Clinical evaluation comparing AxSYM® CA 15-3(TM), IMx® CA 15-3 and truquant® BR(TM)RIA

A retrospective clinical study was conducted to compare results obtained by AxSYM® CA 15-3(TM), IMx® CA 15-3 and Truquant® BR(TM) RIA using surplus serum specimens from healthy volunteers and patients with benign and malignant diseases. Linear regression analysis of AxSYM and IMx CA 15-3 versus Truquant BR RIA for specimens with results 0250 U/ml gave correlation coefficients of 0.888 and 0.910 and slopes of 0.67 and 0.69, respectively. For specimens with results 0-2,000 U/ml, slopes were 0.95 and 0.91, respectively. Receiver operator characteristic analyses, based on results from healthy females plus nonmalignant disease patients versus breast cancer patients, for all three assays gave essentially equivalent areas under the curves. Concordance between AxSYM or IMx CA 15-3 and Truquant BR RIA was greater than 92%. Serial dilution of seven serum specimens yielded linear regression correlation coefficients ranging from 0.997 to 1.000 for AxSYM and IMx CA 15-3, and from 0.962 to 0.998 for Truquant BR RIA. The average percent CVs of the calculated assay values for the 7 specimens were 4.9, 2.7 and 18.1 for AxSYM CA 15-3, IMx CA 15-3 and Truquant BR RIA, respectively. Average percent recoveries ranged from 96.2 to 110.7 for AxSYM and IMx CA 15-3, and 81.8 to 93.3 for Truquant BR RIA. Although assay values differ between the two methodologies, AxSYM CA 15-3, IMx CA 15-3 and Truquant BR RIA showed comparable trending results for the 24 breast cancer patients evaluated for serial monitoring.