Evaluation of an Automated CLIA System for the Determination of Carbohydrate Antigen 19-9
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Updated: Mar 12, 2026

Electrochemiluminescence Assays for Human Islet Autoantibodies
Published on: March 23, 2018
Emanuela Anastasi1, Chantal DI Segni2, Silvestra Tudini2
1Department of Molecular Medicine, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy emanuela.anastasi@uniroma1.it.
Aim:
To compare analytical characteristics between two different methods, a automated chemiluminescent immunoassay (CLIA) versus a radioimmunometric assay (RIA), for the determination of carbohydrate antigen 19-9 (CA19-9).
Materials And Methods:
One hundred and eighty-five blood samples from consecutively enrolled individuals (87 males and 98 females, aged 22-89 and 29-89 years, respectively) were evaluated. For both assays, a cut-off of 37 U/ml was used.
Results:
Comparison between assays was analyzed using Passing-Bablok regression, which showed a high inter-assay correlation (r=0.926). The mean intra-assay coefficient of variation was 17.6% (range=6.1-50.7%) for the RIA (n=10 samples) and 5.2% (range=0.4-17.0%) for the CLIA assay (n=26 samples).
Conclusion:
This study showed that CLIA for CA19-9 has a good reliability on all samples analyzed and should be preferred to RIA with the aim of reducing costs, greater standardization and more harmonized results.

