INTENDED USE

The CA125 Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CA125 in human’s whole blood, serum or
plasma.

INTRODUCTION

CA-125 is the most frequently used prognostic biomarker for ovarian cancer detection.
Around 90% of women with advanced ovarian cancer have elevated levels of CA-125 in their blood serum, making CA-125 a useful tool for detecting ovarian cancer after the onset of symptoms.
Monitoring CA-125 blood serum levels is also useful for determining how ovarian cancer is responding to treatment (with the duration of disease-free survival correlating with the rate of fall of CA-125)- and for predicting a patient’s prognosis after treatment.- This is because the persistence of high levels of CA-125 during therapy is associated with poor survival rates in patients. Also, an increase in CA- 125 levels within individuals in a remission is a strong predictor of the recurrence of ovarian cancer.

PRINCIPLE

The CA125 Rapid Test (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of CA125 in whole blood, serum or plasma. The membrane is pre-coated with anti-CA125 on the test line region of the strip. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-CA125. The mixture migrates upward on the membrane by capillary action to react with anti-CA125 on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.