INTENDED USE
Dengue IgG/IgM Combo 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.
INTRODUCTION
Dengue fever is one of the most important mosquito-borne diseases in the world in the terms of morbidity, mortality. Dengue fever virus (serotypes 1 – 4) belongs to the group flavivirus, and is transmitted in nature by day-biting Aceder mosquitos. The most important mosquito vector is highly domesticated and urban species, Aedes aegypti. Primary Dengue infection, also known as Dengue Fever, is the most common type of dengue illness. It is associated with mild to high fever, headache, muscle pain and skin rash. Secondary infection is known as Dengue Hemorrhagic Fever (DHF) or Dengue Shock Syndrome, and often results in high fever and in many cases, with hemorrhagic events and circulatory failure. The fatality rate in patients with Dengue Shock Syndrome can be as high as 44%. Dengue presents typically as a fever of sudden onset with headache,
retrobullar pain, pain in the back and limbs (break-bone fever), lymphaderopathy and maculopaplar rash. Patients diagnosed with dengue in endemic areas generally have secondary infection, whereas patients in non-endemic areas are usually diagnosed with primary infection. Specific antibody responses to Dengue virus enable serodiagnosis and differentiation between primary and secondary dengue infections. Dengue IgG/IgM Combo Test is a new generation rapid Immuno-chromatographic test using recombinant dengue viral antigens of all four serotypes to detect specific antibody response.
TEST PRINCIPLE
Dengue IgG/IgM Combo Test utilizes the principle of Immuno-chromatography. 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 within the test device, the colored–Dengue specific recombinant antigen-colloidal gold conjugate complexes with specific antibodies (IgM and/or IgG) of Dengue virus, if present in the sample. This complex moves further on the membrane to the test region where it is captured by the anti-human IgM and/or human IgG antibodies coated on the membrane leading to formation of a colored band, which indicates 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.
REAGENTS AND MATERIALS SUPPLIED
Each kit contains:
1. Dengue IgG/IgM Combo Test Card in foil pouch
2. Sample Buffer
3. 2 μL Pipetter
4. Instructions for Use
MATERIALS NOT PROVIDED
1. Sepcimen collection container
2. Timer
STORAGE AND STABILITY
The sealed pouches in the test kit may be stored between 4-30ºC for the duration of the shelf life as indicated
on the pouch.
PRECAUTIONS
1. This kit is for IN VITRO diagnostic use only.
2. This kit is for PROFESSIONAL use only.
3. Read the instructions carefully before performing the test.
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