Department of Laboratory Medicine, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Scientific Research Pole of Endocrinology, Diabetes and Nutrition, Institute of Experimental and Clinical Research, Université Catholique de Louvain, Brussels, Belgium.
J Med Virol. 2021 Mar;93(3):1465-1477. doi: 10.1002/jmv.26430. Epub 2020 Aug 24.
Since December 2019, we have been in the battlefield with a new threat to the humanity, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), characterized by viral pneumonia. It may be asymptomatic or cause various symptoms, ranging from flu-like symptoms to acute respiratory distress syndrome and eventually death. At present, the only reliable test for COVID-19 diagnosis is quantitative reverse transcriptase-polymerase chain reaction. Assessing the immune response against SARS-CoV-2 could increase the detection sensitivity of infected population. Hereby, we report the performances of a fully automated chemiluminescent immunoassay (CLIA) on 276 serum samples. One hundred samples obtained from COVID-19 negative subjects (COVID-19 free) were analyzed to evaluate the diagnostic specificity of antibody (Ab) detection. Thereafter, 176 samples obtained from 125 patients with confirmed COVID-19 (COVID-19 patients) were selected to assess the diagnostic sensitivity of the CLIA. All samples were analyzed on MAGLUMI 800 platform. All COVID-19 free samples had Ab levels below the cutoff values. Hence, the diagnostic specificity was estimated at 100% (95% confidence interval [CI] = 96.3-100.0; positive predictive value = 100%). By the 18th day from the onset of symptoms, we reached an optimal diagnostic sensitivity (more than 95.0%) In fact, the diagnostic sensitivity increased over time and between 15 and 25 days after symptoms onset, reached 95.5% (95% CI = 84.9-99.2). The new automated CLIA analyzer appeared to be a robust and reliable method to measure specific Ab against COVID-19 at high throughput. Our data suggest that combining Ab and nucleic acid detection could increase diagnostic sensitivity.
自 2019 年 12 月以来，我们一直在与一种新的人类威胁作斗争，这种威胁被称为严重急性呼吸综合征冠状病毒 2（SARS-CoV-2），它会导致 2019 年冠状病毒病（COVID-19），其特征是病毒性肺炎。它可能是无症状的，也可能导致各种症状，从流感样症状到急性呼吸窘迫综合征，最终导致死亡。目前，COVID-19 诊断的唯一可靠检测方法是定量逆转录-聚合酶链反应。评估针对 SARS-CoV-2 的免疫反应可以提高感染人群的检测灵敏度。在此，我们报告了一种全自动化学发光免疫分析（CLIA）在 276 份血清样本上的性能。分析了 100 份来自 COVID-19 阴性受试者（COVID-19 阴性）的样本，以评估抗体（Ab）检测的诊断特异性。此后，选择了 176 份来自 125 名确诊 COVID-19 患者（COVID-19 患者）的样本，以评估 CLIA 的诊断敏感性。所有样本均在 MAGLUMI 800 平台上进行分析。所有 COVID-19 阴性样本的 Ab 水平均低于截止值。因此，诊断特异性估计为 100%（95%置信区间[CI] = 96.3-100.0；阳性预测值= 100%）。从症状出现后的第 18 天，我们达到了最佳的诊断敏感性（超过 95.0%）。事实上，诊断敏感性随着时间的推移而增加，在症状出现后 15 至 25 天之间，达到 95.5%（95% CI = 84.9-99.2）。新的自动化 CLIA 分析仪似乎是一种强大且可靠的方法，可以高通量测量针对 COVID-19 的特异性 Ab。我们的数据表明，将 Ab 和核酸检测相结合可以提高诊断敏感性。
