國際生醫新聞

FDA美國食品和藥物管理局局長Stephen Hahn上週四宣布，批准了由Cellex 公司生產的冠狀病毒抗體測試系統，這是首個獲FDA批准使用的抗體檢測病毒。

他解釋說這種類型的測試與FDA先前批准的診斷測試之間的區別，它在監測疾病中起著非常重要的作用，特別是因為這種病毒與其他病毒不同，因為我們懷疑有很大一部分人是無症狀的，或者曾經有過這種病毒，然後甚至在不知情的情況下就消失了。這將幫助我們確定所謂的病毒攻擊率 (attack rate of the virus)，以了解感染多少人以及傳播的方式。

Cellex的抗體測試需要血液樣本，只能在授權實驗室中進行分析。這封信說，測試大約需要15至20分鐘才能得出結果。該測試尋找兩種類型的抗體：免疫球蛋白M和免疫球蛋白G。免疫球蛋白M是人體對異物作出反應的第一個抗體，可在感染後幾天出現。

資料: FDA、Daily Caller

FDA回函文件

檢測：qSARS-CoV-2 IgG / IgM快速測試
公司：Cellex Inc.
適應症：定性檢測血清，血漿中針對SARSCoV-2的IgM和IgG抗體（ EDTA或檸檬酸鹽），或由其醫療人員對懷疑患有COVID-19的個體抽取全血。適用於緊急使用，且此測試僅限於授權實驗室。
授權實驗室：經過1988年臨床實驗室改進修正案（CLIA），42 USC 263a 認證的實驗室，可以執行中度和高度複雜性測試。

資料: FDA、Daily Caller

Chief Executive Officer: James X. Li
76 TW Alexander Drive
Research Triangle Park, NC 27709 US

Device: qSARS-CoV-2 IgG/IgM Rapid Test
Company: Cellex Inc.
Indication: Qualitative detection of IgM and IgG antibodies against SARSCoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole
blood from individuals suspected of COVID-19 by their healthcare
provider. Emergency use of this test is limited to authorized
laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform
moderate and high complexity tests.

Dear Dr. Li:
This letter is in response to yourrequest that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product, pursuant to Section564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of theDepartment of Health and Human Services (HHS) determined that there is a public healthemergency that has a significant potential to affect national security or the health and security ofUnited States citizens living abroad, and that involves the virus that causes COVID-19.

Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary ofHHS then declared that circumstances exist justifying the authorization of emergency use of invitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to theterms of any authorization issued under Section 564(a) of the Act.