Quantitative Measurement of Anti-SARS-CoV-2 Antibodies: Analytical and Clinical Evaluation.
Quantitative Measurement of Anti-SARS-CoV-2 Antibodies: Analytical and Clinical Evaluation.
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DOI：
10.1128/jcm.03149-20
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发表时间：
2021-03-19
影响因子：
9.4
通讯作者：
Kulasingam V
中科院分区：
文献类型：
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作者：
Higgins V;Fabros A;Kulasingam V
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是2019冠状病毒病（COVID-19）的病原体。虽然基于分子的检测用于诊断COVID-19，但SARS-CoV-2特异性抗体的血清学检测用于检测既往感染。严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是2019冠状病毒病（COVID-19）的病原体。基于分子的检测用于诊断COVID-19，SARS-CoV-2特异性抗体的血清学检测用于检测既往感染。虽然大多数血清学检测是定性的，但最近开发了一种定量血清学检测，用于测量针对疫苗靶点S蛋白的抗体。定量抗体测定可以帮助确定抗体滴度，并促进抗体反应的纵向监测，包括对疫苗的抗体反应。我们评价了Roche Elecsys抗SARS-CoV-2S定量检测。在cobas e411（Roche Diagnostics）上使用Elecsys anti-SARS-CoV-2 S检测试剂盒分析了167例PCR阳性患者的标本和103例对照标本。分析评价包括评估线性、不精密度和分析灵敏度。临床评价包括评估临床敏感性、特异性、交叉反应性、阳性预测值（PPV）、阴性预测值（NPV）和从同一患者中连续采样。Elecsys anti-SARS-CoV-2 S检测试剂盒在PCR阳性后15至30天显示出最高灵敏度（84.0%），无交叉反应性，特异性和PPV为100%，PCR阳性后≥14天的NPV在98.3%至99.8%之间，具体取决于血清阳性率估计值。在6天内，9.06 U/ml的不精密度<2%，阴性质控品（QC）始终为阴性（<0.40 U/ml），验证了制造商声称的0.40 U/ml定量限，并观察到分析测量范围内的线性，但下限除外（<20 U/ml）。最后，抗体应答显示抗体滴度峰值的水平和时间以及随时间变化的趋势存在高度个体间差异。
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). While molecular-based testing is used to diagnose COVID-19, serologic testing of antibodies specific to SARS-CoV-2 is used to detect past infection. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). Molecular-based testing is used to diagnose COVID-19, and serologic testing of antibodies specific to SARS-CoV-2 is used to detect past infection. While most serologic assays are qualitative, a quantitative serologic assay was recently developed that measures antibodies against the S protein, the target of vaccines. Quantitative antibody determination may help determine antibody titer and facilitate longitudinal monitoring of the antibody response, including antibody response to vaccines. We evaluated the quantitative Roche Elecsys anti-SARS-CoV-2 S assay. Specimens from 167 PCR-positive patients and 103 control specimens were analyzed using the Elecsys anti-SARS-CoV-2 S assay on the cobas e411 (Roche Diagnostics). Analytical evaluation included assessing linearity, imprecision, and analytical sensitivity. Clinical evaluation included assessing clinical sensitivity, specificity, cross-reactivity, positive predictive value (PPV), negative predictive value (NPV), and serial sampling from the same patient. The Elecsys anti-SARS-CoV-2 S assay exhibited its highest sensitivity (84.0%) at 15 to 30 days post-PCR positivity and exhibited no cross-reactivity, a specificity and PPV of 100%, and an NPV between 98.3% and 99.8% at ≥14 days post-PCR positivity, depending on the seroprevalence estimate. Imprecision was <2% at 9.06 U/ml across 6 days, the negative quality control (QC) was consistently negative (<0.40 U/ml), the manufacturer’s claimed limit of quantitation of 0.40 U/ml was verified, and linearity across the analytical measuring range was observed, except at the low end (<20 U/ml). Lastly, antibody response showed high interindividual variation in level and time of peak antibody titer and trends over time.