AFP Alpha-Fetoprotein Rapid Test (strip/Cassette/Uncut sheet)

INTENDED USE

The AFP Gold Rapid Screen Test (RST) is a chromatographic immunoassay for the detection of alpha fetoprotein (AFP) in human serum or plasma.

PRINCIPLE

The AFP RST is a chromatographic immunoassay (CIA) for the detection of AFP in human serum or plasma. Specific antibody against AFP re-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If AFP present, a pink colored band will develop on the membrane in proportion to the amount of AFP presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of AFP.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. Blood diluent in a dropper bottle, stored at 2-8°C.

3. One piece of operating instruction.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic use only.

2. Do not use after expiration date.

3. Test device should remain sealed until use.

4. The device stored at 4℃ should be balanced to room temperature prior to use.

5. Desiccant in the sealed pouch, don’t eat it.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24months).