A SIMPLE SELF-TEST FOR VAGINAL FLORA STATUS

细菌性阴道病（BV）现在被认为是妇女不良生殖健康后遗症的危险因素。它是由阴道生态的复杂紊乱引起的。正常阴道植物群（FLORA）的特征通常是需氧乳酸杆菌占优势。BV是由主要由兼性和厌氧微生物组成的混合菌群取代正常植物群群引起的。阴道乳酸杆菌通过产生H2 O2和其他可以抑制生殖器病原体生长或存活的因子而充当内源性阴道杀微生物剂。目前正在评估使用含有活乳酸杆菌的阴道栓剂预防生殖道感染。不幸的是，用于检测与BV相关的植物群变化的推荐方法[Amsel标准（AMSEL）和革兰氏染色（Gram stain）]不适合患者和消费者直接使用。Litmus Concepts，Inc. (LCI)已经表明其固有技术可以被修改以区分具有正常植物群优势的女性和具有紊乱的植物群的女性。这一技术进步将被纳入消费者设备，以允许妇女确定自己的阴道植物群状态。在完成产品开发后，LCI将生产三批商业产品;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。临床数据将被汇编到向FDA提交的监管申报中，以获得器械上市许可。拟议的商业应用：LCI产品将适合女性直接使用，作为正常植物群存在的替代品。通过提供一个客观的，可重复的，直观的测定，快速和容易，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，并协助医生监测患者。

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.