A SIMPLE SELF-TEST FOR VAGINAL FLORA STATUS

阴道菌群状态的简单自测

• 批准号: 6344475
• 负责人: PAUL J LAWRENCE
• 金额: $ 38.98万
• 依托单位: LITMUS CONCEPTS, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-01 至 2002-05-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6344475
• 关键词: acidity /alkalinity; bacteria; biomedical equipment development; cervical /vaginal smear; diagnosis design /evaluation; diagnostic tests; female; female reproductive system disorder diagnosis; vagina; vaginitis

Bacterial vaginosis (BV) is now recognized as a risk factor for adverse reproductive health sequelae in women. It results from a complex disturbance of the vaginal ecology. Normal vaginal flora (FLORA) is usually characterized by a predominance of aerobic lactobacilli. BV results from the replacement of the normal FLORA with a mixed FLORA consisting primarily of facultative and anaerobic organisms. Vaginal lactobacilli act as endogenous vaginal microbicides by producing H2O2 and other factors that can inhibit growth or survival of genital pathogens. The use of a vaginal suppository containing viable lactobacilli is now being evaluated as a prophylaxis against genital tract infection. Unfortunately, the recommended methods for detecting FLORA changes associated with BV [the Amsel criteria (AMSEL) and Gram stain (GRAM)] are unsuitable for direct use by patients and consumers. Litmus Concepts, Inc. (LCI) has shown that its resident technology can be modified to distinguish women with a predominance of normal FLORA from women with a disturbed FLORA. This technology advance will be incorporated into a consumer device to permit women to determine their own vaginal flora status. After completing product development, LCI will manufacture three commercial lots of the product; test the ability of untrained women to self-sample VF, use the product, and interpret test results. Clinical data will be compiled into a regulatory submission to the FDA to obtain clearance to market the device. PROPOSED COMMERCIAL APPLICATION: The LCI product will be suitable for direct use by women as a surrogate for the presence of normal FLORA. By providing an objective, reproducible, visual determination quickly and easily, the LCI product can assist women to monitor their gynecological health. A consumer use product can reduce health care costs, improve quality of life and assist physicians in monitoring patients.

细菌性阴道病（BV）现已被认为是女性生殖健康不良后遗症的危险因素。它是阴道生态系统复杂紊乱的结果。正常阴道菌群（FLORA）通常以需氧乳杆菌占优势为特征。 BV 是由主要由兼性和厌氧生物组成的混合菌群取代正常菌群的结果。阴道乳酸杆菌通过产生 H2O2 和其他可抑制生殖器病原体生长或存活的因子，充当内源性阴道杀菌剂。目前正在评估使用含有活乳酸杆菌的阴道栓剂作为预防生殖道感染的方法。不幸的是，推荐的检测与 BV 相关的 FLORA 变化的方法 [Amsel 标准 (AMSEL) 和革兰氏染色 (GRAM)] 不适合患者和消费者直接使用。 Litmus Concepts, Inc. (LCI) 表明，可以对其驻留技术进行修改，以区分菌群正常的女性和菌群紊乱的女性。这项技术进步将被纳入消费设备中，以允许女性确定自己的阴道菌群状态。完成产品开发后，LCI 将生产三个商业批次的产品；测试未经培训的女性自我采样 VF、使用产品和解释测试结果的能力。临床数据将被整理成向 FDA 提交的监管报告，以获得该设备的上市许可。拟议的商业应用：LCI 产品适合女性直接使用，作为正常 FLORA 的替代品。 LCI 产品通过快速、轻松地提供客观、可重复的视觉测定，可以帮助女性监测其妇科健康状况。消费者使用的产品可以降低医疗保健成本，提高生活质量并协助医生监测患者。