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One-Step Dengue IgG/IgM Rapid Test
Dengue IgG/IgM INTENDED USE
THE ONE STEP ANTI-DENGUE (IGM & IGG) TRI-LINE TEST IS A COLLOIDAL GOLD ENHANCED, RAPID IMMUNOCHROMATOGRAPHIC ASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES (IGM & IGG) TO DENGUE VIRUS (DV) IN HUMAN WHOLE BLOOD, SERUM OR PLASMA. THIS TEST IS A SCREENING TEST, AND ALL POSITIVES MUST BE CONFIRMED USING AN ALTERNATE TEST SUCH AS WESTERN BLOT. THE TEST IS INTENDED FOR HEALTHCARE PROFESSIONAL USE ONLY.
Dengue IgG/IgM SUMMARY
Dengue viruses (DVs) are the causative agent of dengue fever, dengue hemorrhagic fever and dengue shock syndrome. It is estimated that at least 80 million DV infections occur worldwide annually. The majority of DV infections are asymptomatic. In symptomatic DV infection, clinical syndromes range from an undifferentiated febrile illness to dengue fever (DF) to dengue hemorrhagic fever (DHF), a plasma leakage syndrome that, in its most severe form dengue shock syndrome (DSS) can be life threatening.
PRINCIPLE OF THE PROCEDURE
The assay starts with a sample applied to the sample well. A recombinant DV antigen conjugated to colloidal gold embedded in the sample pad reacts with the DV antibody present in blood, serum or plasma forming conjugate-DV antibody complex. As the mixture is allowed to migrate along the test strip, the conjugate-DV antibody complex is captured by mouse anti human IgM-µ chain (T1) or mouse anti human IgG(T2) immobilized on a membrane forming a colored test line in the test region. A negative sample does not produce a test line due to the absence of colloidal gold conjugate-DV antibody complex. The antigens used in the conjugate test are recombinant proteins that correspond to highly immunoreactive regions of DV. A colored control line in the control region appears at the end of test procedure regardless of test result. This control line is the result of colloidal gold conjugate binding to the anti-DV antibody immobilized on the membrane. The control line indicates that the colloidal gold conjugate is functional.
Two test lines are coated on the membrane; on T1 region mouse anti human IgM-µ chain is immobilized; On T2 region a mouse anti human IgG is coated, a positive result appearing on T1 region indicates a DV IgM positive samples and a positive result appearing on T2 region indicates a DV IgG positive samples.
REAGENTS AND MATERIALS SUPPLIED
· Test cards/ test strips individually foil pouched with a desiccant
· Sample diluent
· Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
· Pipettes to transfer specimen.
· Positive and negative controls
STORAGE AND STABILITY
1. Store unused kit at 2 - 30°C.
2. Store test cards/strips at 2 - 30°C and away from direct sunlight.
Contact Person: Ms. Anna Lee