■为了从血清学测试中推断可靠的SARS-CoV-2抗体保护水平,在血清学测试中需要适当的定量阈值和可靠的等效性.此外,测试应显示与中和测定以及在大人群队列中观察到的保护作用密切相关,即使是针对新出现的变体。
我们使用11种商业抗体测定法研究了恢复期和接种疫苗的群体。比较结果以评估测试之间的差异。用基于慢病毒的测定在样品的子集中测量中和能力。
■来自恢复期(n=121)和接种疫苗的个体的血清(n=471,260与Comirnaty,110与Spikevax,和96与Vaxzevria)使用11种不同的测定法进行评估,包括雅培的两个人,Euroimmun,联络人,罗氏,和Vircell,还有一个来自西门子。具有荧光报道分子的刺突蛋白-慢病毒载体用于来自恢复期(n=26)和接种疫苗(n=39)个体的血清的中和测定。
■感染后的阳性率介于81.3%和94.3%之间,接种疫苗后的阳性率介于99.4%和99.7%之间。取决于分析。两个队列在测试中都显示出高水平的定性一致性(对于恢复期和接种疫苗,分别为Fleiss\'kappa=0.598和0.719)。Spikevax疫苗接种者在所有测试中显示出最高水平的抗体。每个测试预测SARS-CoV-2中和能力的有效性取决于检测类型和目标,CLIA和抗S比ELISA和抗N检测更有效,分别。
■高通量免疫测定是中和能力的良好预测因子。需要更新目标和更好的标准化,以找到有效的保护关联,特别是考虑到针对新变种的抗体。
UNASSIGNED: To infer a reliable SARS-CoV-2 antibody protection level from a serological test, an appropriate quantitative threshold and solid equivalence across serological tests are needed. Additionally, tests should show a solid correlation with neutralising assays and with the protection observed in large population cohorts even against emerging variants.
UNASSIGNED: We studied convalescent and vaccinated populations using 11 commercial antibody assays. Results were compared to evaluate discrepancies across tests. Neutralisation capacity was measured in a subset of the samples with a lentiviral-based assay.
UNASSIGNED: Serum from convalescent (n = 121) and vaccinated individuals (n = 471, 260 with Comirnaty, 110 with Spikevax, and 96 with Vaxzevria) was assessed using 11 different assays, including two from Abbott, Euroimmun, Liaison, Roche, and Vircell, and one from Siemens. A spike protein-lentiviral vector with a fluorescent reporter was used for neutralisation assay of serum from convalescent (n = 26) and vaccinated (n = 39) individuals.
UNASSIGNED: Positivity ranged between 81.3 and 94.3% after infection and 99.4 and 99.7% after vaccination, depending on the assay. Both cohorts showed a high level of qualitative agreement across tests (Fleiss\' kappa = 0.598 and 0.719 for convalescent and vaccinated respectively). Spikevax vaccine recipients showed the highest level of antibodies in all tests. Effectiveness of each test predicting SARS-CoV-2 neutralising capacity depended on assay type and target, with CLIA and anti-S being more effective than ELISA and anti-N assays, respectively.
UNASSIGNED: High-throughput
immunoassays are good predictors of neutralising capacity. Updated targets and better standardisation would be required to find an effective correlate of protection, especially to account for antibodies against new variants.