Gray J J, Wreghitt T G, McKee T A, McIntyre P, Roth C E, Smith D J, Sutehall G, Higgins G, Geraghty R, Whetstone R
Clinical Microbiology and Public Health Laboratory, Addenbrooke's Hospital, Cambridge.
J Clin Pathol. 1995 Mar;48(3):198-202. doi: 10.1136/jcp.48.3.198.
In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera.
From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera.
The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests).
The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results.
1991年4月,剑桥临床微生物学与公共卫生实验室的病毒学部门引入了额外的质量控制程序。内部质量控制(IQC)样本逐渐纳入实验室进行的血清学检测中,并补充了试剂盒对照和标准血清。
1991年4月至1993年12月,使用参考血清进行了2421次IQC程序。
根据韦斯特加德规则对IQC样本进行评估。在1808次对照中有60次(3.3%)记录到违规情况,在补体结合试验的IQC样本中违规率最高(提交补体结合试验的对照中有25/312(8%))。
在实验室进行的血清学检测中纳入IQC样本凸显了商业检测批次间的差异。为IQC样本设定可接受限度增加了对检测结果有效性的信心。