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  • Dengue IgM/IgG Rapid Test
  • Dengue IgM/IgG Rapid Test

Dengue IgM/IgG Rapid Test

Usage
The Dengue IgM/IgG Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of anti-dengue virus IgM and IgG (DEN 1, 2, 3 and 4) in human whole blood, serum or plasma specimens. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with dengue viruses. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

 

Background of Clinical Indications

Dengue virus (DV) 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 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.1-3Serological detection is a common method for the diagnosis of infection with dengue virus. Anti-dengue virus IgM starts to appear 3 days after initial exposure and remains in circulation for about 30-60 days. Anti-dengue virus IgG levels rise around 7 days, peak at 2-3 weeks and persist for the duration of life.4-6 The Dengue IgM/IgG Rapid Test is a rapid test which utilizes a combination of Dengue antigen coated colored particles for the qualitative detection of anti-dengue virus IgM and IgG in human whole blood, serum or plasma specimens at 15-20 minutes.

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Packing specification

Principle of Inspection

The Dengue IgM/IgG Rapid Test is a qualitative membrane-based immunoassay for the detection of anti-dengue virus IgM and IgG in human whole blood, serum or plasma specimens. A recombinant DV antigen conjugated to colloidal gold embedded in the sample pad reacts with the DV antibody present in human whole blood, serum or plasma specimens, forming antigen conjugate-DV antibody complex. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgM and/or anti-human IgG immobilized on the membrane. If the specimen contains anti-dengue virus IgM and/or IgG, a colored line(s) will appear in test line region M and/or G, indicating a positive result. If the specimen does not contain anti-dengue virus IgM and IgG, colored lines will not appear in test line region (M and G), indicating a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Specification packaging

5 Tests/Kit.

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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