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(HCV) Hepatitis C Virus Test
(HCV) Hepatitis C Virus Test
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.
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  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.

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.
Description Specimen Format Catalog No. Sensitivity Package Size Strip Width Certificate
(HCV) Hepatitis C Virus Test Serum/Plasma Strip B20-11 99.53% 50 Tests 3.0 mm CE2265
Cassette B20-20 25 Tests 4.0 mm
Whole Blood B20-21 25 Tests 4.0 mm ——