REGULATORY UPDATE: AABB Releases HIV Testing, Lookback and Re-Entry Toolkit

October 26, 2021

AABB announces the availability of a new toolkit on HIV testing, lookback and re-entry. Developed at member request, it is the first in a series of resources created to assist blood centers and transfusion services with the regulatory actions necessary following a positive test for a relevant transfusion-transmitted infection (RTTI).

The flowcharts are intended to assist members with compliance efforts but are not intended to replace the review of recommendations found in the Food and Drug Administration’s December 2017 guidance, 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, and the regulations in 21 CFR 610.46.

AABB would like to thank staff at the Mayo Clinic for their assistance with the development of the flowcharts. Contact regulatory@aabb.org with questions.