Preferred Sample Type

Cancer Antigen 15-3 (CA 153)

Suitable Specimen Types

  • Serum
  • EDTA Plasma
  • Li Hep Plasma
5-10 mL vacutainer (minimum sample volume 200 uL)

Sample Processing in Laboratory


Sample Preparation


Turnaround Time

7 days

Sample Stability

Stable at 4 ºC for up to five days. For longer periods store the serum at -20 ºC.

Cancer Antigen 15-3 (CA 153)

General Information

CA 15-3 is a transmembrane glycoprotein encoded by the MUC1 gene. It is defined by reactivity with 2 monoclonal antibodies, i.e., DF3 and 115D8 in a sandwich immunoassay. It is primarilty used as a marker of breast cancer.

Elevated CA 15-3 levels can also be seen in bronchial carcinmona, ovarian carcinoma, pancreatic carcinmona, colo-rectal carcinmoa as well as in non-malignant conditions such as chronic active hepatitis, liver cirrhosis, sarcoidosis, hypothyroidism, and megablastic anemia.

Due to this, and because the incidence of CA 15-3 elevation in breast cancer is low (23%), CA 15-3 should not be used to diagnose or screen for primary breast cancer. In combination with radiology and clinical examination, CA 15-3 may be used to monitor chemotherapy in patients with advanced breast cancer. For patients with nonevaluable disease, sustained increases in marker concentrations suggest progressive disease. 2 successive increases (e.g., each >30%) are likely to indicate progressive disease.

Patient Preparation

Samples from patients receiving high biotin doses (i.e. >5 mg/day) should be taken at least 8 hours post dose.

Please inform the laboratory if the patient has been treated with monoclonal mouse antibodies or may have received them for diagnostic purposes.


Samples should be clot free and free of red blood cells or other particulate matter. The presence of fibrin may cause erroneous results.


Pathology Harmony have recently issued guidance on appropriate tumour marker requesting.  For information please click on the following link:

If you would like some copies of the bookmark please contact the Duty Biochemist (bleep 2506).

Reference Range

<31.3 kU/L

Source : Abbott Diagnostics


  • EQA Scheme?: Yes
  • EQA Status:


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The Trust Laboratories at Heartlands Hospital, Good Hope Hospital and Solihull Hospital were awarded UKAS (United Kingdom Accreditation Service) accreditation to the internationally recognised ISO 15189 standard in May 2015. For a list of accredited tests and other information please visit the test database
Tests not appearing on this scope are either under consideration or in the process of accreditation and so currently remain outside of our scope of accreditation. However, these tests have been validated to the same high standard as accredited tests and are performed by the same trained and competent staff.

For further information contact Louise Fallon, Quality Manager, 0121 424 1235