| Customization: | Available |
|---|---|
| Type: | IVD Instrument |
| Parameter: | Afp |
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The Alpha Fetal-protein (AFP) Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of alpha fetal-protein (AFP) in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of various cancers.
Alpha fetoprotein (AFP) is a single chain glycoprotein with a molecular weight of approximatively 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 the 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. Significant increases are observed in malignant tumours in childhood, such as hepatoblastomas and nephroblastomas, and in hepatocellular carcinoma and certain testicular tumours in adults. AFP levels should be measured at presentation and monitored during treatment and they are very useful in diagnosis and in evaluating the effectiveness of therapy.
The AFP Rapid Test detects alpha fetal-protein (AFP) through visual interpretation of color development on the internal strip. AFP antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with AFP antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient AFP antigens in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
| Brand | Contents | Test | Certificates | Shelf Life |
| Dewei | Rapid Test Cassette+Buffer+Pipette+IFU | Qualitative | CE, ISO13485 | 24 months |
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface.
Label the device with patient or control identification. For best results, the assay should be performed within one hour.
Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the cassette, then add 1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
2. Wait for the colored band(s) to appear. The result should be read within 15 minutes.
3. Results:
POSITIVE:The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
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