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      3. Cassette

         

            Product Name: 
            HEV Hepatitis E Virus IgM Test (Cassette)
            Accessories:
            Instruction for use, pipette
            Principle of Test:
            Immunochromatographic assay
            Product Performance:
            Sensitivity: 99.35% Specificity: 98.32%

          

         

         

        INTENDED USE

        The HEV IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis E virus (HEV) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HEV. Any reactive specimen with the HEV IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

        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 5&micro;l capillary pipette provided,withdraw the specimen to the mark line. Dispense the specimen to "S" well.

        4. Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

        5. Wait for colored lines to appear. Read the results within 15-20 minutes. DO NOT INTERPRET RESULT 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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