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psa tumor marker test
INTRODUCTION PSA rapid test kits, also known as one-step PSA tests, are a rapid direct binding immunoassay in-vitro 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 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 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. Open a pouch containing a cassette, lay the cassette. 2. Using the plastic pipettor provided, draw about 2-3 drops (100µL) the sample into the sample well of the cassette. 3. Read results within 10-15 minutes. Do not read results after 15 minutes. INTERPRETATION OF RESULTS 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. This indicates that the specimen contains PSA 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.
psa tumor marker test