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Design, validation and performance of aspartate aminotransferase- and lactate dehydrogenase-reporting algorithms for haemolysed specimens including correction within quality specifications.
Annals of Clinical Biochemistry: International Journal of Laboratory Medicine ( IF 2.2 ) Pub Date : 2019-09-30 , DOI: 10.1177/0004563219878475
Selcuk Colak 1 , Onur Tasdemir 1 , Marianne van der Schaaf 1 , Frans Opdam 2 , Vincent van den Noort 3 , Daan van den Broek 1 , Huub H van Rossum 1
Affiliation  

BACKGROUND In vitro 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. METHODS 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. 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. CONCLUSIONS 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.

中文翻译:

溶血标本的天冬氨酸氨基转移酶和乳酸脱氢酶报告算法的设计,验证和性能,包括在质量规格范围内的校正。

背景技术体外溶血是医学实验室的主要操作挑战。一种新的实验设计用于研究在什么条件下可以设计出报告定量或定性的天冬氨酸转氨酶和乳酸脱氢酶结果超出制造商溶血指标的算法。需要进行定量校正才能达到预定的质量规格。方法使用25个患者样本来设计报告算法,并使用另外41个患者样本来验证算法。使用Cobas 6000分析仪(Roche diagnostics,曼海姆,德国)测定天冬氨酸转氨酶,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。报告算法的设计基于(i)制造商对溶血指数的临界值,(ii)在总允许误差范围内的更正以及(iii)根据获得的结果进行的定性报告。通过重新计算六个月的天冬氨酸氨基转移酶和乳酸脱氢酶结果,回顾性地确定了报告算法的影响。结果对于低于参考区间上限的结果,天冬氨酸氨基转移酶/乳酸脱氢酶的校正是不可能的,而等于或大于参考区间上限的结果,直到轻度溶血,都可以在总误差标准内进行校正。从经过验证的患者队列中产生的所有样品均符合设定标准。该算法允许报告88.5%和85。分别有9%的未报告天冬氨酸转氨酶和乳酸脱氢酶结果。结论提出了一种方法,该方法可以生成和验证与预定质量规格兼容的天冬氨酸转氨酶和乳酸脱氢酶的报告算法。设计的算法大大降低了其他方面未报告的天冬氨酸转氨酶和乳酸脱氢酶的结果。
更新日期:2019-11-01
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