疫情时事：FDA将进一步提供监管救济措施以加快诊断

阿拉丁翻译苏琳

Today, as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.
为积极应对新冠疫情，针对2月29日发布的新冠病毒诊断检测政策，FDA于2月16日对其内容进行了更新，旨在加速美国的检测能力。

We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests. Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.
我们将敦促国家当局和商业开发商采取一切必要步骤，确保能提供准确的检测。在这一全球性流行病爆发期间，不准确的诊断不仅会妨碍预防工作的开展，还会延误病人的恰当治疗。

Our guidance provides more specific details for the laboratory and commercial manufacturer communities, but I want to highlight three key elements of the update we are issuing today.
我们为实验室和商业化生产商社区提供了更为详细的指导，但今天我将重点描述最新政策的三大要点。

First, we are putting in place a policy for states to take responsibility for tests developed and used by laboratories in their states. States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA. Nor will these laboratories pursue an Emergency Use Authorization (EUA) with the FDA.
首先，我们正在制定一项新政策，要求各州对其辖区内实验室研发和运用的检测负责。各州可建立独立系统授权批准实验室的检测，无需再向FDA申请，亦无需向FDA申请紧急使用授权。

Second, we are expanding who the policy outlined in the Feb. 29 guidance applies to. The policy was originally applicable only to laboratories that are certified to perform high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments. Under the update published today, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances. As noted in the guidance, the FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.
其次，我们还在扩大2月29日指南中概述的政策适用对象。该政策最初仅适用于符合《临床实验室改进法修正案》要求，进行高复杂性检测的认证实验室。而最新政策规定，在某些情况下，即使未获得紧急使用授权，FDA也不反对商业生产商分配商业研发的新检测方法和实验室运用此类检测方法。指南中指出，FDA认为，在生产商已经验证了检测性能后，可以提供15个工作日的期限，供其准备紧急使用授权申请材料。

Finally, our updated policy provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection.
最后，新政策还向疫情期间有意研发血清检测的人员提出了建议。血清检测相对于分子检测来说会更简单，其仅用于识别抗体，限制了诊断的有效性；然而，如最新的指南所述，如果检测已通过验证且已向FDA发出通知，FDA将不会反对其使用血清检测来识别SARS-CoV-2抗体，前提是该类检测须标明警告声明，例如，FDA尚未对检测结果进行审查，抗体检测结果不应作为确诊或排除SARS-CoV-2感的唯一依据。

We’ve also set up a toll-free line, 1-888-INFO-FDA, to help labs with any questions they may have about the EUA process, our policies or getting supplies.
此外，我们还设立了免费咨询热线：1-888-INFO-FDA，帮助实验室解决其对紧急使用授权申请流程、FDA政策或获取物资等方面的疑问。

The FDA continues to maintain operations 24/7 and we are here to support laboratories and test developers during this time of urgent need.
值此危机时刻，FDA将继续保持全天候运作，为实验室和检测研发人员提供支持。

wolflee11

比较中国官方的陈述，可看出，FDA解答民众最为关心的问题，给出了具体的解决方案，而我们的口号和保证则更多。。。一个务实，一个务虚

阿拉丁翻译

Coronavirus (COVID-19) Update: FDAProvides More Regulatory Relief During Outbreak, Continues to Help ExpediteAvailability of Diagnostics

疫情时事：FDA将进一步提供监管救济措施以加快诊断

Today,as part of our ongoing and aggressive commitment to address the coronavirusoutbreak, the FDA updated a policyoriginally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19)in order to achieve more rapid testing capacity in the U.S.

为积极应对新冠疫情，针对2月29日发布的新冠病毒诊断检测政策，FDA于2月16日对其内容进行了更新，旨在加速美国的检测能力。

Weurge state authorities and commercial developers to take all necessary steps toensure the availability of accurate tests. Inaccurate diagnoses during apandemic can impair prevention efforts and delay appropriate treatment for sickpatients.

我们将敦促国家当局和商业开发商采取一切必要步骤，确保能提供准确的检测。在这一全球性流行病爆发期间，不准确的诊断不仅会妨碍预防工作的开展，还会延误病人的恰当治疗。

Ourguidance provides more specific details for the laboratory and commercialmanufacturer communities, but I want to highlight three key elements of theupdate we are issuing today.

我们为实验室和商业化生产商社区提供了更为详细的指导，但今天我将重点描述最新政策的三大要点。

First,we are putting in place a policy for states to take responsibility for testsdeveloped and used by laboratories in their states. States can set up a systemin which they take responsibility for authorizing such tests and thelaboratories will not engage with the FDA. Nor will these laboratories pursuean Emergency Use Authorization (EUA) with the FDA.

首先，我们正在制定一项新政策，要求各州对其辖区内实验室研发和运用的检测负责。各州可建立独立系统授权批准实验室的检测，无需再向FDA申请，亦无需向FDA申请紧急使用授权。

Second,we are expanding who the policy outlined in the Feb. 29 guidance applies to.The policy was originally applicable only to laboratories that are certified toperform high-complexity testing consistent with requirements under the ClinicalLaboratory Improvement Amendments. Under the update published today, the agencydoes not intend to object to commercial manufacturers distributing and labsusing new commercially developed tests prior to the FDA granting an EUA, undercertain circumstances. As noted in the guidance, the FDA believes that 15business days is a reasonable period of time to prepare an EUA submission for atest whose performance characteristics have already been validated by themanufacturer.

其次，我们还在扩大2月29日指南中概述的政策适用对象。该政策最初仅适用于符合《临床实验室改进法修正案》要求，进行高复杂性检测的认证实验室。而最新政策规定，在某些情况下，即使未获得紧急使用授权，FDA也不反对商业生产商分配商业研发的新检测方法和实验室运用此类检测方法。指南中指出，FDA认为，在生产商已经验证了检测性能后，可以提供15个工作日的期限，供其准备紧急使用授权申请材料。

Finally,our updated policy provides recommendations for test developers who may wish todevelop serological tests for use during this coronavirus outbreak. Werecognize that serology tests are less complex than molecular tests and aresolely used to identify antibodies, which limits their effectiveness fordiagnosis; however, as stated in the updated guidance, the FDA does not intendto object to the distribution and use of serology tests to identify antibodiesto SARS-CoV-2 where the test has been validated, notification is provided tothe FDA, and warning statements are included with the tests, for example,noting the test has not been reviewed by the FDA and results from antibodytesting should not be used as the sole basis to diagnose or exclude SARS-CoV-2infection.

最后，新政策还向疫情期间有意研发血清检测的人员提出了建议。血清检测相对于分子检测来说会更简单，其仅用于识别抗体，限制了诊断的有效性；然而，如最新的指南所述，如果检测已通过验证且已向FDA发出通知，FDA将不会反对其使用血清检测来识别SARS-CoV-2抗体，前提是该类检测须标明警告声明，例如，FDA尚未对检测结果进行审查，抗体检测结果不应作为确诊或排除SARS-CoV-2感的唯一依据。

We’vealso set up a toll-free line, 1-888-INFO-FDA, to help labs with any questionsthey may have about the EUA process, our policies or getting supplies.

此外，我们还设立了免费咨询热线：1-888-INFO-FDA，帮助实验室解决其对紧急使用授权申请流程、FDA政策或获取物资等方面的疑问。

TheFDA continues to maintain operations 24/7 and we are here to supportlaboratories and test developers during this time of urgent need.

值此危机时刻，FDA将继续保持全天候运作，为实验室和检测研发人员提供支持。

山顶洞人

警告一次，不要重复发帖，看你ID，是想宣传广告，适可而止。

阿拉丁翻译苏琳

山顶洞人 发表于 2020-3-17 16:06
警告一次，不要重复发帖，看你ID，是想宣传广告，适可而止。

另外我没有留意到有人发过原文，这篇文章是我们自己翻译的，所以不存在重复发帖，谢谢！

山顶洞人

阿拉丁翻译苏琳 发表于 2020-3-17 16:19
另外我没有留意到有人发过原文，这篇文章是我们自己翻译的，所以不存在重复发帖，谢谢！

我说的是，你在本论坛发了两次，虽然在不同板块，花了我一分钟时间核对。

syhorchid

FDA，牛！！！