About
AccuDx CQ PCT Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of Procalcitonin (PCT) in serum, plasma or whole blood. The test is used as an aid in the assessment and evaluation of patients Suspected of bacterial infection, trauma or shock.
PCT is a peptide precursor of the hormone calcitonin, the latter being involved with calcium homeostasis. It is composed of
116 amino acks and is produced by parafollicular cells (C cells) of the thyroid and by the neuroendocrine calls of the lung
and the intestine.
Measurement of PET can be used as a marker of severe sepsis and generally prides well with the degree of sepsis, although levels of PCT in the blood are very k»N. POT has the greatest sensitively and specificity for differentiating patients with systemic inflammatory response syndrome (sIRS) from those with sepsis. PCT levels may be useful to distinguish bacterial infections from nonarterial infectors. Il has shrun that POT may help guide therapy and reduce antibiotic use witch can help save on cost of antibiotic prescriptions and drag resistance.
TEST RESULTS:
Getain 1100/Getein1600 can scan the test card automatically and display the result on the screen. For additional information, please refer to the user manual of Getein 1100/Getein 1600.”
Specification
The test uses an anti-human PCT monoclonal antibody conjugated with fluorescence latex. For PCT product, test line 1 was
coated with anti-human PCT polyclonal antibody and test line 2 was coated with another anti-human PCT monoclonal antibody.
After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human PCT monoclonal antibody binds with the PCT in sample and forms a marked antigen-antibody complex. This complex moves to the test card detection zone by capillary action, Then marked antigen antibody complex is captured on the test line by the other anti- human PCT monoclonal antibody or the polyclonal antibody.
The fluorescence intensity of the test line increases in proportion to the amount of PCT in sample. Then insert test card into Getein1100 Immunofluorescence Quantitative Analyzer/Getein1600 Immunofluorescence Quantitative Analyzer (hereinafter referred to as Getein1100 and Getein1600), the concentration of PCT in sample will be measured and displayed on the screen. The value will be stored in Getein1100/Getein1600 and available for downloading. The result can be easily transmitted to the laboratory or hospital
information system.
Direction for Use
1. Collect specimens according to user manual.
2. Test card, sample and reagent should be brought to room temperature before testing.
For Getein1100:
3. 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 Getein 1100 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 gl of sample (or
3~4 drops of sample when using disposable pipet) into the sample port on the test card (for whole blood sample, one drop of whole blood buffer must be added after loading 100 pl sample on the test card)
8. Reaction time: 15 minutes. Insert the best card into Getein1100 and press “”ENT’ button after reaction time is elapsed. The result will be shown on the screen and printed automatically.
For Getein1600:
9. Each cartridge for Getein1600 contains a specific RFID card which can calbrate autornatically.
10. Place samples in the designed area of the sample holder, insert the holder and select the right test item, Getein1600 will do the testing and print the result automatically.
Notes:
1. It is required to perform “”SD Card Calib^ calibration when using a new batch of kits.
2. It is suggested to calibrate once for one batch of kits for Getein 1100.
3. Make sure the test card and the sample insertion is correct and complete
Other Info
Store the test card at 4-30°C with a valid period of 24 months
Use the test card for Getein1100 within 1 hour once the foll pouch is opened.
For test card of Getein1600: 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 fail pouch and reseal along the entire edge of zlo-segl. The remaining test cards should be used up within 7 days.
Store the sample diluent/whole blood buffer at 0-30°C with a valid period of 24 months.
Store the sample diluent/whole blood buffer at 2-B’C for better results.
Manjiri –
Gives correct result for pct blood test
Vijendra –
Accurex is one the best company in diagnostics.
Nikita Zaveri –
I am happy with product quality & Service . please continue providing quality of products in future also .
Swapnil Kudve –
I like accurex product due to result very satisfied with result.
Satya Poojari –
I have use their product is really nice