코로나바이러스(COVID-19) 업데이트: 데일리 라운드업 2020년 8월 17일 

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The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device ？ a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.
• As part of the FDA’s effort to protect consumers, the agency issued a joint warning letter with the Federal Trade Commission to SilveryGuy, a company that participates in the Amazon Associates program, for selling fraudulent COVID-19 related products. As an Amazon associate, the company earns commissions by promoting the sale of Colloidal Silver products on the company’s website, with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Currently, there are no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
• Testing updates:
  • To date, the FDA has currently authorized 214 tests under EUAs; these include 175 molecular tests, 37 antibody tests, and 2 antigen tests.

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.

즉시 릴리스의 경우:2020년 8월 17일
미국 식품의약국(FDA)은 오늘 COVID-19 전염병에 대한 지속적인 대응 노력에서 취한 다음과 같은 조치를 발표했다.
？FDA는 예일 보건대학원(예일스쿨)이 COVID-19 테스트 시 침샘플을 처리하는 새로운 방법을 사용하는 TacleDirect COVID-19 진단 테스트를 위해 긴급 사용 허가(EUA)를 발행했다. 이 분자 테스트는 건강관리 제공업체가 COVID-19로 의심되는 개인으로부터 살균 용기에 방부제 없이 채취한 침에서 사스-CoV-2의 핵산을 정성적으로 검출하기 위한 것이다. TacleDirect는 특별한 유형의 면봉이나 수집 장치를 필요로 하지 않는다. ？ 침 샘플은 모든 멸균 용기에 수집될 수 있다. 별도의 핵산 추출 단계가 필요하지 않아 특이하기도 하다. 이는 다른 테스트에서 이 단계에 사용된 추출 키트가 과거에 부족하기 쉬웠기 때문에 중요하다.
？FDA의 소비자 보호 노력의 일환으로, 기관은 Amazon Associates 프로그램에 참여하는 회사인 SilveryGuy에 대해 연방 무역 위원회와 합동 경고 서한을 발행하여 COVID-19 관련 제품을 판매했다. 아마존의 제휴사로서, 이 제품은 사람 속에서 COVID-19를 완화, 예방, 치료, 진단 또는 치료할 수 있다는 오해를 불러일으키면서, 회사 웹사이트에 콜로이드 실버 제품의 판매를 촉진하여 수수료를 챙긴다. 현재 COVID-19를 예방하거나 치료할 수 있는 FDA 승인 제품은 없다. COVID-19에 대해 우려하는 소비자는 의료 사업자와 상의해야 한다.
？ 업데이트 테스트: ？ 현재까지 FDA는 EUA에 따라 214개의 테스트를 승인했으며, 여기에는 분자 테스트 175개, 항체 테스트 37개, 항원 테스트 2개가 포함된다.


미국 보건복지부 산하 기관인 FDA는 사람과 수의학 의약품, 백신 및 기타 생물학적 제품, 의료기기의 안전성, 효과성 및 보안을 보장함으로써 공공의 건강을 보호한다. 이 기관은 또한 우리 나라의 식품 공급, 화장품, 건강 보조식품, 전자 방사선을 방출하는 제품, 담배 제품을 규제하는 것에 대한 안전과 보안을 책임지고 있다. 

 Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing

코로나바이러스 (COVID-19) 업데이트: FDA, 새로운 침 샘플 처리 방법을 사용하는 예일대 타액 다이렉트 공중 보건 학교에 긴급 사용 허가서 발급 

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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.

“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”

“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”

SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.

Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.

This is the fifth test that the FDA has authorized that uses saliva as a sample for testing. Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs. Since the saliva sample is self-collected under the observation of a healthcare professional, it could also potentially lower the risk posed to healthcare workers responsible for sample collection. While FDA has seen variable performance in tests using saliva, Yale School of Public Health submitted data with its EUA request from which the FDA determined that Yale’s test meets the criteria for emergency authorization when used to test saliva samples for SARS-CoV-2, the virus that causes COVID-19 infection.

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.