AccuDx CQ TSH

Principle:
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 sample and forms 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 sample.
Insert test card into AccuDx CO Immunofluorescence Quantitative Analyzer/’Automatically inserled by AccuDx CQ Immunofluorescence Quantitative Analyzer (hereafter referred to as AccuDx CQ), the concentration of TSH in sample will be measured and displayed on the screen, The value will be stored in AcouD CQ and available for downloading. The result can be easily transmitted to the laboratory or hospilal information system.

CONTENTS
1. A kit for AccuDx CQ contains:
Package specifications: 25 tests/box, 10 tests/box
1) TSH test card in a sealed pouch with desiccant
2) Disposable pipet
3) User manual: 1 piece/box
4) SD/RFID card: 1 piece/box
2, Sample diluent composition:
Phosphate buffered saline, proteins, detergent, preservative,
stabilizer.
3. A test card consists of.
A plastic shell and a reagent strip which is composed of a
sample pad, 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.

Note: Do not mix or interchange different batches of kits.

Applicable Devices: AccuDx CQ Immunofluorescence Quantitative Analyzer

Storage & Stability:
Store the test card at 4~30 C with a valid period of 24 months.
Use the test card for AccuDx CQ within 1 hour once the foil pouch is opened. For 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 to
the foil pouch and reseal along the entire edge of zip-seal. The remaining test cards should be used up within 7 days.
Store the sample diluent at 0~30°C with a valid period of 24 months.
Store the sample diluent at 2~8 C for better results.

Precautions:
1. For in vitro diagnostic use only.
2. Do not use the kit beyond the expiration date.
3. Do not use the test card if the foil pouch is damaged.
4. Do not open pouches until ready to perform the test.
5, Do not reuse the test card.
6. Do not reuse the pipet.
7. Handle all specimens as potentially infectious. Proper
handling and disposal methods should be followed in
accordance with local regulations.
8. Carefully read and follow user manual to ensure proper
test performance.