The art and science of reproductive donor screening: pooled testing (PT) vs. individual donor nucleic acid testing (ID NAT) and false positive test rate

Abstract

False positive test results can lead to a loss of thousands of dollars invested in stimulating an egg donor and recipient in assisted reproductive technology (ART) if results are received after stimulation has begun. This study reviews the impact of the requirement for ID NAT negative for hepatitis C (HCV) and HIV as opposed to pooled testing (PT). NAT testing is currently performed in pools of 24 (Roche) or 16 (GenProbe) on blood donors, which decreases cost and risk of false positive testing. Because vendors only submitted blood donor data the FDA approved pooled testing only for blood donors and individual donor testing is required for other donor types.