Alpha-fetoprotein test in serum | AFP511

INTENDED USE:

One-Step human alpha-fetoprotein (AFP) Test is a rapid and convenient immunochromatographic assay for the qualitative detection of human AFP in serum samples at or above the cutoff level of 25 ng/ml. It is intended for professional use as an aid in the diagnosis of primary hepatocellular carcinomas, testicular teratocarcinomas, and neural tube defects (NTD). This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test.

SUMMARY AND EXPLANATION:

Alfa-fetoprotein (AFP) is a major protein in fetal circulation during early life. It is mainly synthesized and secreted from the liver and yolk sac. It is a glycoprotein with a molecular weight between 65,000 and 70,000 and contains 4% carbohydrate. Serum AFP has been shown to increase in various disease states, including hepatic primary and metastatic tumors, germ cell tumors, hepatitis, and cirrhosis. AFP is also found at an elevated level in amniotic fluid and maternal serum in the case of neural tube defects (25ng/ml). One Step AFP test device is an antigen-capture immunochromatographic assay, detecting the presence of AFP in blood samples. Monoclonal antibodies specifically against AFP are 1) conjugated with colloidal gold and deposited on the conjugate pad and 2) immobilized on the Test Zone on the nitrocellulose membrane. When adequate volumes of the test sample is added the antibody conjugate is rehydrated and the AFP, if any in the samples, will interact with the colloidal gold conjugated antibodies. The antigen-antibody-colloidal gold complex will migrate towards the test window until the Test Zone (T) where they are captured by immobilized antibodies, forming a visible pink line (Test line), indicating a positive result. If AFP is absent in the sample, no pink line will appear in the Test Zone (T), indicating a negative result. To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. Absence of a pink control line in the Control Zone is an indication of an invalid result.