A SIMPLE SELF-TEST FOR VAGINAL FLORA STATUS

细菌性阴道病(BV)现在被认为是女性生殖健康后遗症的危险因素。它是由复杂的阴道生态失调引起的。正常的阴道菌群通常以需氧乳杆菌为主。BV是由一种主要由兼性和厌氧微生物组成的混合菌群取代正常菌群而产生的。阴道乳杆菌通过产生过氧化氢和其他可以抑制生殖器病原体生长或存活的因素，起到内源性阴道杀菌剂的作用。目前正在评估使用含有活性乳杆菌的阴道栓作为预防生殖道感染的方法。不幸的是，检测与BV相关的菌群变化的推荐方法[Amsel标准(Amsel)和革兰氏染色(Gram)]不适合患者和消费者直接使用。石蕊概念公司(LCI)已经表明，它的常驻技术可以被修改，以区分以正常菌群为主的女性和菌群紊乱的女性。这项技术进步将被整合到一种消费设备中，允许女性确定自己的阴道菌群状况。在完成产品开发后，LCI将生产该产品的三个商业批次；测试未经培训的女性自我采样VF、使用产品并解释测试结果的能力。临床数据将被汇编成提交给FDA的监管文件，以获得上市该设备的许可。建议的商业应用：LCI产品将适合妇女直接使用，作为正常菌群存在的替代品。通过提供客观的、可重复的、直观的快速和轻松的检测，LCI产品可以帮助妇女监测她们的妇科健康。消费者使用的产品可以降低医疗保健成本，提高生活质量，并帮助医生监测患者。

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.