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Clinical Chemistry 39: 522-529, 1993;
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Clinical Chemistry, Vol 39, 522-529, Copyright © 1993 by American Association for Clinical Chemistry

Modified method for determining carcinoembryonic antigen in the presence of human anti-murine antibodies [published erratum appears in Clin Chem 1993 Nov;39(11 Pt 1):2343]

NE Morrissey, SF Quadri, R Kinders, C Brigham, S Rose and MJ Blend
Humana Hospital-Michael Reese, Division of Nuclear Medicine, Chicago, IL 60616.

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.


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Copyright © 1993 by the American Association for Clinical Chemistry.