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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

Product Description

Detail Information

Test Range:

1.0-20 Ng/mL

Intended Use:

For In Vitro Diagnostic Use Only

Sample Type:

Serum,plasma

Qualified:

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.

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products details

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

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

mouse monoclonal antibodies

hybridoma Monoclonal antibodies