Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy;
Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy (http://efcclm.eu/science/wg-biological-variation, www.biologicalvariation.com).
Clin Chem. 2017 Jun;63(6):1141-1150. doi: 10.1373/clinchem.2016.269811. Epub 2017 Apr 20.
We sought to develop estimates of biological variation (BV) for 9 enzymes in blood serum as part of the European Biological Variation Study.
Ninety-one healthy study participants (38 male and 53 female, 21-69 years old) were phlebotomized in each of 10 consecutive weeks at 6 European laboratories. The same preanalytical sample-handling protocol was followed at each center before transport to San Raffaele Hospital, Milan, Italy, for analysis. Sera were stored at -80 °C before analysis in duplicate within a single run on an ADVIA 2400 Clinical Chemistry System (Siemens Healthcare) following a protocol designed to minimize analytical imprecision. Assay traceability was established using frozen sera with target values assigned by reference methods. The results were subjected to outlier analysis before CV-ANOVA to deliver valid BV estimates. Results for 9 enzymes were subsequently partitioned for graphical display allowing visual assessment of the effects of country of origin, sex, and age on BV estimates.
We found no effect of country upon the observed variation, but overall sex-related differences were evident for alanine amino transferase (ALT), γ-glutamyl transferase (GGT), and creatine kinase (CK). The following estimates for within-subject BV (CV) and between-subject BV (CV), respectively, were obtained: ALT: 9.3%, 28.2%; aspartate aminotransferase: 9.5%, 20.3%; GGT: 8.9%, 41.7%; alkaline phosphatase : 5.3%, 24.9%; lactate dehydrogenase: 5.2%, 12.6%; CK: 14.5%, 31.5%; amylase: 6.8%, 30.4%; pancreatic α-amylase: 6.3%, 24.9%; and lipase (LIP): 7.7%, 23.8%.
All CV and some CV estimates were lower than those reported in the online BV 2014 updated database. Analytical performance specifications derived from BV can be applied internationally.
我们旨在通过欧洲生物变异研究，对血清中 9 种酶的生物学变异（BV）进行评估。
91 名健康的研究参与者（38 名男性，53 名女性，年龄 21-69 岁）在欧洲的 6 个实验室连续 10 周每周采血一次。在将样本运往意大利米兰圣拉斐尔医院进行分析之前，每个中心都遵循相同的预分析样本处理方案。在对 ADVIA 2400 临床化学系统（西门子医疗）进行分析之前，将血清在-80°C 下储存，然后在单个运行中重复进行两次分析，采用旨在最大限度减少分析不精密度的方案。通过使用具有参考方法赋值目标值的冷冻血清建立检测溯源性。在进行 CV-ANOVA 以获得有效的 BV 评估之前，对结果进行离群值分析。随后对 9 种酶的结果进行分区，以便直观评估起源国、性别和年龄对 BV 评估的影响。
我们没有发现观察到的变异受国家影响，但丙氨酸氨基转移酶（ALT）、γ-谷氨酰转移酶（GGT）和肌酸激酶（CK）存在明显的性别差异。以下是分别获得的个体内变异（CV）和个体间变异（CV）的估计值：ALT：9.3%，28.2%；天冬氨酸氨基转移酶：9.5%，20.3%；GGT：8.9%，41.7%；碱性磷酸酶：5.3%，24.9%；乳酸脱氢酶：5.2%，12.6%；CK：14.5%，31.5%；淀粉酶：6.8%，30.4%；胰腺α-淀粉酶：6.3%，24.9%；和脂肪酶（LIP）：7.7%，23.8%。
所有 CV 和一些 CV 估计值均低于在线更新的 BV 2014 数据库中报告的值。基于 BV 衍生的分析性能规格可在国际上应用。
