FDA Grants EUA For T-Detect Covid Test To Detect Past COVID-19 Infection

FDA批准EUA用于T-Detect Covid检测以检测过去的COVID-19感染

2021-03-09 00:52:53 RTTNews

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The U.S. Food and Drug Administration granted emergency use authorization for the first and only clinical T cell-based test for patients to detect the unique T-cell signature specific to SARS-CoV-2, the virus that causes COVID-19. The test confirms recent or prior COVID-19 infection. Developed by Adaptive Biotechnologies, T-Detect COVID Test is a next generation sequencing based (NGS) test to help identify individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. T cells are the adaptive immune system's first responders to detect any virus. They quickly multiply and circulate in the blood to attack the virus, often before symptoms appear. T cells can "remember" prior infections and kill pathogens if they reappear. The test assesses the T cell immune response to COVID-19 after it analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells). A T cell response may be detected in blood several days after initial infection. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. The T cell-based test is the first indication resulting from Adaptive's TCR-Antigen Map collaboration with Microsoft. The test uses immunosequencing, proprietary computational modeling, and Microsoft's AI and machine learning to map T-cell receptor sequences. Though the T-Detect COVID Test confirms recent or prior COVID-19 infection, it does not diagnose current SARS-CoV-2 infection. Until now, antibody tests have been the primary way to determine recent or prior COVID-19 infection. T-cell tests take an entirely new approach to determine prior infection. T-cell responses arise earlier than antibodies and persist in the blood for longer. The FDA granted EUA based on a clinical validation study showing that T-Detect COVID Test demonstrated sensitivity or ability to identify a positive case, of 97.1 percent from date of diagnosis using RT-PCR. It also showed 100 percent specificity, the ability to identify a negative case. A positive test result indicates recent or prior infection with SARS-CoV-2, while a negative test result indicates that a patient is unlikely to have been infected with SARS-CoV-2. However, a negative result does not preclude acute or current SARS-CoV-2 infection. The test is indicated for use by qualified healthcare professionals on samples from individuals who are 15 days or more post-symptom onset. Testing is currently limited to laboratories designated by Adaptive Biotechnologies. Patients can opt to visit one of nearly 2,000 Labcorp patient service centers or arrange for a mobile phlebotomy service at their home to have their blood drawn for testing. For comments and feedback contact: editorial@rttnews.com Business News
美国食品和药物管理局授予紧急使用授权,用于首个也是唯一一个针对患者的基于T细胞的临床测试,以检测导致新冠病毒的新型冠状病毒特有的T细胞特征。该检测确认最近或以前感染COVID-19。 由Adaptive Biotechnologies开发的T-Detect COVID测试是一种基于下一代测序(NGS)的测试,用于帮助识别对新型冠状病毒有适应性T细胞免疫反应的个体,表明最近或以前感染过新型冠状病毒。 T细胞是适应性免疫系统检测任何病毒的第一反应者。它们在血液中迅速繁殖和循环以攻击病毒,通常在症状出现之前。T细胞可以“记住”以前的感染,如果病原体再次出现,就可以杀死病原体。 该测试在分析T细胞(白细胞)的DNA(脱氧核糖核酸)序列后,评估T细胞对COVID-19的免疫反应。在最初感染几天后,血液中可能会检测到T细胞反应。 通过简单的抽血,T-Detect将利用map为个体提供免疫状态,从而实现早期疾病诊断、疾病监测和对免疫的关键洞察。 基于T细胞的测试是Adaptive公司与微软合作的TCR抗原图谱的第一个指示。该测试使用免疫测序、专有的计算建模,以及微软的AI和机器学习来绘制T细胞受体序列。 虽然T-Detect COVID检测证实了最近或以前的COVID-19感染,但它并不能诊断当前的新型冠状病毒感染。 到目前为止,抗体检测一直是确定近期或既往COVID-19感染的主要方式。T细胞检测采用了一种全新的方法来确定先前的感染。T细胞的反应比抗体产生得早,并且在血液中持续的时间更长。 FDA批准EUA是基于一项临床验证研究,该研究表明,T检测COVID试验显示出识别阳性病例的敏感性或能力,从RT-PCR诊断之日起,97.1%。它还表现出100%的特异性,能够识别阴性病例。 检测结果呈阳性表明最近或以前感染过新型冠状病毒,而检测结果呈阴性则表明患者不太可能感染过新型冠状病毒。然而,阴性结果并不排除急性或当前新型冠状病毒感染。 该检测被指定用于合格的医疗保健专业人员对来自于症状发生后15天或更长时间的个体的样本进行检测。测试目前仅限于Adaptive BioTechnologies指定的实验室。患者可以选择到近2000个Labcorp患者服务中心中的一个,或者在家中安排流动静脉切开服务,抽血化验。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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