INTENDED USE
The Dengue NS1 Rapid Test kit is a rapid, qualitative test for the detection of dengue virus NS1 antigen in human serum, plasma or whole blood for the diagnosis of early acute dengue infection. 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 Ag Rapid Test 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)1. In children, infection is often subclinical or causes a self-limited febrile disease. 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 causes2. NS1 is a highly-conserved glycoprotein that is present at high concentrations in the sera of dengue-infected patients during the early clinical phase of the disease. NS1 antigen is found from the first day and up to 9 days after onset of fever in sample of primary or secondary dengue infected patients3. Usually IgM does not become detectable until 5 to 10 days after the onset of illness in cases of primary dengue infection and until 4 to 5 days after onset of illness in secondary infections. In primary infections, IgG appear the 14th day and persist for life. Secondary infections show that IgGs rise within 1-2 days after the onset of symptoms and induce IgM response after 20 days of infection4. The Dengue NS1 Rapid Test kit 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 Dengue NS1 Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-dengue NS1 antigen conjugated with colloid gold (Dengue Ab conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with mouse anti-dengue NS1 antigen, and the C band is pre-coated with goat anti-mouse IgG antibody. The antibodies to dengue antigen recognize the antigens from all the four serotypes of the dengue virus. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the test cassette. Dengue NS1 Ag if present in the specimen will bind to the Dengue Ab conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-NS1 antibody, forming a burgundy colored T band, indicating a Dengue Ag positive test result. Absence of the T band 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-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.