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

描述（由申请人提供）：虽然母乳喂养 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。的关系 病毒载量（VL）和传播之间的关系至关重要， 乳腺VL的定量研究和系统而有力的监测 （i）确定经常传播病毒的妇女人数， (ii)证明降低牛奶中VL和HIV传播的效用， 通过短期抗病毒药物治疗婴儿。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 是成本高昂且用于早期检测新的廉价技术， 诊断和准确监测治疗效果是必要的。生物痕迹 Inc.已经开发了用于HIV-1的多光子检测免疫测定（IA/MPD p24蛋白，其灵敏度比标准测定高1,000倍。同相 I，改进的p24 IA/MPD使得能够用免疫荧光法对H1 V-I进行稳健的定量。 灵敏度与当前基于PCR的检测方法相当，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 相关的、超高灵敏度的、低成本的、定量的基于p24的VL测定， 在发展中国家使用。为了实现这一点，灵敏度为5的IA/MPD fg/ml或50个病毒粒子/ml，将首先针对检测进行优化， 定量分化体C p24并用于测量（a）来自母乳的VL和 来自津巴布韦接受治疗和未接受治疗的非洲妇女的血浆（a HIVNET 023 研究）和赞比亚（待研究）（B）早期检测极低的病毒 血清反应阳性母亲所生婴儿中的拷贝数。平行VL测量 使用Roche测定法，将允许直接测定相同样品的等分试样。 基于RNA的技术和基于p24的技术之间的比较。 该测定还将用于HIV-1进化枝B感染的HIV-1感染者的VL测试。 作为迈向商业上可行的测定的第一步。 拟定商业应用： 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