RAPID AND SENSITIVE IDENTIFICATION OF HIV ANTIGEN AT THE POINT OF USE

描述（由申请人提供）：HIV抗体检测在缩小HIV诊断窗口期方面取得了显著的成功。然而，设计用于单独检测抗体的免疫测定法将无法识别尚未开始产生hiv特异性抗体的急性感染个体。检测急性感染个体的尝试大多涉及RNA检测算法，用于汇集的HIV抗体阴性标本。然而，使用基于rna的检测方法是昂贵的，费力的，并且在操作上令人生畏。使用基于rna的方法检测急性艾滋病毒感染的另一种方法是利用抗原-抗体组合试验，也称为“第四代”免疫测定法。第四代免疫测定法最近已被FDA批准在美国使用。这些第四代检测方法存在诸多缺点：a) p24抗原的检出限仍然不低（~ 15 pg/mL）； b)在大型、昂贵、笨重且耗时的临床化学分析仪上进行检测。化验结果不能立即提供给患者。本提案的具体目标是开发一种可靠、准确、具有成本效益的即时（POC）超灵敏的HIV p24抗原定量检测方法，检测限在亚pg/mL范围内。该检测可显著减少检测HIV的血清学窗口期，及时向患者提供检测结果。

DESCRIPTION (provided by applicant): The success of HIV antibody tests in narrowing the window period of HIV diagnosis has been notable. However, immunoassays designed to detect antibody alone will not be able to identify individuals with acute infection who have not yet begun to produce HIV-specific antibodies. Attempts to detect acutely infected individuals have mostly involved RNA detection algorithms used on pooled HIV antibody-negative specimens. However, the use of RNA-based detection methods is expensive, laborious, and can be operationally daunting. An alternative to the detection of acute HIV infections using RNA-based methods is to utilize antigen-antibody combination tests, also known as "fourth-generation" immunoassays. Fourth-generation immunoassays have recently been cleared by FDA for use in the US. These fourth generation assays have multiple shortcomings: a) the detection limits for p24 antigen is still not low (~ 15 pg/mL) and b) the assays are run on large, expensive, cumbersome and time-consuming clinical chemistry analyzers. The assay results are not immediately available to the patient. The specific aim of this proposal is to, develop a reliable, accurate, cost-effective Point-of-care (POC) ultra-sensitive quantification of HIV p24 antigen with detection limits in range of sub pg/mL. This test could significantly reduce the serological window for detection of HIV and provide results to the patient in a timely manner.