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. 5 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 Cassette (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.

 

【DIRECTIONS FOR USE】

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 ul) to the specimen well of test Cassette, then add 1 drop of buffer (approximately 40ul) and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

· Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

· To use a capillary tube: Fill the capillary tube and transfer approximately 50 ul of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.

· To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 ul) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40ul) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.