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.
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.
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
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.
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.
The test is for in-vitro diagnostic use only.
Contact Rebecca Yan