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Interassay Comparison of the Tumor Markers CA125, CA15.3, and CA27.29
Journal article   Open access   Peer reviewed

Interassay Comparison of the Tumor Markers CA125, CA15.3, and CA27.29

Gabrielle N Winston-McPherson, Anna E Merrill, Sheng-Ying Lo, Andrew N Hoofnagle and Dina N Greene
The journal of applied laboratory medicine, Vol.2(1), pp.17-24
07/01/2017
DOI: 10.1373/jalm.2016.021436
PMID: 33636961
url
https://doi.org/10.1373/jalm.2016.021436View
Published (Version of record) Open Access

Abstract

Cancer antigens 125, 27.29, and 15-3 (CA125, CA27.29, and CA15-3) are markers of ovarian and breast cancer. Comparing tumor marker results across methods is challenging because of the lack of harmonization. Documenting comparability of results is important. Siemens Advia Centaur CA125 and CA27.29 assays were compared to their corresponding Beckman Coulter DxI CA125 and CA15-3 assays. The interassay bias was determined and the manufacturer-recommended reference intervals were evaluated. The DxI CA125 assay demonstrated an overall positive 29% bias relative to the Centaur CA125 assay. The DxI CA15-3 assay demonstrated an overall negative 65% bias relative to the Centaur CA27.29 assay. For patients with multiple comparisons during the study period, the trend of results over time was similar across both sets of assays. Implementing the manufacturer-recommended reference interval for the DxI CA125 assay increased the abnormal flagging rate by 4.5%. In contrast, implementing the manufacturer-recommended reference interval for the DxI CA15-3 assay decreased the abnormal flagging rate by 13.0%. The overall trends for the majority of patients were similar. Therefore, despite the overall biases, transitioning tumor marker assays should not affect clinical interpretation of results.

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