| 网站首页 | 专家顾问 | 案例分析 | 热点疾病 | 新闻中心 | 信息中心 | 资源下载 | 图说艾滋 | 艾滋文学 | 艾滋论坛 | 
您现在的位置： 检验天空性艾频道 >> 信息中心 >> 艾滋病常识 >> 检测相关知识 >> 文章正文 用户登录 新用户注册
FDA 批准HIV唾液检测快速试剂    热      【字体：小 大】
FDA 批准HIV唾液检测快速试剂
作者：佚名    文章来源：不详    点击数：    更新时间：2005-6-13
FDA 批准HIV唾液检测快速试剂 FDA today approved the use of oral fluid samples with a rapid HIV diagnostic test kit that provides screening results with over 99 percent accuracy in as little as 20 minutes. Until now, all rapid HIV tests required the use of blood in order to get such rapid results. The original version of this rapid test -- the OraQuick Rapid HIV-1/2 Antibody Test, manufactured by OraSure Technologies, Inc., Bethlehem , Pa. -- was approved November 7, 2002 for detection of antibody to HIV-1 in blood. On March 19, 2004 , FDA approved the test for detection of HIV-2 (a variant of HIV that is prevalent in parts of Africa but rarely found in the United States ) in blood. Today's approval represents another significant new use for the test. As when used on blood, this test can quickly and reliably detect antibodies to HIV-1 and can be stored at room temperature and requires no specialized equipment. "Before the approval of this rapid test in November, 2002, many people being tested for HIV in public clinics did not return for the results of standard tests," said HHS Secretary Tommy G. Thompson. "Where the rapid test is available, those tested get their results within minutes. This oral test provides another important option for people who might be afraid of a blood test. It will improve care for these people and improve the public health as well." To perform the test, the person being tested for HIV-1 takes the device, which has an exposed absorbent pad at one end, and places the pad above the teeth and against the outer gum. The person then gently swabs completely around the outer gums, both upper and lower, one time around. The tester then takes the device and inserts it into a vial containing a solution. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional more specific test. The OraQuick test has not been approved to screen blood donors. Although the test is approved to detect antibodies to HIV-1 and –2 when used on blood, today’s approval of the test for use on oral fluid is limited to detection of antibodies to HIV-1. The OraQuick Rapid HIV-1/2 Antibody test for use on blood was categorized as a waived test under CLIA (Clinical Laboratory Improvements Amendments of 1988) in January, 2003. A waived test system can be given in facilities with any CLIA certificate, rather than only in facilities certified for higher complexity tests. As such, a test categorized as a waived test can be used in many more health care settings by many different health providers. All new test systems are categorized as high complexity systems until they are submitted for categorization under CLIA. "I strongly urge the OraSure company to apply for a CLIA waiver for this test using oral fluid samples as well," said Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D. "If the FDA finds that the company’s data proves that the OraQuick test used with oral fluids is both easy and safe to use in the waived lab setting - as it is with used with blood - then more people will likely be tested for HIV infection. In addition, any risk to healthcare workers of performing the test will be greatly reduced since they will not be exposed to blood." The Centers for Disease Control and Prevention (CDC) has estimated that one fourth of the approximately 900,000 HIV-infected people in the U.S. are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services (CMS) have worked with state and other health officials to make the test widely available and to offer technical assistance and training for its use.   


FDA News
FOR IMMEDIATE RELEASE
P04-36
March 26, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA美国食品药物管理署于今天许可了唾液样本在HIV快速诊断检测设备中的使用.这种检测可以在仅仅20分钟内提供精确度高达99%以上的筛查结果.迄今为止,所有的HIV快速检测都要求使用血液检测来取得这样的快速检测结果.这种快速检测的最初样本-- OraQuick HIV1/2抗体快速检测是由伯利恒的OraSure技术产业公司制造.于2000年11月7号许可用于血液中的HIV一型抗体检测.在2004年3月19号美国食品药物管理署许可通过了血液中HIV-2抗体的快速检测.(HIV-2是HIV的一种变体,在非洲部分地区盛行,但在美国很少见)今天的许可代表了这种快速检测又有了一种新的重要的检测方法.当用血液样本检测时,这种快速检测可以迅速准确地检测出HIV-1抗体的存在,并且可以在室温状态下保存而不需要特殊的设备."
"在2002年11月7号许可使用快速检测前,许多在公共医疗机构的HIV检测者都没有回去确认用标准方法检测的结果."美国卫生及公共事务部秘书 Tommy G. Thompson说."在可以进行快速检测的地方,检测者可以在几分钟内得知他们的检测结果.这种口试HIV检测法为那些可能害怕血检的人提供了又一项重要的检测途径.它在提高对检测者的保护的同时也提高了公众健康水平."
在检测时,HIV-1抗体的检测者先取一头有露着的吸收垫的器具,把吸收垫放在牙齿上靠着外牙龈然后再轻轻地用它彻底地拭抹上下的外牙龈,一次就好.然后检测者把吸收垫放到一个装有溶液的小瓶里,在二十分钟内如果检测样本中有HIV-1抗体存在,装在溶液中的装有吸收垫的器具上的小窗口就会显示出两道紫红色的线.尽管像其它的HIV筛查实验一样,为了防护起见,快速筛查实验的结果会给出相应报告,但如果 OraQuick 快速检测结果呈阳性,这个结果必须要经过附加的更精确的特异性更好的检测进行再确认.这种 OraQuick 快速检测实验还未被许可用于对献血者进行筛查.尽管这种检测方法被许可用于检测血液样本中的HIV一型及二型抗体,今天许可的用唾液样本进行检测的方法仅限于对HIV一型抗体的检测.
用于检测血液样本的OraQuick HIV-1/2 抗体快速检测实验在2003年1月己被CLIA(1998年临床实验室改良法案)规类为放弃检测实验.这种放弃检测实验体系在任何一家有CLIA认证的医疗机构都可以进行而不是像以前一样只能在具有高等复杂检测实验认证的机构才可以做.像这样,被规类为放弃的检测实验可以在更多的不同的医疗机构中进行,运用于更多的保健预防环节.(
目前，FDA根据1998年临床实验室改良法案（Clinical Laboratory Improvements Amendments of 1988）将OraQuick归类于“中等复杂程度”的化验检测，根据CLIA条款，1998年后开发出的化验检测被分为中等程度复杂或高度复杂两类，OraQuick检测只能在获得授权的化验室并由有资格证书的医师或技术人员去完成。如果生产商提出CLIA放弃申请，那么FDA批准其使用的条件就会相应放宽。)
所有新的检测体系都被规类为高度复杂体系除非它们在CLIA批准下被申请规类为放弃实验."我强烈建议OraSure公司向CLIA申请也将这种用于检测唾液样本的实验规类为放弃实验."美国食品药物管理署代理专员Lester M. Crawford博士说:"如果美国食品药物管理署确认OraSure公司的数据证明这种用于检测唾液样本的OraQuick 快速实验在放弃实验条件下进行是简易安全的,那么更多的人就可以被检测是否有HIV感染.不仅如此,医务工作者在进行实验的过程中的危险系数也将被大大降低,因为他们不会有血液接触.
疾病预防控制中心估计在美国900,000 的HIV感染者中大约四分之一的感染者对自己己经感染HIV毫不知情.因为快速检测对公众健康有潜在的助益,疾控中心与CMS(医疗保险与医疗补助服务体系)与其他医疗官员致力于推广这种快速实验,并为其运用提供相应的技术支持与专业培训.
文章录入：admin    责任编辑：admin 
  • 上一篇文章：

  • 下一篇文章：
    • 【发表评论】【加入收藏】【告诉好友】【打印此文】【关闭窗口】
    最新热点 最新推荐 相关文章
  • ELISA检测技术

  • 如何早期发现感染艾滋病毒

  • 免疫胶体金技术(Immune coll

  • 重庆高危人群今后可免费检测

  • 有关艾滋病检测方面的问题解

  • HIV抗体确认实验

  • 对网上检测试纸销售一事的声

  • HIV抗体初筛实验

  • 全国艾滋病检测确认实验室通

  • 艾滋病自愿咨询检测的作用是

    		•
    　　网友评论：（只显示最新10条。评论内容只代表网友观点，与本站立场无关！）
    信息产业部非经营性网站ICP证：渝ICP备05002042号
    重庆市公安局网安备案编号： 渝公网备500383015-00006
    版权所有：检验天空性艾频道
    管理维护：邹静波、韩 梅、周全华、龚曼子