[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.
Chen
Z
Z
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing.
Fan
Z
Z
Yang
J
J
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