Eurofins的POCT可鉴别

是否曾接触过COVID-19病毒

本文摘译自MASSDEVICE 2020年7月1日

以下为详文

法国Eurofins公司近日宣布推出一款POCT设备，用以鉴别过去是否曾接触过COVID-19病毒。

据报道，基于血清学，指尖穿刺试验在症状出现后19天进行抗体检测，灵敏度为94.5%，仅需10分钟就出结果。

Eurofins公司CE认证的INgezim双重识别免疫色谱分析法通过使用核蛋白作为抗原检测抗体，针对SARS-CoV-2在单一血液、血清和血浆样本中的特异性，确定总抗体（IgG、IgA和IgM）是否存在。

虽然这些测试为医疗保健医疗器械创新网所使用，尚不能用于自我诊断，但是用于试验的试剂盒包括了进行手指穿刺试验所需的所有材料，具备在检验科室外进行检验分析的可能。

根据公布的结果，用以验证检测结果的400多份血清样本没有检测到与其他呼吸道冠状病毒的交叉反应，Eurofins公司确认该产品特异性指标为99.3%

原文：

Eurofins launches 10-minute COVID-19 exposure testing device

JULY 1, 2020 BY SEAN WHOOLEY LEAVE A COMMENT

Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19.

The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release.

Eurofins’ CE-Marked INgezim dual-recognition immunochromatographic assays determine the presence of total antibodies (IgG, IgA and IgM) specific to SARS-CoV-2 in a single blood, serum and plasma sample by using nucleoprotein as an antigen to detect the antibodies.

Kits for the assay include all materials needed to perform the finger-prick test, with analysis capable of being performed outside a laboratory, although the tests are intended for use by healthcare professionals and not for self-diagnosis.

According to the release, more than 400 sera samples were observed to validate the assays, as no cross-reactivity with other respiratory coronaviruses was detected and Eurofins determined a specificity of 99.3%.