Preoperative serum levels of the tumor markers CA 50, CA 19‐9, CA 19‐9 TruQuant, CA 72‐4, CA 195, carcinoembryonic antigen (CEA), and tissue polypeptide antigen (TPA) were measured in 94 patients with well‐staged adenocarcinoma of the stomach and in 15 patients with benign gastric diseases. In all patients with carcinoma, a laparotomy was done. The serum levels were correlated with the stage of disease, the location of the primary tumor, and the resectability and grade of differentiation. The marker CA 50 was the best, with an overall positivity of 59.5%. For CA 19‐9, this figure was 34%; for CA 19‐9 TruQuant, 22%; for CA 72‐4, 34%; for CA 195, 29%; for CEA, 33%; and for TPA, 50%. The best combination of two markers was CA 50 and TPA; this combination gave a positivity of 81%. There was no evident correlation with stage of disease and the percentage of positive serum levels or the median serum levels. The marker CA 50 gave the widest range of elevated serum levels between the cutoff level and the 90th percentile (54%). Patients with carcinoma of the cardia had higher preoperative serum levels than those with a tumor in other parts of the stomach. There was no correlation with the respectability of the tumor and the preoperative serum level. Patients with an undifferentiated tumors did not have significantly lower serum levels than those with more differentiated tumors. Currently, preoperative determination of serum tumor marker levels in patients with gastric carcinoma has no significance in clinical practice.
Fifteen immunoassay kits for serum hCG(-β) measurements have been compared for their analytical characteristics and clinical usefulness in tumour monitoring. Three out of 13 radioimmunoassays and two sandwich hCG immunoassays represent the ‘one-component’ techniques for intact hCG detection since they are based on antiserum raised against intact hCG. Within this group, method-comparison slopes ranged between 0·149 and 0·374. The remaining 10 radioimmunoassays all apply antiserum against hCG-β and are designated ‘two (or more)–component’ assays since they detect both intact hCG and the free β-subunit (‘total hCG’). For this reason these assays are of potential value for tumour monitoring. Additional criteria for this are: (1) the expression of assay results in terms of 1st IRP-hCG instead of the unstructured use of the 2nd IS or the 1st IRP-hCG-β; (2) documentation of cross-reactivities especially for the free β-subunits of hCG and hLH which are almost completely lacking; (3) establishment of the minimum detectable dose in the presence of normo-to-hypergonadotrophic hLH levels in serum (the ‘clinical sensitivity’) to allow the follow-up of tumour regression especially in the low-dose region. Method-comparison analysis for these assays revealed regression slopes between 0·001 and 0·873.
An in-house OC 125 monoclonal antibody-based "sandwich" immunofluorometric assay (IFMA) described previously (Clin Chem 1987; 33:2191-4) gave higher results for CA 125 in 37 of 123 serum samples than did a commercially available immunoradiometric assay (IRMA). Discordant results between the two assays became concordant when measurements of the samples were repeated with normal mouse serum (100 mL/L) included in the IFMA reagent. The murine immunoglobulins are thought to block the ability of the heterophilic antibodies in the human serum samples to cross-link the labeled antibody with the solid-phase antibody. Using an enzyme immunoassay, we demonstrated human anti-mouse antibodies (HAMA) in most of the discordant samples examined. We tested the ability of nonimmune sera from other animal species to lower the apparent CA 125 concentrations of the spurious samples and observed that rat, goat, and sheep serum were less effective than mouse serum. One serum sample was discovered to give a falsely increased CA 125 result with the IRMA, but this increase could be prevented by adding murine serum to the IRMA reagent. We conclude that falsely increased CA 125 results are best prevented by adding murine serum (or murine antibodies) to the assay buffer.
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