根据ISO 22196 / JIS Z 2801，影响抗菌测试结果的关键生理因素。,PLOS ONE

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根据ISO 22196 / JIS Z 2801，影响抗菌测试结果的关键生理因素。
PLOS ONE ( IF 2.9 ) Pub Date : 2018-03-21 , DOI: 10.1371/journal.pone.0194339
Cornelia Wiegand ₁ , Andrea Völpel ₂ , Andrea Ewald ₃ , Markko Remesch ₄ , Jan Kuever ₄ , Janine Bauer ₅ , Stefanie Griesheim ₅ , Carolin Hauser ₆ , Julian Thielmann ₆ , Silke Tonndorf-Martini ₂ , Bernd W Sigusch ₂ , Jürgen Weisser ₇ , Ralf Wyrwa ₇ , Peter Elsner ₁ , Uta-Christina Hipler ₁ , Martin Roth ₈ , Carolin Dewald ₉ , Claudia Lüdecke-Beyer ₉ , Jörg Bossert ₉

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杀菌材料在医疗保健领域引起了人们的兴趣，因为它们能够防止材料表面发生微生物定植和随后的感染传播。但是，抗菌材料的商业化需要证明其功效，这通常是使用体外方法进行的。ISO 22196标准（日本测试方法JIS Z 2801）是一种用于测量日用品抗菌活性的方法。由于发现可可靠地测试抗微生物活性材料和表面涂层的杀生物活性，因此参与该研究的大多数实验室都使用此方案。因此，必须建立用于评估抗微生物活性生物材料的循环试验。就我们所知，这是有关ISO 22196 / JIS Z 2801的循环测试的首份报告。第一轮测试表明，不同实验室的分析得出不同的结果，尤其是对于具有中等抗菌作用的材料，其功效明显不同。仔细研究不同参与者使用的协议，并确定影响测试结果的因素，该方法是统一的。在一系列实验中确定了影响抗菌测试结果的四个关键因素：（1）孵育时间，（2）细菌起始浓度，（3）细菌的生理状态（生长的固定或指数期）和（4）营养素浓度。据我们所知，这是首次根据ISO 22196 / JIS Z 2801分析这些参数对测试结果的影响。为了评估获得的结果，必须仔细评估测试方案中的这些单个参数。此外，需要就术语抗菌功效/活性，抑菌作用和杀菌作用达成统一而可靠的定义，以简化结果的交流，并规范有关抗菌素检测，结果和材料的期望。

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Critical physiological factors influencing the outcome of antimicrobial testing according to ISO 22196 / JIS Z 2801.

Bactericidal materials gained interest in the health care sector as they are capable of preventing material surfaces from microbial colonization and subsequent spread of infections. However, commercialization of antimicrobial materials requires proof of their efficacy, which is usually done using in vitro methods. The ISO 22196 standard (Japanese test method JIS Z 2801) is a method for measuring the antibacterial activity of daily goods. As it was found reliable for testing the biocidal activity of antimicrobially active materials and surface coatings most of the laboratories participating in this study used this protocol. Therefore, a round robin test for evaluating antimicrobially active biomaterials had to be established. To our knowledge, this is the first report on inaugurating a round robin test for the ISO 22196 / JIS Z 2801. The first round of testing showed that analyses in the different laboratories yielded different results, especially for materials with intermediate antibacterial effects distinctly different efficacies were noted. Scrutinizing the protocols used by the different participants and identifying the factors influencing the test outcomes the approach was unified. Four critical factors influencing the outcome of antibacterial testing were identified in a series of experiments: (1) incubation time, (2) bacteria starting concentration, (3) physiological state of bacteria (stationary or exponential phase of growth), and (4) nutrient concentration. To our knowledge, this is the first time these parameters have been analyzed for their effect on the outcome of testing according to ISO 22196 / JIS Z 2801. In conclusion, to enable assessment of the results obtained it is necessary to evaluate these single parameters in the test protocol carefully. Furthermore, uniform and robust definitions of the terms antibacterial efficacy / activity, bacteriostatic effects, and bactericidal action need to be agreed upon to simplify communication of results and also regulate expectations regarding antimicrobial tests, outcomes, and materials.

更新日期：2019-11-01

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