[Basic and clinical studies on serum cytokeratin 19 fragment assay using Centocor CYFRA 21-1 kit in patients with lung cancer]. 1994

A Hamase, and Y Sugimoto, and M Maeda, and H Kitani, and M Fukuchi
Department of Nuclear Medicine, Hyogo College of Medicine.

We evaluated the newly developed tumor marker assay kit, "Centocor CYFRA 21-1", an immunoradiometric assay (IRMA) kit for determining the serum cytokeratin 19 fragment using the sera of healthy subjects, patients with benign lung diseases and patients with lung cancer. The assay procedure is simple and based on the one-step IRMA system. There were no problems in reproducibility, dilution test and recovery test. The minimum detectable dose was 0.3 ng/ml. The antigen measured by this kit was immunologically cross-reactive with tissue polypeptide antigen (TPA) and CYFRA 21-1 concentration was closely correlated with TPA concentration in the patient's serum (r = 0.86, p < 0.01). The cut-off value of serum CYFRA 21-1 based on the assay results of this kit was calculated to be 1.6 ng/ml from the receiver operating characteristic curve. Three of 47 healthy subjects (6.4%) and 9 of 30 patients with benign lung diseases (30.0%) showed a concentration over the cut-off value. By contrast, serum CYFRA 21-1 concentration was elevated in 31 of 50 patients with lung cancer (62.0%), 11 of 13 squamous cell carcinoma patients (84.6%), 8 of 12 small cell carcinoma patients (66.7%), 4 of 7 large cell carcinoma patients (57.1%) and 8 of 18 adenocarcinoma patients (44.4%). In addition, the positive rate of serum CYFRA 21-1 in patients with lung cancer gradually increased with staging of the disease: 50.0% in stage I, 50.0% in stage II, 61.9% in stage III, and 76.9% in stage IV. Thus, our results suggested that the Centocor CYFRA 21-1 kit is a useful assay system for serum cytokeratin 19 fragment as a tumor marker in patients with lung cancer.

UI MeSH Term Description Entries
D007633 Keratins A class of fibrous proteins or scleroproteins that represents the principal constituent of EPIDERMIS; HAIR; NAILS; horny tissues, and the organic matrix of tooth ENAMEL. Two major conformational groups have been characterized, alpha-keratin, whose peptide backbone forms a coiled-coil alpha helical structure consisting of TYPE I KERATIN and a TYPE II KERATIN, and beta-keratin, whose backbone forms a zigzag or pleated sheet structure. alpha-Keratins have been classified into at least 20 subtypes. In addition multiple isoforms of subtypes have been found which may be due to GENE DUPLICATION. Cytokeratin,Keratin Associated Protein,Keratin,Keratin-Associated Proteins,alpha-Keratin,Associated Protein, Keratin,Keratin Associated Proteins,Protein, Keratin Associated,alpha Keratin
D008175 Lung Neoplasms Tumors or cancer of the LUNG. Cancer of Lung,Lung Cancer,Pulmonary Cancer,Pulmonary Neoplasms,Cancer of the Lung,Neoplasms, Lung,Neoplasms, Pulmonary,Cancer, Lung,Cancer, Pulmonary,Cancers, Lung,Cancers, Pulmonary,Lung Cancers,Lung Neoplasm,Neoplasm, Lung,Neoplasm, Pulmonary,Pulmonary Cancers,Pulmonary Neoplasm
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010446 Peptide Fragments Partial proteins formed by partial hydrolysis of complete proteins or generated through PROTEIN ENGINEERING techniques. Peptide Fragment,Fragment, Peptide,Fragments, Peptide
D011933 Reagent Kits, Diagnostic Commercially prepared reagent sets, with accessory devices, containing all of the major components and literature necessary to perform one or more designated diagnostic tests or procedures. They may be for laboratory or personal use. Diagnostic Reagent Kits,Diagnostic Reagents and Test Kits,Diagnostic Test Kits,In Vitro Diagnostic Device,In Vitro Diagnostic Devices,In Vitro Diagnostic Medical Device,In Vitro Diagnostic Medical Devices,Kits, Diagnostic Reagent,Diagnostic Reagent Kit,Diagnostic Test Kit,Kit, Diagnostic Reagent,Kit, Diagnostic Test,Kits, Diagnostic Test,Reagent Kit, Diagnostic,Test Kit, Diagnostic,Test Kits, Diagnostic
D005069 Evaluation Studies as Topic Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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