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.
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 (CVA), within-subject biological variation (CVI) and between-subject biological variation (CVG) were determined using a nested ANOVA.
CVA, CVI and CVG were determined on both analyzers and both genders. For CA 125, the CVA ranges from 1.0 to 3.4%, the CVI from 5.7 to 13.8% and the CVG from 32.2 to 42.9%. For CA 15-3, the CVA is between 1.1 and 3.4%, the CVI between 3.9 and 6.5% and the CVG between 43.7 and 196.9%. Lastly, HE 4 has CVA values between 1.4 and 2.4%, CVI between 5.1 and 10.5% and CVG between 7.1 and 12.6%.
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.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: The study protocol was approved by the ethics committee of our institution (Cliniques Universitaires Saint-Luc, Brussels, Belgium; 2019/04SEP/388).
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