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 在人类研究中，精液的生物标志物可以检测避孕套的故障。 这项工作的最终目标是开发一个测试程序， 可以由一个无人监督的研究对象进行， 检测精液的灵敏度和特异性， 避孕套屏障通过避孕套滑动，泄漏或破裂，在 性交这样的测试可以用作研究的终点， 避孕套的功效，并将提供信息，补充和 取代了使用怀孕或疾病作为研究的结果， 成果。 本研究的目的是测量最小可检测量 精液的两种标志物（前列腺酸性磷酸酶抗原和前列腺 特异性抗原），确定该量可与 任何背景水平，以标准化性交后自我采样 协议，并评估一个或两个这些测试的有用性， 避孕套滑动、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.