[Evaluation of a cytokeratin 19 assay kit "BALL ELSA CYFRA21-1"].
We evaluated "BALL ELSA CYFRA21-1" kit, an immunoradiometric assay kit for cytokeratin 19. Monoclonal antibodies KS19-1 and BM19-21 are used for immunoadsorbent and indicator, respectively. There was no problems in reproducibility, dilution test and recovery test. Minimum detectable concentration was 0.42 ng/ml. The antigen measured by this kit was immunologically cross-reactive with tissue polypeptide antigen (TPA) and CYFRA21-1 concentration was closely correlated with TPA concentration in patient's serum. One of twenty-six healthy subjects showed serum concentration over a cut-off value of 2.0 ng/ml. Serum CYFRA21-1 concentration elevated in 5 of 10 esophageal cancer patients, 5 of 10 gastric cancer patients, 7 of 10 colorectal cancer patients and 6 of 10 pancreatic cancer patients. Positive rate in patients with benign disease including hepatopathy was low. BALL ELSA CYFRA21-1 kit is reliable and CYFRA21-1 could be a useful tumor marker in gastrointestinal cancer.
Sakahara
H
H
Department of Nuclear Medicine, Faculty of Medicine, Kyoto University.
Kousaka
T
T
Hattori
N
N
Hosono
M
M
Kobayashi
H
H
Shirato
M
M
Yao
Z
Z
Konishi
J
J
D000328:Adult; D000911:Antibodies, Monoclonal; D000951:Antigens, Neoplasm / Q000097:blood*; D014408:Biomarkers, Tumor / Q000097:blood*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay / Q000379:methods*; D053539:Keratin-19; D007633:Keratins / Q000097:blood*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000175:diagnosis; D011933:Reagent Kits, Diagnostic / Q000592:standards*
D000911:Antibodies, Monoclonal; D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; D053539:Keratin-19; D011933:Reagent Kits, Diagnostic; C102012:antigen CYFRA21.1; D007633:Keratins