[A basic and clinical study of CA 19-9-MP-Mitsui kit for determination of CA 19-9].
Recently, the CA 19-9-MP-Mitsui kit (MP-kit) by a sandwich enzyme immunoassay using two mouse monoclonal antibodies of C192 and C241 for the determination of CA 19-9 was developed by Mitsui Pharmaceutical Co., Ltd.. We carried out basic and clinical studies of MP-kit for the serum CA 19-9 in comparison with the Immunoclone CA 19-9 EIA kit (I-kit) which was provided by Fuji-Rebio Company. It was found that MP-kit appeared to have excellent reproducibility with high sensitivity and specificity for CA 19-9. Furthermore, the coefficient of positive correlation was as high as 0.92 in serum CA 19-9 level between MP-kit and I-kit in the determination of serum CA 19-9 in 67 cases by each of two kits. On the other hand, with two kits, it was found that employment of a cut off value more than 70 U/ml brought a highest diagnostic efficiency for pancreatic and bile duct cancers, while employment of a cut off value of 37 U/ml which was used routinely resulted in a high false positive incidence, particularly in liver cirrhosis or hepatitis. From the results, it is concluded that a pertinent cut off value of CA 19-9 in serum was about 70 U/ml and MP-kit was available for determination of CA 19-9 in serum such as the other known kits on the market for CA 19-9.
Ishii
M
M
Division of Gastroenterology Clinic, Saitama Cancer Center.
Iida
M
M
Seino
Y
Y
D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology; D014408:Biomarkers, Tumor / Q000097:blood*; D018395:CA-19-9 Antigen / Q000097:blood*; D005069:Evaluation Studies as Topic; D006505:Hepatitis / Q000175:diagnosis; D006801:Humans; D007124:Immunoenzyme Techniques; D008103:Liver Cirrhosis / Q000175:diagnosis; D051379:Mice; D009369:Neoplasms / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity
D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D011933:Reagent Kits, Diagnostic