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PRINCIPLE
Qualitative rapid PSA Test strip
also known as onestep PSA tests, are a rapid direct binding immunoassay invitro diagnostic (IVD) test for the qualitative 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 Whole bloodserum plasma 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 blood of all adult men. In human blood, the normal concentration range of this biomarker is 0.0 to 4.0 ng/ml, which are variable among different human races (refer to thetable 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 serum detection devices.
