实验室微生物数据偏差调查分析的建立及运用

Establishment and application of microbial data deviation investigation and analysis in laboratory

目的建立实验室微生物数据偏差(microbial data deviation,MDD)的调查分析,并应用于实践。方法通过查阅文献资料,建立实验室MDD的调查分析,并对1例无菌检查试验MDD超标情况进行分析调查。结果第12天起,样品在培养基中出现有菌生长,鉴别结果为反硝化无色杆菌。调查结果表明,该例试验检出菌并非是实验室检验过程中带来的污染,而是来自样品本身。结论初步建立了实验室MDD调查分析方案。

ObjectiveTo establish investigation and analysis for microbial data deviation(MDD)in the laboratory and apply it to practice.MethodsBy consulting literature,a laboratory MDD investigation process was established.The investigation and analysis were conducted on a case of MDD exceeding the standard in a sterility test.ResultsFrom the 12th day,there was bacterial growth in the sample in culture medium,and the identification result was Achromobacter denitrificans.The investigation results indicated that the bacteria detected in this case were not caused by contamination during laboratory testing,but from the sample itself.ConclusionA preliminary laboratory MDD investigation and analysis scheme is established.