CorDx

HCV Hepatitis C Virus Test Serum/Plasma(Strip)

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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.

    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 strip to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

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

3. Immerse the test strip in the specimen with the arrow end pointing toward the specimen solution. Do not immerse the strip above the printed MAX line. After a minimum of 15 seconds, remove the test strip from the specimen solution and lay flat on a nonabsorptive clean surface. Alternatively, the test strip may be left in the test specimen as long as the strip is not immersed above the MAX line. A separate test strip must be for each specimen or control.

4. Wait for colored lines to appear. Read results within 10-15 minutes. Do not interpret 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:

Two colored lines should be observed in the viewing area, 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 control line appears.

Invalid:

No line appears in the control region 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 strip. If problem persists, please contact your local distributor.