Reference intervals for serum alpha-fetoprotein and carcinoembryonic antigen in Chinese Han ethnic males from the Fangchenggang Area Male Health and Examination Survey

摘要

Objectives: We calculated upper 95% reference limits for serum alpha-fetoprotein (AFP)and carcinoembryonic antigen (CEA) according to the CLSI/NCCLS C28-A3 guideline. Material and methods: Serum samples from 1400 healthy male subjects were collected from the Fangchenggang Area Male Health and Examination Survey (FAMHES). Serum AFP and CEA values were measured by electrochemiluminescence immu-noassay on COBAS 6000 system E601 (Elecsys module) immunoassay analyzers. Results: Serum AFP and CEA values were not normally distributed but log normally distributed. The upper 95% reference limits of the reference intervals were ≤4.76 IU/mL (nonparametric) or ≤4.56 IU/mL (parametric) for AFP and ≤5.57 ng/mL (nonparametric) or ≤5.82 ng/mL (parametric) for CEA. The distribution of AFP levels was found to be consistent between the non-smoking and smoking (p=0.740) and non-drinking and drinking groups (p=0.698). The distribution of serum CEA levels was signifcantly higher in the smoking than the non-smoking group (p<105), whereas there was no signifcant difference in this respect between the non-drinking and drinking groups (p=0.147). A signifcant increase with age was found both for serum AFP and CEA levels, and the age-dependent reference intervals were calculated. Conclusions: The reference intervals for serum AFP and CEA show a slight deviation compared to previously reported reference levels. Distinct reference intervals of serum CEA must be established for smoking and non-smoking populations. In addition, age-dependent reference intervals should be implemented in clinical laboratories.