Cancer Antigen 15-3 Rapid Test Cassette

• Easy to use
• No equipment required
• High sensitivity and specificity
• Fast results at 10 minutes

Cancer antigen 15-3(CA15-3) is a mucinous carbohydrate antigen product of the MUC1 gene, originally identified by two monoclonal antibodies: DF3 raised against metastatic breast cancer cells and 115D8 raised against human milk fat globule membrane.1,2It is found on the surface of many types of cancer cells and shed into the blood stream.CA15-3 is a tumor marker used to monitor certain cancers, especially breast cancer. It is most useful for monitoring patients post-operatively for recurrence, particularly metastatic diseases.3,4 96% of patients with local and systemic recurrence have elevated CA15-3, which can be used to predict recurrence earlier than radiological and clinical criteria.50% decrease in serum CA15-3 is associated with response to treatment. CA15-3 is more sensitive than CEA in early detection of breast cancer recurrence.

CA15-3, although preferentially associated with breast cancer, is not tissue specific, and only about 10% of women with early localized breast cancer have elevated CA15-3. Besides, CA15-3 may also be elevated in a variety of conditions, including cancer of the lung, pancreas, ovary, prostate, and colon as well as cirrhosis, hepatitis, and benign breast disorders and in a certain percentage of apparently healthy individuals.5The CA15-3 Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a combination of colloidal gold conjugare and anti-CA15-3 antibodies to selectively detect total CA15-3 in whole blood, serumor plasma. The test has a cut-off value or a reference value of 30 U/ml. The reference range of CA 15-3 is less than 30 IU/ml.

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the cassette on a clean and level surface. For Serum, Plasma or Venipuncture Whole Blood specimen:
• Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40µl) or 2 drops of venipuncture whole blood (approximately 80 µl)) to the specimen well (S) of thecassette, then add 1 drop of buffer (approximately 40µl) and start the timer.See illustration below.
For Fingerstick Whole Blood specimen:
• To use a capillary tube: Fill the capillary tube and transfer approximately 80 µl of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40µl) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear .Read results at 10 minutes. Do not interrupt the result after 20minutes.

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