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          Cassette

           

           

              Product Name:
              HCV Hepatitis C Virus Test
              Accessories:
              Instruction for use, pipette
              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 to draw and add 2 drops of serum/plasma specimen 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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