NON-INVASIVE IMMUNODETECTION OF ECTOPIC PREGNANCY

宫外孕的无创免疫检测

• 批准号: 3499795
• 负责人: DAVID C CASAL
• 金额: $ 5万
• 依托单位: ADEZA BIOMEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-09-05 至 1991-03-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3499795
• 关键词: cervix; chorionic gonadotropin; diagnosis design /evaluation; early diagnosis; ectopic pregnancy; embryo implantation; enzyme linked immunosorbent assay; human subject; immunochemistry; monoclonal antibody; mucus; noninvasive diagnosis; pregnancy tests; progesterone; proteins; ultrasonography

We propose to develop a new diagnostic test to substantially improve the definitive diagnosis of ectopic pregnancy (EP) . This new test would complement serial quantitative beta-hcg and ultrasound testing, currently used for diagnosing EP, and provide earlier and more accurate diagnosis of this potentially fatal condition. The new test is based on a recently discovered marker, a unique pregnancy-related protein (PRP) secreted by the proliferative trophoblast during the early stages of pregnancy. PRP can be immunologically detected by monoclonal antibody, known as A137, developed at Aspen Diagnostics. PRP is present in he cervical mucous of pregnant women with intrauterine implantation but appears to be absent in women with extrauterine implantation. The ability to predict the location of a regnancy could provide earlier, non-invasive diagnosis of EP, bypassing costly ultrasound r invasive diagnostic laparoscopy. Furthermore, rapid and accurate diagnosis and treatment could lower the rate of tubal rupture thereby lowering morbidity and mortality associated with EP. Early diagnosis and treatment of EP may also improve future fertility of the affected patient.

我们建议开发一种新的诊断测试，以大大改善 明确诊断异位妊娠（EP）。这项新的测试将 补充系列定量β-hcg和超声检测，目前 用于诊断EP，并提供早期和更准确的诊断， 这种潜在的致命疾病新的测试是基于最近的一项 发现的标志物，一种独特的妊娠相关蛋白（PRP）分泌的 滋养层细胞在怀孕早期增生。PRP可以被 通过单克隆抗体（称为A137）进行免疫检测， 在白杨诊断公司PRP存在于妊娠妇女的宫颈粘膜中， 子宫内植入的妇女，但似乎没有在妇女 宫外植入能够预测一个 电生理检查可提供早期、非侵入性的EP诊断， 昂贵的超声或侵入性诊断腹腔镜检查。此外，快速和 正确的诊断和治疗可降低输卵管破裂的发生率 从而降低与EP相关的发病率和死亡率。早期 EP的诊断和治疗也可能改善未来的生育能力， 受影响的病人