[Immunoradiometric assay of tumor marker CA15-3 and its clinical application].
OBJECTIVE
To develop a new tumor marker immunoradiometric assay and to evaluate its preliminary clinical application.


METHODS
With monoclonal antibodies Ma552 and Ma695 from Sweden, a sandwich immunoradiometric assay was developed with Ma552 as catching antibody and Ma695 as tracer. The Ma552 was coated on polystyrene beads, and Ma695 was labeled with 125-I. The reaction was one step at room temperature.


RESULTS
Bmax/B0 of the standard curve was 82. The sensitivity of this assay was 0.3 u/ml, CV within assay and CV between assays were 8% and 10%, respectively. Serum level of CA 15-3 in 50 normal women was 11.3 +/- 3.9 u/ml with a false positive rate of 0% based on the cut-off value of 30 U/ml. In 40 patients with benign breast diseases the serum level was 9.6 +/- 5.8 u/ml with a false positive rate of 0%. In 65 cases of breast cancers in different stages it was 88.4 +/- 159.6 u/ml before treatments with a total positive detection rate of 50.8%. Metastases, especially, bone metastases caused significant serum CA15-3 elevation, with 100% positive rate(n = 9). The positive rate of recurrences of beast cancers was 80% (n = 5).


CONCLUSIONS
The newly established immunoradiometric assay of CA15-3 is highly useful in the diagnosis, differential diagnosis, and monitoring of metastases and recurrences of breast cancer, and is superior to CEA.
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing.
Z
Z
Chen
Z
Z
Fan
J
J
Yang
D000951:Antigens, Neoplasm / Q000097:blood*; D014408:Biomarkers, Tumor / Q000097:blood*; D001859:Bone Neoplasms / Q000175:diagnosis / Q000556:secondary; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D003937:Diagnosis, Differential; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay; D018396:Mucin-1 / Q000097:blood*; D009364:Neoplasm Recurrence, Local
D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; D018396:Mucin-1