Arjas Healthcare

ICMR Approved	Yes
Brand	J. Mitra
Packaging Type	Box
Usage/Application	Hospital
Disposable/ Reusable	Disposable
Country of Origin	Made in India
Pack Size	25 Test

DENGUE IGG IGM 25 TEST                             

Packaging Type	Box
Manufacturer	J Mitra
Packaging Size	96 Test
Storage Condition	Store at room temperature (20-30 Degree Celsius)
Calibration factor	0.7
Sensitivity	98.66%
Usage	GAC- ELISA Test for the Detection of Dengue IgG Antibodies in Human Serum/Plasma

1. Introduction

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.

2. Intended use
Dengue 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.

3. Principle
DENGUE 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. 

4. Description of symbols used
The 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.

Result Time (Rapid Kits)	20 Minutes
Packaging Type	Box
Manufacturer	J MItra
Usage	Rapid visual test for the detection of Dengue NS1 Antigen
Packaging Size	10 Test
Storage Condition	Store at 2 Degree Celsius to 30 Degree Celsius
Sensitivity	96%
Specificity	98%

Introduction
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.

Packaging Type	Box
Manufacturer	J Mitra
Packaging Size	24 Test Pack
Sensitivity	96.72%
Specificity	97.45%
Usage	Fluorescence immunoassay for qualitative detection of Dengue IgM antibodies in Human Serum/ Plasma

Introduction
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.

Intended useDengue 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. 

Principle
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. 

Materials providedDengue IgM Quanti Card kit contains following components to perform the assay: a) Dengue IgM Quanti CardDevice
b) Assay Buffer
c) Instruction Manual

Result Time (Rapid Kits)	40 Minutes
Packaging Type	Box
Manufacturer	J Mitra
Principle	Based on most advanced fluorescence immunoassay
Usage	Detection of all 4 serotypes of Dengue Virus.
Sensitivity	96.72%
Specificity	97.45%.
Shelf life	15 Months
Storage Conditions	Store at 2-8 Degree Celsius
Packaging Size	24 tests

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.

Principle (antigen-antibody reaction)

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.

Salient features

• Principle : Based on most advanced fluorescence immunoassay
• Detection of all 4 serotypes of Dengue Virus.
• Individually pouched test cartridge, each cartridge is precision engineered with embedded lot data.
• Results within 40 Minutes .
• Results are directly displayed in Dengue units .
• Excellent Sensitivity: 96.72% & Specificity: 97.45%.
• Longer shelf life: 15 Months at 2-8°C.
• Convenient pack size: 24 tests.
• Prompt service back-up

 

ICMR Approved	Yes
Sterile/ Non Sterile	Sterile
Packaging Type	Box
Usage/Application	Hospital
Disposable/ Reusable	Disposable
Country of Origin	Made in India

Dengue Test Kit