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[China]
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DE Medical Technology Jiangsu Co.,Ltd |
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IVD Tumor Marker AFP rapid test kit Rapid diagnostic AFP specimen whole blood/serum/plasma CE certificate
Intended Use of AFP Rapid Test Device
TheAFP Rapid Test Device (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.
Principle of AFP Rapid Test Device
TheAFP Rapid Test Device (Whole Blood/Serum/Plasma) detects alpha fetal-protein (AFP) through visual interpretation of color development on theinternal strip. AFP antibodiesare immobilized on the testregion 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 membraneby capillary action, and interacts with reagents on the membrane. Ifthere aresufficientAFP antigensin the specimen, a colored bandwill 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 controlregion serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
AFP Test Cassette Catalog:
| Product Name | Production Information | |||
| Catalog No. | Specimen Used | Test Format | Kit Size | |
| AFP | AFT-P11 | Serum/Plasma | Strip | 50 pcs / box |
| AFT-W11 | Whole blood/Serum/Plasma | Device | 50pcs / box | |
| AFT-W23 | Device | 40 pcs /box | ||
Procedure and Result Reading of AFP Rapid Test Device
Intended USE
The One Step AFP Test is a rapid chromatographic immunoassay for the qualitative detection of AFP antigen in Serum or Plasma to aid in the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.
Test Procedure
Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well(S) of the test device, then start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Notes:
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of specimen (serum or plasma) to the specimen well.
