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프리시젼바이오, ‘코로나19’ 항원진단키트 식약처 허가 - 바이오스펙테이터

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프리시젼바이오, ‘코로나19’ 항원진단키트 식약처 허가

입력 2021-08-04 14:29 수정 2021-08-04 14:29

바이오스펙테이터 서윤석 기자

현장서 10분이내 코로나19 감염 판별가능..민감도90%, 특이도 100% 성능

체외진단 전문기업 프리시젼바이오는 4일 식품의약품안전처로부터 코로나19 신속항원진단 키트에 대한 국내 허가를 획득했다고 밝혔다.

회사에 따르면 이번에 승인된 코로나19 신속항원진단키트 ‘PBCheck COVID-19 Ag’는 전문가용 육안진단 제품으로 현장에서 10분 이내에 코로나19 감염 여부를 판별할 수 있다. 민감도 90%, 특이도 100%로 간편하고 빠르게 결과를 볼 수 있어 PCR 검사의 보조수단으로 사용된다.

이 진단키트는 지난해 수출 허가 및 CE 인증을 완료하고 현재 유럽, 아시아, 중남미 등 글로벌 시장에서 판매채널을 확대 중이다.

프리시젼바이오의 항원진단키트 PBCheck COVID-19 Ag과 검사기 기반의 Exdia COVID-19 Ag 제품은 알파,(영국), 베타(남아공), 감마,(브라질), 델타(인도) 변이형 코로나19 바이러스의 진단이 가능하다는 설명이다.

프리시젼바이오 관계자는 “선별 진료와 모니터링 용도로 사용되는 신속진단의 특성상 PCR 검사와 함께 사용되면 방역에 도움이 될 수 있다"며 “국내외 코로나19 확진자가 다시 급증하고 있는 가운데 이번 인허가 획득으로 프리시젼바이오 제품이 신속한 선별 진료 진행에 많은 도움이 될 것으로 기대한다"고 말했다.

한편 프리시젼바이오는 지난 5월 대전 본사에 신사옥을 준공해 면역진단 카트리지 500만개, 임상화학 카트리지 200만개 규모의 생산시설을 확보했으며 지난 7월부터 임상화학 검사기 및 카트리지의 양산에 돌입했다.

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