School of Medicine, Anhui University of Science and Technology, Anhui, China.
Medical Laboratory of Shenzhen Luohu Hospital Group, Shenzhen Luohu People's Hospital, Shenzhen, China.
J Clin Lab Anal. 2022 Apr;36(4):e24325. doi: 10.1002/jcla.24325. Epub 2022 Mar 2.
Currently, mass vaccine inoculation against coronavirus disease-2019 (COVID-19) has been being implemented globally. Rapid and the large-scale detection of serum neutralizing antibodies (NAbs) laid a foundation for assessing the immune response against SARS-CoV-2 infection and vaccine. Additional assessments include the duration of antibodies and the optimal time for a heightened immune response.
The performance of five surrogate NAbs-three chemiluminescent immunoassay (CLIA) and two enzyme-linked immunosorbent assays (ELISAs)-and specific IgM and IgG assays were compared using COVID-19-vaccinated serum (n = 164). Conventional virus neutralization test (cVNT) was used as a criterion and the diagnostic agreement and correlation of the five assays were evaluated. We studied the antibody responses after the two-dose vaccine in volunteers up to 6 months.
The sensitivity and specificity of five surrogate NAb assays ranged from 84% to 100%. Our cVNT results indicated great consistency with the surrogate assays. At 28 days after primary vaccination, the seropositivities of the NAbs, IgG, and IgM were 6%, 4%, and 13%, respectively. After the booster dose, seropositivities reached 14%, 65%, and 97%, respectively. Six months after receipt of the second dose, the NAb positive rate was eventually maintained at 66%. In all COVID-19 convalescents, patients were detected with 100% NAb sat three months after discharge.
COVID-19 vaccine induced a humoral immune response lasting at least six months. Rapid serological detection was used as a proxy for identifying changes in immunity levels and as a guide to whether an individual may require a booster vaccination.
目前，全球正在大规模接种针对 2019 年冠状病毒病（COVID-19）的疫苗。快速且大规模地检测血清中和抗体（NAb）为评估针对 SARS-CoV-2 感染和疫苗的免疫反应奠定了基础。其他评估包括抗体的持续时间和增强免疫反应的最佳时间。
使用 COVID-19 疫苗接种血清（n=164）比较了五种替代 NAb-三种化学发光免疫分析（CLIA）和两种酶联免疫吸附测定（ELISA）-以及特异性 IgM 和 IgG 测定的性能。将常规病毒中和试验（cVNT）用作标准，并评估了五种测定方法的诊断一致性和相关性。我们研究了志愿者在接种两剂疫苗后长达 6 个月的抗体反应。
五种替代 NAb 测定的灵敏度和特异性范围为 84%至 100%。我们的 cVNT 结果与替代测定结果具有很好的一致性。在初次接种后 28 天，NAb、IgG 和 IgM 的血清阳性率分别为 6%、4%和 13%。在加强剂量后，血清阳性率分别达到 14%、65%和 97%。在接受第二剂疫苗六个月后，NAb 的阳性率最终维持在 66%。在所有 COVID-19 康复患者中，出院三个月后，患者的 NAb 阳性率达到 100%。
COVID-19 疫苗诱导了至少持续六个月的体液免疫反应。快速血清学检测可作为识别免疫水平变化的替代指标，并指导个体是否需要加强接种。
