Fernandez Pilar, Llopis María Antonia, Perich Carmen, Alsina Maria Jesús, Alvarez Virtudes, Biosca Carmen, Busquets Gloria, Domenech Maria Vicenta, Gómez Rubén, Llovet Isabel, Minchinela Joana, Pastor Rosa, Ruiz Rosa, Tarrés Ester, Ibarz Mercè, Simón Margarita, Montesinos Mercè
Clin Chem Lab Med. 2014 Nov;52(11):1557-68. doi: 10.1515/cclm-2013-0935.
Hemolysis is the main cause of non-quality samples in clinical laboratories, producing the highest percentage of rejections in the external assurance programs of preanalytical quality. The objective was to: 1) study the agreement between the detection methods and quantification of hemolysis; 2) establish comparable hemolysis interference limits for a series of tests and analytical methods; and 3) study the preanalytical variables which most influence hemolysis production.
Different hemoglobin concentration standards were prepared using the reference method. Agreement was studied between automated methods [hemolytic indexes (HI)] and reference method, as well as the interference according to hemolysis degree in various biochemical tests was measured. Preanalytical variables which could influence hemolysis production were studied: type of extraction, type of tubes, transport time, temperature and centrifugation conditions.
Good agreement was obtained between hemoglobin concentrations measured using the reference method and HI, for the most of studied analyzers, particularly those giving quantitative HI. The hemolysis interference cut-off points obtained for the majority of tests studied (except LDH, K) are dependent on the method/analyzer utilized. Furthermore, discrepancies have been observed between interference limits recommended by the manufacturer. The preanalytical variables which produce a lower percentage of hemolysis rejections were: centrifugation at the extraction site, the use of lower volume tubes and a transport time under 15 min at room temperature.
The setting of interference limits (cut-off) for each used test/method, and the study of preanalytical variability will assist to the results harmonization for this quality indicator.
溶血是临床实验室非合格样本的主要原因，在分析前质量的外部保证计划中产生的拒收率最高。目的是：1）研究溶血检测方法与定量之间的一致性；2）为一系列检测和分析方法建立可比的溶血干扰限值；3）研究最影响溶血产生的分析前变量。
使用参考方法制备不同血红蛋白浓度标准品。研究自动方法[溶血指数（HI）]与参考方法之间的一致性，并测量各种生化检测中根据溶血程度的干扰情况。研究可能影响溶血产生的分析前变量：提取类型、试管类型、运输时间、温度和离心条件。
对于大多数研究的分析仪，尤其是那些给出定量HI的分析仪，使用参考方法测量的血红蛋白浓度与HI之间具有良好的一致性。大多数研究测试（除乳酸脱氢酶、钾外）获得的溶血干扰临界值取决于所使用的方法/分析仪。此外，已观察到制造商推荐的干扰限值之间存在差异。产生较低百分比溶血拒收的分析前变量为：在提取地点离心、使用较小体积的试管以及在室温下运输时间少于15分钟。
为每个使用的测试/方法设置干扰限值（临界值）以及研究分析前变异性将有助于该质量指标结果的一致性。
