Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers.

Objectives: Tumor markers are well-known for being important tools in the support of diagnosis, monitoring of treatment efficacy and follow-up of cancers. CA 125, CA 15-3 and HE 4 have demonstrated potential efficacy in other clinical indications. The main objective was to evaluate the biological variation of these glycoproteins using two different immunoassays in an apparently healthy Caucasian population.

Methods: Nineteen healthy volunteers including 11 women and 8 men were sampled weekly for 5 consecutive weeks. Samples were analyzed in duplicate on Lumipulse G600II (Fujirebio) and on the Cobas e602 (Roche Diagnostics) analyzers. After assessment of normality, exclusion of outliers and analysis of homogeneity of variance, analytical variation (CV), within-subject biological variation (CV) and between-subject biological variation (CV) were determined using a nested ANOVA.

Results: CV, CV and CV were determined on both analyzers and both genders. For CA 125, the CV ranges from 1.0 to 3.4%, the CV from 5.7 to 13.8% and the CV from 32.2 to 42.9%. For CA 15-3, the CV is between 1.1 and 3.4%, the CV between 3.9 and 6.5% and the CV between 43.7 and 196.9%. Lastly, HE 4 has CV values between 1.4 and 2.4%, CV between 5.1 and 10.5% and CV between 7.1 and 12.6%.

Conclusions: Our study provided updated data on the biological variation of CA 125, HE 4 and CA 15-3. These data allow to improve the clinical interpretation and thus the management of the patient.