Accurex TSH Fast Test Kit

Accurex TSH Fast Test Kit
TSH is a sensitive biomarker of hypothalamic-pituitary-thyroid function. The test uses an anti-human TSH monoclonal antibody conjugated with fluorescence latex and another anti-human TSH monoclonal antibody coated on the test line. After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human TSH monoclonal antibody binds with the TSH in the sample and forms a marked antigen-antibody complex. The complex moves to the detection zone by capillary action. Then marked antigen-antibody complex is captured on the test line by the anti-human TSH monoclonal antibody. The fluorescence intensity of the test line increases in proportion to the amount of TSH in the sample. The results can be easily transmitted to the laboratory or hospital information system


Uses:
It is intended for in vitro quantitative determination of thyroid-stimulating hormone (TSH) in serum and plasma. This test is used in the screening, clinical diagnosis, prognosis and therapeutic effect evaluation of thyroid diseases


Product Specifications and Features:

• Content: 25 tests/box, 10 tests/box, TSH test card in a sealed pouch with desiccant, disposable pipet, user manual: 1 piece/box, SD/RFID card: 1 piece/box

• Sample diluent composition: Phosphate buffered saline, proteins, detergent, preservative, stabiliser

• A test card consists of: A plastic shell and a reagent strip which is composed of a sample pad, and a nitrocellulose membrane (one end of the membrane is coated with a fluorescence latex-labelled anti-human TSH monoclonal antibody, the test line is coated with another anti-human TSH monoclonal antibody and the control line is coated with rabbit anti-mouse IgG antibody),
  absorbent paper and liner

• Applicable Devices: AccuDx CQ immunofluorescence quantitative analyser

Directions For Use:

• Collect specimens according to the manual

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

• Confirm SD card lot no. in accordance with test kit lot no.

• Perform “SD card calib” calibration when necessary (details refer to 8.5.2 of Getein1100 user manual)

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

• 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, 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 the test card of AccuDx CQ: if the cartridge is opened, it could be stable within 24 hours once exposed to air

• If the test cards can't be used up at a time, please put the cartridge back in the foil pouch and reseal along the entire edge of the zip-seal

• The remaining test cards should be used up within seven days

• For in vitro diagnostic 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 user manual to ensure proper test performance

• Do not mix or interchange different batches of kits