在外部质量实验试验中使用中央配制的试剂。

A Loria, F Pizano, J Perez-Dominguez
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引用次数: 0

摘要

这组作者提供了墨西哥卫生部在42个临床实验室进行的一项关于外部质量评估的短期试验的结果。葡萄糖、尿素和肌酐的检测试剂盒由卫生部准备。结果可能对第三世界国家的外部质量评估组织者有用,他们可能会选择这种策略来提高绩效。实验室对同样由卫生部制备的重组冻干对照血清进行了试验。所有三项检测均采用比色法手工进行。根据其实验室内精度(高、中、低精度的变异系数分别小于8%、8-12%和大于12%),12个实验室在所有三种测试中均表现出高精度。8个实验室对不同的测试显示中等和低精度,而其他22个实验室介于两者之间。结果表明,使用集中配制试剂提高实验室间一致性的策略在尿素和肌酐方面效果不佳,但在葡萄糖方面达到了预期。在第一次试验中,实验室间的葡萄糖变异系数为10%。
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The use of centrally prepared reagents in an external quality experimental trial.

The authors provide the results of a short-term experimental trial in external quality assessment in 42 clinical laboratories conducted by the Mexican Ministry of Health. Assay kits for glucose, urea, and creatinine were prepared by the Ministry. The results may prove useful to organizers of external quality assessments in third-world countries who may opt for this strategy to improve performance. The laboratories performed the tests on reconstituted lyophilized control serum, also prepared by the Ministry. All three assays were performed manually using colorimetric methods. On the basis of their intralaboratory precision (coefficients of variation less than 8%, 8-12%, and greater than 12% for high, medium, and low precision, respectively), 12 laboratories demonstrated high precision for all three tests. Eight laboratories showed medium and low precision for different tests, while the other 22 fell in between. The results showed that the strategy of using centrally prepared reagents to improve interlaboratory agreement did not work well for urea and creatinine, but met expectations for glucose. The laboratories achieved an interlaboratory coefficient of variation of 10% for glucose in this first trial.

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