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Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

机译:临床病毒学实验室的内部质量保证。二。内部质量控制。

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AIMS--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. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--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). CONCLUSIONS--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.
机译:目的-1991年4月,附加的质量控制程序被引入剑桥大学临床微生物学和公共卫生实验室的病毒学部门。内部质量控制(IQC)样品逐渐包括在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。方法-从1991年4月至1993年12月,采用参考血清进行了2421次IQC程序。结果-根据Westgard规则评估了IQC样品。在1808个对照组中有60个(3.3%)违反记录,在补体固定测试的IQC样本中最高(提交补体固定测试的对照组中有25/312(8%))。结论-在实验室进行的血清学检测中将IQC样品包括在内,突显了商业检测中批次之间的差异。 IQC样品的可接受限度设置提高了对测定结果有效性的信心。

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