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Prostate-specific antigen is found in the prostate in two forms, one with a low (30,000) and one with a high (100,000) relative molecular mass. The latter has recently been found to be a complex of prostate-specific antigen with alpha 1-antichymotrypsin. Immunoluminometric assays were designed for the prostate-specific antigen-alpha 1-antichymotrypsin complex as well as for alpha 1-antichymotrypsin, the former being compared with a commercially available radioimmunoassay for prostate-specific antigen (ProsChek RIA-Yang Laboratories). The precision of the immunoluminometric assays was acceptable (intra-assay variation less than 7%; inter-assay variation less than 8.5%) in the measuring ranges 0-90 micrograms/l for the prostate-specific antigen-alpha 1-antichymotrypsin complex and 0-12 g/l for alpha 1-antichymotrypsin. The correlation between the assays for prostate-specific antigen and prostate-specific antigen-alpha 1-antichymotrypsin complex was acceptable, showing a correlation coefficient r = 0.83 after double logarithmic transformation, or r = 0.85 using the Spearman rank correlation on 131 data pairs. Extremely high alpha 1-antichymotrypsin levels (above 2 g/l) caused interference in the prostate-specific antigen-alpha 1-antichymotrypsin complex assay. Such levels, although rare, are encountered in pulmonary inflammatory disease. The reference ranges for the three assays were found to be as follows: prostate-specific antigen 0.13-4.63 micrograms/l, prostate-specific antigen-alpha 1-antichymotrypsin complex 0.08-1.78 microgram/l, and for alpha 1-antichymotrypsin 0.27-0.61 g/l. These values were obtained from 82 hospitalised males for the first two assays and from 80 males and females free from infection for the latter.(ABSTRACT TRUNCATED AT 250 WORDS)

The Establishment and Evaluation of Luminescent-Labelled Immunometric Assays for Prostate-Speciflc Antigen-α 1 -Antichymotrypsin Complexes in Serum