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i-CHROMATM T4 Test

Thyroxine (T4) is one of two major hormones produced by the thyroid gland (the other is called triiodothyronin,

or T3). T4 and T3 are regulated by a sensitive feedback system involving the hypothalamus and pituitary gland.

The hypothalamus releases the thyrotropin releasing hormone (TRH), which stimulates the pituitary to release the

thyroid stimulating hormone (TSH). This causes the thyroid to release T3 and T4 and these in turn regulate the

release of TRH and TSH via a feedback control mechanism. Normally, increased blood levels of T4 and T3 act to

decrease the amount of TSH secreted, thereby reducing the production and release of T4 and T3. Greater than

99% of T4 is reversibly bound to three plasma proteins in blood; thyroxine binding globulin (TBG) binds 70%,

thyroxine binding pre-albumin (TBPA) binds 20%, and albumin binds 10%. Approximately 0.03% of T4 is in the

free, unbound state in blood at any one time.

T4 is a useful marker for the diagnosis of hypothyroidism and hyperthyroidism. The level of T4 is decreased in

hypothyroidism, myxedema, chronic thyroiditis (Hashimoto’s disease). Increased levels of T4 have been found in

hyperthyroidism due to Grave’s disease and Plummer’s disease.

General Information

Key Features of i-CHROMATM T4 Test

• Quantitative Test Result

• Sample Type: Serum, and Plasma.

• Sample volume: 10 µl

• Detection Limit: 20 nmol/L

• Working range: 20-300 nmol/L

• Cut Off(normal range): 60-160 nmol/L

• Precision: CV% 2-10 in working range.

• Long Shelf Life: 20 months

• Fast Test Result: 10 minutes

• User Friendliness: 10 µl, 75 µl Pipette

• Comparable Test Result with Full Automatic Analyzer

• No Calibration Needed

Principle

The test uses a competitive immunodetection method, such that the detector antibody in buffer binds to T4 in

blood sample and antigen-antibody complexes competes with T4 covalently coupled to BSA that has been

immobilized on test strip as sample mixture migrates nitrocelluose matrix. Thus the presence of more T4 antigen

in blood would lead to accumulation of less antigen-antibody complexes on the test strip. Signal intensity of

fluorescence on detector antibody reflects amount of antigen captured and is processed from i-CHROMATM

Reader to show T4 concentration in specimen. The working range of i-CHROMATM T4 test is 20~300 nmol/L.

Comparison Data with Access2

1. Set a Test Device on a dust-free clean surface.

2. Check and insert ID Chip onto the instrument. Make sure that the Test Device lot # matches ID Chip lot #.

3. Take out a tube containing Detection Buffer from refrigerator and leave it at room temperature for 20

minutes.

4. Draw 10 µl of serum/plasma or control with a transfer pipette and add it to the tube containing Detection

Buffer.

5. Mix the specimen and Detection Buffer by tapping or inverting the tube

6. Take 75 µl of sample mixture and load it onto the well of disposable Test Device.

7. Leave the Test Device at room temperature for 10 minutes before inserting the device into the holder.

8. Insert Test Device onto the holder of i-CHROMATM Reader. And press “SELECT” button.

Checking the direction of Test Device, push the device back all the way.

9. Read the results on the display screen of i-CHROMATM Reader.

10. Test results will be shown on the display screen of i-CHROMATM Reader.

Test Procedure

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i-CHROMATM T4 Test

BMP

ID chip

LOT:i-CHROMA T4

BMP

ID chip

LOT:i-CHROMA T4

BMP

ID chip

LOT:i-CHROMA T4

T4

T4

EXP :LOT :

for in vitro diagnostic use only

25Test

Detection Buffer Pouch 25 tubes of Detection Buffer

i-CHROMA Contents

Contents Box 25 Test Device Pouches(1 Test Device per Pouch)

Test Device 1 Mannual1 ID Chip

Select

123456

21 443Check the contents :1 ID chip, 25 Test Device,25 tubes of Detection buffer

Check and make sure thatthe ID chip lot number matchesTest Device lot number.

Insert the ID chip into the instrument.

Press "Select"

875 6Add the sample(10ul of serum/plasma) into the tube containing Detection buffer.

Collect 75ul of the mixture

10 times

Shake the tube up and down10 times or more : the mixture of buffer and thesample has to be used within 30 seconds.

T4

T4

D-Dm

er

1210 11

Transfer the mixture ontothe sample well of the Test Device.

10 minutes

Wait 10 minutes. Place the Test Device on theTest Device holder of the instrument.

000

D-Dm

er

Read the result on thedisplay screen.

Select

PSA

Press "Select" 13

T4

T4

same lot number

Detection Buffer

T4

TM