Accurex T4 Fast Test Kit

Accurex T4 Fast Test Kit T4 is the most commonly measured substance in the assessment of thyroid function. Elevated total thyroxine levels have been associated with hyperthyroidism, a condition with an excess amount of circulating thyroid hormone and decreased total thyroxine levels associated with hypothyroidism, a condition with insufficient levels of thyroxine concentration. The test uses anti-human T4 monoclonal antibody conjugated with fluorescence latex coated on the junction of nitrocellulose membrane and sample sad, and T4 antigen coated on the test line. After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human T4 monoclonal antibody binds with the T4 in the sample and forms marked antigen-antibody complex. The complex moves to the detection zone by capillary action, which is then captured on the test line by the T4 antigen. The fluorescence intensity of the test line increases in proportion to the amount of T4 in the sample. Then Insert the test card into AccuDxCQ Immunofluorescence Quantitative Analyzer/Automatically inserted by AccuDxCQ Immunofluorescence Quantitative Analyser (hereafter referred to as AccuDx CQ), the concentrations of T4 in the sample will be measured and displayed on the screen. The value will be stored in AccuDx CQ and available for downloading. The result can be easily transmitted to the laboratory or hospital information system


Uses:
It is intended for in vitro quantitative determination of T4 in serum and plasma. It can be used in monitoring hyperthyroidism and hypothyroidism and as an aid in the functional diagnosis of the thyroid


Product Specifications and Features:

• Content: AccuDx CQ T4 test card with desiccant (25), disposable pipet (25), blood sample diluent (1), sd card (1), user manual (1)

• It stores the values, which are available in downloadable form

• These values are displayed on the screen, which can be transmitted to the laboratory or hospital information system

• Easy to use and operate

Directions For Use:

• Collect specimens according to the manual

• Test card, sample and reagent should be brought to room temperature prior to testing

• Confirm SD card lot no. in accordance with test kit lot no. perform “SD card calib” calibration when necessary (details refer to 8.5.2of Getein1100 user manual)

• On the main interface of Getein1100, press the "ENT" button to enter the testinginterface

• Remove the test card from the sealed pouch immediately before use. Label the test card with patient or control identification

• Put the test card on a clean table, horizontally placed

• Using a sample transfer pipette, deliver 100 μl of sample into one tube of sample diluent, and mix gently and thoroughly. Then drop 100 μl (or three drops of the sample when using a disposable pipet) of sample mixture into the sample port on the test card

• After 10 minutes, insert the test card into Getein1100 and press the "ENT" button

• The result will be shown on the screen

Safety Information:

• Read the label carefully before use

• Store in a cool and dry place, away from sunlight

• Keep out of reach of children

• Store the test card at 4-30 degree Celcius with a valid period of 24 months

• Use the test card within 1 hour once the foil pouch is opened

• Store the blood sample diluent at 0-30 degree Celcius for a valid period of 24 months

• Store the blood sample diluent at 2-8 degree Celcius for better results

• For in vitro diagnostic use only

• For professional use only

• Do not use the kit beyond the expiration date

• Do not use the test card if the foil pouch is damaged

• Do not open pouches until ready to perform the test

• Do not reuse the test card

• Do not reuse the pipet

• Handle all specimens as potentially infectious

• Proper handling and disposal methods should be followed in accordance with local regulations

• Carefully read and follow the manual to ensure proper test performance