Section of Clinical Biochemistry, University Hospital of Verona, Piazzale LA Scuro, 37100 - Verona, Italy.
Department of Laboratory Medicine, Paracelsus Medical University, Salzburg, Austria.
Clin Chem Lab Med. 2018 Apr 25;56(5):718-727. doi: 10.1515/cclm-2017-1104.
We suggest here a pragmatic approach for managing results of clinical chemistry testing in hemolyzed samples collected from adults/older children, attempting to balance the need to produce quality laboratory data with clinical urgency of releasing test results. Automatic measurement of the hemolysis index (H-index) in serum or plasma is highly advisable, whilst low-quality assessment of this test remains less good than a visual inspection. Regarding its practical use, when the H-index value does not generate an analytically significant bias, results can be released, whilst when the value is associated with analyte variation in a range between analytically and clinically significant bias (i.e. variation does not exceed the reference change value [RCV]), results of hemolysis-sensitive tests can be released in association with a comment describing the direction in which data are potentially altered, suggesting the need to collect another sample. When the H-index is associated with analyte variation exceeding clinically significant bias (i.e. variation exceeds the RCV), results of hemolysis-sensitive tests should be suppressed and replaced with a comment that biased results cannot be released because the sample is preanalytically compromised and advising the recollection of another sample. If H-index values reach an even higher critical cut-off (i.e. H-index corresponding to a cell-free hemoglobin concentration ≥10 g/L), all laboratory data may be unreliable and should hence be suppressed and replaced with a comment that all data cannot be released because the sample is grossly hemolyzed, also suggesting the recollection of another sample. Due to inaccuracy and imprecision, the use of corrective formulas for adjusting data of hemolysis-sensitive tests is discouraged.
我们在此建议一种实用的方法来管理成人/大龄儿童采集的溶血样本的临床化学检测结果，试图在满足发布检测结果的临床紧迫性的同时，兼顾生成高质量实验室数据的需求。在血清或血浆中自动测量溶血指数（H-index）是非常可取的，而对该测试的低质量评估仍不如肉眼观察。关于其实际应用，当 H-index 值不会导致分析上显著的偏差时，可以发布结果，而当值与分析上和临床上显著偏差范围内的分析物变化相关联时（即变化不超过参考变化值[RCV]），可以发布与描述数据潜在变化方向的注释相关联的溶血敏感测试结果，表明需要收集另一个样本。当 H-index 值与分析物变化相关联，超出临床上显著的偏差（即变化超过 RCV）时，应抑制溶血敏感测试的结果，并替换为注释，说明由于样本在分析前受到影响，不能发布有偏差的结果，并建议重新采集另一个样本。如果 H-index 值达到更高的临界截止值（即对应于无细胞血红蛋白浓度≥10 g/L 的 H-index 值），所有实验室数据可能都不可靠，因此应抑制并替换为注释，说明所有数据都无法发布，因为样本严重溶血，也建议重新采集另一个样本。由于不准确和不精确，不鼓励使用校正公式来调整溶血敏感测试的数据。
