Product Name:
  One Step Prostate Specific Antigen (PSA) Test (Strip) 
  Instruction for use, pipette, buffer
  Principle of Test:
  Immunochromatographic assay
  Product Performance:
  Sensitivity: 4ng/ml  Accuracy: >99%


INTENDED USE: One step PSA Test is a rapid direct binding test for the visual detection of Prostate Specific Antigen (PSA) in serum as an aid in the diagnosis of prostate cancer. The test is based on the principle of sandwich immunoassay for determination of PSA in human serum.

1. Bring the pouched test strip to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly dispense 1 drop (25μl) serum to the sample pad of the strip.
4. Hold the buffer bottle vertically and add 1-2 drops of buffer and start the timer.
5. Read the test result between 10 --15 minutes. Do not read the result after 20 minutes.


Positive: Two colored lines appear, one in the test region (T) and another one in the control region (C). This indicates a positive result and PSA having been detected.
Note: The intensity of the test line may vary depending on the concentration of PSA present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
Negative: Only one colored line appears in the control region (C). This indicates a negative result and no PSA having been detected.
Invalid: If the control line does not appear, the test result is invalid regardless of the presence or absence of the test line.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control  line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.