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Home / Product / Colloidal Gold / Dengue NS1 Ag/Ab Combo Rapid Test
  • Dengue NS1 Ag/Ab Combo Rapid Test
  • Dengue NS1 Ag/Ab Combo Rapid Test

Dengue NS1 Ag/Ab Combo Rapid Test

Usage
The Dengue NS1 Ag/Ab Combo Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of anti-dengue virus IgM, IgG and dengue NS1 antigen (DEN1, 2, 3, 4) qualitatively 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.1-3 Serological 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 rises around 7 days, peaks at 2-3 weeks and persists for the duration of life.4-6 Detection of antigens, such as dengue NS1, 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.7 The Dengue NS1 Ag/Ab Combo Rapid Test utilizes a combination of Dengue antigen coated colored particles for the qualitative detection of anti-dengue virus IgM, IgG, and a combination of Dengue antibodies coated colored particles for the qualitative detection of dengue NS1 antigen in human whole blood, serum or plasma specimens.

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Packing specification

Principle of Inspection

The Dengue NS1 Ag/Ab Combo Rapid Test contains two test strips, the left side for Dengue NS1 Antigen Rapid Test, and the other side for Dengue IgM/IgG Rapid Test (see illustration of the test procedures on this package insert). The Dengue NS1 Ag Rapid Test is a qualitative membrane-based immunoassay for the detection of dengue NS1 antigen in human whole blood, serum or plasma specimens. During the test procedure, capture reagent is immobilized in the test line region (T) of the test. After specimen is added to the specimen well (S) of the device, Dengue NS1-Specific monoclonal antibodies conjugated to colloidal gold embedded in the sample pad reacts with the dengue NS1 antigen present in the specimen, forming an antibody-antigen-antibody gold particle complex. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-NS1 antibody immobilized in the membrane. If the specimen contains dengue NS1 antigen, a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain dengue NS1 antigen, a colored line will not appear in this region, indicating a negative result. 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. After specimen is added to the specimen well (S) of the device, a recombinant DV antigen conjugated to colloidal gold embedded in the sample pad reacts with the DV antibody present in the specimen, 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 in 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, respectively, 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. Dengue NS1 antigen positive result suggests an active infection. Dengue IgM positive result suggests a primary infection. Dengue IgG positive result suggests a secondary or past infection, and Dengue IgG and IgM positive result suggests late primary or early secondary infection. The results obtained with this test should be used in conjunction with other diagnostic procedures and clinical findings. An internal quality control is included in each 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

25 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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