NewScen Coast Bio-Pharmaceutical Co., Ltd

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/ plasma or whole blood. 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.

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

ASSAY PROCEDURE
Serum or Plasma Sample
Add 70-100 ul or 2-3 drops of serum or plasma into sample well. Observe the result in 10-20 minutes.
Whole Blood Sample
Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 10-20 minutes.

INTERPRETATION OF RESULTS

Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.