Intended Use
One Step Test for CK-MB/cTnI/Myo (Colloidal Gold) applies colloidal gold immunochromatography to detect CK-MB/cTnI/Myo in serum and plasma samples with Colorimetric Card semi-quantitatively or with FIA8000 Quantitative Immunoassay Analyzer quantitatively.
Matching Equipment
One Step Test for CK-MB/cTnI/Myo (Colloidal Gold) applies colloidal gold immunochromatography to detect CK-MB/cTnI/Myo in serum and plasma samples with Colorimetric Card semi-quantitatively or with FIA8000 Quantitative Immunoassay Analyzer quantitatively.
Matching Equipment
FIA8000 Quantitative Immunoassay Analyzer
Warnings and Precautions
1. For In-Vitro diagnostic use.
2. For use by healthcare professionals.
3. Do not use the kit beyond the expiry date printed on the outside of the box.
4. Keep the test card in the sealed pouch until ready to use. Discard after single use.
5. The transfer pipette should be used for one specimen only. Discard after single use.
6. Patient specimen, used test card and transfer pipettes may be potentially infectious. Proper handling and disposal methods should be established in accordance with local regulations.
7. Carefully follow the instructions and procedures described in this insert.
Storage and Stability
Test Procedure
Storage and Stability
Store at 4~30℃ with a valid period of 24 months.
Use the test card within 1 hour once the foil bag is opened.
Sample Collection and Preparation
1. A serum or plasma sample is required for testing with this product. It is suggested that the plasma sample use heparin as anticoagulant.
2. Test the serum or plasma sample on the test card immediately. If testing can not be completed immediately, the sample should be stored at 2~8℃ for 7 days or stored at -20℃ for 6 months until it can be tested.
3. Samples must be allowed to reach room temperature before testing. Frozen samples are required to be completely thawed and mixed thoroughly prior to testing, avoiding repeatedly freezing and thawing.
4. Avoid heating the samples, which can cause hemolysis and protein denaturation, inactivating the samples. It is recommended to avoid using severely hemolyzed sample whenever possible. If a sample appears to be severely hemolyzed, another sample should be obtained and tested.
SAMPLE VOLUME: 120 μl serum or plasma.Test Procedure
1. Restore the specimen and the test card to room temperature and number the card.
2. Confirm SD card lot No. Same with test kit lot No., insert the SD card into FIA8000 analyzer and wait self-checking successfully. (see analyzer manual for details)
3. When the specimen quantity is small, Suggest to choose inside-board testing and set board-running time at 15 minutes (see analyzer manual for details). take 120 μl serum or plasma by pipette, drop vertically to the sample port on the test card, insert the card immediately into FIA8000 analyzer and press "OK" key, the test card can be detected and the result will be printed automatically.
Note: Assure of card side towards the analyzer is correct and insert the card completely.
When the specimen quantity is big, suggest to choose outside-board testing, by using the clock, to insert the card into analyzer 15 minutes after adding specimen. Suggest to detect 1 specimen every 2 minutes.
For more information,please contact me ASAP.
When the specimen quantity is big, suggest to choose outside-board testing, by using the clock, to insert the card into analyzer 15 minutes after adding specimen. Suggest to detect 1 specimen every 2 minutes.
For more information,please contact me ASAP.