The FPSA Test Cassette (Serum/Plasma) is intended for in vitro quantitative
determination of free Prostate Specific Antigen (FPSA) in human serum or plasma
specimen.
【SUMMARY】
PSA is a protein that the body produces in the prostate gland and parts of the urinary
system. There are different forms of PSA, including total and free PSA. They can either
bind to another protein or float freely.1 If a man’s PSA level is between 4-10 ng/mL
doctors sometimes call it a borderline result. This is because, although the PSA is
higher than average, most men who have a PSA of between 4 and 10 won't have
prostate cancer. This is especially the case for men whose prostate feels normal on
digital rectal examination (DRE). The free PSA test is a test doctors sometimes use to
help them decide how likely it is that a man has prostate cancer when the total PSA
result is borderline.
The percentage of free PSA that makes up the total PSA is not the same for all men. It
is believed that the higher the percentage of free PSA a man has, the less likely it is that
he has prostate cancer. Some studies have shown that if the free PSA makes up more
than a 25% of a man's total PSA he is at low risk of having prostate cancer. And, that
men with a lower percentage of free PSA are at higher risk of having prostate
cancer.2,3,4,5
【PRINCIPLE】
The FPSA Test Cassette (Serum/Plasma) detects free prostate specific antigen based
on Fluorescence Immunoassay. During testing, the specimen contains FPSA
conjugated with fluorescence particles in the label pad of test. Then the mixture
migrates upward on the membrane chromatographically by capillary action and reacts
with the PSA antibody in test line region of NC membrane. The concentration of FPSA
in the specimen correlates with the fluorescence signal intensity captured on the Test
testing result of FPSA will display on the Dry-type Fluorescent Immunoassay Analyzer
screen.
【REAGENTS】
The test include FPSA antibody coated particles and PSA antibody coated on the
membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. This test contains products of animal origin. Certified knowledge of the origin and/or
sanitary state of the animals does not completely guarantee the absence of
transmissible pathogenic agents. It is therefore recommended that these products
be treated as potentially infectious, and handled observing usual safety precautions
(e.g., do not ingest or inhale).
4. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
5. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing
such as laboratory coats, disposable gloves and eye protection when specimens
are assayed.
6. Do not interchange or mix reagents from different lots.
7. Humidity and temperature can adversely affect results.
8. Used testing materials should be discarded in accordance with local regulations.
9. Read the entire procedure carefully prior to any testing.
10. The FPSA Test Cassette is only operational in the Dry-type Fluorescent
Immunoassay Analyzer. And tests should be applied by professionally trained staff.
【STORAGE AND STABILITY】
1. The test should be stored at 4-30 °C until the expiration date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the test from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Specimen Collection
Collect the specimens according to standard procedures.
EDTA K2, Citrate sodium and Potassium Oxalate can be used as the anticoagulant for
collecting the plasma specimens.
A clean tube without anticoagulants can be used to collect serum specimens.
Specimen Storage and Shipping
Serum and plasma specimens may be stored at 2-8 °C for up to 7 days, for long term
storage, specimens should be kept below -20 °C. Frozen specimens should be thawed
and mixed before testing. Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, these should be packed in compliance with local
regulations covering the transportation of etiological agents.
Preparation
Before performing the test, please balance the sample to room temperature (15-30 °C).
Frozen specimens must be completely thawed and mixed well prior to testing.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge • Dry-type Fluorescent Immunoassay Analyzer
• Pipettes
• Specimen collection containers
【DIRECTIONS FOR USE】
Refer to Dry-type Fluorescent Immunoassay Analyzer User Manual for the complete
instructions for the use of analyzer. The test should be conducted at room temperature.
Allow the test, specimen and buffer to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the Analyzer ID Card Slot. Choose test mode
and/or sample type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it within 1 hour. Best
results will be obtained if the assay is performed immediately after opening the foil
pouch.
4. Place the test on a flat and clean surface.
Pipette 75 μL of serum or plasma into the buffer tube; mix the specimen and the
buffer well.
5. Pipette 75 μL of diluted specimen into the sample well. Start the timer at the same
time.
6. Test results should be interpreted at 15 minutes with the use of Dry-type
Fluorescent Immunoassay Analyzer.
Caution: There are different test modes of the Dry-type Fluorescent Immunoassay
Analyzer. The difference between them is incubation of the test cassette is outside or
inside the analyzer. Choose test mode accordingly and confirm sample type. Consult
the user manual of the analyzer for detailed operation information.
Operator must consult the Dry-type Fluorescent Immunoassay Analyzer User Manual
prior to use and become familiar with the processes and quality control procedures.
【INTERPRETATION OF RESULTS】
Results read by Dry-type Fluorescent Immunoassay Analyzer.
The test result of FPSA is calculated by Analyzer and displayed on the screen with
concentration range of 0.1-30 ng/mL.
