The consistency of aminotransferase analysis in China: a comparison of six mainstream aminotransferase routine methods and recalibration using human pooled serum preparations supplemented with human recombinant aminotransferases

References

• Kwo PY, Cohen SM, Lim JK. ACG clinical guideline: evaluation of abnormal liver chemistries. Am J Gastroenterol. 2017;112(1):18–35.
   PubMed Web of Science ®Google Scholar
• Goessling W, Massaro JM, Vasan RS, et al. Aminotransferase levels and 20-year risk of metabolic syndrome, diabetes, and cardiovascular disease. Gastroenterology. 2008;135(6):1935–1944.
   PubMed Web of Science ®Google Scholar
• Ioannou GN, Weiss NS, Boyko EJ, et al. Elevated serum alanine aminotransferase activity and calculated risk of coronary heart disease in the United States. Hepatology. 2006;43(5):1145–1151.
   PubMed Web of Science ®Google Scholar
• Kain K, Carter AM, Grant PJ, et al. Alanine aminotransferase is associated with atherothrombotic risk factors in a British South Asian population. J Thromb Haemost. 2008;6(5):737–741.
   PubMed Web of Science ®Google Scholar
• Song HR, Yun KE, Park HS. Relation between alanine aminotransferase concentrations and visceral fat accumulation among nondiabetic overweight Korean women. Am J Clin Nutr. 2008;88(1):16–21.
   PubMed Web of Science ®Google Scholar
• Xie K, Chen CH, Tsai SP, et al. Loss of life expectancy by 10 years or more from elevated aspartate aminotransferase: finding aspartate aminotransferase a better mortality predictor for all-cause and liver-related than alanine aminotransferase. Am J Gastroenterol. 2019;114(9):1478–1487.
   PubMed Web of Science ®Google Scholar
• Schumann G, International Federation of Clinical Chemistry and Laboratory Medicine, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International federation of clinical chemistry and laboratory medicine. Part 4. Reference procedure for the measurement of catalytic concentration of alanine aminotransferase. Clin Chem Lab Med. 2002;40(7):718–724.
   PubMed Web of Science ®Google Scholar
• Schumann G, International Federation of Clinical Chemistry and Laboratory Medicine, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International federation of clinical chemistry and laboratory medicine. Part 5. Reference procedure for the measurement of catalytic concentration of aspartate aminotransferase. Clin Chem Lab Med. 2002;40(7):725–733.
   PubMed Web of Science ®Google Scholar
• Ono K, Ono T, Matsumata T. The pathogenesis of decreased aspartate aminotransferase and alanine aminotransferase activity in the plasma of hemodialysis patients: the role of vitamin B6 deficiency. Clin Nephrol. 1995;43(6):405–408.
   PubMed Web of Science ®Google Scholar
• Westerhuis LW, Hafkenscheid JC. Apoenzyme content of serum aminotransferases in relation to plasma pyridoxal-5'-phosphate concentration. Clin Chem. 1983;29(5):789–792.
   PubMed Web of Science ®Google Scholar
• Wang Y, Wang J, Zhao H, et al. Assessment of enzyme measurement procedures in China through a trueness verification program. Clin Chim Acta. 2016;461:98–102.
   PubMed Web of Science ®Google Scholar
• Tong Q, Chen B, Zhang R, et al. Standardization of clinical enzyme analysis using frozen human serum pools with values assigned by the international federation of clinical chemistry and laboratory medicine reference measurement procedures. Scand J Clin Lab Invest. 2018;78(1–2):74–80.
   PubMed Web of Science ®Google Scholar
• Long Q, Qi T, Zhang T, et al. Commutability assessment of candidate external quality assessment materials for aminotransferase activity measurements based on different approaches in China. Ann Lab Med. 2021;41(1):68–76.
   PubMed Web of Science ®Google Scholar
• CLSI. EP09-A3: measurement procedure comparison and bias estimation using patient samples; approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute; 2013.
   Google Scholar
• RELA-IFCC External quality control for Reference Laboratories. Available from: http://dgklrfb.de:81/ [Accessed on Feb 2020].
   Google Scholar
• Carobene A, European Biological Variation Study of the EFLM Working Group on Biological Variation, Røraas T, Sølvik U, et al. Biological variation estimates obtained from 91 healthy study participants for 9 enzymes in serum. Clin Chem. 2017;63(6):1141–1150.
   PubMed Web of Science ®Google Scholar
• CLSI. C37-A: preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures, approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute; 1999.
   Google Scholar
• CLSI. EP15-A3: user demonstration of performance for precision and trueness; approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute; 2014.
   Google Scholar
• Ceriotti F, Fernandez-Calle P, Klee GG, et al. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM strategic conference. Clin Chem Lab Med. 2017;55(2):189–194.
   PubMed Web of Science ®Google Scholar
• Yin Y, Ma C, Yu S, et al. Comparison of three different chemiluminescence assays and a rapid liquid chromatography tandem mass spectrometry method for measuring serum aldosterone. Clin Chem Lab Med. 2019;58(1):95–102.
   PubMed Web of Science ®Google Scholar
• Cattozzo G, Enzyme Working Group of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC), Guerra E, Ceriotti F, et al. Commutable calibrator with value assigned by the IFCC reference procedure to harmonize serum lactate dehydrogenase activity results measured by 2 different methods. Clin Chem. 2008;54(8):1349–1355.
   PubMed Web of Science ®Google Scholar
• Rami L, Roura M, Canalias F. Evaluation of commutability of several materials for harmonization alkaline phosphatase catalytic concentration measurements. Clin Chim Acta. 2012;413(15–16):1249–1254.
   PubMed Web of Science ®Google Scholar
• Guo Q, Wang J, Yi X, et al. Commutability of reference materials for alkaline phosphatase measurements. Scand J Clin Lab Invest. 2020;80(5):388–394.
   PubMed Web of Science ®Google Scholar
• Eto A, Shiki A, Chikaura Y, et al. Multienzyme control serum (Seraclear-HE) containing human enzymes from established cell lines and other sources. 1: preparation and properties. Clin Chem. 1995;41(6):872–880.
   PubMed Web of Science ®Google Scholar
• Nakano NI, Eto A, Chikaura Y, et al. Multienzyme control serum (Seraclear-HE) containing human enzymes from established cell lines and other sources. 2: evaluation as candidate working enzyme reference material for alanine and aspartate aminotransferases. Clin Chem. 1995;41(6 Pt 1):881–891.
   PubMed Web of Science ®Google Scholar