Clinical validation of the new ELSA-CA 125 II assay: Report of a european multicentre evaluation
✍ Scribed by Maryvonne Clement; Paul Bischof; Claire Gruffat; Gabriel Ricolleau; Eliane Auvray; Véronique Quilien; Carmen Pacheco; Miguel Torres; Marco Ferdeghini
- Book ID
- 102277893
- Publisher
- John Wiley and Sons
- Year
- 1995
- Tongue
- French
- Weight
- 472 KB
- Volume
- 60
- Category
- Article
- ISSN
- 0020-7136
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✦ Synopsis
The ELSA-CA 125 II is a second-generation radioimmunoassay for the quantification of CA I25 in serum. In a multicentre study involving 49 follow-ups of patients with ovarian cancers, and 880 other patients, 2.8% of healthy persons, 25% of 149 patients with benign gynaecological diseases and 39% of 82 patients with benign non-gynaecological diseases had CA I25 levels above 35 U/ml. Using the 35 U/ml cut-off, sensitivities among epithelial ovarian cancers were found to be 85% in serous tumors, 41% in mucinous tumors and 83% in other types. During follow-up of patients with serous ovarian cancers, we observed an equivalent behaviour of both assays-first-and second-generation-with the clinical evolution. We also compared results obtained with other assays commercially available; these were significantly different when a polyclonal antibody was used in the sandwich assay.