Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：目前，2019年冠状病毒病(COVID-19)大规模疫苗接种已在全球实施。快速、大规模检测血清中和抗体(NAb),为评估抗SARS-CoV-2感染和疫苗的免疫反应奠定了基础。另外的评估包括抗体的持续时间和增强的免疫应答的最佳时间。
方法：使用COVID-19疫苗接种血清（n=164）比较了5种替代NAb-3种化学发光免疫测定（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。以常规病毒中和试验(cVNT)为标准,评价5种试验的诊断一致性和相关性。我们在志愿者中长达6个月的两剂量疫苗后研究了抗体反应。
结果：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结果表明与替代测定非常一致。初次接种疫苗后28天，NAs的血清阳性，IgG,IgM为6%,4%,13%,分别。加强剂量后，血清阳性率达到14%，65%,97%,分别。在接受第二次剂量六个月后，NAb阳性率最终维持在66%.在所有COVID-19疗养院中，患者在出院后3个月检测到100%NAb.
结论：COVID-19疫苗诱导了持续至少6个月的体液免疫应答。快速血清学检测被用作识别免疫水平变化的代理，并作为个体是否需要加强疫苗接种的指导。
方法：使用COVID-19疫苗接种血清（n=164）比较了5种替代NAb-3种化学发光免疫测定（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。以常规病毒中和试验(cVNT)为标准,评价5种试验的诊断一致性和相关性。我们在志愿者中长达6个月的两剂量疫苗后研究了抗体反应。
结果：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结果表明与替代测定非常一致。初次接种疫苗后28天，NAs的血清阳性，IgG,IgM为6%,4%,13%,分别。加强剂量后，血清阳性率达到14%，65%,97%,分别。在接受第二次剂量六个月后，NAb阳性率最终维持在66%.在所有COVID-19疗养院中，患者在出院后3个月检测到100%NAb.
结论：COVID-19疫苗诱导了持续至少6个月的体液免疫应答。快速血清学检测被用作识别免疫水平变化的代理，并作为个体是否需要加强疫苗接种的指导。
