Coronavirus Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs


2021-03-17 07:00:04 BioSpace


 Testing remains an important cornerstone of our nation's fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions, such as whether an individual should participate in an activity, based on the test results.   Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs. Our actions complement those taken by the Centers for Disease Control and Prevention (CDC) and are not intended to replace CDC's testing or other public health guidance. First, the FDA issued a new supplemental template for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission. This template applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This includes tests conducted in any location, including in a laboratory, at the point-of-care (POC), or even places such as a person's home or certain non-traditional sites such as offices, sporting venues, airports, schools, etc. We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing. As part of this new template for test developers, the agency provided recommendations aimed to streamline the authorization of screening tests with serial testing. The recommendations apply to test developers who seek an EUA from the FDA for certain screening tests prior to conducting certain performance evaluations with asymptomatic individuals. For example, in certain circumstances, a POC test or an at-home test could be authorized for over-the-counter (OTC) use without the need for validating its use in asymptomatic individuals prior to authorization. The FDA believes that evidence of a test's strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals. Additionally, today the FDA issued a fact sheet that outlines considerations for selecting a test for use in a screening testing program. The fact sheet will help schools, workplaces, communities and other locations as they are selecting a test for screening and help them understand the difference between tests used for diagnosis of suspected COVID-19 compared to those used for screening asymptomatic individuals. This information we're providing will be helpful to groups as they set up testing programs. We believe these combined efforts will further expand the availability of tests authorized for screening asymptomatic individuals, including OTC use, help bolster existing and new testing programs and increase consumer access to testing. Additional Resources: Emergency Use Authorization Supplemental Template  Fact Sheet FAQs on Testing for SARS-CoV-2 Media Contact: FDA Office of Media Affairs, 301-796-4540 Consumer Inquiries: 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products. multimedia:
检测仍是我国抗击新冠肺炎疫情的重要基石。这包括学校、工作场所、社区和其他地点使用检测来筛查仍可能传播病毒的无症状个体。筛查涉及检测没有已知或疑似接触新冠的无症状个人,以便根据检测结果做出个人决定,如个人是否应该参加一项活动。 今天,我们为测试开发人员提供关于这些重要筛选工具的紧急使用授权的简化路径的信息,以及帮助这些组建立测试程序的信息。我们的行动是对疾病控制和预防中心(CDC)采取的行动的补充,并不打算取代CDC的检测或其他公共卫生指导。 首先,FDA发布了一个新的补充模板,用于测试开发商寻求紧急使用授权(EUA)的某些测试,以筛选与系列测试。连续检测包括在几天内对同一个体进行多次检测,可以增加检测到可能不总是通过一次检测出现的无症状感染的机会。CDC建议每周至少进行一次连续检测,同时采取其他缓解措施,如遮盖和保持社交距离,以减少疾病传播。该模板适用于分子和抗原测试的开发者,用于系列测试程序,以及用于测试程序之外的系列方式的家庭测试,目的是检测没有症状或其他流行病学原因的个人的新型冠状病毒,以怀疑COVID-19感染。这包括在任何地点进行的测试,包括在实验室、护理点(POC),甚至是在个人的家中或某些非传统场所,如办公室、体育场馆、机场、学校等。 我们相信,这一努力将为进一步扩大用于筛查无症状个体的授权检测的可用性铺平道路,帮助支持现有和新的检测计划,并增加消费者获得检测的机会。 作为测试开发人员新模板的一部分,该机构提供了一些建议,旨在简化筛选测试和系列测试的授权。该建议适用于在对无症状个体进行某些性能评估之前,向FDA寻求某些筛选试验的EUA的试验开发者。例如,在某些情况下,POC测试或家庭测试可以被授权用于非处方药(OTC)使用,而无需在授权之前验证其在无症状个体中的使用。FDA认为,一项检测在有症状患者中表现强劲的证据与系列检测相结合,可以减轻在检测无症状个体时出现错误结果的风险。 此外,今天FDA发布了一份概况介绍,概述了筛选测试程序中选择测试的考虑因素。这份概况介绍将帮助学校、工作场所、社区和其他地点选择筛查检测,并帮助他们了解用于诊断疑似新冠肺炎的检测与用于筛查无症状个体的检测之间的区别。 我们提供的这些信息将有助于小组建立测试程序。我们相信,这些联合努力将进一步扩大用于筛查无症状个体(包括非处方药使用)的授权检测的可用性,帮助加强现有的和新的检测项目,并增加消费者获得检测的机会。 额外资源: 应急使用授权补充模板 概况介绍 新型冠状病毒测试常见问题解答 媒体联系人:FDA媒体事务办公室301-796-4540 消费者咨询:888-INFO-FDA FDA是美国卫生与公众服务部下属的一个机构,通过确保人类和兽药、疫苗和其他人类使用的生物制品以及医疗器械的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、产生电子辐射的产品的安全和保障,并负责管制烟草产品。 多媒体: