STUDY OF BIOLOGIC MARKERS OF SEMEN IN VAGINAL FLUIDS

这项采购将产生一项研究，以评估使用 人类研究中检测避孕套故障的精液生物标记物。 这项工作的最终目标是开发一种测试程序， 可以由无监督的研究对象进行，并且具有较高的 检测破损精液的敏感性和特异性 避孕套在使用过程中因避孕套滑脱、泄漏或破损而形成的屏障 性交。这样的测试可以作为研究的终点 避孕套的功效，并将提供信息，既补充和 取代了使用怀孕或疾病作为研究对象的研究结果 结果。 这项研究的目标是测量最小可检测到的量 精液的两种标志物(前列腺酸性磷酸酶抗原和前列腺癌 特定抗原)，确定这一数量可以与 任何背景水平，以标准化性交后自我采样 协议，并评估其中一项或两项测试的有用性作为 避孕套滑脱、泄漏或破损的证据。

This procurement will produce a study to assess the feasibility of using biologic markers of semen to detect condom malfunction in human studies. The ultimate goal of this effort is to develop a testing procedure that can be undertaken by an unsupervised study subject and which has high sensitivity and specificity for detecting semen that has breached the condom barrier through condom slippage, leakage, or breakage during intercourse. Such a test could be utilized as an endpoint in a study of condom efficacy and would provide information that both complements and supersedes that found from studies using pregnancy or diseases as outcomes. The objectives of this study are to measure the least detectable amount of two markers for semen (prostatic acid phosphatase antigen and prostate specific antigen), determine that this amount can be differentiated from any background level, to standardize a post-coital self-sampling protocol, and to assess the usefulness of one or both of these tests as evidence of condom slippage, leakage, or breakage.