Dengue Combo Home Testing Kits , Convenient Home Disease Test Kits 96% Accuracy

Multiple cassette set, Dengue Combo Home Testing kits, individual package, personal use, high accuracy

Product Name: Dengue Combo Home Testing kits

INTENDED USE:

The Dengue Combo NS1 Ag and IgG/IgM Ab Combo Home Testing kit an immunochromatographic assay for the qualitative Detection of NS1 antigen and differential detection of IgG and IgM antibodies to dengue virus in human Serum/Plasma/Whole Blood

BACKGROUND

Dengue virus belongs to family Flaviviridae, having four serotypes that spread by the bite of infected Aedes mosquitoes. It causes a wide spectrum of illness from mild asymptomatic illness to severe fatal dengue haemorrhagic fever/dengue shock syndrome (DHF/DSS). Dengue is characterized clinically by biphasic fever, rash and hematopoietic depression, and by constitutional symptoms such as malaise, arthralgia, myalgia and headache. Infrequently, more severe disease is seen, manifested by hemorrhage fever which may progress to lethal shock. It is endemic in the tropics and subtropics, worldwide, where an estimated 100,000,000 cases occur annually . It has been estimated that about 50 to 100 million cases of Dengue Fever (DF) occur every year with about 250,000 to 500,000 cases of Dengue Hemorrhagic Fever (DHF). During 2002, more than 30 Latin American countries reported over 10,000,000 (DF) cases with large number of DHF cases. This has been followed by extensive epidemics of DHF in several parts of India during 2003 through 2005. In the Americas, the reported incidence has more than tripled from 1996 to 2002. The incidence of Dengue outbreak has been reported in Hawaii, and in Laredo, Texas. The potential for the virus to cause a severe disease has also resulted in the inclusion of this pathogen on the CDC “category A” list for potential biological warfare and bioterrorism agents. Dengue NS1 (non-structural) protein is a multimeric secreted protein that is believed to play a role in viral RNA replication. It is strongly immunogenic eliciting antibodies with complement fixing activity. NS1 antigen can be detected in circulating blood during acute Dengue infection. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels upto 9 days after the onset of symptoms and this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication.

Test Principle

The Dengue Combo NS1 Ag and IgG/IgM Ab Rapid Test is a qualitative, membrane based immunoassay for the detection of NS1 antigen and IgG/IgM antibodies in human Serum/Plasma/Whole blood. Test consists two devices one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgG/IgM antibodies. Dengue NS1 antigen device contains two lines; “C” (Control Line) & “T” (Test line). The test membrane is pre-coated with a NS1 specific antibody on the Test line region and utilizes a separate control to assure assay flow and performance. During testing, the test sample is added directly to the sample region and the 2 drops of buffer is added into the buffer well. The sample interact with NS1-specific monoclonal antibodies conjugated to gold nano particles. The solution migrates upward on the membrane (via capillary action) to react with the anti-NS1 antibody on the membrane. If NS1 antigen is present, a purple/pink line will appear at the test line. The purple/pink line at the control region should always appear if the assay is performed correctly. The Dengue IgG/IgM Ab test consists of two components, an IgG component and an IgM component. Dengue IgG/IgM Ab test device contains three lines, C’ (Control line) IgG and IgM (Tests Lines) IgM Test line is pre coated with anti-human IgG and IgM Ab Test line is pre coated with anti-human IgG. When a sample and buffer added to the device the mixture migrates upward on the membrane chromatographically by capillary action and reacts with anti-human IgG or IgM antibodies coated on the membrane respectively, colloidal gold complex containing dengue antigens is captured by the anti- dengue IgG or IgM Ab on respective “ T ” lines. 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.

TEST PROCEDURE

1. Bring the kit components to room temperature before testing.
2. Open the pouch and remove the Card. Once opened, the test card must be used immediately.
3. Label the test card with patients identity.
4. Apply 5 µL of serum or plasma to the “S1” area indicated by the arow mark.
5. Add 2 to 3 drops of sample buffer to well marked as “S”. Please note that S1 and S are refering to the same well.
6. At the end of 20 minutes read the results. A strong positive sample may show result earlier.

INTERPRETATION OF RESULTS

PERFORMANCE STUDY

The Dengue Combo NS1 Ag & IgG/IgM Antibodies Rapid Test has been evaluated in- house with positive and negative clinical samples tested by commercially available Elisa Test data as follows.