DIAGNOSTIC SOLUBLE URINE TEST FOR INTERSTITIAL CYSTITIS

描述：（改编自研究者摘要）间质性 膀胱炎（IC）或非细菌性膀胱炎，是一种定义模糊的慢性 炎症性膀胱尿路上皮综合征， 在美国有多达45万名患者，其中90%是女性。 IC的泌尿诊断目前需要侵入性程序，例如 膀胱镜检查或直接膀胱活检，以确定 肾小球或Hunner溃疡。 临床上没有共识 IC病因学模型，这是反映了关键缺乏一个有用的 用于明确诊断和治疗监测的实验室检查 反应 在第一阶段的研究中，建议开发一个有利于 商业服务实验室环境，可再现的半自动化 可溶性尿标本的超灵敏ELISA免疫测定及其评价 它的诊断有效性IC使用尿液样本从一个确定的临床 人口试验基础将涉及抗增殖药物的定量 与可溶性低分子量 尿推定抗增殖因子应用于体外培养 细胞研究人群将包括NIDDK定义的IC患者 标准，以及来自妇科的诊断为非IC的尿液标本 和症状类似IC的泌尿科患者。 检测结果将 进行统计学分析，以获得灵敏度、特异性、阳性 这些定义患者的预测值和阴性预测值 人口。 拟议商业应用：不可用

DESCRIPTION: (Adapted from the investigator's abstract) Interstitial cystitis (IC), or non-bacterial cystitis, is a vaguely defined chronic inflammatory bladder uroepithelial syndrome responsible for a debilitated lifestyle in up to 450,000 patients in the U.S., 90% of which are women. Urologic diagnosis of IC currently requires invasive procedures such as cystoscopy or a direct bladder biopsy for evidence of either glomerulations or Hunner's ulcers. There exists no clinical consensus model for IC etiology, which is reflected by the critical lack of a useful laboratory test for definitive diagnosis and therapeutic monitoring response. In this Phase I study, it is proposed to develop, conducive to a commercial service laboratory environment, a reproducible semi-automated ultrasensitive ELISA immunoassay for soluble urine specimens and evaluate its diagnostic validity for IC using urine samples from a defined clinical population. Assay basis will involve quantitation of antiproliferative factor immunoreactivity associated with a soluble low molecular weight urine putative antiproliferative factor as applied to in vitro-cultured cells. The studied populations will entail IC patients defined by NIDDK criteria, as well as diagnosed non-IC urine specimens from gynecological and urologic patients whose symptoms mimic IC. Assay results will be statistically analyzed to yield sensitivity, specificity, positive predictive values and negative predictive values for these defined patient populations. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE