Klinik für Hautkrankheiten, Universitätsklinikum Jena, Jena, Germany.
Poliklinik für Konservierende Zahnheilkunde und Parodontologie, Universitätsklinikum Jena, Jena, Germany.
PLoS One. 2018 Mar 20;13(3):e0194339. doi: 10.1371/journal.pone.0194339. eCollection 2018.
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.
杀菌材料因其能够防止材料表面被微生物定植并随后传播感染而在医疗保健领域受到关注。然而，抗菌材料的商业化需要证明其功效，这通常是通过体外方法完成的。ISO 22196 标准（日本测试方法 JIS Z 2801）是一种测量日用品抗菌活性的方法。由于该方法被发现可用于测试抗菌活性材料和表面涂层的杀菌活性，因此本研究中大多数参与实验室都使用了该方案。因此，必须建立评估抗菌生物材料的循环测试。据我们所知，这是关于启动 ISO 22196/JIS Z 2801 循环测试的第一份报告。第一轮测试表明，不同实验室的分析结果不同，特别是对于具有中等抗菌效果的材料，明显注意到了不同的功效。通过仔细审查不同参与者使用的方案并确定影响测试结果的因素，方法得到了统一。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（静止或生长指数期），和（4）营养浓度。据我们所知，这是第一次根据 ISO 22196/JIS Z 2801 分析这些参数对测试结果的影响。总之，为了能够评估获得的结果，有必要在测试方案中仔细评估这些单个参数。此外，还需要就抗菌效果/活性、抑菌作用和杀菌作用等术语达成一致和稳健的定义，以简化结果的交流，并规范对抗菌测试、结果和材料的期望。
