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[试剂信息] FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV...

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发表于 2013-8-12 20:56 | 显示全部楼层 |阅读模式

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The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional health care settings. The test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors.

Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test, can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.

"This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "Earlier diagnosis may also help to reduce additional HIV transmission."   

HIV infection can result in the development of Acquired Immune Deficiency Syndrome, or AIDS. HIV damages the body's defense mechanisms by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified, HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention estimates that each year approximately 50,000 people are infected with HIV in the United States. Of the more than 1 million people living with HIV in the United States, approximately 20 percent of those people have not been diagnosed.

The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics, Ltd. (an Alere, Inc. company) of Yavne, Israel.


Read more: FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies - FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/fda-approves-first-rapid-diagnostic-test-detect-both-hiv-1-antigen-and-hiv#ixzz2bl7lv7dE
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 楼主| 发表于 2013-8-30 14:01 | 显示全部楼层
8月8日,首个可同时检测HIV-1 p24抗原以及HIV-1和HIV-2抗体的快速诊断试验通过了美国食品药品管理局(FDA)的核准。
与其他HIV检测方法相同,Alere Determine HIV-1/2 Ag/Ab联合检测可检出人体静脉和指尖血样品的血清、血浆中的HIV-1(最常见的HIV类型)和HIV-2抗体。不同的是,新的检测方法可区分急性HIV-1感染和既有的HIV-1感染。如血液样品为HIV-1 p24抗原阳性,而HIV-1和 HIV-2抗体阴性,则为急性HIV-1感染。
Karen Midthun博士
对于识别在传统医疗机构中可能无法检出的HIV感染个体,这种新的检测方法可作为一种重要工具,FDA生物学评估与研究中心主管Karen Midthun博士在声明中指出:“这种检测方法有助于在更大范围内更早诊断HIV感染,使感染患者可更快寻求医疗服务。”
Orgenics公司是Alere Determine HIV-1/2 Ag/Ab联合检测方法的制造商。
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