Intended Use

One Step PSA Rapid Screen Test is a rapid direct binding immunoassay in-vitro diagnostic (IVD) test for the qualitative detection of Prostate Specific Antigen (PSA) tumor markers in human Serum. PSA tumor marker tests are based on the principle of sandwich immunoassay for determination of PSA in human Serum. 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 Serum detection devices.

TEST PROCEDURE

1. Do not open foil pouch until ready to begin testing.  Refrigerated test devices should be allowed to come to room temperature (15°- 28°C) before opening the pouch. 
2. Remove the device from the protective pouch and label the device with specimen identification.  
3. Add 50 ul of fresh serum to the Sample Well (for Card) or Sample Pad (for Dipstick),Then add 2 drops (50 ul) of test running buffer into the sample well or sample pad.
4. Read the result within10-15 minutes. Do not read results after 15 minutes. Observe the colored band developed over the control region indicating the assay is complete.