Background

Serology tests for detecting the antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can identify previous infection and help to confirm the presence of current infection.

Objective

The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgG antibody detection.

Results

Clinical agreement studies were performed in 107 COVID-19 patient serum samples and 226 negative donor serum/plasma samples. Positive percent agreement (PPA) was 46.15 % (95 % CI: 19.22 % ∼74.87 %), 61.54 % (95 % CI: 31.58 % ∼86.14 %), and 97.53 % (95 % CI: 91.36 % ∼99.70 %) for samples collected on 0−7 days, 8−14 days, and ≥15 days from symptom onset, respectively. Negative Percent Agreement (NPA) was 98.23 % (95 % CI: 95.53 % ∼99.52 %). No cross-reactivity was observed to patient samples positive for IgG antibodies against the following pathogens: HIV, HAV, HBV, RSV, CMV, EBV, Rubella, Influenza A, and Influenza B. Hemoglobin (200 mg/dL), bilirubin (2 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay.

Conclusion

An anti-SARS-CoV-2 IgG antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up anti-SARS-CoV-2 IgG testing.

中文翻译：

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用于COVID-19的高通量抗SARS-CoV-2 IgG测试平台

背景

进行血清学检测以检测重症急性呼吸系统综合症冠状病毒2（SARS-CoV-2）的抗体可以识别以前的感染，并有助于确认当前感染的存在。

目的

这项研究的目的是评估一种新开发的用于抗SARS-CoV-2 IgG抗体检测的高通量免疫分析的性能。

结果

临床协议研究在107个COVID-19患者血清样本和226个阴性供体血清/血浆样本中进行。对于从症状发作开始分别在0-7天，8-14天和≥15天收集样本。负百分比协议（NPA）为98.23％（95％CI：95.53％〜99.52％）。对于针对以下病原体的IgG抗体呈阳性的患者样品未观察到交叉反应：HIV，HAV，HBV，RSV，CMV，EBV，风疹，甲型流感和乙型流感。血红蛋白（200 mg / dL），胆红素（2 mg / dL）和EDTA（10 mM）对本试验无明显干扰作用。

结论

已经开发出具有高灵敏度和特异性的抗SARS-CoV-2 IgG抗体测定法。具有高通量，该测定将加快抗SARS-CoV-2 IgG检测。