Modified method for determining carcinoembryonic antigen in the presence of human anti-murine antibodies.
The increasing use of monoclonal antibodies (MAbs) for disease diagnosis and therapy has created a class of patients at risk for systematic error in clinical testing due to interference by human anti-murine antibodies (HAMA). HAMA interference is often difficult to detect and can cause either an increase or a decrease in apparent concentrations of antigen present. We undertook a clinical study to test a HAMA-resistant enzyme immunoassay (EIA) format for carcinoembryonic antigen (CEA) determination. Using the Food and Drug Administration-approved CEA-EIA Monoclonal One-Step Assay (Abbott) with the addition of an acid/heat extraction of patients' specimens, we found that the resulting CEA values accurately reflected the patients' status. We demonstrated that the acid/heat-extracted specimens yield linear dilution curves and show analytical recoveries of added CEA in the range of 76-123% in HAMA-positive specimens and 86-103% in HAMA-negative specimens. The correlation of CEA values in extracted vs unextracted specimens from 184 patients and control subjects was 0.9963. The CEA detection limit of the assay was 1.6 micrograms/L for the extracted samples.
Morrissey
N E
NE
Humana Hospital-Michael Reese, Division of Nuclear Medicine, Chicago, IL 60616.
Quadri
S F
SF
Kinders
R
R
Brigham
C
C
Rose
S
S
Blend
M J
MJ
D000818:Animals; D000911:Antibodies, Monoclonal / Q000097:blood*; D002272:Carcinoembryonic Antigen / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques; D051379:Mice; D015203:Reproducibility of Results
D000911:Antibodies, Monoclonal; D002272:Carcinoembryonic Antigen