商业抗 SARS-CoV-2 受体结合域抗体检测与化学发光减少中和检测的相关性,以及对新兴变异体抗体的可能检测。
Correlation of the Commercial Anti-SARS-CoV-2 Receptor Binding Domain Antibody Test with the Chemiluminescent Reduction Neutralizing Test and Possible Detection of Antibodies to Emerging Variants.
机构信息
Department of Microbiology, Toyama University Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan.
Department of Virology, Toyama Institute of Healthgrid.417376.0, Toyama, Japan.
出版信息
Microbiol Spectr. 2021 Dec 22;9(3):e0056021. doi: 10.1128/Spectrum.00560-21. Epub 2021 Dec 1.
Serological tests are beneficial for recognizing the immune response against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). To identify protective immunity, optimization of the chemiluminescent reduction neutralizing test (CRNT) is critical. Whether commercial antibody tests have comparable accuracy is unknown. Serum samples were obtained from COVID-19 patients ( = 74), SARS-CoV-2 PCR-negative ( = 179), and suspected healthy individuals ( = 229) before SARS-CoV-2 variants had been detected locally. The convalescent phase was defined as the period after day 10 from disease onset or the episode of close contact. The CRNT using pseudotyped viruses displaying the wild-type (WT) spike protein and a commercial anti-receptor-binding domain (RBD) antibody test were assayed. Serology for the B.1.1.7 and B.1.351 variants was also assayed. Both tests concurred for symptomatic COVID-19 patients in the convalescent phase. They clearly differentiated between patients and suspected healthy individuals (sensitivity: 95.8% and 100%, respectively; specificity: 99.1% and 100%, respectively). Anti-RBD antibody test results correlated with neutralizing titers ( = 0.31, 95% confidence interval [CI] 0.22-0.38). Compared with the WT, lower CRNT values were observed for the variants. Of the samples with ≥100 U/mL by the anti-RBD antibody test, 77.8% and 88.9% showed ≥50% neutralization against the B.1.1.7 and the B.1.351 variants, respectively. Exceeding 100 U/mL in the anti-RBD antibody test was associated with neutralization of variants ( < 0.01). The CRNT and commercial anti-RBD antibody test effectively classified convalescent COVID-19 patients. Strong positive results with the anti-RBD antibody test can reflect neutralizing activity against emerging variants. This study provides a diagnostic evidence of test validity, which can lead to vaccine efficacy and proof of recovery after COVID-19. It is not easy to know neutralization against SARS-CoV-2 in the clinical laboratory because of technical and biohazard issues. The correlation of the quantitative anti-receptor-binding domain antibody test, which is widely available, with neutralizing test indicates that we can know indirectly the state of acquisition of functional immunity against wild and variant-type viruses in the clinical laboratory.
血清学检测有利于识别针对严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的免疫反应。为了确定保护性免疫,化学发光减少中和试验(CRNT)的优化至关重要。目前尚不清楚商业抗体检测是否具有相当的准确性。在当地检测到 SARS-CoV-2 变异株之前,从 COVID-19 患者(=74)、SARS-CoV-2 PCR 阴性者(=179)和疑似健康个体(=229)中获得血清样本。恢复期定义为从发病或密切接触之日起第 10 天以后的时期。使用显示野生型(WT)刺突蛋白和商业抗受体结合域(RBD)抗体的假型病毒进行 CRNT 和商业抗 RBD 抗体检测。还检测了针对 B.1.1.7 和 B.1.351 变异株的血清学。两种检测方法均与恢复期有症状的 COVID-19 患者一致。它们清楚地区分了患者和疑似健康个体(敏感性:分别为 95.8%和 100%;特异性:分别为 99.1%和 100%)。抗 RBD 抗体检测结果与中和滴度相关(=0.31,95%置信区间[CI]0.22-0.38)。与 WT 相比,变异株的 CRNT 值较低。在抗 RBD 抗体检测中≥100 U/mL 的样本中,分别有 77.8%和 88.9%对 B.1.1.7 和 B.1.351 变异株的中和率≥50%。抗 RBD 抗体检测中超过 100 U/mL 与对变异株的中和作用有关(<0.01)。CRNT 和商业抗 RBD 抗体检测有效地对恢复期 COVID-19 患者进行分类。抗 RBD 抗体检测的强阳性结果可以反映对新型变异株的中和活性。本研究提供了检测有效性的诊断证据,可导致 COVID-19 后的疫苗效力和康复证明。由于技术和生物危害问题,在临床实验室中很难知道对 SARS-CoV-2 的中和作用。广泛可用的定量抗受体结合域抗体检测与中和检测的相关性表明,我们可以间接地了解临床实验室中对野生型和变异型病毒获得功能性免疫的状态。