Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum

• Published in: Clinical chemistry (Baltimore, Md.) Md.), 2017-06, Vol.63 (6), p.1141-1150
• Main Authors: Carobene, Anna, Røraas, Thomas, Sølvik, Una Ørvim, Sylte, Marit Sverresdotter, Sandberg, Sverre, Guerra, Elena, Marino, Irene, Jonker, Niels, Barla, Gerhard, Bartlett, William A, Fernandez-Calle, Pilar, Díaz-Garzón, Jorge, Tosato, Francesca, Plebani, Mario, Coşkun, Abdurrahman, Serteser, Mustafa, Unsal, Ibrahim, Ceriotti, Ferruccio
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alanine; Alanine Transaminase - blood; Alanine Transaminase - metabolism; Alkaline phosphatase; Alkaline Phosphatase - blood; Alkaline Phosphatase - metabolism; Amylases; Amylases - blood; Amylases - metabolism; Aspartate aminotransferase; Aspartate Aminotransferases - blood; Aspartate Aminotransferases - metabolism; Biological variation; Clinical Enzyme Tests; Creatine; Creatine kinase; Creatine Kinase - blood; Creatine Kinase - metabolism; Dehydrogenases; Enzymes; Estimates; Female; gamma-Glutamyltransferase - blood; gamma-Glutamyltransferase - metabolism; Healthy Volunteers; Humans; L-Lactate dehydrogenase; L-Lactate Dehydrogenase - blood; L-Lactate Dehydrogenase - metabolism; Laboratories; Lactate dehydrogenase; Lactic acid; Lipase; Lipase - blood; Lipase - metabolism; Male; Medicine; Middle Aged; Pancreas; Pancreatic alpha-Amylases - blood; Pancreatic alpha-Amylases - metabolism; Phosphatase; Sex; Sex differences; Values; Variance analysis; Visual effects; Working groups; Young Adult; α-Amylase
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1373/clinchem.2016.269811

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.