The preparation of human serum based reference materials for alpha-fetoprotein assay through quantity value transmission from multiple analysis systems

Objective To prepare the frozen human serum pools for AFP reference materials through quantity value transmission from several analysis systems. Methods Method establishment. According to the requirement of preparation for the national standard materials, the studies of homogeneity and stability of frozen human serum pools for AFP reference materials were carried out. The commutability of prepared AFP reference materials and WHO AFP 72/225 reference material were assessed.By use of four automated chemiluminescence analysis systems, the prepared reference materials and different dilutions of WHO reference material 72/225 were tested in the same run.The values of prepared AFP reference materials were assigned by comparing these results and the uncertainty was evaluated. Results The three levels of AFP reference materials were tested to be homogeneous. The long term stability had been observed at -80 ℃ for 14 months.The different dilutions of WHO AFP 72/225 reference material and three levels of prepared reference materials were commutable with patient serum samples among the four analysis systems.Through multiple system quantity value transmission and total uncertainty evaluation, the assigned values (IU/ml) of three levels of AFP reference materials were 23.0±3.0, 93.2±7.2, (26.1±2.4)×102 respectively. Conclusions The three levels of AFP reference materials were homogeneous and stable in accordance with requirement of preparation for national standard materials.The assigned values were reliable.The materials showed accepted commutability across 4 analytical systems.These materials had been approved as the national certified reference materials.These reference materials could be applied for the calibration or calibration verification of clinical analytical systems and the external quality assessment schemes for clinical laboratories.(Chin J Lab Med, 2016, 39: 930-935) Key words: alpha-fetoproteins; Reference standards; Reference values