RayBiotech, Guangzhou, China.
RayBiotech Life, Peachtree Corners, Georgia, US.
Lab Med. 2022 May 5;53(3):225-234. doi: 10.1093/labmed/lmab085.
Real-time reverse transcription-polymerase chain reaction is the gold standard for the diagnosis of COVID-19, but it is necessary to utilize other tests to determine the burden of the disease and the spread of the outbreak such as IgG-, IgM-, and IgA-based antibody detection using enzyme-linked immunosorbent assay (ELISA).
We developed an indirect ELISA assay to quantitatively measure the amount of COVID-19 IgG, IgM, and IgA antibodies present in patient serum, dried blood, and plasma.
The population cutoff values for positivity were determined by receiver operating characteristic curves to be 1.23 U/mL, 23.09 U/mL, and 6.36 U/mL for IgG, IgM, and IgA, respectively. After albumin subtraction, the specificity remained >98% and the sensitivity was 95.72%, 83.47%, and 82.60%, respectively, for IgG, IgM, and IgA antibodies to the combined spike subunit 1 receptor binding domain and N proteins in serum. Plasma and dried blood spot specimens were also validated on this assay.
This assay may be used for determining the seroprevalence of SARS-CoV-2 in a population exposed to the virus or in vaccinated individuals.
实时逆转录聚合酶链反应是 COVID-19 诊断的金标准，但需要利用其他测试来确定疾病负担和疫情传播情况，例如使用酶联免疫吸附测定（ELISA）的 IgG、IgM 和 IgA 基于抗体的检测。
我们开发了一种间接 ELISA 测定法，以定量测量患者血清、干血斑和血浆中存在的 COVID-19 IgG、IgM 和 IgA 抗体的量。
通过接受者操作特征曲线确定了人群阳性截断值，分别为 IgG、IgM 和 IgA 的 1.23 U/mL、23.09 U/mL 和 6.36 U/mL。白蛋白扣除后，特异性仍保持>98%，对血清中结合刺突亚单位 1 受体结合域和 N 蛋白的 IgG、IgM 和 IgA 抗体的灵敏度分别为 95.72%、83.47%和 82.60%。还在该测定法上验证了血浆和干血斑标本。
该测定法可用于确定接触病毒的人群或接种疫苗人群中 SARS-CoV-2 的血清流行率。
