验证一种用于阴道插入的羟乙基纤维素填充杀微生物剂给药器的染料染色检测方法。
Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators.
机构信息
Population Council, New York, NY, USA.
出版信息
Sex Transm Dis. 2011 Nov;38(11):1050-5. doi: 10.1097/OLQ.0b013e31822e6160.
BACKGROUND
The reliability and validity of self-reports of vaginal microbicide use are questionable given the explicit understanding that participants are expected to comply with study protocols. Our objective was to optimize the use of Population Council's previously validated dye stain assay (DSA) and related procedures, and to establish predictive values for the DSAs ability to identify vaginally inserted single-use, low-density polyethylene microbicide applicators filled with hydroxyethylcellulose gel.
METHODS
Applicators, inserted by 252 female sex workers enrolled in a microbicide feasibility study in Southern India, served as positive controls for optimization and validation experiments. Before validation, optimal dye concentration and staining time were ascertained. Three validation experiments were conducted to determine sensitivity, specificity, and negative and positive predictive values.
RESULTS
The dye concentration of 0.05% (wt/vol) FD&C Blue No. 1 Granular Food Dye (Prime Ingredients, Inc, Saddlebrook, NJ) and staining time of 5 seconds were determined to be optimal and were used for the 3 validation experiments. There were a total of 1848 possible applicator readings across validation experiments; 1703 (92.2%) applicator readings were correct. On average, the DSA performed with 90.6% sensitivity, 93.9% specificity, and had a negative predictive value of 93.8% and a positive predictive value of 91.0%. No statistically significant differences between experiments were noted.
CONCLUSIONS
The DSA was optimized and successfully validated for use with single use, low-density polyethylene applicators filled with hydroxyethylcellulose gel. We recommend including the DSA in future microbicide trials involving vaginal gels so as to identify participants who have low adherence to dosing regimens. In doing so, we can develop strategies to improve adherence as well as investigate the association between product use and efficacy.
背景
鉴于参与者需要遵守研究方案，因此对他们自行报告阴道杀微生物剂使用情况的可靠性和有效性存在疑问。我们的目的是优化人口理事会先前经过验证的染色试验（Dye Stain Assay，DSA）及其相关程序的使用，并确定 DSA 识别单次使用、低密度聚乙烯杀微生物剂给药器（填充羟乙基纤维素凝胶）的能力的预测值。
方法
将 252 名在印度南部参加杀微生物剂可行性研究的性工作者插入的给药器作为优化和验证实验的阳性对照。在验证之前，确定了最佳的染料浓度和染色时间。进行了 3 项验证实验，以确定灵敏度、特异性、阴性和阳性预测值。
结果
确定了 0.05%（重量/体积）FD&C 蓝色 1 号颗粒食用染料（Prime Ingredients，Inc.，Saddlebrook，NJ）的染料浓度和 5 秒的染色时间为最佳，并用于 3 项验证实验。在验证实验中共有 1848 个可能的给药器读数；1703 个（92.2%）给药器读数是正确的。平均而言，DSA 的灵敏度为 90.6%，特异性为 93.9%，阴性预测值为 93.8%，阳性预测值为 91.0%。实验之间没有统计学上的显著差异。
结论
DSA 已针对单次使用、填充羟乙基纤维素凝胶的低密度聚乙烯给药器进行了优化和成功验证。我们建议在涉及阴道凝胶的未来杀微生物剂试验中纳入 DSA，以识别出那些低剂量方案依从性差的参与者。通过这样做，我们可以制定提高依从性的策略，并研究产品使用与疗效之间的关联。
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