CA15-3 Rapid Test Cassette

【SUMMARY】
CA15-3, for Carcinoma Antigen 15-3, is a tumor marker for many types of cancer, most notably breast cancer. It is derived from MUC1. CA15-3 and associated CA 27-29 are different epitopes on the same protein antigen product of the breast cancer-associated MUC1 gene.

Elevated CA15-3, in conjunction with alkaline phosphatase (ALP), was found to be associated with an increased chance of early recurrence in breast cancer. Both CA15-3 and CA 27-29 may be elevated in patients with benign ovarian cysts, benign breast disease, and benign liver disease. Elevations may also be seen in cirrhosis, sarcoidosis and lupus. CA 15-3 is now being regarded as a reliable prognostic marker for breast cancer.

【DIRECTIONS FOR USE】
Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature (15-30℃) prior to testing.
1. Remove the Test Cassette from the foil pouch and use it as soon as possible. Best results will
be obtained if the assay is performed within one hour.
2. Place the test cassette on a clean and level surface.
For Serum or Plasma specimens:
Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 ul) to the specimen well (S) of the test cassette, then start the timer. See illustration below.
For Venipuncture Whole Blood specimens:
Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 ul) to the specimen well (S) of the test cassette, and add 1 drop of buffer (approximately 40 ul), then start the timer. See illustration below.
For Fingerstick Whole Blood specimens:
To use a capillary tube: Fill the capillary tube and transfer approximately 75 ul of fingerstick whole blood specimen to the specimen well (S) of the test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. Wait for the colored line is appeared. The result should be read at 10 minutes. Do not interpret
the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.