INTENDED USE

The CEA Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of CEA in whole blood, serum or plasma to aid in monitoring of cancer patients.

INTRODUCTION

Carcinoembryonic Antigen (CEA) is a tumor-associated antigen characterized as an oncofetal glycoprotein. CEA is expressed in a variety of malignancies, particularly pulmonary or gastrointestinal tumors (e.g. colon cancer, liver cancer and lung cancer).
CEA normally occurs in fetal gut tissue with detectable serum levels essentially disappearing after birth. Therefore, elevated levels of CEA can be of significant value in the diagnosis of primary carcinomas.
In addition to qualitative assessment, CEA testing plays an important role in the monitoring of cancer patients. Clinical evidence indicates that CEA levels can serve as predictive markers in both pre- and post-treatment cancer. Progressive elevation of CEA may signal tumor recurrence 3-36 months before clinical evidence of metastasis. Persistent elevation of circulating CEA following treatment is strongly indicative of occult metastatic and residual diseases and deficient therapeutic response.
The CEA Rapid Test utilizes a combination of anti-CEA antibody coated particles and anti-CEA antibodies to detect elevated levels of CEA in whole blood, serum or plasma. The minimum detection level is 5ng/ml.

PRINCIPLE

The CEA Rapid Test is a qualitative membrane based immunoassay for the detection of CEA in whole blood, serum or plasma. The membrane is pre-coated with anti-CEA antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-CEA antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-CEA antibodies on the membrane and generate a colored line. The presence of this colored line in the test line 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.