INTENDED USE

The CA19-9 Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CA 19-9 in human’s whole blood, serum or plasma.

INTRODUCTION

CA19-9 (carbohydrate antigen 19-9, also called cancer antigen 19-9 or sialylated Lewis(a) antigen) is a tumor marker2 that is used primarily in the management of pancreatic cancer.
CA19-9 is an antigen defined by monoclonal antibody binding to CA19-9, the tumor surface marker Sialyl-Lewis A. CA19-9 was discovered in the serum of patients with colon cancer and pancreatic cancer in 1981 The main use of CA19-9 is to see whether a pancreatic tumor is secreting it; if that is the case, then the levels should fall when the tumor is treated, and they may rise again if the disease recurs.5 In people with pancreatic masses, CA19-9 can be useful in distinguishing between cancer and other diseases of the gland.16 Because of its rising and falling levels with treatment, CA 19-9 is used as a prognostic marker for pancreatic cancer.

PRINCIPLE

The CA19-9 Rapid Test (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of CA19-9 in Whole Blood, serum or plasma. The membrane is pre-coated with anti-CA19-9 on the test line region of the strip. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-CA19-9. The mixture migrates upward on the membrane by capillary action to react with anti-CA19-9 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.