Good sensitivity Tumor Marker Prostate specific antigen (PSA) rapid
test, 4mm Strip, blood test
PSA Rapid Diagnostic Test strip
The PSA Rapid Test is a lateral flow chromatographic immunoassay
for the qualitative detection of prostate specific antigen (PSA) in
human serum or plasma at a cut-off level of 2.0 ng/mL. It is
intended to be used as a screening test and as an aid in the
diagnosis of prostate cancer. Any reactive specimen with the PSA
Rapid Test must be confirmed with alternative testing method(s) and
PSA is a serine protease with a molecular weight of approximately
34,000 daltons containing 7% carbohydrate by weight. PSA is
immunologically specific for prostatic tissue, exiting in normal,
benign hyperplasic, in malignant prostate tissue, in metastatic
prostate carcinoma, and in prostate fluid and seminal plasma. PSA
is not present in any other normal tissues.
Elevated serum PSA concentration has been reported in patients with
prostate cancer, benign prostate hypertrophy, or inflammatory
conditions of other adjacent genitourinary tissues, but not in
apparently healthy men, men with non-prostate carcinoma, apparently
healthy women, or women with cancer. Studies have suggested that
serum PSA is one of the most useful tumor markers in oncology. PSA
measurements can enhance early prostate cancer detection when
combined with digital rectal examination (DRE). It may also serves
as an accurate marker for assessing response to the treatment of
prostate cancer. Therefore, measurement of serum PSA concentration
can be an important tool in monitoring patients with prostate
cancer and in determining the potential and actual effectiveness of
surgery or other therapies.
The PSA Rapid Test is a lateral flow chromatographic immunoassay.
The test cassette consists of: 1) a burgundy colored conjugate pad
containing anti-PSA antibody conjugated with colloid gold (PSA
antibody conjugates), 2) a nitrocellulose membrane strip containing
a test band (T band) and a control band (C band). The T band is
pre-coated with polyclonal anti-PSA antibody, and the C band is
pre-coated with goat anti-mouse IgG antibody.
When an adequate volume of test specimen is dispensed into the
sample well of the test cassette, the specimen migrates by
capillary action across the test cassette. Elevated PSA if present
in the specimen will bind to the PSA antibody conjugates. The
immunocomplex is then captured on the membrane by the pre-coated
anti-PSA antibodies, forming a burgundy colored T band, indicating
a PSA positive test result.
Absence of the T band suggests a negative result. The test contains
an internal control (C band) which should exhibit a burgundy
colored band of the immunocomplex of goat antimouse IgG/mouse
IgG-gold conjugate regardless of color development on the T band.
Otherwise, the test result is invalid and the specimen must be
retested with another device.
Step 1: Bring the specimen and test components to room temperature
if refrigerated or frozen. Mix the specimen well prior to assay
Step 2: When ready to test, open the pouch at the notch and remove
device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: Fill the plastic dropper with the specimen. Holding the
dropper vertically, dispense 23 drops (about 60- 90 µL) of specimen
into the sample well making sure that there are no air bubbles.
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the control line
region (C) and another apparent colored line should be in the test
line region (T).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of TP antibodies present in the
specimen. Therefore, any shade of color in the test line region (T)
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line
appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.
Sensitivity and Specificity
The PSA Rapid Test Cassette (Whole blood /Serum /Plasma) has been
tested with a leading commercial PSA EIA Test using clinical
|PSA Rapid Test Cassette||Results||Positive||Negative|
Relative Sensitivity: 99.0% (95%CI:*96.6%-99.9%) *Confidence
Relative Specificity: 99.2% (95%CI:*97.5%-99.8%)
Overall accuracy: 99.1% (95%CI:*97.9%-99.7%)
|ORIENT NEW LIFE MEDICAL CO., LTD.|
|Email:||Jerry @ newlifebiotest .com|