AFP Rapid Test Cassette

AFP Rapid Test Cassette

INTENDED USE

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

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).

SAMPLE COLLECTION AND PREPARATION

Fingerstick Specimens (Whole Blood)

1.Clean the area to be lanced with an alcohol swab.

2.Squeeze the end of the fingertip and pierce it with a sterile lancet.

3.Wipe away the first drop of blood with sterile gauze or cotton.

4.Use micropipet to obtain about 100 ul fresh blood .

Plasma

1.Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2.Separate the plasma by centrifugation.

3.Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1.Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2.Allow the blood to clot.

3.Separate the serum by centrifugation.

4.Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.