There is considerable variation in laboratory practices with regard to the review of internal quality control (IQC), and the literature is not exhaustive on the subject of own control limits, its interpretation, when to switch it over, and its benefits for routine practice and even for patient monitoring. The purpose of the present article is to stress the routine interpretation and challenges related to own results for IQC management. The first 20 (initial) measures, as well as monthly and cumulative IQC results of immunochemical tests, were analyzed for the selected tumor markers and hormones. While the average tended to get closer to the manufacturer value by increasing the number of measurements, the analytical coefficient of variation (CVA) tended to increase. Most parameters showed significant differences between initial and cumulative CVA, which were lower than the manufacturer’s specifications. While the quality specifications based on biological variation best fit the analytical and clinical purpose of our laboratory tests, we must be aware that the manufacturer’s control range, and even the method specification, should be used carefully, because it is usually wider than our goals.

中文翻译：

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验证和分配自己的目标值和范围以进行内部质量控制

在内部质量控制 (IQC) 审查方面，实验室实践存在相当大的差异，并且关于自身控制限度、其解释、何时转换以及其对常规实践和甚至用于患者监护。本文的目的是强调与自己的 IQC 管理结果相关的常规解释和挑战。对选定的肿瘤标志物和激素分析前 20 个（初始）测量值以及免疫化学测试的月度和累积 IQC 结果。虽然通过增加测量次数，平均值趋于接近制造商值，但分析变异系数 (CVA) 趋于增加。大多数参数在初始和累积 CVA 之间显示出显着差异，低于制造商的规格。虽然基于生物变异的质量规范最适合我们实验室测试的分析和临床目的，但我们必须意识到制造商的控制范围，甚至方法规范，都应该谨慎使用，因为它通常比我们的目标更广泛。