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 semi-quantitatively or quantitatively. Principle of the Procedure: Two kinds of high specific and sensitive CK-MB/cTnI/Myo monoclonal antibodies are used for the test strips. One is gold-labelled and coated on the polyester film, and the other is fixed on the test lines. The antibodieson the test lines form sandwich complexes with any CKMB/cTnI/Myo in the blood sample.The sample passes through the detection zone, in which the sandwich complexes gather along a line, appearing as a purplish red streak (the test or signal line). Excess gold-labelled antibodies gather along the control line, signaling visually that the test is valid. The intensity of the test line increases in proportion to the CK-MB/cTnI/Myo concentration. Test Procedure: 1. Restore the test card and the blood specimen to room temperature (20~25°C better).2. Open the pouch and label the strip with the patient specimen number.3. Use the pipette to transfer blood from a sample collection tube.4. Release the bulb slowly, dropping 3 to 4 drops (or 120 μl) of the sample.5. Referring to standard colorimetric card, get the semi-quantitative result by eye or read the quantitative result with the matching equipment. The result must be read within 10~30 mins. Warnings and Precautions: 1. Use for in vitro diagnostics. 2. Use by healthcare professionals. 3. The best testing temperature is 15~30 C, and the best humidity is 40~60%. 4. Do not use the stri p beyond the expiration date pri nted on the outside of the box. 5. The stri p must be used within 1 hour once its foil pouch has been opened. 6. The transfer pipette shoul d be used for one specimen only. Discard it after used. 7. Patient specimens, used strip and transfer pipettes may be potentially infectious. Proper handling and disposal methods should be established by the laboratory direction in accordance with local regulations. 8. Proper laboratory safety techniques should be followed at all times when working with potentially infectious blood specimens.
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