IMMUNODETECTION OF WOMEN AT RISK FOR PRETERM DELIVERY

对有早产风险的妇女进行免疫检测

• 批准号: 3499915
• 负责人: DAVID C CASAL
• 金额: $ 2.58万
• 依托单位: ADEZA BIOMEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1992-12-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3499915
• 关键词: carcinoembryonal antigen; diagnosis design /evaluation; disease /disorder proneness /risk; embryo /fetus antigen; fibronectins; gene expression; genital secretion; human pregnant subject; human subject; immunologic assay /test; monoclonal antibody; mucus; plasma; pregnancy tests; premature labor

DESCRIPTION (Adapted from the applicant's abstract): It is the intent of the investigators to develop a new diagnostic test for use during pregnancy to identify women at elevated risk for preterm delivery (PTD). An immunoassay using a monoclonal antibody directed against oncofetal fibronectin (fFN), a pregnancy-related protein of placental origin found in the amniotic fluid, has been standardized for this purpose. Preliminary studies have shown that greater than 50 ng/ml of fFN was present in the cervicovaginal secretions of 81 percent of women at 23 to 36 weeks of gestation who sought medical attention for suspected rupture of membranes of PTD, in contrast to only 20 percent (p less than 0.001) of 267 women with uncomplicated term pregnancies. This difference could not be explained by differences in gestational age at sampling, cervical dilation or presence of blood in the secretions. The primary objective of Phase I will be to characterize the relationship between cervicovaginal fFN expression and incidence of PTD in a longitudinal study of 100 high risk pregnancies.In Phase I, the investigators will design a prospective clinical trial to thoroughly evaluate the diagnostic efficacy of an anti- fFN assay for commercial application.

描述（改编自申请人的摘要）：这是