FDA, 세계 최초 가정용 급속 COVID-19 자가진단 시험키트 허가 FDA authorizes 1st fully at-home COVID-19 test


FDA authorizes 1st fully at-home COVID-19 test

By Rachael Rettner - Senior Writer 12 hours ago


It allows people to test themselves and get the results at home, within 30 minutes.

The Food and Drug Administration (FDA) has authorized the first fully at-home rapid COVID-19 test.


The test, made by Lucira Health in California, requires a prescription and provides results within 30 minutes, according to a statement from the FDA.


Sign outside the FDA headquarters.(Image: © Shutterstock)


 

FDA, 세계 최초 가정용 급속 COVID-19 자가진단 시험키트 허가


30분 이내 결과 나와


   이제 사람들이 집에서 코로나를 테스트하고 30분 안에 결과를 얻을 수 있게 됐다.

미국 식품의약국(FDA)은 최초의 완전 가정용 급속 COVID-19 테스트를 허가했다.




FDA는 성명에서 캘리포니아의 루치라 헬스사가 만든 이 테스트는 처방전이 필요하며 30분 이내에 결과를 제공한다고 밝혔다.


FDA가 수백 개의 COVID-19 테스트(가정 내 테스트 포함)를 승인했지만, 이러한 초기 테스트는 의료 서비스 제공업체가 관리하거나 분석을 위해 실험실로 보내야 했다.


FDA 커미셔너인 Dr. Commission은 "이 새로운 테스트는 "자체적으로 완전히 관리되고 가정에서 결과를 제공할 수 있는 첫 번째 테스트"라고 말했다. 스티븐 한은 성명서에서 말했다. "이 새로운 테스트 옵션은 전염병을 해결하고 전염병의 공공 부담을 줄이기 위한 중요한 진단 발전이다."


"사람들은 건강관리사에게 그 결과를 보고해야 하며, 의료기관은 모든 검사 결과를 공중 보건 당국에 보고해야 한다"고 성명은 말했다.


황기철 콘페이퍼 에디터

Ki Chul Hwang Conpaper editor curator



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edited by kcontents


Although the FDA has authorized hundreds of COVID-19 tests (including at-home tests), these earlier tests either needed to be administered by a health care provider or sent to a lab for analysis.


MobiHealthNews



edited by kcontents


The new test "is the first that can be fully self-administered and provide results at home," FDA Commissioner Dr. Stephen Hahn, said in the statement. "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission."


To use the test, people first swab themselves inside both nostrils. To get a good swab, people should tilt their head back and insert the swab tip fully inside the nostril, until they meet resistance, according to instructions from Lucira. The company says the test should not hurt, but may sometimes feel uncomfortable or tickly. After swabbing, users place the swab in a vial and swirl it around. The vial is then placed in a battery-powered device with a light-up display. After a half hour, the display lights show if the person has tested positive or negative.


People should report their results to their health care providers, who are then required to report all test results to public health authorities, the statement said.


The test is authorized for home use in people ages 14 and older who are suspected to have COVID-19, the FDA said. In children younger than 14, a health care provider must administer the test.


https://www.livescience.com/fda-home-covid-test-lucira.html




Coronavirus: US FDA approves 1st at-home COVID-19 test kit — Will Canada follow suit?

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