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'타액 기반' 코로나19 진단 FDA 긴급사용승인 - 바이오스펙테이터

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'타액 기반' 코로나19 진단 FDA 긴급사용승인

입력 2020-04-14 10:46 수정 2020-04-14 10:56

바이오스펙테이터 서일 기자

미 럿거스대학 연구팀 개발, 검체 채취 및 보관 용이.."의료진 감염위험과 보호장구 소비 줄일 수 있어"

타액을 사용한 코로나19 진단방법이 미국 식품의약국(FDA)에서 긴급사용승인(EUA)를 받았다. 기존 면봉 검사법에 비해 의료진의 감염위험을 낮추고 보호장구의 소비를 줄일 수 있을 것으로 보인다.

기존 검사법은 코와 목에 면봉을 사용해 검체를 채취한데 반해, 이 진단법은 플라스틱 튜브에 타액을 모아 코로나19의 감염을 RT-PCR로 진단하는 방식이다. 타액 검체는 상온에서 보관해 운송하고, 48시간내에 테스트해야 한다.

미국 럿거스 대학교(Rutgers University)는 타액기반 코로나19 진단 키트에 대해 미국 FDA의 긴급사용승인(EUA)를 받았다고 지난 13일 밝혔다.

FDA에 따르면 60명의 피검자를 대상으로 면봉검사와 럿거스대 연구팀의 타액검사를 동시에 진행한 결과 두 검사의 결과가 100% 일치했다. FDA는 “타액 채취는 의료시설에서 의료진의 감독 아래에 이루어져야 하고, 코로나19 증상이 있다면 타액 검사에서 음성이 나왔다 하더라도 추가적인 검사가 필요하다”고 설명했다.

앤드류 브룩스(Andrew Brooks) RUCDR(Rutgers University Cell and DNA Repository Infinite Biologics) COO는 “의료진이 인두에서 검체를 채취하는 과정에서 더 이상 감염위험에 노출될 필요가 없으며, 환자 치료에 사용하기 위해 귀중한 보호장구를 보존할 수 있다”며 “타액 채취는 면봉을 이용한 채취보다 빠르므로, 매일 검사하는 인원도 늘릴 수 있다”고 말했다.

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