[A study of preclinical and clinical usefulness of new tumor markers of ovarian carcinoma, CA 54/61 and CA 602. 1. Evaluation of the diagnostic accuracy of CA 54/61, a study of the normal range of its values and its correlation with other tumor markers].
We made a preclinical study of CA 54/61, a recently developed marker of ovarian tumors, and also conducted a clinical study of it using serum samples collected from 58 institutions located throughout Japan. This paper describes the results of the preclinical study of the CA 54/61 marker that were obtained with a kit based on an enzyme immunoassay (EIA), and also the findings with the kit in the clinical study pertaining to the normal range of its values, its values relative to age, menstrual cycle, and pregnancy, and its correlations with other tumor markers. The tests for reproducibility of assay results, the analytical recovery test, and the dilution test all gave favorable results: the marker proved reliable in both precision and reproducibility. Two cut-off values were used: the mean + 2 S.D. of the mean for healthy subjects, or 20 U/ml; and the value for the maximum diagnostic efficacy, i.e., 12 U/ml. The assay results did not vary greatly with either age, menstrual cycle or pregnancy stage, which suggested that CA 54/61 might be a marker less liable to be affected by physiological conditions prevailing at the time of sample collection. The result correlated poorly with those of assays with other markers; thus CA 54/61 proved to differ in property from the previously recognized tumor markers.
Nozawa
S
S
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo, Japan.
Udagawa
Y
Y
Sasaki
H
H
Ito
K
K
Akiya
K
K
Terashima
Y
Y
Takamizawa
H
H
Ohkura
H
H
Fujimoto
S
S
Hasimoto
M
M
D000293:Adolescent; D000328:Adult; D015295:Antigens, Tumor-Associated, Carbohydrate / Q000097:blood*; D014408:Biomarkers, Tumor / Q000097:blood / Q000592:standards*; D002940:Circadian Rhythm; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D008597:Menstrual Cycle; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010051:Ovarian Neoplasms / Q000175:diagnosis*; D011247:Pregnancy
D015295:Antigens, Tumor-Associated, Carbohydrate; D014408:Biomarkers, Tumor