Guidelines for preventing "dilution false negatives" in in vitro laboratory testing of the donor population.
In this article we develop a calculation or formula for use in determining the potential dilution effect of fluids administered during patient treatment on serologic testing parameters. The formula uses basic principles of (a) fluid distribution over time from administration; (b) ratios of plasma and extravascular fluid volumes to body weight; and (c) common practices of fluid resuscitation. A dilution threshold of 50% was set using data from enzyme-linked immunosorbent assay human immunodeficiency virus antibody determinations performed on in vitro diluted seropositive serum samples. These data respond to issues raised by guidelines from the Centers for Disease Control and the U.S. Food and Drug Administration to achieve recipient safety without unnecessarily restricting the potential donor pool.
Heck
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Transplant Services Center, University of Texas Southwestern Medical Center, Dallas 75235.
Baxter
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D001803:Blood Transfusion; D003951:Diagnostic Errors; D004797:Enzyme-Linked Immunosorbent Assay; D005188:False Negative Reactions; D005260:Female; D005440:Fluid Therapy; D017408:Guidelines as Topic; D015483:HIV Antibodies / Q000032:analysis*; D006679:HIV Seropositivity / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D007223:Infant; D008297:Male; D016377:Organ Transplantation; D014019:Tissue Donors
D015483:HIV Antibodies