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Quality and suitability of antimicrobial discs: theoretical and practical sources of error and variability.
Expert Review of Molecular Diagnostics ( IF 3.9 ) Pub Date : 2020-01-27 , DOI: 10.1080/14737159.2020.1719070
Stefan T Orszulik 1
Affiliation  

Introduction: The use of antimicrobial discs remains one of the main methods for assessing antibiotic activity. Most discs are made to one of three main standards (FDA, WHO, DIN); these all describe an assay method for assessing the quality of discs using a linear method. Theory predicts a curved relationship, and this is backed up in many cases in practice. In such cases, the assays are potentially invalid. Other sources of uncertainty arising from the manufacturing processes employed are also discussed.Areas covered: This includes error arising from applying FDA, WHO, and DIN standards, the manufacturing techniques employed, and variation in the materials used in production. The need for a specification that relates directly to the use of the discs is also discussed.Expert opinion: Manufactured discs, some of which may be out of specification due to curvature and other sources of error, have been used to establish quality zone sizes. Quality zone sizes have then been used to measure the quality of discs. This circular quality system where there is no quantitative check is potentially unsafe. In the many decades of their use, there has been no comprehensive check on the quality of manufactured discs using quantitative, validated assays.

中文翻译:

抗菌光盘的质量和适用性:误差和变异性的理论和实践来源。

简介:抗菌光盘的使用仍然是评估抗生素活性的主要方法之一。大多数光盘都是按照以下三个主要标准之一制作的:FDA,WHO,DIN。这些都描述了一种使用线性方法评估光盘质量的测定方法。理论上可以预测出一种弯曲的关系,并且在很多情况下都可以证明这一点。在这种情况下,测定可能无效。还讨论了由所采用的制造过程引起的其他不确定性来源。所涵盖的领域:这包括因采用FDA,WHO和DIN标准而产生的误差,所采用的制造技术以及生产中所用材料的变化。还讨论了对与光盘使用直接相关的规范的需求。专家意见:人造光盘,其中一些由于曲率和其他误差源而可能超出规格,已用于确定质量区域大小。然后使用质量区域大小来测量光盘的质量。没有定量检查的这种循环质量体系可能不安全。在其使用的几十年中,还没有使用经过验证的定量检测方法来全面检查制成的光盘的质量。
更新日期:2020-01-27
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