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[临床生化研究质量的内部实验室控制系统]

[System of internal laboratory control over the quality of clinical biochemical research].

作者信息

Marinov S, Tsvetkova R, Parashkevova E

出版信息

Vet Med Nauki. 1987;24(2):17-23.

PMID:3617472
Abstract

An analysis and testing of the system of on-laboratory control on the quality of biochemical investigations with the use of control cards, has been performed. The system provides for the working out of control cards, the carrying out of control investigations, the evaluation of the results, and the correction of the control cards. Data for the built-up of the cards has been obtained with the practice of as many as 30 replications with one and the same sample, under the same conditions, the values of the average quadratic deviation (S) being in compliance with Tonks criterion. The action of control is substantiated through doubling the study of 10 per cent of the samples of each batch for each analysis and evaluation of the differences with regard to S by a two-mark system. An average mark from 0.00 to 2.00 per batch of samples is formed for each analysis. Filled in control cards for the total calcium and inorganic phosphorus are presented as an example. The changes in the S values are followed up after the introduction of control cards for 9 indices. With 7 indices reproducibility has proved higher. A total of 90 series of analyses have been controlled and evaluated--54 series (60 per cent) have proved 'good' (from 1.5 to 2.00), 22 series (24.44 per cent)--'satisfactory' (from 1.00 to 1.49), and 14 series (15.56 per cent)--'bad' (from 0.00 to 1.00 or at differences greater than 2.5 S) which implied that the respective analyses of the series of samples had to be replicated. A total of 24 control cards for various indices have been built up.

摘要

已对使用控制卡进行生化检验质量的实验室内部控制系统进行了分析和测试。该系统包括制定控制卡、进行对照检查、评估结果以及修正控制卡。通过在相同条件下对同一样品进行多达30次重复操作来获取构建控制卡的数据,平均二次偏差(S)值符合汤克斯标准。通过对每批样品的10%进行双倍检测,并采用双标记系统分析和评估与S的差异来证实控制措施的有效性。每次分析为每批样品形成一个从0.00到2.00的平均分数。以总钙和无机磷的填写好的控制卡为例。在引入9项指标的控制卡后,对S值的变化进行了跟踪。7项指标的重现性更高。总共对90组分析进行了控制和评估——54组(60%)结果为“良好”(1.5至2.00),22组(24.44%)——“满意”(1.00至1.49),14组(15.56%)——“差”(0.00至1.00或差异大于2.5S),这意味着相应系列样品的分析必须重复进行。总共构建了24张针对不同指标的控制卡。

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