Evaluation of Results of the Chagas Incidence 结果评价发病率.pptVIP

T. cruzi Incidence Study in Blood Donors and its Implications for One-time Testing of Blood Donors Robert Duncan, Ph.D. DETTD, CBER, FDA Blood Products Advisory Committee August 2, 2011 Background-1 Trypanosoma cruzi: causative agent of Chagas’ disease Small protozoan parasite Chronic, asymptomatic infection Difficult or impossible to treat, severe symptoms late in about 30% of cases Endemic to portions of Mexico, Central America, and S. America, 10 million people infected worldwide with 300,000 in the U.S. Transmission: feces of an infected triatomine insect, congenital, organ transplant, transfusion, oral (breast milk, cane juice), via conjunctiva, laboratory accident Blood transfusion transmission is a recognized problem in endemic areas. An infected unit is estimated to have a 12-20% probability of causing infection in the recipient (WHO TRS 905, 2002) Background-2 9 cases of transfusion transmission documented in US/Canada 5 reported cases of solid organ transplant transmission. Seroprevalence in the US donor population based on testing with licensed assays ranges from 0.001-0.02% with the higher rates in areas with large numbers of immigrants from Central and South America. Increasing rates of immigration raises concern about the potential for increased transmission. Background-5 April 2009 BPAC voted in favor of one-time testing for antibodies to T. cruzi in blood donors contingent on the outcome of studies to establish the rate of incidence of new T. cruzi infections. ARC and BSI volunteered to perform studies. June 6, 2009, ARC and BSI submitted a proposal for an Incidence study defined on the next slide Aug. 2009, ARC and Apr. 2010, BSI initiated one-time testing of all donors. Dec. 2010, the FDA published Final Guidance recommending one-time testing for T. cruzi that would be reevaluated based on the outcome of incidence studies. ARC and BSI Proposed T. cruzi Incidence Study Aim: To attempt to determine the rate of newly acquired T. cru