Dengue Test Kit #9379427

The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to sub-tropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondary infection is the more common form of the disease in many parts of Southeast Asia and South America. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, haemorrhagic events, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific IgM antibody levels 3 to 5 days after the onset of symptoms; this generally persists for 30 to 60 days. IgG levels also become elevated after 10 to 14 days and remain detectable for life. During secondary infection, IgM levels generally rise more slowly and reach lower levels than in primary infection, while IgG levels rise rapidly from 1 to 2 days after the onset of symptoms.

Intended useDengue IgG Microlisa is designed for in-vitro qualitative detection of Dengue IgG Antibodies in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for DENGUE. The kit detects all four subtypes; DEN1, DEN2, DEN3 & DEN4 of Dengue Virus.

PrincipleDENGUE IgG MICROLISA test is an enzyme immunoassay based on “GAC-Capture ELISA”. Anti-human IgG antibodies are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. Antibodies to Dengue if present in the specimen, will bind to the Anti-human IgG antibodies adsorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRPO) conjugated dengue antigen (DEN1-4) is added to each well. This dengue antigen conjugate will bind to Dengue specific IgG antibodies which is complexed with anti- human IgG antibodies. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of Dengue antibodies present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain Dengue IgG antibodies then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colour develops. 

Description of symbols usedThe following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.

Dengue IgM Quanti Card is a sensitive immuno- chromatographic test for the qualitative detection of dengue IgM antibodies in human Serum/ Plasma with iQuant Analyzer . This test is for in vitro diagnostic use only and is intended as an aid in the diagnosis of dengue infection.Dengue IgM Quanti Card is a fluorescence immunoassay. The test area is coated with dengue antigen (1-4). When a sample is added to the device, dengue IgM antibodies in the sample react with anti-human IgM antibodies complex to flourescent dye in the conjugate. On addition of Assay Buffer, this complex migrates along the nitrocellulose membrane to the test region and forms an antibody-antigen-antibody fluorescence immunocomplex. The result will be displayed by iQuant Analyzer.

Dengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are four distinct but antigenically related serotypes of dengue viruses, and transmission is by mosquito, prinicipally Aedes aegypti and Aedes albopictus. The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to sub-tropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondry infection is the more common form of the disease in many parts of Southeast Asia and South America. IgM antibodies are not detectable until 5- 10 days in case of primary dengue infection and until 4-5 days in secondary infection after the onset of illness. IgG appear after 14 days and persist for life in case of primary infection and rise within 1-2 days after the onset of symtoms in secondary infection. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, haemorrhagic fever, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels 0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in countries where dengue is endemic.

Intended useDengue NS1 Ag Quanti Card is a sensitive immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen in human Serum/ Plasma with iQuant Analyzer . This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection 

Principle (antigen-antibody reaction)Dengue NS1 Ag Quanti Card is a fluorescence immunoassay based on sandwich principle. The test area is coated with specific anti-dengue NS1 Ag antibodies. When a sample is added to the cartridge, Dengue NS1 antigen if present will form a complex with another specific NS1 antibodies conjugate to fluorochorme. On addition of Assay Buffer, this complex migrates along the nitrocellulose membrane to the test region and forms an antibody-antigen-antibody fluorescence immunocomplex. The result will be displayed by iQuant Analyzer.

1. IntroductionDengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are four distinct but antigenically related serotypes of dengue viruses, and transmission is by mosquito, prinicipally Aedes aegypti and Aedes albopictus. The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to subtropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondry infection is the more common form of the disease in many parts of Southeast Asia and South America. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, haemorrhagic evets, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels 0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in countries where dengue is endemic.

2. Intended useDENGUE NS1 Ag MICROLISA is designed for in vitro qualitative detection of Dengue NS1 antigen in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for DENGUE. The kit detects all four subtypes; DEN1, DEN2, DEN3 & DEN4 of Dengue Virus.

3. PrincipleDengue ns1 ag microlisa is a solid phase enzyme linked immunosorbent assay (ELISA) based on the “Direct Sandwich” principle. The microwells are coated with Antidengue NS1antibodies with high reactivity for Dengue NS1 Ag. The samples are added in the wells followed by addition of enzyme conjugate (monoclonal anti-dengue NS1 antibodies linked to Horseradish Peroxidase (HRPO)). A sandwich complex is formed in the well wherein dengue NS1 (from serum sample) is “trapped” or “sandwiched” between the antibody and antibody HRPO conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound peroxidase is proportional to the concentration of dengue NS1 antigen present in the sample. Upon addition of the substrate buffer and chromogen, a blue colour develops. The intensity of developed blue colour is proportional to the concentration of dengue NS1 antigen in sample. To limit the enzyme-substrate reaction, stop solution is added and a yellow colour develops which is finally read at 450nm spectrophotometrically.

4. Description of symbols usedThe following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.

The Dengue NS1 Rapid Test is an immunochromatographic assay for the qualitative Detection of non-structural protein 1 (NS1) in human serum/plasma.

Summary and explanation of the test

Dengue is an acute viral disease, which is transmitted by Aedes aegypti mosquitoes. Dengue is characterized clinically by biphasic fever, rash and hematopoietic depression, and by constitutional symptoms such as malaise, arthralgia, myalgia and headache (1). Infrequently, more severe disease is seen, manifested by hemorrhage fever which may progress to lethal shock (2, 3). It is endemic in the tropics and subtropics, worldwide, where an estimated 100, 000, 000 cases occur annually (4). 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 (5), 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. The Aspen Dengue NS1 Rapid Test detects NS1 antigen in serum samples following infection.

Principle of the test

The Dengue NS1 Rapid Test is a qualitative, membrane based immunoassay for the detection of NS1 antigen in human serum/Plasma. The rapid 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 test is placed into a well containing 3 drops of buffer. The buffer and serum mix and interact with NS1-specific monoclonal antibodies conjugated to gold nanoparticles. 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 red line will appear at the test line. The red line at the control region should always appear if the assay is performed correctly.

Kit  storage  and  precautions

The sealed pouch containing the test device and Buffer is designed to be stored at room temperature (22°C-30°C) till the expiry. Exposure to the otemperatures over 30C can impact performance of the test. The kit should not be frozen. The test should be used within 15 minutes after removal from the pouch to prevent exposure to humidity (5 minutes in high humidity areas).

Test  procedure

Remove the  Dengue NS1 Rapid test from the foil pouch and assure that all test serum samples are allowed to reach room temperature.

1. Of to the sample well (s) by using a pipette (or 2 drops of sample by using provided sample dropper).
2. Of buffer in buffer (b)well
3. Read the result after 15 minutes. Do not interpret results  after  30 minutes.

Dengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are four distinct but antigenically related serotypes of dengue viruses, and transmission is by mosquito, principally Aedes aegypti and Aedes albopictus. The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to sub-tropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondary infection is the more common form of the disease in many parts of Southeast Asia and South America. IgM antibodies are not detectable until 5-10 days in case of primary dengue infection and until 4-5 days in secondary infection after the onset of illness. IgG appear after 14 days and persist for life in case of primary infection and rise within 1-2 days after the onset of symptoms in secondary infection. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, hemorrhagic events, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels 0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in countries where dengue is endemic. 

Intended useDengue Day 1 Test is a rapid solid phase immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to dengue virus in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid to an early diagnosis of dengue infection & presumptive diagnosis between primary and secondary dengue infection.

Principle (antigen-antibody reaction)Dengue Day 1 Test kit consists two devices; one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgM/ IgG antibodies in human serum/ plasma. Dengue NS1 antigen device contains two lines; “C” (Control Line) & “T” (Dengue NS1 Antigen detection Test Line). Test line is coated with antibodies, anti-dengue NS1 Ag. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloid conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at “T” as antibody-antigen-antibody gold conjugate complex. Dengue IgM/IgG test device contains three lines; “C” (Control line), “M” (IgM test line) & “G” (IgG test line). IgM test line is coated with anti-human IgM monoclonal antibodies and IgG test line is coated with anti-human IgG monoclonal antibodies. When a sample is added to the device, IgM and IgG antibodies in the sample react with anti-human IgM or IgG antibodies coated on the membrane respectively.