FDA Approves Roche COVID-19 Test that Aims to Test Vaccines’ Antibody Response

FDA批准罗氏COVID-19试验,该试验旨在检测疫苗的抗体反应

2020-12-03 05:30:14 BioSpace

本文共922个字,阅读需3分钟

Taljat David/Shutterstock The  U.S. Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood. The test appears to be geared toward measuring the antibody response produced by the vaccines currently under review.  “Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against Covid-19. Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response,” Roche Diagnostics’ CEO Thomas Schinecker  said in a press release. Roche explained that the test, Elecsys ® Anti-SARS-CoV-2 S, works by targeting “antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell.” Pfizer and Moderna’s vaccines each target the spike (S) protein –  a knobby protrusion on the SARS-CoV-2 virus that allows the virus to attach and invade cells, instigating infection. Pfizer’s vaccine received temporary authorization just this morning in the UK, the first official signal that we are entering the next phase of this fight where tests like Roche’s will play a significant role.  Elecsys ® specifically detects antibodies against this S protein found within blood samples. Roche added that “the test may help guide the allocation of plasma donations from recovered Covid-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus.” Donors possessing these antibodies can contribute plasma to initiatives such as the CoVIg-19 Plasma Alliance, spearheaded by 12 plasma-focused Life Sciences companies such as CSL Behring and Takeda Pharmaceutical, to develop a plasma-based hyperimmune globulin intended for the hospitalized treatment of patients at risk for complications.  The test has a lot of logistical upside as well, as Roche said that clinical laboratories can run it on their own widely-available cobas e analyzer units, and can receive results in approximately 18 minutes, with a test throughput of up to 300 tests per hour. Roche will begin shipping the test to U.S. laboratories within the next week.  Elecsys ® was approved in the EU in mid-September in markets that accept the CE mark – a designation which shows that products sold conform with European health, safety, and environmental protection standards. In the U.S., Roche joins Siemens, which was the first company to have a COVID-19 antibody-estimation test approved by the FDA in July.
Taljat David/Shutterstock 美国食品和药物管理局(FDA)已经对罗氏公司开发的用于测量血液中抗体的COVID-19测试给予紧急使用授权(EUA)。这项试验似乎是为了测量目前正在审查的疫苗所产生的抗体反应。 “自从这一大流行开始以来,我们的重点一直是为抗击Covid-19带来有效的诊断测试解决方案。罗氏诊断公司的首席执行官Thomas Schinecker在一份新闻稿中说:“像这样的抗体测试将在测量人的疫苗诱导的免疫反应方面发挥关键作用。” 罗氏公司解释说,这项名为Elecsys®抗SARS-CoV-2 S的试验是通过“针对被称为尖峰蛋白的新型冠状病毒区域的抗体来发挥作用的,特别是使病毒能够与宿主细胞受体结合的区域,这是病毒进入宿主细胞所必需的。” 辉瑞公司和Moderna公司的疫苗都针对spike(S)蛋白--新型冠状病毒病毒上的一个多节突起,它允许病毒附着并侵入细胞,从而引发感染。辉瑞的疫苗今天上午刚刚在英国获得临时授权,这是我们进入下一阶段的第一个官方信号,像罗氏的试验将发挥重要作用。 Elecsys®公司专门检测血液样本中针对这种S蛋白的抗体。 罗氏公司补充说,“该测试可能通过识别具有新型冠状病毒病毒抗体的捐献者,帮助指导将康复的Covid-19患者的血浆捐献分配给目前的患者。” 拥有这些抗体的捐赠者可以向CoVIg-19血浆联盟等倡议提供血浆,CoVIg-19血浆联盟由CSL Behring和Takeda Pharmaceutical等12家以血浆为重点的生命科学公司牵头,开发一种基于血浆的超免疫球蛋白,用于有并发症风险的患者的住院治疗。 这项测试在后勤方面也有很多好处,正如罗氏所说,临床实验室可以在他们自己的广泛可用的cobas e分析仪上运行这项测试,大约18分钟就能收到结果,每小时的测试吞吐量可达300次。罗氏将在下周内开始向美国实验室运送该测试。 Elecsys®公司于9月中旬在接受CE标志的欧盟市场获得批准,CE标志表明所售产品符合欧洲健康,安全和环保标准。 在美国,罗氏加入了西门子的行列,西门子是第一家获得FDA 7月批准的COVID-19抗体评估测试的公司。

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文