Development of a new Prolifigen TPA IRMA assay using monoclonal anti-cytokeratin antibodies.
A new immunoassay for TPA determination has been developed in which anticytokeratin monoclonal antibodies are used. A three-Mab combination with different anticytokeratin antibody specificities has been selected to mimic the complex pattern found for the polyclonal anti-TPA antibody. The accuracy of the assay is good, as judged from analytical-recovery experiments, analysis of quality-assessment samples and comparison with the polyclonal Prolifigen TPA IRMA. No significant interferences or cross-reactivities have been identified. The lower limit of detection of the assay (mean + 3 SD of the zero standard) is below 15 U/L and the imprecision in low, giving a working range of 15-4000 U/L. The improved handling of the assay, including a single incubation step of 2 hours with shaking at room temperature, results in a narrower normal distribution, thereby giving a better separation of normal and pathological samples.
Sundström
B E
BE
AB Sangtec Medical, Bromma, Sweden.
D'Amico
Y
Y
Brundell
J
J
D000818:Animals; D000911:Antibodies, Monoclonal; D000918:Antibody Specificity; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000097:blood / Q000276:immunology; D000939:Epitopes; D005069:Evaluation Studies as Topic; D006801:Humans; D015592:Immunoradiometric Assay / Q000379:methods*; D007633:Keratins / Q000276:immunology*; D051379:Mice; D009369:Neoplasms / Q000097:blood / Q000175:diagnosis / Q000276:immunology; D010455:Peptides / Q000032:analysis* / Q000097:blood / Q000276:immunology; D019396:Tissue Polypeptide Antigen
D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D000939:Epitopes; D010455:Peptides; D019396:Tissue Polypeptide Antigen; D007633:Keratins