艾滋病唾液检测试剂面世 已在北京一些疾控中心及医院试用
2011年05月05日09:37 来源:健康报网 叶龙杰
将采集器海绵端置于舌下5分钟,待海绵软化后,将海绵在牙龈外周来回擦拭1分钟~2分钟,然后将采集液体收集于样品管中进行试剂检测,整个过程耗时30 分钟左右,就可获得艾滋病病毒感染初筛结果。5月4日,我国自主研发的艾滋病唾液检测试剂宣布面世,并已通过国家食品药品监督管理局注册审批,获准上市。
据研发该技术的企业负责人邱子欣介绍,该企业委托中国疾控中心、军事医学科学院等单位对1200多名艾滋病高危者进行临床试验,考核报告结果为:该试剂与参考试剂的阳性符合率为99.1%,阴性符合率为99.8%,总符合率达到99.6%,检测性能高度一致。
根据中国疾控中心2009年发布修订后的《全国艾滋病检测技术规范》,艾滋病病毒抗体筛查可采用血清、血浆、滤纸干血斑、唾液和尿液样品。然而,目前国内检测机构一般都采集检测者静脉血液作为检测标本,存在采集不便、易发生职业暴露等问题。相对于采集唾液,采集血液标本易受医疗条件限制,难以在边远地区及大规模人群中普及。
邱子欣介绍,该唾液检测技术采用免疫渗滤法,定性检测唾液中的艾滋病病毒抗体,可用于辅助诊断。美国已批准艾滋病唾液检测试剂进入药店,高危人群及“恐艾症”患者可自行购买,按照说明书进行初筛检测。他表示,希望在两年内能实现进驻药店的目标,使更多潜伏期的感染者及患者及早发现病情,接受治疗,避免传播风险。
目前,该唾液检测试剂已在北京市的一些疾控中心及医院试用。
艾滋病不治会早死,早治才康复 艾滋病不治会早死,早治才康复 艾滋病不治会早死,早治才康复 艾滋病不治会早死,早治才康复
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图示∶2010年12月即将出版的《中国特色医疗金鉴》登载的刘君主任及其机构 |
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HIV saliva test kit has been around for some of the CDC and the Hospital in Beijing, the trial
At 09:37 on May 5, 2011 Source: Health News Network Ye Longjie
Sponge end of the collector under the tongue for 5 minutes until softened sponge, the sponge back and forth in the peripheral gums clean one minute to 2 minutes, and then will collect samples of liquid collected in test tubes for reagents, the whole process takes about 30 minutes , you can get HIV screening results. May 4, China's own R & D announced the launch HIV saliva test kit, and has passed the State Food and Drug Administration for regulatory approval, be allowed to market.
According to research and development of the technology business executives Qiuzi Xin introduced, the company commissioned by the Chinese Center for Disease Control, Military Academy of Medical Sciences and other units of more than 1,200 high risk of AIDS clinical trials, assessment report the results as follows: the reagent and reference reagent, the positive coincidence rate 99.1%, negative coincidence rate was 99.8%, 99.6% overall compliance rate of detection performance is highly consistent.
According to the Chinese CDC in 2009 issued revised "National HIV Testing technical specifications", can be used HIV antibody screening of serum, plasma and filter paper dried blood spots, saliva and urine samples. However, the current domestic testing organizations are generally detected by collecting venous blood samples for testing, there are collection inconvenience, high incidence of occupational exposure and other issues. Relative to the collection of saliva, blood samples were collected vulnerable to medical conditions, it is difficult in remote areas and large-scale popularization of the crowd.
Qiu Zixin introduced by the salivary immune infiltration detection method, qualitative detection of HIV antibodies in saliva can be used to aid diagnosis. AIDS in the United States has approved the test kit saliva into the pharmacy, high-risk groups and the "fear of AIDS disease" patients can self-purchase, in accordance with the instructions for screening test. He expressed the hope that within two years to achieve the goal stationed in pharmacies, so that more patients with latent period of infection and early detection of disease, treatment to prevent transmission of risk.
Currently, the saliva test kit has been in Beijing some of the CDC and hospital trial.
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