Detection of XXXX in urine-derived injectable fertility products by a targeted proteomic approach.

@entity1 @entity249 @entity8 @entity16 @entity3605 @entity1579 @entity3669
BACKGROUND: Iatrogenic transmission of @entity1 @entity1579 can occur through medical or surgical procedures, including injection of hormones such as gonadotropins extracted from cadaver pituitaries. Annually, more than 300,000 @entity1 in the United States and Canada are prescribed urine-derived gonadotropins for @entity249 . Although menopausal urine donors are screened for symptomatic @entity16 , incubation of @entity3605 ( @entity3605 ) is impossible to exclude by non-invasive testing. Risk of carrier status of @entity3605 ( @entity3605 ), a disease associated with decades-long peripheral incubation, is estimated to be on the order of 100 per million population in the United Kingdom. Studies showing infectious prions in the urine of experimental animals with and without @entity8 suggest that prions could be present in asymptomatic urine donors. Several @entity1 fertility products are derived from donated urine; recently @entity3669 has been detected in preparations of @entity1 menopausal gonadotropin (hMG). METHODOLOGY/PRINCIPAL FINDINGS: Using a classical proteomic approach, 33 and 34 non-gonadotropin proteins were identified in urinary @entity1 chorionic gonadotropin (u-hCG) and highly-purified urinary @entity1 menopausal gonadotropin (hMG-HP) products, respectively. @entity3669 was identified as a major contaminant in u-hCG preparations for the first time. An advanced @entity3669 targeted proteomic approach was subsequently used to conduct a survey of gonadotropin products; this approach detected @entity1 @entity3669 peptides in urine-derived injectable fertility products containing hCG, hMG and hMG-HP, but not in recombinant products. CONCLUSIONS/SIGNIFICANCE: The presence of protease-sensitive @entity3669 in urinary-derived injectable fertility products containing hCG, hMG, and hMG-HP suggests that prions may co-purify in these products. Intramuscular injection is a relatively efficient route of transmission of @entity1 @entity1579 , and young @entity1 exposed to prions can be expected to survive an incubation period associated with a minimal inoculum. The risks of urine-derived fertility products could now outweigh their benefits, particularly considering the availability of recombinant products.
