FDA批准一种新的血液筛查查格斯氏病的方法以保障输血血源的安全性。查格斯氏病是一种严重的、可致命的血源性寄生虫病。新被批准的筛查方法又称为ORTHO T. cruzi ELISA检测系统是一种通过检测锥虫抗体来确定感染的方法。
 
　　“我们的血源是非常安全的，但是同时我们也面临着各种新的、可能出现的威胁”FDA生物评估与研究中心主任Jesse L. Goodman 博士说，“评估一种检测方法需要有多方面的合作，包括FDA的科学家们、血液制品行业以及检测方法研究者。这是我们不断努力识别新的安全隐患，采取相应解决办法，保证供血血源安全工作的一部分。”
查格斯氏病多发于南美洲，如墨西哥等国家。目前感染的人数大约有11,000,000人。查格斯氏病的传染途径一般是通过已感染的昆虫叮咬，或经过输送已感染的血液或脏器移植。人体受到感染后，起初常常无任何明显症状。长时间的感染可导致器官的损伤，如心脏或食管。每年全世界约有50,000 人死于查格斯氏病。

　　来源：http://www.fda.gov/bbs/topics/NEWS/2006/NEW01524.html

　　FDA Approves First Test to Screen Blood Donors for Chagas Disease
　　The U.S. Food and Drug Administration (FDA) today approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a serious and potentially fatal parasitic infection. The test, called the ORTHO T. cruzi ELISA Test System, detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite and is the first such test approved by FDA.
　　“Our blood supply is now extremely safe from diseases once frequently transmitted by blood, such as HIV. However, we are constantly faced with new threats,” said Jesse L. Goodman, MD, MPH, Director of CBER. “Evaluating this test involved a high degree of interaction between FDA scientists, the blood industry and test developers. It is part of an ongoing effort to, wherever possible, identify emerging threats and provide the tools needed to help keep blood safe.”
　　It is estimated that as many as 11 million people are currently infected by T. cruzi, most commonly in parts of Mexico, Central and South America. Most have no symptoms or signs of the disease. The infection is usually acquired from the bite of an infected insect but also can be transmitted through blood transfusions or organ transplants. Early infection is usually mild and unrecognized, but persists lifelong and may lead to organ damage, particularly of the heart and esophagus, causing an estimated 50,000 deaths annually worldwide. Infection also can be severe in people whose immune systems are suppressed, such as organ transplant recipients. Concerns about the potential for transfusion and organ transmitted Chagas disease in the United States have heightened due to the increase in the number of U.S. residents who previously lived in countries where the infection is common. This new test identifies infected donors and therefore can reduce the risk of disease transmission through blood transfusion or organ transplantation.
　　“The availability of this test offers an important new safety measure to protect recipients of blood, organs and tissues against a potentially very serious, though uncommon infection,” said Jay Epstein, MD, Director of the Office of Blood Research and Review in FDA’s Center for Biologics Evaluation and Research (CBER).
　　In studies reviewed by FDA, the test was found to be accurate 99% or more of the time-detecting 198 out of 199 blood specimens from individuals believed to be infected. In field trials of over 70,000 donor samples, the number of individuals falsely identified as positive was extremely small, only 2-3 per 100,000 test results.
In addition to screening people who donate whole blood, this test is intended for use in screening plasma and serum samples from organ, cell and tissue donors. At this time, the test is not approved to diagnose the disease.

　　　　　　　　　　　　　　　　　　　　　　　摘自《37度医学》