(P-BC-41) Infectious Disease Rates Before and After Implementing Individual Donor Assessment: Our Center’s Experience

The FDA released the guidance, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” in May 2023. The changes, known as individual donor assessment (IDA), removed screening questions related to men who have sex with men (MSM) and women who have sex with MSM and added individual risk-based questions relevant to HIV risk asked of all donors. Our center looked at infectious disease rates before and after implementing the guidance.

Study

Design/Methods:

Our center implemented the FDA guidance in August 2023. Initial screening included: chemiluminescent microparticle immunoassay (CMIA) (Abbott) for antibody (ab) to human immunodeficiency virus (HIV)1/2, human T-lymphotrophic virus (HTLV) I/II, hepatitis B virus (HBV) core, hepatitis C virus (HCV), and chagas and for HBV surface antigen (ag); microhemagglutination for syphilis ab (Beckman Coulter); pooled nucleic acid amplification (Grifols) for HIV/HCV/HBV with individual resolution. Confirmatory testing included: immunochromatographic assay (BioRad) for HIV1/2 ab; enzyme-linked immunosorbent assay (Ortho) for HCV ab; neutralization (Abbott) for HBV surface ag; enzyme immunoassay (MP Diagnostics) and (Trinity Biotech) for HTLV I/II and syphilis ab; and enzyme strip assay (Abbott) for chagas ab. Data was pulled from our blood establishment computer system for all first-time donors tested August 2022 to March 2023 and August 2023 to March 2024.

Results/Findings:

A total of 11,628 first-time donors were tested during August 2022 to March 2023 and 11,862 were tested during August 2023 to March 2024. Table 1 shows initial and confirmatory tests in both cohorts. Of note, not all initial positive donors had enough residual sample to complete confirmatory testing and an equivocal or indeterminate confirmatory result was not considered a confirmed positive. Fisher's exact analysis showed no statistically significant difference between initial or confirmatory rates in the two cohorts. 

Conclusions: Following the implementation of the FDA Guidance for individual donor assessment, our center did not see a significant change in initial or confirmatory positive infectious disease rates in first-time donors.