The development of vCJD-infected blood reference materials

Wednesday, October 26, 2011 — Poster Session IV
2:00 p.m. – 4:00 p.m.	Natcher Conference Center	FDA/CBER	INFECTDIS-7

Authors

• K McDowell
• P McMahon
• N Nag
• J Beren
• D Asher
• L Gregori

Abstract

Transmissible spongiform encephalopathies (TSEs, prion diseases) are rare fatal neurodegenerative diseases with long asymptomatic incubation periods (usually 7 to > 40 years in humans). Variant Creutzfeldt-Jakob disease (vCJD), a human TSE of special concern, is an infection most often linked to eating meat products contaminated with the agent of bovine spongiform encephalopathy. Blood transfusions and injections of human plasma product have also transmitted vCJD. No test detects vCJD-infected blood donors during the asymptomatic incubation period, so transfusion-transmitted vCJD endangers public health. Sensitive tests are needed to detect vCJD infectivity in donor blood. A major challenge to developing TSE blood screening tests is lack of reference materials to validate candidate assays. Our goal is to generate such material. Because vCJD-infected human blood is not generally available, animal models must be developed. We infected four macaques—a species of monkey susceptible to vCJD—with vCJD agent and are collecting blood samples at intervals during incubation period. We will use transgenic mice susceptible to vCJD agent to detect and titrate infectivity in macaque blood. Our studies may yield a well-characterized vCJD blood reference material, resolving a major obstacle that currently impedes development of a donor screening test.

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