DiaSorin SpA, Saluggia, Italy.
DiaSorin Inc., Stillwater, MN, USA.
Clin Chem Lab Med. 2021 Mar 15;59(8):1463-1467. doi: 10.1515/cclm-2021-0023. Print 2021 Jul 27.
COVID-19 has brought about tests from many manufacturers. While molecular and rapid antigen tests are targeted for early diagnosis, immunoassays have a larger role in epidemiological studies, understanding longitudinal immunity, and in vaccine development and response.
The performance of the LIAISON SARS-CoV-2 TrimericS IgG assay was evaluated against the Beckman ACCESS SARS-CoV-2 IgG assay in New Mexico, and against the Siemens ADVIA Centaur COV2G assay in New York. Discordant samples were parsed using a microneutralization assay.
A SARS-CoV-2 antibody positivity rate of 23.8% was observed in the samples tested in New York (September 2020), while in the same month the positivity rate was 1.5% in New Mexico. Positive and negative agreement were 67.6% (95% CI 49.5-82.6%) and 99.8% (95% CI 99.5-99.9%), respectively, with the Beckman test, and 98.0% (95% CI 95.7-99.3%) and 94.8% (95% CI 93.4-96.0%), respectively, with the Siemens test. Receiver operating characteristic analysis for the detection of SARS-CoV-2 antibodies discloses an AUC, area under the curve, of 0.996 (95% CI 0.992-0.999) for the LIAISON SARS-CoV-2 TrimericS IgG assay. The criterion associated to the Youden Index was determined to be >12.9 kAU/L with a sensitivity of 99.44% and a specificity of 99.82%.
The LIAISON SARS-CoV-2 TrimericS IgG assay is highly sensitive and specific. The balance of these parameters, without emphasis on high specificity alone, is particularly important when applied to high prevalence populations, where a highly sensitive assay will result in reporting a lower number of false negative subjects.
COVID-19 带来了许多制造商的检测方法。虽然分子和快速抗原检测旨在进行早期诊断，但免疫测定在流行病学研究、了解纵向免疫以及疫苗开发和反应中具有更大的作用。
在新墨西哥州，评估 LIAISON SARS-CoV-2 三聚体 IgG 检测与贝克曼 ACCESS SARS-CoV-2 IgG 检测的性能，并在纽约评估与西门子 ADVIA Centaur COV2G 检测的性能。使用微量中和测定法对不一致的样本进行解析。
在纽约（2020 年 9 月）检测的样本中观察到 SARS-CoV-2 抗体阳性率为 23.8%，而在同月，新墨西哥州的阳性率为 1.5%。贝克曼检测的阳性和阴性符合率分别为 67.6%（95%CI 49.5-82.6%）和 99.8%（95%CI 99.5-99.9%），西门子检测的阳性和阴性符合率分别为 98.0%（95%CI 95.7-99.3%）和 94.8%（95%CI 93.4-96.0%）。SARS-CoV-2 抗体检测的接收者操作特征分析显示，LIAISON SARS-CoV-2 三聚体 IgG 检测的 AUC（曲线下面积）为 0.996（95%CI 0.992-0.999）。确定与约登指数相关的标准为>12.9 kAU/L，灵敏度为 99.44%，特异性为 99.82%。
LIAISON SARS-CoV-2 三聚体 IgG 检测具有高度的敏感性和特异性。在应用于高流行人群时，这些参数之间的平衡尤为重要，此时，高灵敏度的检测方法会导致报告的假阴性受试者数量减少。
