About
TSH Fast Test Kit (Immunofluorescence Assay) 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.
Sumamry:
TSH is the main regulator of thyroid cell growth, thyroid hormone synthesis and secretion. TSH (MW 30 kDa) is synthesized and secreted by tsh cells of pituitary gland, it has negative feedback to the synthesis and secretion process. The fluctuation of TSH is faster and more significant than thyroid hormones when thyroid function was changed, it is a sensitive biomarker of hypothalamic-pituitary-thyroid function.
Specification
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
Direction for Use
1. Collect specimen according to manual.
2. Test card, sample and reagent should be brought to room temperature prior to testing.
3. Confirm SD card lot No. in accordance with test kit lot No.. Perform “SDCard Calib” calibration when necessary (Details refer to 8.5.2of
Getein1100 User Manual).
4. On the main interface of Getein1100, press “”ENT”” button to enter testing interface.
5. Remove the test card from the sealed pouch immediately before use. Label the test card with patient or control identification.
6. Put the test card on a clean table, horizontally placed.
7. Using sample transfer pipette, deliver 100 μl of sample into one tube of sample diluent, mix gently and thoroughly. Then drop 100 μl (or 3dropsof sample when using disposable pipet) of sample mixture into the sample port on the test card.
8. After 10 minutes, insert the test card into Getein1100 and press “”ENT”” button. The result will be shown on the screen and”
Other Info
“STORAGE AND STABILITY:
Store the test card at 4~30oC 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 0~30oC with a valid period of 24 months.
Store the blood sample diluent at 2~8oC for better results.”
Prashant Joshi –
Regarding my experience with accurex is excellent. Quality Products….Quality Service.