INTENDED USE

The AFP Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of AFP in whole blood, serum or plasma to aid in the diagnosis of Hepatocellular Carcinoma orfetai open neural tube defects.

INTRODUCTION

Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the liver, yolk sac and in small concentrations by the gastrointestinal tract. By the second year of life, AFP concentrations decrease rapidly, and thereafter only trace amounts are normally detected in serum. In general, normal adults have serum AFP concentrations of less than 10ng/ml. Elevated AFP levels occur in several malignant diseases including hepatocellular carcinoma, testicular nonseminomatous origin, and occasionally of other entodermal origin AFP has also been used to detect early tumors in people at high risk for liver cancer. Studies of patients with large hepatic metastases or viral hepatitis also indicate slightly elevated or persistent AFP values. In areas where liver cancer is common, the use of AFP tests for screening has resulted in the detection of many tumors at an earlier stage. Detection of elevated AFP levels can also be used in the detection of fetal open neural tube defects.
The AFP Rapid Test (Whole Blood /Serum /Plasma) utilizes a combination of anti- AFP
antibody coated particles and anti-AFP antibodies to detect elevated levels of AFP in whole blood, serum or plasma. The minimum detection level is 10ng/ml.

PRINCIPLE

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