ISO/TS 16782:2016 临床实验室检测 可接受量脱水水解酪蛋白琼脂和液体培养基用药敏检测标准

标准编号：ISO/TS 16782:2016

中文名称：临床实验室检测 可接受量脱水水解酪蛋白琼脂和液体培养基用药敏检测标准

英文名称：Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

发布日期：2016-10

标准范围

ISO/TS 16782:2016提供了脱水穆勒-辛顿肉汤（dMHB）和穆勒-辛顿琼脂（dMHA）物理性能的标准描述，以及制造商可以评估其生产批次dMHA和dMHB性能特征的性能标准。然后，所有用户，包括体外药敏试验设备制造商，都可以使用大量的肉汤或琼脂作为进行抗生素敏感性试验的试验介质。ISO/TS 16782:2016未涉及补充内容（e。g、 添加到培养基中以支持挑剔细菌生长的血液或血液制品[3][4][5][6]。这些添加剂是在脱水介质作为最终产品以液态制备后提供的，不属于本技术规范的范围。尽管dMHA可用于使用琼脂稀释法[4][6]或梯度扩散法测定MIC，但ISO/TS 16782:2016仅包括使用临床和实验室标准研究所（CLSI）[5]和欧洲抗菌药物敏感性试验委员会（EUCAST）[3]所述的圆盘扩散法对dMHA进行性能测试。

ISO/TS 16782:2016 provides a standard description of the physical properties of dehydrated Mueller-Hinton broth (dMHB) and Mueller-Hinton agar (dMHA) and performance criteria by which manufacturers can assess the performance characteristics of their production lots of dMHA and dMHB. Production lots of broth or agar can then be utilized by all users, including in vitro susceptibility testing device manufacturers, as the test medium for performance of antimicrobial susceptibility testing.ISO/TS 16782:2016 does not address supplements (e.g. blood or blood products) that are added to the medium to support growth of fastidious bacteria[3][4][5][6]. Those additives are provided after the dehydrated medium is prepared in its liquid state as a final product and fall outside of the scope of this Technical Specification. Although dMHA can be used for determination of MICs using the agar dilution method[4][6] or the gradient diffusion method, ISO/TS 16782:2016 only includes performance testing of dMHA using disc diffusion methodology as described by the Clinical and Laboratory Standards Institute (CLSI)[5] and European Committee on Antimicrobial Susceptibility Testing (EUCAST)[3].

标准预览图