。ELISA Coronapass、ELISA Vector-Best 和 CMIA Abbott 的敏感性分别为 91.1%（95%置信区间[CI]：78.8-97.5）、90%（95% CI：76.4-96.4）和 63.1%（95% CI [50.2-74.7]）。所有检测的特异性均为 100%。接收者操作特征的比较表明，CMIA Abbott 的 AUC 较低。CMIA Abbott 的 SC/O 比值为 0.28 的截止值在相同特异性水平下产生了 80%的敏感性。抗体检测结果呈阳性的参与者中，不到 33%的人具有中和抗体滴度为 1:80 及以上。抗体检测结果与 MNA 中度相关。本研究鼓励使用当地的抗体检测，并为血清阳性率校正设定参考。现有的检测方法的敏感性允许在大多数 PCR 阳性个体中检测到抗体。通过采用新的截止值，可以提高 Abbott 检测的敏感性。制造商的检测特性可能会给研究结果带来偏差。
