Lomina CA15-3 breast tumor test

CA15-3 (Carcinoma Antigen 15-3) is a tumor marker for many types of cancer, especially 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. Elevated values may also be seen in cirrhosis, sarcoidosis, and lupus. CA 15-3 is now considered a reliable prognostic marker for breast cancer.

Intended Use:

The Lomina CA15-3 Test is a rapid chromatographic immunoassay for the qualitative detection of CA15-3 in human whole blood.

CA15-3 tumor test:

The Lomina CA15-3 Test is a qualitative membrane immunoassay for the detection of CA15-3 in whole blood, serum or plasma. The membrane is pre-coated with anti-CA15-3 in the test area of the strip. During testing, a sample of whole blood, serum or plasma reacts with the anti-CA15-3 coated particle. The mixture of blood/serum/plasma and reagent migrates across the membrane where an immunochemical reaction occurs during capillary migration and reacts with the anti-CA15-3 on the membrane to form a colored line. The presence of the coloured line in the test area indicates a positive result, while its absence indicates a negative result. As a check on the procedure, a colored line always appears in the control area, indicating that the correct volume of sample has been added and membrane activation has occurred.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of blood samples taken from a finger.

Whole blood

Major Parameters, Characteristics & Limits

Test duration: 5 min

IVD category: IVD other

Sensitivity: 96,4 % (95%CI: 87,7 % ~ 99,6 %)
Specificity: 98,8 % (95%CI: 96,4 % ~ 99,7 %)
Accuracy: 98,3 % (95%CI: 96,1 %~99,5 %)


A. Negative test result:

A single coloured line appears in the control area (C). No coloured line appears in the test area (T).

B. Positive test result:

Two coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area (T). The intensity of the colour in the test area (T) will vary depending on the concentration of antibodies present in the sample. Therefore, any shade of colour in the test area (T) should be considered positive.

C. Invalid test result:

The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.




Instructions for use (IFU)




CE Certificate




High sensitivity and specificity of tests

Quick test

Tested in accredited laboratories


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