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Flourescence Immunoassay Test Kits for TSH Measurement in Serum and Plasma

Basic Information
Brand Name: ALLTEST Novatrend Plus
Model Number: FI-TSH-302
Minimum Order Quantity: N/A
Price: negotiation
Payment Terms: Ex works
Qualified: CE Specificity: High
Sensitivity: High Specimens: Serum /plasma
Test Type: Flourescence Immunoassay Storage: 4-30℃
Kit Size: 10/25T/kit Intended Use: For In Vitro Diagnostic Use Only
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TSH Test Cassette (Immunofluorescence Assay) is intended for in vitro quantitative
determination of Thyroid Stimulating Hormone (TSH) in serum, plasma. Measurement of
TSH is useful to aid in the screening the adult population for primary hypothyroidism by
medical professionals. It could also be used in screening neonates for hypothyroidism.
【SUMMARY】
Thyroid-stimulating hormone (also known as thyrotropin, thyrotropic hormone, TSH, or
hTSH for human TSH) is a pituitary hormone that stimulates the thyroid gland to produce
thyroxine (T4), and then triiodothyronine (T3) which stimulates the metabolism of almost
every tissue in the body.[1] It is a glycoprotein hormone synthesized and secreted by
thyrotrope cells in the anterior pituitary gland, which regulates the endocrine function of
the thyroid. [2][3] TSH (with a half life of about an hour) stimulates the thyroid gland to
secrete the hormone thyroxine (T4), which has only a slight effect on metabolism. T4 is
converted to triiodothyronine (T3), which is the active hormone that stimulates metabolism.
About 80% of this conversion is in the liver and other organs, and 20% in the thyroid itself.
[1] Laboratory testing of thyroid stimulating hormone* levels in the blood is considered the
best initial test for hypothyroidism. [4] It is important to note the statement from the
Subclinical Thyroid Disease Consensus Panel: “There is no single level of serum TSH at
which clinical action is always either indicated or contraindicated. The higher the TSH, the
more compelling is the rationale for treatment. It is important to consider the individual
clinical context (e.g. pregnancy, lipid profile, ATPO antibodies),” [5]
【PRINCIPLE】
Novatrend Plus TSH Test Cassette is based on fluorescence immunoassay technology.
Novatrend Plus TSH Test Cassette (Serum/Plasma) detects Thyroid Stimulating Hormone
through Immunochromatographic quantitative detection technology. The sample moves
through the strip from sample pad to absorbent pad by the chromatographic force. If the
test sample contains TSH, it attaches to the TSH antibody which is conjugated with
fluorescent microspheres. Then the complex will be captured by the capture antibody
coated on the nitrocellulose membrane(Test line).The concentration of TSH in the
sample correlates linearly with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and product standard curve, the
concentration of TSH in the sample can be calculated by Novatrend Plus Analyzer to show
TSH concentration in specimen.
【REAGENTS】
The test include TSH antibody coated particles and TSH 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 Novatrend Plus TSH Test Cassette is only operational in the Novatrend Plus FIA
Analyzer. And tests should be applied by professionally trained staff working in
certified laboratories at some remove from the patient and clinic at which the
sample(s) is taken by qualified medical personnel.
【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】
Blood Sample Taking
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.
4. EDTA, Heparin sodium, can be used as the anticoagulant tube for collecting the blood
specimen.
Sample Dilution/Sample Stability
1. Transfer 75 μL of serum or plasma to the buffer tube with the micro pipette.
2. Close the tube and shake the sample by hand forcefully for approximately 10
seconds so sample and dilution buffer mix well.
3. Let the diluted sample rest for approximately 1 minute.
4. The diluted 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 • FIATEST GO Fluorescence Immunoassay Analyzer
• Pipettes • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Novatrend Plus 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. Remove the ID card and insert it into the Analyzer port.
3. Serum or plasma: Pipette 75 μL serum or plasma into the buffer tube, mix the
specimen and the buffer well.
4. Add diluted specimen with a Pipette: Pipette 75 μL diluted specimen into the
sample well. Start the timer at the same time.
5. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Novatrend Plus 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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