OVCA (CA125) 2ND-GENERATION - TECHNICAL ASPECTS AND SERUM LEVELS IN CONTROLS, PATIENTS WITH LIVER-DISEASE, PREGNANT-WOMEN AND PATIENTS WITHOVARIAN DISEASE

An immunoradiometric method of the second generation (IR-MA II) is wid ely used to determine CA125 serum levels. In this study we have evalua ted the performance characteristics of a commercially available IRMA C A125 II (Byk-Gulden, Sangtec Diagnostica); The CA125 serum levels were determined in several groups of patients (healthy women, pregnant wom en, subjects affected by benign and malignant ovarian cancer, patients with liver diseases) with two IRMAs CA125 II (Byk-Gulden, Sangtec Dia gnostica and Centocor, Diagnostic Division) and IRMA CA125 I (Byk-Guld en, Sangtec Diagnostica). Our results show a good analytic performance of IRMA CA125 II (Byk-Gulden, Sangtec Diagnostica), a good correlatio n between IRMAs CA125 II (Byk-Gulden. Sangtec Diagnostica and Centocor , Diagnostic Division), but an unacceptable correlation between IRMAs CA125 II (Byk-Gulden, Sangtec Diagnostica and Centocor, Diagnostic Div ision) and IRMA CA125 I. A statistically significant difference was ob served comparing the values obtained with both IRMAs CA125 II and IRMA CA125 I in the groups of patients, In contrast no statistically signi ficant difference was observed when we compared the values obtained wi th IRMA CA125 II (Byk-Gulden, Sangtec Diagnostica) and IRMA CA125 II ( Centocor, Diagnostic Division), CA125 serum values obtained with the s econd-generation kits were different from those obtained with the firs t-generation one; consequently, it is important, especially in the fol low-up of cancer patients, that CA125 serum values be obtained with ki ts of the same generation. Our data seem to suggest the use of second generation kits to determine CA125 serum levels.