AFP Rapid Test

Product information

The AFP (Alpha-fetoprotein) test is a rapid qualitative assay for the detection of human AFP in serum, plasma or whole blood.

Advantages of AFP test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Alpha-fetoprotein (AFP) is a single-chain glycoprotein with a molecular weight of approximately 70,000. It is produced by the fetal yolk sac and proximal structures of the liver and gastrointestinal tract. In the human fetus, AFP is a major serum protein which reaches a level of several milligrams per milliliter at week 12 of gestation and then drops to trace concentration in normal non pregnant adult.

The clinical value of AFP as a tumor marker was not immediately appreciated because the assays used for quantitation were not sensitive enough to detect the nanogram amounts associated with early disease. As more sensitive radioimmune assays became available, the utility of AFP as a tumor marker became increasingly apparent.

Marked increases are found in malignant tumors in childhood, such as hepatoblastomas and nephroblastomas and in hepatocellular carcinoma and certain testicular tumors in adults. Less commonly, malignant tumors of the gastro intestinal tract and other organ systems with massive hepatic metastases are associated with increased concentrations of AFP in serum.

The AFP Rapid Test is a rapid qualitative assay for the detection of human AFP in serum, plasma or whole blood. The method employs an unique combination of monoclonal-dye conjugate and polyclonal solid phase antibodies to identify AFP in the test samples with a high degree of specificity.

As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the AFP forming an antibody-antigen complex. This complex binds to the anti-AFP antibody in the positive reaction zone and produces a pink-rose color band when AFP concentration is greater than 10 ng/mL.

In the absence of AFP, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the reaction zone and control zone. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.

Test procedure

1. Allow samples and AFP-Check-1 test devices to come to room temperature prior to testing.
2. Remove the reaction device from its protective wrapper by tearing along the split.
3. Label device with the patient’s name or control number.
4. Fill the serum dropper with specimens (serum or plasma) and by holding it vertically, dispense one drop (25 μL) into sample well. If the whole blood is used, dispense two drops (50 μL) into the sample well and wait for the whole blood sample to be completely absorbed before adding diluent.
5. Add exactly 5 or 6 full drops of diluent (200 μL) in the sample well.
6. Read the results after 10 to 15 minutes.

Interpretation of the results

Negative result: Only one colored band appears on the control zone (C).

Positive result: Two clearly distinguishable lines appear (T and C).

Invalid result: If there is no distinct color band visible in the test and control windows, the test is inconclusive. It is recommended in this case to repeat the test.