Technical performance of the Elecsys (R) CA 72-4 test - Development and field study

Tumor-associated glycoprotein (TAG) 72 is a mucin-like protein of high mole cular weight (220-400 kd). Elevated se,um levels of TAG72 are preferentiall y observed in patients suffering from gastric cancer. Additionally the dete rmination of TAG72 may be a helpful tool in the management of patients suff ering from mucinous ovarian cancer, in whom the clinical sensitivity of CA1 25 is low. The new Elecys(R) CA72-4 assay-available as Elecsys(R) 2010 and 1010-was evaluated in a first field study. The test has a wide measuring ra nge (300 U/ml) and low detection limit (0.5 U/ml) which favours its routine use. Typical precision values are 2% for intra-assay, 4% for inter-assay a nd 6% for inter-instrument-precision. Method comparisons to Enzymun-Test(R) CA72-4 showed a correlation between 0.91 and 0.96. The correlation to a co mmercially available RIA was 0.8. With human ascites material no Hook-effec t was observed up to 20,000 U/ml. No HAMA-interference with clinically rele vant HAMA-samples was detected.