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          Cassette

            Product Name:
            One Step
          Mycoplasma Pheumoniae IgM Test 
            
          Accessories:
            Instruction for use, feces collection tube
            
          Principle of Test:
            Immunochromatographic assay
            
          Product Performance
            Sensitivity:
          97.48%


           

            

          INTENDED USE

          One Step MP-IgM test is used to qualitatively detect the existence of MP -IgM antibodies in serum or plasma sample, as an auxiliary diagnostic reagent of MP infection in clinic.

          TEST PROCEDURE

          1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

          2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

          3. Use the pipette to draw and slowly add 1 drop (10ul)of serum/plasma to the sample well.

          4. Hold the buffer bottle vertically and add 1 drop (40ul)to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2drops of buffer to the sample well.

          5. Wait for colored lines to appear. Read result between 15-20 minutes. The observation is invalid after 20 minutes.

          INTERPRETATION OF RESULTS

                         

          Positive: Two colored lines appear in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

          Negative: Only the control line appears in the result window.

          Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.

          NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

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