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【社会人文】FDA批准了一种新型的AIDS检测方法
The U.S. Food and Drug Administration (FDA) has approved the APTIMA HIV-1 RNA Qualitative Assay, manufactured by Gen-Probe Incorporated (San Diego, Calif.). The APTIMA assay, which detects the RNA--the nucleic acid or genetic material--of the HIV-1 virus, is the first test approved for the detection of HIV-1 RNA to help diagnose HIV-1 infection. HIV-1 is the main virus that causes AIDS.
"This product offers medical diagnostic laboratories the ability to perform a gene-based test for HIV-1 that, until now, was only available as part of a larger kit used to screen blood and plasma donors," said Jay Epstein, M.D., director, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA. "This test also can detect infection with HIV-1 earlier than HIV antibody tests when used to detect primary HIV-1 infection."
This test has important implications for medical diagnostic use because it could be a potential alternative to the traditional Western blot test now used for confirmation of HIV-1 infection when screening tests for HIV-1 antibodies are positive. In addition, the Western blot can, in some instances, be difficult to interpret and may not always provide a conclusive result. In such cases, the APTIMA test may be helpful in HIV-1 diagnosis. The APTIMA test can also be used in clinical laboratories and public health facilities to detect early HIV-1 infection, before the appearance of antibodies to HIV-1.
The sensitivity of the APTIMA assay is comparable to that of FDA approved viral load assays that measure the amount of HIV-1 virus circulating in the blood of patients with established HIV-1 infection to monitor the treatment and progression of AIDS. Unlike the viral load tests, the APTIMA test has been approved for the diagnosis of primary HIV-1 infection, as well as for confirming HIV-1 infection when tests for antibodies to HIV-1 are positive.
CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products. CBER also regulates AIDS-related diagnostic tests.
#### FDA Approves Test to Help Diagnose Main Virus that Causes AIDS
FDA批准了一种帮助检测导致AIDS主要病毒的方法
The U.S. Food and Drug Administration (FDA) has approved the APTIMA HIV-1 RNA Qualitative Assay, manufactured by Gen-Probe Incorporated (San Diego, Calif.). The APTIMA assay, which detects the RNA--the nucleic acid or genetic material--of the HIV-1 virus, is the first test approved for the detection of HIV-1 RNA to help diagnose HIV-1 infection. HIV-1 is the main virus that causes AIDS.
美国FDA已经批准了一种由Gen-Probe公司制造的APTIMA HIV-1 RNA定性分析方法。APTIMA 分析能够通过检测HIV－1的RNA帮助诊断HIV－1感染，是首个通过批准的检测方法。HIV－1是导致AIDS的主要病毒。
"This product offers medical diagnostic laboratories the ability to perform a gene-based test for HIV-1 that, until now, was only available as part of a larger kit used to screen blood and plasma donors," said Jay Epstein, M.D., director, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA. "This test also can detect infection with HIV-1 earlier than HIV antibody tests when used to detect primary HIV-1 infection."
这个产品使医学诊断实验室能够对HIV－1进行基因库检测，是目前唯一可用来筛选血液和血浆供体的大型试剂盒组成部分。医学博士，FDA血液研究与观察办公室，生物制品评估与研究中心（CBER）主任，Jay Epatein说道。这个方法同样能够在检测初始HIV－1感染时比HIV抗体检测更早发现。
This test has important implications for medical diagnostic use because it could be a potential alternative to the traditional Western blot test now used for confirmation of HIV-1 infection when screening tests for HIV-1 antibodies are positive. In addition, the Western blot can, in some instances, be difficult to interpret and may not always provide a conclusive result. In such cases, the APTIMA test may be helpful in HIV-1 diagnosis. The APTIMA test can also be used in clinical laboratories and public health facilities to detect early HIV-1 infection, before the 。appearance of antibodies to HIV-1.
这个方法对于医学诊断非常有用。因为当筛选HIV－1抗体实验为阳性时，它可以作为传统Western blot检测的潜在替代方法来确认HIV－1感染。此外，Western blot检测在某些时候很难解释并且不能够提供明确结论。在这种情况下，APTIMA检测对HIV－1诊断变得十分有用。APTIMA检测也可用于在HIV－1抗体出现前临床实验室和公共卫生机构检测早期HIV－1感染。
The sensitivity of the APTIMA assay is comparable to that of FDA approved viral load assays that measure the amount of HIV-1 virus circulating in the blood of patients with established HIV-1 infection to monitor the treatment and progression of AIDS. Unlike the viral load tests, the APTIMA test has been approved for the diagnosis of primary HIV-1 infection, as well as for confirming HIV-1 infection when tests for antibodies to HIV-1 are positive.
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作者:admin@医学,生命科学 2010-12-02 17:11
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