25T Alpha-fetoprotein AFP Colloidal Gold Rapid Test For Home Hospital Use

Alpha-fetoprotein (AFP) Rapid test cassette

Product Description:

Rapid AFP Test is an immunochromatography-based, one-step in vitro test. It is designed for the rapid qualitative determination of AFP in serum or plasma specimens to aid in the diagnosis of hepatocellular carcinoma or fetal open neural tube defects.

Alpha-fetoprotein (AFP) is produced by the liver, yolk sac, and gastrointestinal tract during fetal and neonatal development. However, after the second year of birth, AFP levels sharply decline, and thereafter, only trace amounts are usually detectable. In healthy adults, the serum concentration of AFP should be below 10 ng/ml. However, various malignant diseases such as hepatocellular carcinoma, non-seminomatous germ cell tumors of the testis, and other cancers originating from embryonic layers may cause elevated AFP levels. AFP is also used for early detection of tumors in high-risk populations for liver cancer. In areas with a high incidence of liver cancer, AFP testing is widely used for early tumor detection. Furthermore, elevated AFP levels can also be used to detect open neural tube defects in fetuses. This test utilizes a combination of colloidal gold conjugates and monoclonal antibodies to selectively detect AFP levels in serum or plasma. The critical value for this test is generally 20 ng/ml.

Principles of the Assay:

The rapid AFP test employs a sandwich immunoassay method. When serum samples are added to the sample pad, they pass through the conjugate pad and react with the gold-rat monoclonal anti-AFP antibody complex coated on the conjugate pad. The mixture migrates along the membrane via capillary action and reacts with the mouse monoclonal anti-AFP antibody coated on the test zone. If AFP is present, the result is the formation of a colored band at the test zone. The gold conjugate continues to migrate until captured by the immobilized goat anti-mouse IgG antibody at the control zone, aggregating into a red line, indicating the validity of the test.

Storage and Stability

The test kit can be stored at room temperature (4 to 30℃) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.

Test Procedure

1. Bring all materials and specimens to room temperature.

2. Remove the test from the sealed foil pouch.

3. Place the test kit on a flat, dry surface.

4. Using the provided plastic dropper, dispense 30μl of serum sample (1 drop) and 1 drop of solution to the sample well of the test card. Start timing.

5. Read the result  10 minutes after adding the sample.

Note: Results after 20 minutes may not be accurate.

Positive: If two colored bands are visible within 10 minutes, the test result is positive and valid.

Negative: If the test area has no color band and the control area displays a colored band, the result is negative and valid.

Invalid result: The test result is invalid if a colored band does not form in the control region. The sample must be re-tested, using a new test device.

Support and Services:

The Colloidal Gold Rapid Test product provides technical support and services to ensure accurate and reliable results. Our team of experienced professionals is available to assist with any questions or concerns regarding the product's usage, interpretation of results, or troubleshooting issues. We offer comprehensive training and education resources to help users optimize their testing process and minimize errors. Additionally, we provide regular product updates and maintenance services to ensure the highest level of performance and customer satisfaction. Contact us for more information on our technical support and services.

Packing and Shipping:

25x1 tests (Cassette)

Precautions

1. Both plate and sample should be with room temperature 20-25°C

2. Failure to detect rotavirus may be a result of factors such as collection of specimen at an improper time in the disease when too few virions are present and improper sampling or handling of the specimen.

3. Wrong result might be caused by expired kit or problematic samples.