2005D-0261 Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
FDA Comment Number : EC1
Submitter : Ms. Erica Padilla Date & Time: 08/01/2005 07:08:30
Organization : BloodSource
Category : Drug Industry
Issue Areas/Comments
GENERAL
GENERAL
The use of the term 'individual NAT' (vs Multiplex NAT) was very confusing, as you frequently use the term 'individual' to talk about donor testing too. I suggest either using 'Separate NAT' as this test type, such as is used on page 9, or listing both the terms 'individual NAT' and 'individual donor testing' in the definitions section.
Thank you, otherwise I found this a very easy to read and clear guidance.