Department of Laboratory Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Division of Clinical Pharmacology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Ann Clin Biochem. 2024 Jul;61(4):239-247. doi: 10.1177/0004563219878475. Epub 2019 Sep 30.
haemolysis is a major operational challenge for medical laboratories. A new experimental design was used to investigate under what conditions algorithms could be designed to report either quantitative or qualitative aspartate aminotransferase and lactate dehydrogenase results outside the manufacturer's haemolysis specifications. Quantitative corrections were required to meet prespecified quality specifications.
Twenty-five patient samples were used to design reporting algorithms and another 41 patient samples were used to validate the algorithms. Aspartate aminotransferase, lactate dehydrogenase and haemolysis index were determined using a Cobas 6000 analyser (Roche diagnostics, Mannheim, Germany). Correction factors were determined, and the accuracy of the correction was investigated. Reporting algorithms were designed based on (i) the manufacturer's cut-off for the haemolysis index, (ii) corrections within the total allowable error specification and (iii) qualitative reporting based on obtained results. The impact of the reporting algorithms was retrospectively determined by recalculating six months of aspartate aminotransferase and lactate dehydrogenase results.
No correction for aspartate aminotransferase/lactate dehydrogenase was possible for results below the upper reference interval limit, while results equal to or greater than the upper reference interval limit could, up to mild haemolysis, be corrected within the total error criterion. All samples generated from the validated patient cohort fulfilled the set criteria. The algorithms allowed reporting 88.5% and 85.9% of otherwise unreported aspartate aminotransferase and lactate dehydrogenase results, respectively.
An approach is presented that allows to generate and validate reporting algorithms for aspartate aminotransferase and lactate dehydrogenase compatible with prespecified quality specifications. The designed algorithms resulted in a significant reduction of otherwise unreported aspartate aminotransferase and lactate dehydrogenase results.
溶血是医学实验室面临的主要操作挑战。本研究采用新的实验设计，旨在研究在何种条件下可设计算法，在超出制造商溶血规定的情况下报告定量或定性天门冬氨酸氨基转移酶和乳酸脱氢酶结果。需要进行定量校正以满足规定的质量标准。
使用 25 份患者样本设计报告算法，另使用 41 份患者样本验证算法。使用 Cobas 6000 分析仪（罗氏诊断公司，德国曼海姆）测定天门冬氨酸氨基转移酶、乳酸脱氢酶和溶血指数。确定校正因子，并研究校正的准确性。根据（i）制造商的溶血指数截止值、（ii）总允许误差范围内的校正和（iii）根据获得的结果进行定性报告，设计报告算法。通过重新计算六个月的天门冬氨酸氨基转移酶和乳酸脱氢酶结果，回顾性确定报告算法的影响。
在低于参考上限的结果处，无法对天门冬氨酸氨基转移酶/乳酸脱氢酶进行校正，而在等于或高于参考上限的结果处，在总误差范围内，可以在轻度溶血时进行校正。所有来自验证患者队列的样本均符合设定标准。该算法允许报告 88.5%和 85.9%的原本无法报告的天门冬氨酸氨基转移酶和乳酸脱氢酶结果，分别。
本研究提出了一种方法，可生成和验证与预设质量标准兼容的天门冬氨酸氨基转移酶和乳酸脱氢酶报告算法。设计的算法显著减少了原本无法报告的天门冬氨酸氨基转移酶和乳酸脱氢酶结果。
