Rapid Diagnostic Dengue IgG/IgM/NS1 Combo Rapid Test Kit 15 - 20 Min Cassette Type

【INTENDED USE】

The Dengue NS1 & IgG/IgM Rapid Test Combo is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen, IgG and IgM antobody in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.

【INTRODUCTION】

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 lifethreatening 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. The test is user friendly, does not require cumbersome laboratory equipment and requires

【PRINCIPLE】

The Dengue IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) is  a qualitative membrane- based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with Dengue antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to Dengue, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. Dengue IgM antibodies, if present in the specimen, reacts with the anti- human IgM and the Dengue antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region.
Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains Dengue IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The Dengue NS1 Rapid Test Cassette(Whole Blood/Serum/Plasma)  is a qualitative membrane- based immunoassay for the detection of Dengue NS1 antigen in whole blood, serum, or plasma. During testing, the specimen reacts with Dengue antibody-conjugate in the test cassette. The Gold antibody conjugate will bind to Dengue antigen in the specimen sample which in turn will bind with Anti-Dengue NS1 coated on the membrane. As the reagent moves across the membrane, the Dengue NS1 antibody on the membrane will bind the antibody-antigen complex causing pale or dark pink line to form at the test line region of the test membrane. The intensity of the lines will vary depending upon the amount of antigen present in the sample. The appearance of pink line in the test region should be considered as positive result.

【CONTENTS】

• Rapid Test

• Buffer

• Disposable pipettes

• Instruction for use

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

• The test must remain in the sealed pouch until use.

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】

1.Bring tests, specimens, buffer and/or controls to roomtemperature(15- 30°C) before use.

2.Remove the test from its sealed pouch, and place it onaclean, levelsurface. Label the device with patient or control identification. Forbest results, the assay should be performed within one hour. NS1 Antigen: Transfer 1 drop of sample into the center of the specimenwell(s)ofthe test cassette, then add 1 to 2 drops of buffer, and start thetimer.IgG/IgM Antibody: Transfer 1 drop of sample into the center of the specimenwell(s)ofthe test cassette, then add 1 to 2 drops of buffer, and start thetimer.

3.Wait for the colored band(s) to appear. The result shouldbereadat10 minutes. Do not interpret the result after 20 minutes.