Department of Clinical Biochemistry, Aydın Public Health Laboratory, Aydın, Turkey.
Department of Medical Biochemistry, Aydın Adnan Menderes University Faculty of Medicine, Aydın, Turkey.
Biochem Med (Zagreb). 2022 Oct 1;32(3):030705. doi: 10.11613/BM.2022.030705. Epub 2022 Aug 5.
Measurement uncertainty is a non-negative parameter that characterizes the distribution of all values appropriate to the measured size and is associated with the measured result. In this study, we aimed to compare the results with various suggestions and produce more qualified results by calculating the measurement uncertainties of the immunoassays like fertility hormones, drug concentration tests, cardiac markers, thyroid function tests and tumour markers.
Uncertainty calculation was made in accordance with the top-down approach according to Nordtest guide. The 12-month study of internal and external quality assessment results were used. The parameters of drug concentration tests were performed on the Abbott Architect c8000, other hormones/markers on the i2000 of the same brand.
Factors that increased the measurement uncertainty of a test were due to external quality control data. The calculations showed that 13 of 26 parameters satisfied quality requirements. The highest uncertainty value, with 28% belonged to cancer antigen 19-9 test. The lowest value was calculated for prolactin with 8.3%. Dehydroepiandrosterone sulfate and phenytoin performed poorly in terms of measurement uncertainty, although internal and external quality control assessment results were considered favourable for both.
It is recommended that the concept of measurement uncertainty, which plays an important role in the total quality performance of the laboratory, should be followed up by the clinical laboratory experts at certain time intervals and should be increased the awareness of clinicians about the subject.
测量不确定度是一个非负参数，用于描述与被测量尺寸相关的所有合适值的分布，并与测量结果相关联。本研究旨在比较各种建议的结果，并通过计算生育激素、药物浓度测试、心脏标志物、甲状腺功能测试和肿瘤标志物等免疫分析的测量不确定度来获得更合格的结果。
根据 Nordtest 指南，采用自上而下的方法进行不确定度计算。使用了为期 12 个月的内部和外部质量评估结果的研究。药物浓度测试的参数在同一品牌的 Abbott Architect c8000 上进行，其他激素/标志物在 i2000 上进行。
增加测试测量不确定度的因素是由于外部质量控制数据。计算表明，26 个参数中有 13 个满足质量要求。不确定性值最高的是癌症抗原 19-9 测试，为 28%。催乳素的最低值计算为 8.3%。硫酸脱氢表雄酮和苯妥英的测量不确定度表现不佳，尽管内部和外部质量控制评估结果都认为这两种药物的质量良好。
建议临床实验室专家在一定时间间隔内跟踪测量不确定度这一概念，这对实验室的全面质量性能起着重要作用，并提高临床医生对该主题的认识。
