Padoan Andrea, Sciacovelli Laura, Aita Ada, Antonelli Giorgia, Plebani Mario
Department of Medicine - DIMED, University of Padova, via Giustiniani 2, 35128 Padova, Italy; Department of Laboratory Medicine, University-Hospital of Padova, via Giustiniani 2, 35128 Padova, Italy.
Department of Laboratory Medicine, University-Hospital of Padova, via Giustiniani 2, 35128 Padova, Italy.
Clin Biochem. 2018 Jul;57:41-47. doi: 10.1016/j.clinbiochem.2018.03.009. Epub 2018 Mar 13.
Measurement uncertainty (MU) estimation has been introduced by ISO 15189 for the accreditation of clinical laboratories. Although MU reporting is not required, its inclusion in medical reports is of potential assistance to physicians in results interpretation.
MU reporting was evaluated with respect to different test purposes, namely comparison with reference intervals (RI), patient monitoring or comparison with clinical decision limits. Clinical Biochemistry, Hematology, Coagulation and Clinical Immunology measurands were used as examples. Assuming Gaussian RI distribution, the probability of retesting due to MU was determined by simulations. Significant MU variations were compared against the reference change value (RCV) and clinical decision limits.
Three potential scenarios emerged for RI. For 12 measurands, depending on the MU interval, a potential change in results interpretation was found only for Sodium and S-Protein. On considering only the results within RI, simulations confirmed that up to 8.6% of MU intervals encompassed the RI limits, thus potentially leading to retesting. For tests used in patient monitoring, significant MU variations were comparable to those calculated by RCV, with the exception of CEA. For tests results evaluated with respect to clinical decision limits, on including MU, the clinical interpretation may be improved (e.g. for tPSA).
The findings made in the present study, which considers real MU data and hypothetical results obtained for a series of measurands, support the concept that MU may aid the physician's interpretation thus ensuring reliable clinical decision making.
国际标准化组织（ISO）15189已引入测量不确定度（MU）评估用于临床实验室认可。虽然不要求报告MU，但将其纳入医学报告可能有助于医生解读结果。
针对不同的检测目的评估MU报告，即与参考区间（RI）比较、患者监测或与临床决策限比较。以临床生物化学、血液学、凝血和临床免疫学测量值为例。假设RI呈高斯分布，通过模拟确定因MU而重新检测的概率。将显著的MU变化与参考变化值（RCV）和临床决策限进行比较。
RI出现了三种潜在情况。对于12种测量值，根据MU区间，仅发现钠和S蛋白的结果解读可能发生变化。仅考虑RI内的结果时，模拟证实高达8.6%的MU区间包含RI限值，因此可能导致重新检测。对于用于患者监测的检测，除癌胚抗原（CEA）外，显著的MU变化与RCV计算值相当。对于根据临床决策限评估的检测结果，纳入MU后，临床解读可能会得到改善（例如总前列腺特异性抗原[tPSA]）。
本研究考虑了实际MU数据和一系列测量值的假设结果，其结果支持MU可辅助医生解读从而确保可靠临床决策的概念。
