Objective: Adhering to current IFCC recommendations, we calculated upper 97.5 % reference limits for serum tumor markers.
Material and methods: Serum samples from 498 healthy individuals from the Nordic reference interval project (NORIP) were investigated for carcinoembryonic antigen (CEA), CA125 and MUC1 (episialin, CA15.3) using in-house immunofluorometric assays and, for alpha-foetoprotein (AFP), a PerkinElmer Life Sciences assay, neuron-specific enolase (NSE) using an in-house immunoradiometric assay and CA19.9 using a Beckman Access assay. All assays participate in external quality assessment programs.
Results: CEA concentrations increased with age and smoking. Upper reference limits for non-smokers were 3.59 microg/L at 50 years and 4.12 microg/L at 70 years. CA125 concentrations were age-independent and the upper reference limit was 35.8 kU/L. MUC1 increased with age and body mass index (BMI). Upper reference limits were 31.7 kU/L at 40 years and BMI 24, 37.5 kU/L at 70 years and BMI 24, and 33.7 kU/L at 40 years and BMI 30. AFP increases with age, and the upper reference limits were 3.82 kU/L at 20 years and 8.70 kU/L at 60 years. An upper reference limit for NSE was 8.91 microg/L in non-smokers; smokers exhibited significantly lower levels. The upper reference limit for individuals expressing CA19.9 was 28.3 kU/L.
Conclusions: For AFP, CA125 and CA19.9, the reference levels obtained were close to previously reported reference ranges. Smoking and age were confirmed as covariates for CEA. The associations between MUC1 with age and BMI and between NSE and smoking have not been reported previously.