ACCUDx CQ PCT Immunofluorescence Assay

ACCUDx CQ PCT Immunofluorescence Assay 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 transmitied to the laboratory or hospital information system.

Uses:
It 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.

Product Specifications and Features:

• Getain 1100/Getein1600 can scan the test card automatically and display the result on the screen

• 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 paralollicular cells (C cells) of the thyroid and by the neurcendocrine calls of the lung and the intestine

Directions For Use:

• Collect specimens according to user manual

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

For Getein1100:

• 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)

• On the main interface of Getein1100, press The ENT button to enter 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 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)

• Reaction time: 15 minutes. Insert the best card into Getein1100 and press the ENT button after reaction time is elapsed. The result will be shown on the screen and printed automatically

For Getein1600

• Each cartridge for Getein1600 contains a specific RFID card which can calibrate automatically

• 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

Safety Information:

• For in vitro diagnostic use only

• For professional use only

• Do not use the kit beyond 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 test

• Do not reuse the test card

• Do not reuse the pipet tips

• Mandie ail specimens as potentially iniecious. Proper hendiing and disposal methods should be followed in acoordance with local regulations and good safety practices

• Carefully read and follow the user manual to ensure test performance