CA-125 Rapid Test

Product information

The CA-125 test is a rapid qualitative assay for the detection of ovarian cancer antigen in serum, plasma or whole blood to be used as a screening test.

Advantages of CA-125 test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

A wide variety of biomarkers have been identified to monitor growth of ovarian cancer and to detect disease at an early stage to give the best prognosis to the patient. Useful predictive cancer markers have the potential to increase efficacy and decrease toxicity of the treatment. Optimal use of tumor markers in routine requires that to adhere to good clinical and laboratory practices.

CA 125 is a serum tumor marker for monitoring response to chemotherapy, detecting disease recurrence and distinguishing malignant from benign pelvic masses, but is not recommended for cancer prime diagnosis. A rapid fall in CA-125 during the chemotherapy process predicts a favorable prognosis. A rising in CA-125 can be used to trigger transvaginal sonography in a small fraction of patients.

Most of ovarian cancers are from epithelial origin and 70 % of cases occur in women aged of more than 50 years. Most studies recommend a decision level of 35 U/mL (4). However the CA-125 is not specific of the ovarian cancer and rising can be observed in some breast, lung or digestive tract cancers. Moreover, concentration higher than the reference level can also be found in some benign ovarian, uterus or liver pathologies.

CA 125 is also commonly increased in decompensated cirrhotic patients in proportion to the degree of ascites. Moreover the elevation of ovarian cancer antigen suggests an association between the activation of the peritoneal defense mechanisms and the production of CA-125 by the mesothelial tissue.

The CA-125 Rapid Test is a qualitative assay for the detection of ovarian cancer antigen in serum, plasma or whole blood to be used as a screening test. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to identify CA-125 in the test samples with a high degree of specificity.

As the sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the CA-125 contained in sample. This complex migrates on the membrane and is bound by the polyclonal anti-CA-125 antibodies coated on the solid phase in the reaction zone. If the sample contains a CA 125 concentration higher than 35 U/mL, a colored band will appear in the test zone. The mixture continues flowing through the absorbent device past the reactive zone and control zone. Unbound conjugate binds to the reagents in the control zone, producing a pink color band and demonstrating that the reagents are functioning correctly.

Test procedure

1. Allow samples and CA-125 test devices to come to room temperature prior to testing.
2. Remove the “reaction device” from its protective wrapper by tearing along the split.
3. Label device with the patient’s name or control number.
4. Fill the serum dropper with specimens (serum, plasma or whole blood) and by holding it vertically, dispense one drop (25μL) of serum or plasma into sample well. If whole blood is used, dispense 2 drops (50 μL) into sample well and wait for the whole blood sample to be completely absorbed before adding diluent.
5. Add exactly 5 full drops of diluent (200 μL) into the sample well.
6. Read the results after 15 minutes. Do not interpret after 20 minutes.

Interpretation of the results

Negative result: Only one colored band appears on the control zone (C).

Positive result: Two clearly distinguishable lines appear (T and C).

Invalid result: If no line at all appears the test is inconclusive. In this case it is recommended that the test be repeated or a fresh specimen obtained and tested 48 hours later.