Direct oral questions to blood donors: the impact on screening for human immunodeficiency virus

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Abstract
BACKGROUND: In December 1990, the Food and Drug Administration recommended that all United States blood centers implement a policy of asking prospective donors direct oral questions (DOQs) about human immunodeficiency virus (HIV) risk behaviors to increase the safety of the blood supply. STUDY DESIGN AND METHODS: To evaluate the impact of the DOQ policy, HIV‐related deferral and HIV seroprevalence data were analyzed at four American Red Cross blood centers for the year before the policy change and the year after. An epidemiologic analysis with stratification was conducted, including the calculation of odds ratios (OR) and 95‐percent CIs. RESULTS: Two of the four blood centers showed an overall significant increase in HIV‐related deferral after implementation of the DOQ policy: OR = 4.04, (95% CI = 3.41, 4.76); OR = 2.93, (95% CI = 2.67, 3.21). The increase in HIV‐related deferral was higher for women. HIV seroprevalence decreased at all four centers, including the two that did not see an increase in HIV‐related deferrals. Seroprevalence declined by 14 percent in the two centers with increases in HIV‐related deferral, which was neither significant nor attributable to DOQs. CONCLUSION: Given that HIV antibody screening cannot detect HIV‐seronegative (but infectious) “window‐period” donations, the deferral of at‐risk donors may offer some additional protection to the blood supply. However, evidence was not found of an increase in safety of the blood supply as measured by HIV seroprevalence.