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          Cassette

           

           

              Product Name:
             
          HCV Hepatitis C Virus Test (Cassette)
              Accessories:
             
          Instruction for use, pipette, buffer, sterile lancet
              Principle of Test:
              Immunochromatographic assay
              Product Performance:
              Sensitivity: 97.9%     specificity: 97.9%



          INTENDED USE: One Step HCV Test is a rapid and convenient immunochromatographic assay for qualitative
          detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma. It is intended for professional
          use as an aid in diagnosis of HCV infection. This test is a screening test and provides only a preliminary
          result. All positive results should be confirmed using clinical expertise and professional judgments.

          TEST PROCEDURE

          1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the 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 packed in the pouch to draw and slowly add 1 drop of whole blood specimen to the sample well. 

          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 drops of buffer to the sample well. 

          4. Wait for 10-15 minutes and read results. Do not read results after 20 minutes.

          Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is

           significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

           

          INTERPRETATION OF RESULTS

                                                  

                                                                      Positive               Negative                   Invalid 

          Positive:          
          Two colored lines should be observed in the result window, one in the test region and another one in the 
          control region. 
          Negative: 
          Only the control line appears in the result window.
          Invalid:   
          No line appears in the control region regardless of the presence or absence of the line in the test region. 
          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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