Dengue virus is an enveloped, single-stranded, positive-sense RNA virus that comprises four related but distinct serotypes (Den 1, 2, 3, and 4). The virus is transmitted by mosquitoes of the daytime-biting Stegomyia family, principally Aedes aegypti and Aedes albopictus. Today, more than 2.5 billion people living in the areas of tropical Asia, Africa, Australia and the Americas are at risk for dengue infection.
An estimated 100 million cases of dengue fever and 250,000 cases of life-threatening dengue hemorrhagic fever occur annually on a worldwide basis. Serological detection is a common method for the diagnosis of infection with dengue virus. IgM anti-dengue virus starts to appear at 3 days after initial exposure and remains in circulation for about 30- 60 days. IgG anti-dengue virus is raised at around 7 days, peaks at 2-3 weeks and persists for the duration of life4-6. Detection of antigens released during virus replication in the infected patient show very promising results; 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, allowing early detection and prompt treatment.
The Dengue Ag NS1-IgM/IgG rapid test detects IgG and IgM anti-dengue virus and circulating dengue antigen in one test within 20 minutes. This dengue rapid test kit is user-friendly, does not require cumbersome laboratory equipment and requires minimal staff training.
The Dengue NS1+IgM/IgG Combo rapid test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti– dengue virus, IgM anti-dengue virus and dengue antigen (Dengue Ag) in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with dengue virus. Any reactive specimen with the Dengue Ag NS1-IgM/IgG rapid test must be confirmed with alternative testing method(s).
1. For in vitro diagnostic use and professional use only.
2. Read the package insert instruction before use the kit.
3. Do not use beyond the expiration date which appears on the package label.
4. Do not open the sealed pouch, unless ready to conduct the assay
5. Bring all reagents to room temperature (15°C-30°C) before use.
6. Haemolized blood may be used for the testing, but do not take precipitants.
7. Wear protective clothing and disposable gloves while assaying samples. Wash hands thoroughly after performing the test.
8. Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour. Alternatively, they can be treated with 0.5 to 1% solution of sodium hypochlorite for one hour before disposal.
9. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
10. Read result after 30 minutes may give erroneous results.
11. Do not perform the test in a room with strong air flow, an electric fan or strong air-conditioning.
12. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
13. Excess sample volume (>5µL) can give false positives