MedEx Neotest Dengue Combo NS1 Ag and IgG/IgM Antibodies Test Kit

MedEx Neotest Dengue Combo NS1 Ag and IgG/IgM Antibodies Test Kit Mechanism of Action

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Action
Summary and Principle of the Assay: Dengue diseases are potentially life-threatening diseases caused by the Dengue virus. The virus (serotypes 1-4) belongs to the group flavivirus and is transmitted in nature by day-biting Aedes mosquitoes. According to WHO, there are 50 million cases of dengue infection worldwide every year and the disease is an epidemic in over 100 countries.
The primary and secondary infections of dengue virus exhibit different clinical profiles. Primary Dengue infection, also known as Dengue Fever, is the most common type of dengue illness. It is associated with mild to high fever, headache, muscle pain, and skin rash. Secondary infection is known as Dengue Hemorrhagic Fever (DHF) or Dengue Shock Syndrome, and often results in high fever and, in many cases, hemorrhagic events and circulatory failure. The fatality rate in patients with Dengue Shock Syndrome can be as high as 44%.
Dengue NS1 antigen is a highly-conserved glycoprotein that is present at high concentrations in the serum of dengue-infected patients during the early clinical phase of the disease. NS1 antigen is found from the first day and up to 9 days after onset of fever in blood sample of primary or secondary dengue infected patients. The Dengue NS1 portion of this test is an antigen-capturing immunochromatographic assay, which detects the presence of Dengue NS1 antigen in human blood samples. Monoclonal antibodies specifically against NS1 antigen are conjugated with colloidal gold and deposited on the conjugate pad, and immobilized on the test line of the nitrocellulose membrane. When blood sample is added the antibody conjugate is rehydrated and the NS1 antigens, if any in the samples, will interact with the colloidal gold conjugated antibodies. The antigen-antibody-gold complex will migrate towards the test window until the Test Zone (NS1) where they will be captured by immobilized antibodies, forming a visible red line (Test band), indicating a positive result. If Dengue NS1 antigen are absent in the sample, no red line will appear in the Test Zone (NS1), indicating a negative result.
Serological studies have shown that during primary infections, dengue-specific IgM antibodies are found by 5th day of infection and remain in circulation for 30-60 days, while IgG antibodies appear by the 14th day of infection and persist for life. In contrast, during secondary dengue virus infection, specific IgG and IgM levels significantly increase at 1-2 days and the 20th day after infection, respectively. Thus, different profiles of humoral immune responses in primary and secondary dengue viral infections can be used for differential diagnosis. This is of clinical significance in predicting progression and prognosis of the disease.
The presence of high titers of IgG antibodies does not interfere with the detection of IgM antibodies in the sample. The principle of the Dengue IgG/IgM portion of this test is an antibody-capture immunochromatographic assay for the simultaneous detection and differentiation of IgG & IgM antibodies to Dengue virus in human blood samples. Dengue virus-specific antigens are conjugated to a colloidal gold and deposited on the conjugate pad. A unique combination of anti-human IgG & IgM antibodies are immobilized on the test zone of the nitrocellulose membrane as two individual test lines (IgG line and IgM line) in the test window of the test device. The IgG line in the test window is closer to the sample well and followed by IgM line. When the sample is added the gold-antigen conjugate is rehydrated and the dengue IgG and/or IgM antibodies, if any in the sample, will interact with the gold conjugated antigen. The antigen-antibody-gold complex will migrate towards the test window until the test zone where it will be captured by the relevant anti human IgG and/or anti-human IgM, forming a visible pink line, indicating a positive result. If dengue antibodies are absent in the sample, no pink line will appear in the Test Zone, indicating a negative result.
To serve as an internal process control, a control line should always appear at the Control Zone (C) of both test windows after the test is completed. Absence of a pink control line in either Control Zone is an indication of an invalid result.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in