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 : EC7
Submitter : Ms. Antoinette Mattoch Date & Time: 10/27/2005 05:10:14
Organization : Armed Services Blood Program
Category : Federal Government
Issue Areas/Comments
1. Page 2 Add definition for IDT. The definition needs to be a specific definition for IDT and not just a breakdown from a master pool.

2. Page 11 (IV.ii.(b)) Chiron's package insert considers an IDT that was multiplex reactive, discriminatory non-reactive to be Non-Discriminated. If the specimen is further tested and is non-reactive for multiplex testing then the specimen is considered non-reactive.

The FDA guidelines is proposing that blood units from these specimens be Quarantined and destroyed and the donor deferred. Chiron considers these test results as non-reactive, therefore proposed guidelines for testing product disposition, donor management should be changed to reflect Chiron's package insert as already approved by FDA. Why should the unit be destroyed and the donor deferred as proposed in the guidelines? Changes to Table 1 and Figure 1 must reflect this.

3. Request complete algorithms: one for facilities that start with IDT and one for donor centers that start with pooled testing. Do not combine the IDT tables for original IDT and pooled breakdown to IDT.