Preliminary Data of a Quantitative Point of Care Test for SARS-CoV-2 Antibodies From Greece
Preliminary Data of a Quantitative Point of Care Test for SARS-CoV-2 Antibodies From Greece
复制标题
DOI：
10.21873/invivo.12138
复制
发表时间：
2020-09-01
期刊：
影响因子：
2.3
通讯作者：
Kelekis, Alexis
中科院分区：
文献类型：
--
作者：
Fragkou, Paraskevi C.;Papaevangelou, Vassiliki;Kelekis, Alexis
背景：抗体检测对于在COVID-19大流行后的最初一波中识别免疫个体是必要的。患者和方法：我们前瞻性地评估了SARS-CoV-2抗体的定量即时检测（POCT）的性能。患者组（PG）包括住院确诊的COVID-19病例。rRT-PCR阴性的无症状健康护理志愿者被纳入对照组（CG）。用干荧光免疫法测定IgM和IgG。结果：纳入26例PG（65.9 ± 15.4岁，男性57.7%）和18例CG（45.6 ± 10.1岁，男性33.3%）。以厂家的临界值（≥ 0.04mIU/ml）为标准，IgM的敏感性和特异性分别为73.08%和88.89%，IgG的敏感性和特异性分别为88.46%和33.33%。IgM和IgG的ROC曲线下面积估计值分别为0.907和0.848。使用IgM >= 0.05 mIU/ml和IgG >= 0.10 mIU/ml的临界值改善了结果。结论：使用严格的截止值，SARS-CoV-2抗体POCT检测免疫人群，可用于社区的社会经济正常化。
Background: Antibody testing is necessary to identify immune individuals in the post-initial wave of the COVID-19 pandemic. Patients and Methods: We prospectively evaluated the performance of a quantitative point-of-care test (POCT) for SARS-CoV-2 antibodies. The patient group (PG) comprised of hospitalized confirmed COVID-19 cases. Asymptomatic healthcare volunteers with negative rRT-PCR were included in the control group (CG). Measurement of IgM and IgG was obtained by dry fluorescence immunoassay. Results: Twenty-six PG (65.9 +/- 15.4 years old, male 57.7%) and 18 CG (45.6 +/- 10.1 years old, male 33.3%) were included. By manufacturer's cut-off (>= 0.04 mIU/ml), sensitivity and specificity were 73.08% and 88.89% for IgM and 88.46% and 33.33% for IgG, respectively. Estimated areas under the ROC curve were 0.907 and 0.848 for IgM and IgG, respectively. Results were improved using a cut-off of IgM >= 0.05 mIU/ml and IgG >= 0.10 mIU/ml. Conclusion: Using stringent cut-off values, SARS-CoV-2 antibody POCT detects immune people and can be used during socioeconomic normalization of communities.