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Flourescence Immunoassay Test Kits
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Fast and Easy Flourescence Immunoassay Test cassette for Testo/sterone Testing

Fast and Easy Flourescence Immunoassay Test cassette for Testo/sterone Testing

Brand Name: ALLTEST Novatrend Plus
Model Number: FI-TES-302
MOQ: N/A
Price: negotiation
Payment Terms: Ex works
Supply Ability: 2000mg/month
Detail Information
Test Range:
1.0-20 Ng/mL
Intended Use:
For In Vitro Diagnostic Use Only
Sample Type:
Serum,plasma
Qualified:
CE
Sensitivity:
High
Reading Time:
15 Minutes
Storage Temperature:
4-30℃
Test Type:
Flourescence Immunoassay
Specificity:
High
Principle:
Fluorescence Immunoassay
Packaging Details:
0.5mg/tube 1mg/tube, 2mg/tube、5mg/tube、10mg/tube、20mg/tube、30mg/tube
Supply Ability:
2000mg/month
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Product Description
Testost/erone Test Cassette (Serum/Plasma) is based on Fluorescence Immunoassay for
the quantitative determination of Testost/erone in serum, plasma by using Novatrend Plus
fluorescence immunoassay analyzer, it is clinically mainly used for auxiliary diagnosis of
related diseases with abnormal testo/sterone levels.
【SUMMARY】
Testos/terone (17ß-hydroxyandrost-4-en-3-one) is an anabolic stero/id synthesized
primarily by Leydig cells in the testes of male, the ovary of female, and adrenal glands of
both sexes[1] . It is synthesized from cholesterol, androstenediol, Dehydro/epiandrosterone
(DHEA), progesterone, and pregn/enolone acting as some of the intermediate substrates.
Testoste/rone level in male increase 10 to 20-fold during puberty, driving the physiological
changes associated with male puberty. It also exerts a powerful, wide-ranging influence
over emotional well-being, sex/ual function, muscle mass and strength, energy,
cardiovascular health, bone integrity, and cognitive ability throughout a man’s entire life. In
the blood only 1 to 15% of testos/terone is in its unbound or biologically active form. The
remaining testost/erone is bound to serum proteins.
【PRINCIPLE】
The Testos/terone Test Cassette (S/P) detects testoster/one based on Fluorescence
Immunoassay. The specimen moves through the strip from sample pad to absorbent pad.
Testost/erone in the specimen will compete with the Testos/terone antigen coated on the
membrane. The less Testostero/ne in the specimen, the more chance that fluorescent
microspheres-conjugated anti-Tes/tosterone antibodies can be captured by the
Testoster/one antigen coated on the membrane (Test line). The concentration of
Testos/terone in the specimen is inversely related to the intensity of the fluorescent signal
captured on the T line. According to the fluorescence intensity of the test and the standard
curve, the concentration of Testos/terone in the specimen can be calculated by 
Analyzer to show Testos/terone concentration in specimen.
【REAGENTS】
The test include anti-Testost/erone antibody coated fluorophore and testos/terone antigen
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 Testos/terone 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】
1. Collect the specimens 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. Only clear, non-hemolyzed specimens can be used.
4. EDTA can be used as the anticoagulant tube for collecting the blood specimen.
【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 requirements, select “Standard
test” or “Quick test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3. Pipette 75 μL serum or plasma into the specimen collection tubes with buffer, mix the
specimen and the buffer well.
Note: The diluted specimen should be used immediately or stored for up to 4 hours
at 2-8 °C.
4. Pipette 75 μL diluted specimen 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: Insert the test cassette into the Analyzer at 15 minutes after
sample application, 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
sample application, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, the Analyzer will automatically counting down 15 minutes.
After the countdown, the Analyzer will give the result at once.