T4 Test Cassette is intended for in vitro quantitative
determination of total Thyroxine (T4) in serum or plasma. Measurement of T4 is
used as an aid to assessment of thyroid function.
【SUMMARY】
Thyroid hormones are two hormones produced and released by the thyroid gland,
namely triiodothyronine (T3) and thyroxine (T4). They are tyrosine-based
hormones that are primarily responsible for regulation of metabolism. The major
form of thyroid hormone in the blood is thyroxine (T4), which has a longer half-life
than T3.[2] In humans, the ratio of T4 to T3 released into the blood is
approximately 14:1.[3] so the thyroxine (T4) is a primary diagnostic marker for
thyroid function.
The thyroid hormones act on nearly every cell in the body. They act to increase
the basal metabolic rate, affect protein synthesis, help regulate long bone growth
(synergy with growth hormone) and neural maturation, and increase the body's
sensitivity to catecholamines (such as adrenaline) by permissiveness. The
thyroid hormones are essential to proper development and differentiation of all
cells of the human body. These hormones also regulate protein, fat, and
carbohydrate metabolism, affecting how human cells use energetic compounds.
They also stimulate vitamin metabolism. Numerous physiological and
pathological stimuli influence thyroid hormone synthesis.
【PRINCIPLE】
The T4 Test Cassette (Serum/Plasma) detects T4 based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to
absorbent pad. T4 in the sample will compete with the T4 antigen coated on the
membrane. The less T4 in the sample, the more fluorescent microspheres
conjugated with anti-T4 antibodies can be captured by the T4 antigen coated on
the membrane (Test line). The concentration of T4 in the sample 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 T4 in the sample can be calculated by
Analyzer to show T4
concentration in the sample.
【REAGENTS】
The test include T4 antibody coated particles and T4-BSA 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. 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 T4 Test Cassette is only operational in the 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 75μl 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 as soon as possible.
【MATERIALS】
Materials Provided
• Test Cassettes • Specimen Collection Tubes with Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge
• Pipettes
【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. Remove the ID card and insert it into the Analyzer port.
3. Serum or plasma: Pipette 75μl serum or plasma into the buffer tube, mix
the specimen and the buffer well.
4. Add diluted specimen with a Pipette: Pipette 75μldiluted specimen into
the sample well. 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 FIATESTTM Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 10 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 10 minutes. After the countdown, the Analyzer will give the
result at once.
