INTENDED USE
The Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of dengue virus IgG/IgM antibody in human serum ,plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses. Any reactive specimen with the Dengue IgG/IgM Rapid Test kit must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY AND EXPLANATION THE TEST
Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes, are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (dengue virus 1, 2, 3 and 4). In children, infection is often subclinical or causes a self-limited febrile disease1-2. However, if the patient is infected second times with a different serotype, a more severe disease, dengue hemorrhagic fever or dengue shock syndrome, is more likely to occur. Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes3-4. Serological detection of IgM antibody is the most common method for the diagnosis of dengue virus infection. Lately, detection of antigens released during virus replication in the infected patient showed very promising result. It enables diagnosis from the first day after the onset of fever up to day 9, once the clinical phase of the disease is over, thus allows early treatment in placed promptly5-6.The Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is developed to detect circulating dengue antigen in serum ,plasma or whole blood. The test can be performed by untrained or minimally skilled personnel, without laboratory equipment.

PRINCIPLE
The test cassette consists of: 1) a burgundy colored conjugate pad containing Dengue recombinant envelope antigens (Including 4 serotypes)conjugated with colloid gold (dengue conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (G and M bands) and a control band (C band). The G band is pre-coated with the antibody for the detection of IgG anti-dengue virus, M band is coated with antibody for the detection of IgM anti-dengue virus, and the C band is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-dengue virus if present in the specimen will bind to the dengue conjugates. The immunocomplex is then captured by the reagent coated on the G band, forming a burgundy colored G band, indicating a dengue virus IgG positive test result and suggesting a recent or repeat infection. IgM anti-dengue virus, if present in the specimen, will bind to the dengue conjugates. The immunocomplex is then captured by the reagent pre-coated on the M band, forming a burgundy colored M band, indicating a dengue virus IgM positive test result and suggesting a fresh infection. Absence of any test bands (G and M) suggests a negative result.The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.