INTRODUCTION

The One Step PSA Test is a chromatographic immunoassay in-vitro diagnostic 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 immunossay 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 discase 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 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.

SPECIMEN COLLECTION

For serum, collect blood into a container without anticoagulant.  Allow the blood to clot and separate the serum from the clot.  Use the serum for testing.

If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer.  Bring the specimens to room temperature before testing.  Do not freeze and thaw the specimen repeatedly.

TEST PROCEDURE

1,When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.

2,Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.

3,Wait 10-15 minutes and read result.  Do not read results after 15 minutes.

INTERPRETATION OF RESULTS

Negative:  Only one colored band appears on the control (C) region.  No apparent band on the test (T) region.

Positive:  In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region.  Please consult your physician to perform a much more detailed exam.

Invalid:  A total absence of color in both regions is an indication of procedure error and/or the test reagent has been deteriorated.

STORAGE AND STABILITY

The test kit should be stored at room temperature (18 to 30°C) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION:

1,Must use fresh specimen and avoid repetitive freezing, the result will be invalid

2,Use it before expiry date.

3,The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.

4,Old Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS

The test is for in-vitro diagnostic use only.

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