Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, P.R. China.
Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, P.R. China.
Clin Chem Lab Med. 2023 Oct 23;62(4):646-656. doi: 10.1515/cclm-2023-0865. Print 2024 Mar 25.
Large biological variation hinders application of patient-based real-time quality control (PBRTQC). The effect of analyte ratios on the ability of PBRTQC to improve error detection was investigated.
Four single analyte-ratio pairs (alanine aminotransferase [ALT] vs. ALT to aspartate aminotransferase ratio [R]; creatinine [Cr] vs. Cr to cystatin C ratio [R]; lactate dehydrogenase [LDH] vs. LDH to hydroxybutyrate dehydrogenase ratio [R]; total bilirubin [TB] vs. TB to direct bilirubin ratio [R]) were chosen for comparison. Various procedures, including four conventional algorithms (moving average [MA], moving median [MM], exponentially weighted moving average [EWMA] and moving standard deviation [MSD]) were assessed. A new algorithm that monitors the number of defect reports per analytical run (NDR) was also evaluated.
When a single analyte and calculated ratio used the same PBRTQC parameters, fewer samples were needed to detect systematic errors (SE) by taking ratios (p<0.05). Application of ratios in MA, MM and EWMA significantly enhanced their ability to detect SE. The influence of ratio on random error (RE) detection depended upon the analytes and PBRTQC parameters, as consistent advantage was not demonstrated. The NDR method performed well when appropriate parameters were used, but was only effective for unilateral SE. Rearrangement of sample order led to a significant deterioration of conventional algorithms' performance, while NDR remained almost unaffected.
For analytes with large variation and poor PBRTQC performance, using ratios as PBRTQC indexes may significantly improve performance and achieve better anti-interference ability, providing a new class of monitoring indicators for PBRTQC.
较大的生物学变异会妨碍基于患者的实时质量控制（PBRTQC）的应用。本研究旨在探讨分析物比值对 PBRTQC 提高误差检测能力的影响。
选择了 4 对单分析物比值对（丙氨酸氨基转移酶 [ALT] 与 ALT 与天冬氨酸氨基转移酶比值 [R]；肌酐 [Cr] 与 Cr 与胱抑素 C 比值 [R]；乳酸脱氢酶 [LDH] 与 LDH 与羟丁酸脱氢酶比值 [R]；总胆红素 [TB] 与 TB 与直接胆红素比值 [R]）进行比较。评估了包括 4 种传统算法（移动平均值 [MA]、移动中位数 [MM]、指数加权移动平均值 [EWMA] 和移动标准偏差 [MSD]）在内的各种程序。还评估了一种新的算法，该算法监测每个分析运行的缺陷报告数（NDR）。
当单一分析物和计算比值使用相同的 PBRTQC 参数时，通过采用比值可以检测到系统性误差（SE）所需的样本量更少（p<0.05）。在 MA、MM 和 EWMA 中应用比值显著提高了它们检测 SE 的能力。比值对随机误差（RE）检测的影响取决于分析物和 PBRTQC 参数，因为并没有表现出一致的优势。当使用适当的参数时，NDR 方法表现良好，但仅对单侧 SE 有效。重新排列样本顺序会显著降低传统算法的性能，而 NDR 几乎不受影响。
对于具有较大变异和较差 PBRTQC 性能的分析物，使用比值作为 PBRTQC 指标可能会显著提高性能并实现更好的抗干扰能力，为 PBRTQC 提供了一类新的监测指标。
