Accurex Accudx CQ HS-Crp Test Kit

Accurex Accudx CQ HS-Crp Test Kit
ACCUDx CQ hs-CRP+CRP Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of C-reactive protein (CP) in serum, plasma or whole blood. Measurement of CRP helps detect and evaluate infection, tissue injury and inflammatory disorders. Measurement of high sensitivity CRP (hs-CRP), when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes (ACS), may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or ACS.

Uses: For determination of CRP levels in the blood.

Product Features and Specifications:

• The test uses an anti-human CRP monoclonal antibody conjugated with fluorescence latex and another anti-human CP monoclonal antibody coated on the test line

• After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human CRP monoclonal antibody binds with the CRP in the sample and forms a marked antigen-antibody complex

• This complex moves to the test detection zone by capillary action

• Then, the marked antigen-antibody complex is captured on the test line by the anti-human CRP monoclonal antibody

• The fluorescence intensity of the test line increases in proportion to the amount of CRP in the sample

• Then, the test card is inserted into ACCUDx CQ Immunofluorescence Quantitative Analyzer

• The concentration of CRP in the sample will be measured and displayed on the screen

• The value will be stored in ACCUDx CQ Analyzer. The result can be transmitted to the laboratory or hospital information system

Directions For Use:

• Collect specimens according to safe phlebotomy procedures

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

• Confirm that SD card lot no. matches with the test kit lot no.

• Perform SD card calibration whenever the lot number is changed and when necessary

• On the main menu of ACCUDx CQ Analyzer, press the ENT button to enter the testing interface

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

Test Results: ACCUDx CQ Analyzer can scan the test card automatically and display the result on the screen. For additional information, please refer to the user manual of ACCUDx CQ Analyzer

Storage and Safety Information:

• For in vitro diagnostic use only

• For professional use only

• Use the kit up to the expiration date

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

• Do not open pouches or the cartridge until you are ready to perform the test

• Do not reuse the test card

• Do not reuse the pipet tips

• Handle all specimens as potentially infectious

• Proper hendiing and disposal methods should be followed in acoordance with local regulations and good safety practices

• Read the label carefully to ensure test performance