psa test cassette
PSA rapid test kits, also known as one-step PSA tests, are a rapid direct binding immunoassay in-vitro diagnostic (IVD) test for the semi-quantatitive detection of Prostate Specific Antigen (PSA) tumor markers in human serum specimen. PSA tumor marker tests are based on the principle of sandwich immunoassay for determination of PSA in human serum specimen. Two monoclonal antibodies are employed to identify cancer PSA specifically.
The prostate specific antigen (PSA) is the most commonly tested tumor marker for the prostate gland disease diagnosis. PSA tumor marker is normally present in low levels in the serum of all adult men. In human serum, the normal concentration range of this biomarker is 0.0 to 4.0 ng/ml, which are variable among different human races (refer to the table at the end of this page). But when prostate specific antigen rise beyond the normal range, it can be taken as a signal of prostate gland cancer or other problems. That is why PSA becomes the subject of PSA whole blood detection devices.
Negative: Two pink bands appear on test region of the Cassette. This indicates that there is no PSA in the serum.
Positive: Three pink bands appear on test region of the Cassette. .
* if the color of T line is lower than R line, it means concentration of PSA s between 4ng/ml and 10ng/ml. People who are at this regional level belong to the moderate risk patients group.
* if the T line is darker than R line, it means the concentration of PSA is higher than 10ng/ml. People who are at this regional level belong to the high risk patients group.
Invalid: If without colored band appears on test region or one pink band appears on test line, this is an indication of a possible error in performing the test. The test should be repeated using a new device.