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Human Blood and Transfusion-screening tests

December 2010, FDA has issued its final guidance for the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and human cells/tissues/products thereof . Excerpted from the Guidance-These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T.cruzi in plasma and serum samples from individual human donors.Recommendations also cover blood donor and product management.(1)
On December 14-15, 2010, the Blood Products Advisory Committee (BPAC) will hold a public meeting. In the morning 12/14, the committee will discuss the risk of dengue virus infection in blood donors (Topic I). In the afternoon, the committee will discuss murine leukemia virus(MLV)-related human retroviruses and blood safety (Topic II). On 12/15-Updates on certain other current topics, including T. cruzi Guidance. From the Meeting Materials (2) On Topic I, FDA is seeking advice from BPAC on strategies to mitigate the risk of transmitting Dengue virus through the blood and blood components by donor deferral strategy. FDA is also seeking advice on the potential utility of nucleic acid, antigen, or antibody tests in donor screening as a safeguard against the transmission of DENV by blood transfusion. OnTopic II, based on the current scientific knowledge of MLV-related viruses in humans and their reported disease association, FDA is seeking BPAC's recommendations on 1) indefinite deferral for blood and plasma donors with a diagnosis of CFS or PC, and 2) donor screening for MLV-related virus in absence of confirmed disease causation. FDA is also seeking the advice of the BPAC on the potential suitability of NAT and/or serology testing of blood donations as safeguards against transmission of MLV related viruses by blood transfusion. From the Summary:The science of MLV related viruses in humans is still evolving. While many laboratories have detected MLV-related sequences in prostate cancer samples, others have not. The frequency of positive samples varies widely between laboratories. There is controversy about the detection of MLV-related sequences in CFS with the majority of laboratories failing to detect MLV sequences. ... Potential transmission through blood has not been demonstrated. There is no known causative relationship between MLV infection in humans and disease.(2)
Of related interest: The November 9, 2010 the New York State Council on Human Blood and Transfusion Services meeting discussion is available as a DOH archived webcast .(3) Their discussion focused on certain proposed regulatory amendments(open for comments), as well as a helpful comparison of the differences between limited services labs and permitted labs. The Council enacts and amends regulations ( Blood Banks Subpart 58-2 ,Hematopoietic Progenitor Cell Banks Subpart 58-5) affecting the safety of blood in New York State, subject to approval by the Commissioner. The Council also develops practice guidelines for the use of blood.(3) Info. bits from the Center for Disease Control, NIH and international perspectives below.
(1)http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm235855.htm
(2)http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm235888.htm
(3)http://www.health.state.ny.us/events/webcasts/2010/2010-11-09_human_blood_transfusion_council.htmdelayed archived webcast

-Chagas disease is caused by the protozoan parasite, T. cruzi. The disease is considered endemic in Mexico and Central and South America; rarely, the pathogenic agent has been reported to cause human infection in the U.S. by natural vector transmission.(1)
-10/12 /2010- NIH news reports that researchers discovered a key step in how the dengue virus infects a cell. The discovery one day may lead to new drugs to prevent or treat the infection. Read about it at http://www.nih.gov/news/health/oct2010/nichd-12.htm
- CDC’s new XMRV webpage at http://www.cdc.gov/xmrv/updates.html
-At the 1st International Workshop on XMRV held in September, 2010 several conflicting findings were reported on detection of MLV related viruses in the blood of CFS patients. A very interesting Web cast Q&A wrap-up session of this event touches on the latest XMRV studies and developments in the field in order to evaluate the state of our knowledge, address controversies, and develop an understanding between experts that will help direct future research. View the video at http://videocast.nih.gov/Summary.asp?file=16098
The Blood Products Advisory Committee (BPAC) reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs of its findings.
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/default.htm
FDA/CBER is responsible for regulatory oversight of the U.S. blood supply. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/default.htm-From the AABB- An International Consensus Development Conference (CDC) on Risk-based Decision Making for Blood Safety was held in Toronto, Canada, October 26-28, 2010. The conference was hosted by Canadian Blood Services, and organized by an international consortium of blood organizations consisting of AABB, America’s Blood Centers, American Red Cross, Australian Red Cross Blood Services, Blood Systems, Inc, European Blood Alliance, Héma-Québec and National Health Service Blood & Transplant (UK). The goal of the conference was to design a framework that can guide decision-making for blood safety in various jurisdictions taking into account local laws and social values. In general, the panel found no current process for making risk-based decisions in either healthcare or other fields addressing life and health safety issues served as a complete model in the blood safety area. http://www.aabb.org/events/misc/Pages/icdc.aspx
AABB statement on XMRVTask Force Nov.. 1, 2010-http://www.aabb.org/pressroom/statements/Pages/statement110110.aspxt
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies.

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This page contains a single entry from the blog posted on December 7, 2010 3:38 PM.

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