Lomina CA-125 ovarian tumor test

Approximately 90% of women with advanced ovarian cancer have elevated serum CA-125 levels, making CA-125 a useful tool for detecting ovarian cancer after symptoms appear. Monitoring CA-125 levels in blood serum is also useful for determining how ovarian cancer responds to treatment (disease-free survival correlates with the rate of decline in CA-125) and for predicting a patient‘s prognosis after treatment.

Intended Use:

The Lomina CA125 Test is a rapid chromatographic immunoassay for the qualitative detection of CA125 in human whole blood.

CA-125 ovarian
tumor test

CA-125 is the most commonly used prognostic biomarker for the detection of ovarian cancer. Approximately 90% of women with advanced ovarian cancer have elevated serum CA-125 levels, making CA-125 a useful tool for detecting ovarian cancer after symptoms appear. Monitoring CA-125 levels in blood serum is also useful for determining how ovarian cancer responds to treatment (disease-free survival correlates with the rate of decline in CA-125) and for predicting a patient‘s prognosis after treatment. Indeed, persistence of high CA-125 levels during treatment is associated with a lower prognosis for patient survival. Also, an increase in CA-125 levels in individuals in remission is a strong predictor of ovarian cancer recurrence.

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: 10 min
IVD category: IVD other
Sensitivity: 94,8 % (95%CI: 85,6 %~98,9 %)
Specificity: 98,0 % (95%CI: 95,4 %~99,4 %)
Accuracy: 97,4 % (95%CI: 95,0%~98,9%)

Interpretation:

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.

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Instructions for use (IFU)

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CE Certificate

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

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