致病菌测试片质量评价方法研究

Study on quality evaluation methods of pathogenic bacteria rapid test strips

中文关键词:  致病菌  测试片  产品评价

英文关键词:pathogenic bacteria  rapid test strips  product evaluation

中文摘要:

      目的 建立一种相对简单、实用性强的致病菌测试片质量评价方法, 用于评估其可靠性和适用性, 并探讨致病菌测试片的发展现状与不足。方法 使用纯化后的非目标菌株及人工污染样品, 对市售致病菌测试片的特异性、最低检出水平、重现性等参数进行技术性评价。结果 特异性测试中, 测试片非目标菌假阳性结果占测试比例的10.3%, 副溶血性弧菌测试片及蜡样芽胞杆菌测试片非目标菌交叉反应严重。最低检测水平测试, 有3个产品所有检测水平未检出阳性结果, 部分产品最低检出限可达1 CFU/mL。重现性测试中, 部分产品回收率小于53%, 其余产品重现性良好。结论 本研究的质量评价方法可以对致病菌测试片进行科学客观的质量评价。指标设置科学合理, 实验验证操作简单, 针对性强, 能够快速、简便筛选出稳定可靠的产品, 为测试片提供了科学合理的评价方法。

英文摘要:

      Objective To establish a relatively simple and practical method for evaluating the quality of pathogenic bacteria rapid test strips, aiming to assess their reliability and applicability, and to explore the current status and shortcomings of pathogenic bacteria rapid test strips. Methods The purified non-target strains and artificial pollution samples were used to evaluate the specificity, the minimum detection level, reproducibility of test strips on market. Results In the specific test, the false positive results of non-target bacteria accounted for 10.3% of the test tablets, and the cross-reaction of non-target bacteria between Vibrio parahaemolyticus test tablets and Bacillus cereus test tablets was serious. In the test of the lowest detection level, no positive results were detected in all the test levels of 3 products, and the minimum limit of detection of some products could reach 1 CFU/mL. In the reproducibility test, the reproducibility of some products was less than 53%, and the reproducibility of other products was good. Conclusion The quality evaluation method in this study can evaluate the quality of pathogenic bacteria rapid test strips scientifically and objectively. The index setting is scientific and reasonable, the experimental verification operation is simple and targeted, and the stable and reliable products can be selected quickly and easily, which provides a scientific and reasonable evaluation method for the test film.