INTENDED USE

The CA15-3 Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CA15-3 in human’s whole blood, serum or plasma.

INTRODUCTION

CA15-3, for Carcinoma Antigen 15-3, is a tumor marker for many types of cancer, most notably breast cancer.1 It is derived from MUC1,2CA15-3 and associated CA 27- 29 are different epitopes on the same protein antigen product of the breast cancer- associated MUC1 gene.
Both CA15-3 and CA 27-29 may be elevated in patients with benign ovarian Elevated CA15-3, in conjunction with alkaline phosphatase (ALP), was found to be associated with an increased chance of early recurrence in breast cancer. 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.

PRINCIPLE

The CA15-3 Rapid Test (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of CA15-3 in Whole Blood, serum or plasma. The membrane is pre-coated with anti-CA153 antibody on the test line region of the strip. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-CA15-3.
The mixture migrates upward on the membrane by capillary action to react with anti-CA15-3 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.