Accu Test HCV Chromatographic Immunoassay

Accu Test HCV Chromatographic Immunoassay is a rapid chromatographic immunoassay for the qualitative detection of antibodies generated against proteins encoded by the conserved sequence of core NS3, NS4, and NS5 parts of the HCV genome in human whole blood/serum or plasma. Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. Antibody to HCV is found in over 80% of individuals with well-documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualise it by electron microscope. Cloning the viral genome has allowed it to develop serologic assays that use recombinant antigens. New serologic tests have added multiple antigens using recombinant protein and/or synthetic peptides to avoid nonspecific cross-reactivity and increase HCV antibody test sensitivity.

Uses:

• AccuTest HCV Test is a rapid Chromatographic Immunoassay for the Qualitative detection of antibodies generated against proteins.

Product Specifications and Features:

• AccuTest HCV Rapid Hepatitis C Virus Test (serum/plasma/whole blood) is a lateral flow chromatographic immunoassay based on the principle of the double antigen-sandwich technique

• The membrane is coated with recombinant HCV antigen on the test line region of the device

• During testing, the serum/plasma or w.blood specimen reacts with HCV antigen-coated particles

• The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen or membrane and generate a coloured line

• Presence of this coloured line indicates a positive result, while its absence indicates a negative result

• To serve as a procedural control, a coloured line will always appear at the control line region, indicating that the correct specimen volume has been added and membrane wicking has occurred

Directions For Use:

• Allow the test, specimen and or control to room temperature before the testing

• Remove one test card from the pouch and place it on a clean flat surface

• Using the dropper, provide one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well

• Avoid overflowing

• Read results within 15 minutes

• Strong positive reaction may be visible within 5 minutes

• Do not read results after 15 minutes

Test Results:

• Positive: If a distinct purple line is formed at the test one marked ‘T’ (Test Line) and the Control Zone marked ‘C’ (Control Line) the test result is positive, indicating the sample contains Hepatitis C antibody. The interpretation of test results (+ve for hepatitis) remains unchanged even if there is a difference in intensity of colour in positive line and control line as is many a time found

• Negative: If a distinct purple line is formed only at the control zone marked ‘C’ (control line) the test result is negative

• Invalid: A total absence of color in both © and (T) regions or no colored band appears on the control © region is an indication of procedure error and/or the test reagent has deteriorated. Repeat with a new test kit

Safety Information:

• AccuTest HCV should be stored at 4-30C. However, the card may be stored in the original sealed pouch at room temperature, not exceeding 30C

• Read the label carefully before use

• Keep out of reach of children

• For external use only