Shanghai Eugene Bio tech Co.,Ltd.(Eugene) was established in 2007,which is a subsidiary of CIRC (China Isotope&Radiation Corporation, stock code:01763.hk, dedicated to the research and production of colloidal gold, CLIA, ELISA, RIA and other rapid detection methods. Our headquarters is Beijing North Institute of Biological Technology (BNIBT), it was established on July01,1985, which has engaged in researching, producing and selling of in vitro diagnose kits. It's one of the biggest and earliest institutes of the field in China. EUGENE series of human colloidal gold rapid detection products cover infectious diseases such as hepatitis, gastrointestinal, respiratory infections, tropical diseases, sexual transmitted diseases, fertility hormones and natal-healthcare, the rapid detection of tumor markers, cardiovascular disease markers, drugs and alcohol, and so on.
Eugene products are widely used in domestic and foreign hospitals, clinics, physical examination centers, disease prevention and control systems, epidemic prevention stations, blood stations, family, laboratories, research institutions, public security and traffic system, etc. We have exported to more than 50 countries in the world, won the consistent praise of the majority of users with excellent performance and excellent service.
We Eugene mainly contribution to the human health.As we had supported the Dengue fever epidemic of Bangladesh in 2019. Our Cox-19 test had been registered in Italy,Indonesia,and exported to many countries of the Global market, and receive the good reputation and good feedback by all of our customers.
A lateral flow immunochromatographic assay for the rapid qualitative detection and differentiation of IgG and IgM antibodies to dengue virus in human whole blood, serum or plasma.
The EUGENE® Dengue IgG / IgM Rapid Test is a lateral flow immunochromatographic assay for the rapid qualitative detection and differentiation of IgG and IgM antibodies to dengue virus in human whole blood, serum or plasma. It is intended for professional use to aid in the presumptive diagnosis for primary and secondary dengue infection. This test provides only a preliminary test result. Therefore, isolation of virus, antigen detection in fixed tissues, RT-PCR and serological test like haemagglutination-inhibition test, more specific alternative diagnosis method must be used in order to obtain a confirmation of dengue virus infection.
Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes, are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (dengue virus 1,2,3 and 4). In children, infection is often subclinical or causes a self-limited febrile disease. However, if the patient is infected second times with a different serotype, a more severe disease, dengue hemorrhagic fever or dengue shock syndrome, is more likely to occur. Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes. Traditionally, the serological diagnosis of an acute dengue virus infection has relied on showing a 4-fold or greater rise in anti-dengue virus antibody between paired acute- and convalescent-phase sera from a patient. The haemagglutination-inhibition test has been the most commonly used serological assay for dengue diagnosis. Rapid and reliable tests for primary and secondary infections of dengue are essential for patient management. Primary Dengue infection is associated with mild to high fever, headache, muscle pain and skin rash. Immune response includes IgM antibodies produced by 5th day of symptoms and persist for 30-60 days. IgGs appear the 14th day and persist for life. Secondary infections often result in high fever and in many cases with haemorrhagic events and circulatory failure. Secondary infections show that IgGs rise within 1-2 days after the onset of symptoms and induce IgM response after 20 days of infection.
INTERPRETATION OF RESULTS NEGATIVE Only the Control line (C) is visible. No T2 line or T1 line appears. The result is negative.
POSITIVE IgM Positive The Control line (C) and a colored T2 line (IgM) appear. This is positive for IgM antibodies to Dengue virus and is indicative of a primary dengue infection. IgG Positive The Control line (C) and a colored T1 line (IgG) appear. This is positive for IgG antibodies to Dengue virus and is indicative of secondary or past dengue infection. IgG and IgM Positive The Control line and both colored T2 test line (IgM) and T1 test line (IgG) appear. The color intensities of the lines do not have to match. This is positive for both IgM and IgG antibodies and is indicative of a secondary dengue infection. Note: The intensity of the color in the TEST line regions (T1 and T2) may vary depending on the concentration of Dengue antibodies present in the specimen. Therefore, any shade of color of the TEST lines (IT1 and/or T2) should be considered positive. Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.
INVALID Result is invalid if Control line (C) is not colored, regardless of any colored line in the T2 line (IgM) or T1 line (IgG). Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test device. If the problem persists, discontinue using the kit immediately and contact your local distributor.
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