New South Wales Health Pathology, Liverpool Hospital, Liverpool, Australia.
St Vincent's Clinical School, Faculty of Medicine, The University of New South Wales, Sydney, Australia.
Clin Chem Lab Med. 2024 Mar 5;62(10):2037-2047. doi: 10.1515/cclm-2024-0041. Print 2024 Sep 25.
Laboratory results are increasingly interpreted against common reference intervals (CRIs), published clinical decision limits, or previous results for the same patient performed at different laboratories. However, there are no established systems to determine whether current analytical performance justifies these interpretations. We analysed data from a likely commutable external quality assurance program (EQA) to assess these interpretations.
The use of CRIs was assessed by evaluating instrument group medians against minimum specifications for bias. The use of clinical decision limits was assessed using specifications from professional bodies, and the monitoring of patients by testing at different laboratories was assessed by comparing all-laboratory imprecision to within-subject biological variation.
Five of the 18 analytes with Australasian CRIs did not meet specification for all instrument groups. Among these, calcium and magnesium failed for one instrument group out of seven, while bicarbonate, chloride, and lipase failed for two instrument groups. Of the 18 analytes reviewed currently without CRIs in Australasia, 10 candidates were identified. Among analytes with clinical decision limits, i.e. lipids, glucose, and vitamin D, only triglycerides met both bias and imprecision specifications, while vitamin D met the imprecision specification. Monitoring patients by testing at different laboratories was supported for 15 of the 46 (33 %) analyte-method principles groups that met minimum imprecision specifications.
Analysis of data from commutable EQA programs can provide a mechanism for monitoring whether analytical performance justifies the interpretations made in contemporary laboratory practice. EQA providers should establish systems for routinely providing this information to the laboratory community.
实验室结果越来越多地根据常见参考区间（CRI）、发布的临床决策限值或在不同实验室为同一患者进行的先前结果进行解释。然而，目前还没有确定的系统来确定当前的分析性能是否证明这些解释是合理的。我们分析了来自一个可能可转移的外部质量保证计划（EQA）的数据，以评估这些解释。
通过评估仪器组中位数与偏倚的最低规格来评估 CRI 的使用。使用专业机构的规格来评估临床决策限值，并通过将所有实验室的不精密度与个体内生物学变异进行比较来评估通过在不同实验室测试来监测患者。
在具有澳大拉西亚 CRI 的 18 种分析物中，有 5 种不符合所有仪器组的规格。在这些分析物中，钙和镁有 7 种仪器组中的 1 种不符合规格，而碳酸氢盐、氯化物和脂肪酶有 2 种仪器组不符合规格。在目前澳大拉西亚没有 CRI 的 18 种分析物中，确定了 10 种候选物。在具有临床决策限值的分析物中，即脂质、葡萄糖和维生素 D，只有三酰甘油符合偏倚和不精密度规格，而维生素 D 符合不精密度规格。通过在不同实验室进行测试来监测患者的方法得到了 46 个分析物-方法原理组中的 15 个（33%）的支持，这些组符合最低不精密度规格。
对可转移 EQA 计划数据的分析可以提供一种监测分析性能是否证明当代实验室实践中所作解释合理的机制。EQA 提供者应建立系统，定期向实验室社区提供此信息。
