Product Specifications
| Prod Model: |
IDEAb-402 |
| Markets: |
North America,South America,Eastern Europe,Southeast Asia,Africa,Oceania,Mid East,Eastern Asia,Western Europe |
| Certification: |
ISO9001 |
| Type: |
Biochemistry Analyzer |
| Classification: |
Biological Diagnostics |
| Group: |
All Ages |
Product Description
[APPLICATION]
The Dengue IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti dengue virus and IgM anti dengue virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with dengue viruses. Any reactive specimen with the Dengue IgG/IgM3.0 Rapid Test must be confirmed with alternative testing method(s).
[TEST PRINCIPLE]
The Dengue IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy
Colored conjugate pad containing dengue recombinant envelope antigens conjugatedwith colloid gold (dengue conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (G and M bands) and a control band (C band). The G band is pre-coated with the antibody for the detection of IgG anti-dengue virus, M band is coated with antibody for the detection of IgM anti-dengue virus, and the C band is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-dengue virus if present in the specimen will bind to the dengue conjugates. The immunocomplex is then captured by the reagent coated on the G band, forming a burgundy colored G band, indicating a dengue virus IgG positive test result and suggesting a recent or repeat infection.
IgM anti-dengue virus, if present in the specimen, will bind to the dengue conjugates. The immunocomplex is then captured by the reagent pre-coated on the M band, forming a burgundy colored M band, indicating a dengue virus IgM positive test result and suggesting a fresh infection.
Absence of any test bands (G and M) suggests a negative result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands(G and M). Otherwise, the test result is invalid and the specimen must be retested with another device.
Zhuhai Encode Medical Engineering Co., Ltd (hereinafter referred to as Encode) was established in 1994, as one of the earliest and largest manufactures of in-vitro diagnostic flied in China. Encode specialized in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic products and immunology diagnostic rapid tests, which are used for diagnosis of Mycoplasma, Chlamydia, Pneumonia, Pathogenic Fungus, Tuberculosis, Bacterial Vaginosis, Neisseria Gonorrhea, Helicobacter Pylori, Rotavirus, Adenovirus ect.
Encode occupies a land of 15, 000m2 in Zhuhai. There are 2, 000m2 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA andGDFDA.
Encode has established extensive cooperation with research center in university, such as Lanzhou University, South China University of Technology and Jinan University etc. With strong R&D and technological innovation ability, Encode ranks leading level in China. We also obtained ISO 13485: 2003, ISO9001: 2000, CE and granted the title of national hi- tech enterprise.
Today, we not only provide medical products and health care solutions to clients in China, but also in the worldwide, which include Europe, Africa, Middle East, Sourth East Asia etc.
With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co., Ltd will continue to provide professional in-vitro diagnostic products and health care solutions to the worldwide and fight for the career of human health forever.
