PSA Whole Blood/Serum Test
A rapid chromatographic immunoassay for the detection of prostate specific
antigen in human blood, serum, and plasma samples
NAME AND INTENDED USE
The One Step PSA Whole Blood/Serum Test Cassette is a colloidal gold/antibody
complex based immunoassay designed for the qualitative determination of human
prostate specific antigen in serum. It is intended for professional use as an aid in the
diagnosis and staging of prostate cancer, as well as to monitor response to therapy.
Summary and Explanation
Prostate specific antigen (PSA) is a signal chain glycoprotein containing two hundred
forty amino acid residues and four carbohydrate side chains. The complete gene encoding
PSA has been sequenced and localized to chromosome 19. PSA functions as a kallikrein
like serine protease and is produced exclusively by the epithelial cells lining the acini and
ducts of the prostate gland. It is secreted into the prostatic ducts and at ejaculation it
serves to liquefy the seminal coagulum.
Quantitative PSA detection by enzyme linked immunosorbent assay (ELISA) indicates
the range of normal human serum PSA concentration is between 0.1 and 2.6ng/ml; and
that the half life of serum PSA is between 2.2. and 3.2 days.
Many studies confirm that PSA is the most useful and meaningful tumor marker known
for prostate cancer.
The One Step PSA Whole Blood/Serum Test Cassette is a chromatographic immunoassay
which utilizes monoclonal antibodies to selectively detect PSA in serum with a high
degree of sensitivity.
Test Principle
The One Step PSA Whole Blood/Serum Test Cassette consists of a chromatographic
absorbent device and a unique combination of monoclonal antibodies that selectively
detect PSA in test samples with a high degree of sensitivity. In ten minutes, levels of
PSA as low as 4 ng/ml are detected.
Serum migrates through the absorbent area and along the test membrane. PSA present in
the specimen is bound by antibody-dye conjugate forming antibody-antigen complex.
The complex is captured by anti-PSA antibody immobilized in the test ZONE(T) of the
membrane forming a pink-rose band ( in the absence of PSA, no line will form in the test
ZONE). Dye conjugate is captured by the antibody immobilized in the control ZONE(C)
of the membrane, producing pink-rose color bands which gives a color intensity
equivalent to 4ng/ml PSA.
Specimen Collection and Preparation
Either whole blood, plasma or serum may be used as samples for this procedure. For the
whole blood or plasma procedure, collect blood in a tube containing anticoagulant. If
serum samples are to be used, collect blood in a tube without anticoagulant and allow to
clot. Heat inactivation of samples may lead to hemolysis or protein denaturation and
therefore should be avoided.
Storage and Handling
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Store the PSA Whole Blood/Serum Test at room temperature
The shelf life of the test is indicated on the test pouch
Wear disposable glove while handling specimens and thoroughly wash hands afterwards. All
patient samples should be handled as if they are potentially infectious.
If serum or plasma samples have been stored in the refrigerator, allow them to return to room
temperature before testing
Test Procedure
1. Bring test components including serum, plasma or whole blood to room
temperature Open the foil pouch and lay the cassette on a level surface
2. Label the cassette with the patient’s name or control number.
3. Add three to four drops (120 to 160uL) of whole blood, or three drops (100 to
120uL) of serum, or plasma into the sample well.
4. Read the test result at 15 minutes.
Interpretation of Test Results
Read the result 15 minutes after application of the specimen.
A positive or negative result is determined by comparing the color intensity of the
test line with that of the cassette run in the 4 ng/mL PSA standard ( one part of free
psa and nine parts of complex)
a. POSITIVE: The test band is equal to or darker than the test band of the cassette run in
the 4 ng/mL PSA standard. The color intensity of the test band reflects the concentration
level of PSA.
b. NEGATIVE: the test band's color intensity is lighter than the cassette run in the 4
ng/mL PSA standard, meaning that the PSA level is below the 4ng/ml cutoff.
c. INVALID: If there is no rose-color band visible in the control window, then the test
result is invalid. It is recommended that the specimen be retested.
IMPORTANT: A positive result will not change once established at fifteen minutes.
However, in order to prevent any incorrect results, do not interpret results after fifteen
minutes.