RAPID DENGUE IgG/IgM COMBO TEST

A Rapid qualitative Immunochromatographic test for the simultaneous detection of IgG and IgM Antibodies to Dengue Virus in human Whole Blood, Serum or plasma

INTENDED USE:

Rapid Dengue Test is a rapid immunochromatographic assay for the simultaneous detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum or plasma. The assay is used as a screening test for Dengue viral infection and as an aid for differential diagnosis of primary and secondary infections in conjunction with other criteria.

SPECIFICATION:

1)        Specimen: whole blood/serum/plasma

2)        Format: cassette

FEATURE:

1)        Simple: simply add specimen and dilution(if necessary) into sample well

2)        Rapid: results come out at 20 minutes

3)        Visually interpreted: don’t need any equipment

4)        Stable: more than 12 month period of validity

PACKING

Cassette: 25 tests/box, 50 tests/box

PROCEDURE

1)        Bring the kit components to room temperature before testing.

2)       Open the pouch and remove the Card. Once opened, the test card must be used immediately.

3)        Label the test card with patients identity.

4)        Apply 5 μL of serum, plasma or whole blood to the “S1” area indicated by the arrow mark.

5)        Add 2 drops of sample buffer to well marked as “S”.

6)        At the end of 20 minutes read the results. A strong positive sample may show result earlier.

PRINCIPLE:

Rapid Dengue Test utilizes the principle of Immunochromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device.  The IgG line in the test window is closer to the sample well and followed by IgM line. As the test sample flows through the membrane assembly within the test device, the colored–Dengue specific recombinant antigen-colloidal gold conjugate complexes with specific antibodies (IgM or IgG) of Dengue virus, if present in the sample.  This complex moves further on the membrane to the test region where it is immobilized by the anti-human IgM and/or human IgG binding proteins coated on the membrane leading to formation of a colored band, which confirms a positive test results.  Absence of this colored band in the test window indicates a negative test result.  A built-in control line will always appear in the test window when the test has performed properly, regardless of the presence or absence of anti-Dengue virus antibodies in the specimen.