Technical performance of the Elecsys CA 72-4 test--development and field study.
Tumor-associated glycoprotein (TAG) 72 is a mucin-like protein of high molecular weight (220-400 kd). Elevated serum levels of TAG72 are preferentially observed in patients suffering from gastric cancer. Additionally the determination of TAG72 may be a helpful tool in the management of patients suffering from mucinous ovarian cancer, in whom the clinical sensitivity of CA125 is low. The new Elecsys CA72-4 assay-available as Elecsys 2010 and 1010--was evaluated in a first field study. The test has a wide measuring range (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 and 6% for inter-instrument-precision. Method comparisons to Enzymun-Test CA72-4 showed a correlation between 0.91 and 0.96. The correlation to a commercially available RIA was 0.8. With human ascites material no Hook-effect was observed up to 20,000 U/ml. No Hama-interference with clinically relevant HAMA-samples was detected.
Filella
X
X
Laboratorio de Biochimica, Hospital Clinic Provinciac del Barcelona, Barcelona, Spain.
Friese
S
S
Roth
H J
HJ
Nussbaum
S
S
Wehnl
B
B
D000951:Antigens, Neoplasm / Q000032:analysis*; D019937:Diagnostic Techniques and Procedures; D006023:Glycoproteins / Q000032:analysis*; D006801:Humans; D007753:Laboratories / Q000592:standards; D011786:Quality Control; D011933:Reagent Kits, Diagnostic
D000951:Antigens, Neoplasm; D006023:Glycoproteins; D011933:Reagent Kits, Diagnostic; C047052:tumor-associated antigen 72