NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
The PSA gold Rapid Diagnostic Test (RDT) is a Chromatographic immunoassay (CIA) for direct qualitative detection of prostate specific antigen (PSA) in human serum/plasma or whole blood.

PRINCIPLE
PSA is a normal secretion that secreted by normal prostatic epithelial cell and malignant cancer of prostate. PSA is normal product, but when its concentration exceed over 4ng/ml, it can be taken as an index to the risk probability of prostate cancer. The prostate cancer is the most frequent malignant tumor in male; PSA is considered as the most valuable tumor maker, so the detection of high level of PSA is a specific and effective way to diagnose the prostate cancer, also an index to examine the cancer relapse and therapy monitoring.
The PSA RDT is a chromatographic immunoassay (CIA) for the detection of PSA in human serum/plasma or whole blood. Specific antibody against PSA is pre-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 PSA present, a pink colored band will develop on the membrane in proportion to the amount of PSA 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 PSA.

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

PROCEDURE
Add 70-100ul or 2-3 drops of serum/plasma into the sample well. For whole blood tests, add 1 drops of whole blood into the sample well and then add 1 drops of chasing buffer into the sample well. Observe the result in 15 minutes.

INTERPRETATION OF RESULTS

Negative: No apparent band in the test region(T), a pink colored band appears in the control region(C). This indicates that no PSA has been detected.
Positive: In addition to a pink colored band in the control region(C), another pink colored band will appear in the test region(T). This indicates that the specimen contains PSA.
Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.