Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus

Title:
Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus

https://www.gmp-compliance.org/files/guidemgr/Further_Testing_Donations_Reactive_Licensed_Donor_Screening_Test_9-20-2018.pdf

Origin/Publisher:

FDA Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,

Document Type:
Draft Guidance for Industry
Content:
Currently, certain hepatitis C virus (HCV) nucleic acid tests (NAT) licensed for donor screening are also licensed for use as a supplemental test to confirm HCV infection for specimens that are repeatedly reactive on a licensed donor screening test for anti-HCV.

Go back