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Fluorescence Immunoassay Test cassette for Quantitative Detection of Prostate Specific Antigen (PSA)

Basic Information
Brand Name: ALLTEST Novatrend Plus
Model Number: FI-PSA-302
Minimum Order Quantity: N/A
Price: negotiation
Packaging Details: 10T/25T
Payment Terms: Ex works
Test Type: Flourescence Immunoassay Usage: For Professional Use Only
Pack: 10/25T Assay Time: 15 Minutes
Test Range: 2-100 Ng/mL Specimens: Serum,plasma
Format: Cassette
Highlight:

mouse monoclonal antibodies

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hybridoma Monoclonal antibodies

The Prostate Specific Antigen (PSA) Test Cassette (Serum/Plasma) is based on
Fluorescence immunoassay for the quantitative detection of Prostate Specific Antigen in
serum or plasma.
【SUMMARY】
Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It
is a single chain glycoprotein with a molecular weight of approximate 34 kDa.1 PSA exists
in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1
– Antichymotrypsin (PSA-ACT) and PSA complexed with α2–macroglobulin (PSA-MG).2
PSA has been detected in various tissues of the male urogenital system but only prostate
glandular and endothelial cells secrete it. The PSA level in serum of healthy men is
between 0.1ng/mL and 2.6ng/mL. It can be elevated in malignant conditions such as
prostate cancer, and in benign condition such as benign prostatic hyperplasia and
prostatitis. A PSA level of 4 to 10ng/ml is considered to be in the “gray-zone” and levels
above 10ng/ml are highly indicative of cancer.3 Patients with PSA values between
4-10ng/ml should undergo further analysis of the prostate by biopsy.
The prostate specific antigen test is the most valuable tool available for the diagnosis of
early prostate cancer. Many studies have confirmed that the presence of PSA is the most
useful and meaningful tumor marker known for prostate cancer and prostate infection of
Benign Prostatic Hyperplasia (BPH).4
【PRINCIPLE】
The PSA Test Cassette (Serum/Plasma) detects PSA based on
Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad If the specimen contains PSA, it attaches to the fluorescent
microspheres-conjugated anti-PSA antibodies. Then the complex will be captured by the
capture antibodies coated on the nitrocellulose membrane(Test line).The concentration
of PSA in the sample correlates with the fluorescence signal intensity captured on the T
line. According to the fluorescence intensity of the test and standard curve, the
concentration of PSA in the sample can be calculated by Analyzer to show
PSA concentration in specimen.
【REAGENTS】
The test includes anti- PSA monoclonal antibody coated fluorphores and anti-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. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. 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.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The  PSA Test Cassette should only be used with the 
Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The test should be stored at 4-30°C until the expiry 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】
Sample Taking
1. Collect the specimen according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum and
plasma specimens may be stored at 2-8 °C for up to 3 days, for long term storage,
specimens should be kept below -20 °C.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing
of specimens.
4. EDTA, Heparin sodium can be used as the anticoagulant tube for collecting the
specimen.
Sample Dilution / Sample Stability
1. Transfer 20 μl of serum or plasma to the buffer tube with the micro pipette.
2. Close the tube and shake the sample by hand vigorously for approximately
10seconds to mix the sample and dilution buffer.
3. Let the diluted sample homogenize for approximately 1 minute. The sample can then
be used immediately or stored for up to 8 hours.
【MATERIALS】
Materials provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
Materials required but not provided
• Timer
• Centrifuge •  Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to  Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test” or
“Quick test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Pipette 20 μl of serum or plasma into the buffer tube, mix the specimen and the
buffer well.
4. Pipette 75 μl diluted sample into the sample well of the cassette. Start the timer at
the same time.
5. There are two test modes for  Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
 Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample,Insert the test cassette into
the Analyzer click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time. The Analyzer will automatically countdown 15 minutes. After
the countdown, the Analyzer will give the result at once.
【INTERPRETATION OF RESULTS】
Results read by  Fluorescence Analyzer.
The result of tests for PSA is calculated by  Fluorescence Immunoassay
Analyzer and will be displayed on the screen. For additional information, please refer to
the user manual of  Fluorescence Immunoassay Analyzer.
Linearity range of  PSA is 2-100 ng/ml.
Reference range:< 4ng/ml.

Contact Details
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