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AFP Rapid Test is an immunochromatography based one step in vitro test. It is specially designed for the rapid qualitative determination of AFP (Alpha-Fetoprotein) in the serum or plasma specimens to aid in the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.
AFP is normally produced during fetal and neonatal development by the yolk sac, liver, and in small concentrations by the gastrointestinal tract. AFP concentrations decrease rapidly by the second year of life, and thereafter only trace amounts are detected in the serum. Normal adults have AFP concentrations of less than 10ng/ml. Increased AFP levels occur in several malignant diseases like testicular non-seminomatous origin, hepatocellular carcinoma, and occasionally of other entodermal origins.
AFP is also used to detect early tumors in people who are at high risk for liver cancer. As per the studies that were done on the patients with large hepatic metastases or viral hepatitis indicates slight elevation or persistent of AFP values. The use of this test for screening has resulted in the detection of many tumors at an earlier stage. Detection of increased levels of AFP can also be used for the detection of fetal open neural tube defects. This test utilizes a combination of monoclonal antibodies and colloidal gold conjugate to selectively detect the increased levels of AFP in serum or plasma, it has a cut-off value of 20ng/ml.
PRINCIPLE OF THE ASSAY
AFP Rapid test is a sandwich immunoassay. When the serum sample is added to the sample pad, it moves through the conjugate pad and mobilizes gold-mice monoclonal an anti-AFP antibody conjugate that is coated on the pad. The mixture then moves along the membrane by capillary action and reacts with mice monoclonal anti-AFP antibody that is coated on the test region. If there is an AFP present, the result will be the formation of a colored band in the test region. The gold conjugate continues to migrate until it is captured in the control region by the immobilized Goat-anti-Mouse IgG antibody and then aggregating in a red line that indicates the validity of the test.
Make sure that all the materials and specimens are at room temperature
Remove test kit from the sealed foil pouch
Place the kit on a flat dry surface
Use the provided plastic dropper and dispense 30μl of serum sample (1 drop) and 1 drop of solution to the sample well of the test card, start timing
Read the result after 10 minutes adding the sample
Note: Results will be shown after 20 minutes may not be accurate.
INTERPRETATION OF RESULTS
Positive: If 2 colored bands appear within 10 minutes, then the test result is positive and valid.
Negative: If the test area has no color band visible and the control area displays a colored band, then the result is negative and valid.
Invalid result: The test result is invalid if the colored band is not formed in the control region, then the sample must be re-tested by using a new test device.
STORAGE AND STABILITY
The test kit should be stored at room temperature (4 to 30℃) in a sealed pouch to the date of expiration. The test kit should be always kept away from direct sunlight, moisture, and heat.