HIV-1 p24 based viral load assay in breast milk & serum

描述(申请人提供)：虽然母乳喂养由 众所周知，感染艾滋病毒的妇女会增加母婴传播的风险， 母乳喂养的文化不太可能很快改变。两国关系 病毒载量(VL)和传播之间的关系至关重要，需要谨慎 乳房VL的定量研究和系统而有力的监测 妇女的乳汁(一)以确定经常排出病毒和 (Ii)证明将牛奶中的VL和艾滋病毒传播降低到 婴儿服用短程抗病毒药物。目前，常规监测 发展中国家感染艾滋病毒的母乳喂养妇女及其婴儿的情况 成本高得令人望而却步，而且是早期检测的廉价新技术， 诊断和准确监测治疗效果是必要的。BIOTRACES 北京，北京：L P24蛋白，其灵敏度是标准检测的1000倍。同相 I，改进的p24 IA/MPD使甲型H1V-L能够用 与目前基于聚合酶链式反应的检测方法相当的灵敏度，即灵敏度 相当于每毫升10个病毒粒子。第二阶段的目标是开发一种临床上的 相关、超高灵敏度、低成本、基于p24的VL定量检测 在发展中国家使用。为了实现这一点，灵敏度为5的IA/MPD 每毫升FG或每毫升50个病毒粒子，将首先优化用于检测和 用于母乳和母乳中(A)VL测定的Clade C p24的定量 津巴布韦经治疗和未治疗的非洲妇女的血浆(HIVNET 023 研究)和赞比亚(待研究)(B)早期检测极低病毒 血清阳性母亲所生婴儿的复制体。并行VL测量打开 相同样本的等量，使用罗氏分析，将允许直接 比较基于RNA的技术和更便宜的基于p24的技术。 本试验还将用于L B支感染者的VL检测 作为迈向商业可行检测的第一步。 建议的商业应用： 不可用

DESCRIPTION (Provided by the applicant): Although breast feeding by HIV-infected women is known to increase the risk of mother-child transmission, the culture of breast feeding is not likely to change soon. The relationship between viral load (VL) and transmission is critical and requires careful quantitative studies and systematic and vigorous monitoring of VL in breast milk of women (i) to identify the number of women who constantly shed virus and (ii) to prove the utility of reducing the VL in milk and HIV transmission to babies by a short course of anti-viral drugs. Currently, the routine monitoring of HIV-infected breast feeding women and their infants in developing countries is cost prohibitive and new inexpensive technology for early detection, diagnosis and accurate monitoring of treatment efficacy is necessary. BIOTRACES Inc. has developed a Multiple Photon Detection immunoassay (IA/MPD) for HIV-l p24 protein which is 1,000-fold more sensitive than standard assays. In Phase I, an improved p24 IA/MPD enabled robust quantitation of H1V-l with a sensitivity comparable to current PCR based assays, i.e. sensitivities equivalent to 10 virions per ml. The aim of Phase II is to develop a clinically relevant, ultra high sensitivity, low cost, quantitative p24-based VL assay for use in developing countries. To achieve this, an IA/MPD with a sensitivity of 5 fg per ml or 50 virion per ml, will first be optimized for the detection and quantitation of Clade C p24 and used for measuring (a) VL from breast milk and plasma from treated and untreated African women in Zimbabwe (a HIVNET 023 Study) and Zambia (pending study) (b) for the early detection of very low viral copies in infants born to seropositive mothers. Parallel VL measurements on aliquots of the same samples, using the Roche assay, will allow a direct comparison between the RNA-based and the less expensive p24 -based technology. This assay will also be used for VL testing of HIV-l Clade B-infected individuals as a first step towards a commercially viable assay. PROPOSED COMMERCIAL APPLICATION: Not Available