ACCUDx CQ CK-MB/c Tnl/Myo Immunofluorescence Assay

Overview ACCUDx CQ CK-MB/c Tnl/Myo Immunofluorescence Assay

The ACCUDx CQ CK-MB/cTnI/Myo Immunofluorescence Assay employs fluorescently labeled monoclonal antibodies targeting human CK-MB, cTnI, and Myo. These antibodies, bound to latex particles, react with corresponding analytes in the patient sample. Capillary action draws the resulting complexes to detection zones on the test strip, where immobilized capture antibodies bind the complexes. Fluorescence intensity at each detection zone, measured by the ACCUDx CQ Immunofluorescence Quantitative Analyzer, directly correlates with the sample's CK-MB, cTnI, and Myo concentrations. Results, stored and downloadable from the analyzer, are readily transferable to LIS and HIS systems. This assay aids in diagnosing, prognosing, and assessing myocardial injury, including AMI, unstable angina, acute myocarditis, and acute coronary syndrome. It quantitatively measures CK-MB, cTnI, and Myo in serum, plasma, or whole blood. **Instructions:** Follow the provided manual for specimen collection. Ensure all components reach room temperature before use. Verify the SD card and test kit lot numbers match; calibrate using "SDCard Calib" if needed. On the Getein1100, press "ENT" to begin testing. Immediately before use, remove the test card from its sealed pouch and label appropriately. Place the card horizontally on a clean surface. Add 100 µl of sample to 100 µl of diluent, mix thoroughly, and dispense 100 µl (or 3 drops using a disposable pipette) into the sample port. After 10 minutes, insert the card into the Getein1100 and press "ENT". Results will be displayed. **Precautions:** For in-vitro diagnostic use by trained professionals only. Do not use beyond the expiration date or if the pouch is damaged. Avoid opening pouches prematurely and never reuse test cards or pipettes. Handle all samples as potentially infectious and dispose of them according to local regulations. Always adhere to the instructions for optimal test performance.

How to Use ACCUDx CQ CK-MB/c Tnl/Myo Immunofluorescence Assay:

Following the provided instructions, prepare the sample. Allow the test card, sample, and reagent to reach ambient temperature before analysis. Verify the SD card lot number matches the test kit lot number; calibrate ("SDCard Calib") if needed. Navigate to the Getein1100 testing interface via the "ENT" button. Immediately before use, remove the test card from its packaging and label it with the patient or control identifier. Lay the card flat on a clean surface. Using a transfer pipette, combine 100 μl of sample with 100 μl of diluent (or 3 drops with a disposable pipette), mix well, and transfer 100 μl to the test card's sample well. After 10 minutes, insert the card into the Getein1100 and press "ENT"; the results will display.

Safety Instruction of ACCUDx CQ CK-MB/c Tnl/Myo Immunofluorescence Assay:

• Intended solely for laboratory diagnostic applications.
• Exclusive to healthcare practitioners.
• Discard the kit after the expiry date.
• Discard the test card if its foil packaging is compromised.
• Keep the pouches sealed until you are prepared to administer the test.
• Discard the test strip after use.
• Discard the pipette after each use.
• Treat all samples as if they are capable of transmitting infection.
• Adhere to local guidelines for safe medication handling and disposal.
• Adhere strictly to the instructions in the user guide for accurate test results.