AFP Tumor Marker Test Cassette , Tumor Marker Blood Test Accurate Result

High sensitivity Tumor Marker Alpha-protein (AFP) rapid test, gold colloidal method, blood test

AFP Rapid Diagnostic Test

Intended Use:

AFP Cassette (whole blood/serum/plasma) is a rapid chromatographic immunoassay for the qualitative detection of AFP in whole blood, serum or plasma to aid in the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.

CLINICAL SIGNIFICANCE

Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the liver, yolk sac and in small concentrations by the gastrointestinal tract.1 By the second year of life, AFP concentrations decrease rapidly, and thereafter only trace amounts are normally detected in serum.2 In general, normal adults have serum AFP concentrations of less than 10 ng/mL.3 Elevated AFP levels occur in several malignant diseases including hepatocellular carcinoma, testicular nonseminomatous origin, and occasionally of other entodermal origin. 4 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. 6 Detection of elevated AFP levels can also be used in the detection of fetal open neural tube defects. 7 The „DIAQUICK“ AFP 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 10 ng/mL.

Test Principle:

AFP Cassette (whole blood/serum/plasma) is a qualitative membrane based immunoassay for the detection of AFP in whole blood, serum or plasma. The membrane is pre-coated with anti-AFP antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-AFP antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-AFP antibodies on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid

cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The AFP Cassette (whole blood/serum/plasma) has correctly identified a panel of specimens and has been compared to a leading commercial AFP EIA test using clinical specimens. The results show that the relative sensitivity of the „DIAQUICK“ AFP Cassette (whole blood/serum/plasma) is 99.0%, and the relative specificity is 98.7%.