Eurofins的POCT可鑒別

是否曾接觸過COVID-19病毒

本文摘譯自MASSDEVICE 2020年7月1日

以下為詳文

法國Eurofins公司近日宣布推出一款POCT設(shè)備，用以鑒別過去是否曾接觸過COVID-19病毒。

據(jù)報道，基于血清學(xué)，指尖穿刺試驗(yàn)在癥狀出現(xiàn)后19天進(jìn)行抗體檢測，靈敏度為94.5%，僅需10分鐘就出結(jié)果。

Eurofins公司CE認(rèn)證的INgezim雙重識別免疫色譜分析法通過使用核蛋白作為抗原檢測抗體，針對SARS-CoV-2在單一血液、血清和血漿樣本中的特異性，確定總抗體（IgG、IgA和IgM）是否存在。

雖然這些測試為醫(yī)療保健醫(yī)療器械創(chuàng)新網(wǎng)所使用，尚不能用于自我診斷，但是用于試驗(yàn)的試劑盒包括了進(jìn)行手指穿刺試驗(yàn)所需的所有材料，具備在檢驗(yàn)科室外進(jìn)行檢驗(yàn)分析的可能。

根據(jù)公布的結(jié)果，用以驗(yàn)證檢測結(jié)果的400多份血清樣本沒有檢測到與其他呼吸道冠狀病毒的交叉反應(yīng)，Eurofins公司確認(rèn)該產(chǎn)品特異性指標(biāo)為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%.