北海市研制出新型艾滋病毒检测试剂

北海市研制出新型艾滋病毒检测试剂
 
http://www.gxnews.com.cn    2008年11月20日13时57分   来源:北海市政府门户网站  
 
一种简便、快捷的检测手段使艾滋病检测易如反掌——从手指上采一滴血,涂在试纸上,3—5分钟即可得出艾滋病毒检测结果。近日,这种由我市一公司研制出的这种艾滋病毒检测试剂已获得国家《医疗器械注册证》、《医疗器械生产许可证》和医疗器械生产质量体系认证通过,市民们年底在市场就可见到这种产品。

据悉,这种新型试剂的名称是“人类免疫缺陷病毒抗体检测试剂盒(胶体金法)”,采用曾经任教于美国哈佛大学医学院的留美博士长期的科研成果。这种检测方法不仅可以直接采用全血为检测的样本,而且具有检测时间短,检测灵敏度高的特点。这种新型检测试剂已经分别经过广东、广西两省区的疾病预防控制中心艾滋病确认实验室和和深圳市出入境检验检痊局艾滋病确认实验室的临床检测,623例艾滋病抗体阳性样本全部检出,灵敏度100%;922例阴性样本特异性为97.1%。这种处于国内领先水平的试剂是国内目前唯一一个完全以多肽为抗原来检测人类免疫缺陷病毒抗体的体外诊断试剂,我市的研究生产企业年生产能力可满足1200万人次检测需要。

记者从市卫生部门了解到,当前,艾滋病正以迅猛的势头在我国蔓延。国家最新结果显示,中国艾滋病毒总感染人数已超过100万人,并以每年30%的速度增长,而目前国内检测试剂大部分从国外进口。国家大力扶持国内企业开发检测试剂,艾滋病检测试剂的市场前景非常乐观。
 
 
编辑: 黄伟 作者: 来莅

Beihai developed a new type of HIV testing reagent
 
http://www.gxnews.com.cn 2008 on 11 years on 20 when 13 hours 57 Source: Beihai city government portal
 
A simple and efficient means of detection so easy detection of AIDS - a drop of blood taken on his fingers, painted in the paper, 3-on 5 minutes to arrive at the results of HIV testing. In recent days, this city by a company that developed the HIV testing reagent has been "Medical Device Registration" and "permit the production of medical equipment" and medical equipment production quality certification system adopted by the members of the public are in the market by the end of the Can see the product.

It is reported that this new reagent is the name of "human immunodeficiency virus antibody detection kit (colloidal gold)," has been used to teach at Harvard University School of Medicine, Dr. U.S. long-term scientific research. This detection method can be used not only for the detection of whole blood samples, and have detected a short time, high sensitivity detection. The new reagent has been detected, respectively, after Guangdong and Guangxi provinces of the District AIDS Center for Disease Control and Prevention confirmed that laboratory and the Shenzhen Entry-Exit Inspection and recover from illness Inspection Bureau confirmed AIDS clinical laboratory testing, 623 cases of HIV-positive samples detected in all , 100% sensitivity; 922 cases of negative samples for the specificity of 97.1%. This is the domestic leader in the reagent is the only one entirely for the peptide antigen to detect HIV antibodies in vitro diagnostic reagents, the city's study of manufacturing enterprises with an annual production capacity to meet the needs of detection of 12,000,000 passengers.

Reporters from the city health department learned that at present, AIDS is rapidly spreading in our momentum. The latest national results show that Chinese HIV total number of infections has more than 1,000,000 people and an annual growth rate of 30%, and most of the current detection reagent to be imported. Strongly support the development of domestic enterprises detection reagent, AIDS testing reagents are very optimistic about the prospects for the market.
 

Editor: Michael Author: Li to


 
 

个人简介
协和专家门诊部艾滋病治疗中心主任、教授、专家,中医药疑难病专治网站长等。论文《艾滋病中医论治探析》登载《中国性病艾滋病》2003版杂志,发明的艾滋病治疗新药康生丹自2002年临床应用至今疗效显著,现有中国唯一艾滋病新药3代…
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