The commutability study of processed materials for serum alanine aminotransferase measurements / 中华检验医学杂志

ABSTRACT

Objective To evaluate the commutability of 22 processed materials for serum alanine aminotransferase measurements which were performed in 11 routine assays without and 2 assays with pyridoxal-5′-phosphate.Methods 100 serum specimens were collected in Beijing Hospital,Zhao Yang Hospital and Tong Ren Hospital from May,2017 to August,2017.50 individual specimens together with fresh frozen human serum pools(HSPs), external quality assessment(EQA)materials, commercial calibrators and controls were measured by 11 routine assays without pyridoxal-5′-phosphate.Measurement results of the 50 individual samples were pairwise analyzed by Deming regression for slopes and intercepts, and 95%prediction interval(PI)were calculated to evaluate the commutability of processed materials.Another 50 individual specimens and 22 above-mentioned materials were analyzed by 2 assays with pyridoxal-5′-phosphate as the evaluated methods and internationally recognized reference method as the comparative method.The ordinary linear regression(OLR)and 95% PI were used to identify the commutability of 22 materials.Results The Deming slopes ranged from 0.879 to 1.064 and intercepts from -1.96 to 3.30;the OLR slopes were 0.905 and 0.955 while intercepts were -6.71 and 9.53.The HSPs were commutable for 51/57 and 56/57 assay pairs.The EQA materials, commercial calibrators and controls showed noncommutability from 8/57 to 47/57,38/57 and pairs after that, and from 13/57 to 43/57 assay pairs, respectively.Conclusion The lyophilized materials including EQA materials, commercial calibrators and controls demonstrated poor commutability in different degrees.