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HCV Hepatitis C Virus Test Serum/Plasma(Cassette)

HCV Hepatitis C Virus Test Serum/Plasma(Cassette) Image

    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.

HCV Hepatitis C Virus Test Serum/Plasma(Cassette)

HCV Hepatitis C Virus Test Serum/Plasma(Cassette) Image

    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.