CTK Biotech, USA Duo Dengue Ag-IgG/IgM Rapid 10 Test

The OnSite Duo Dengue Ag-IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti-dengue virus, IgM anti-dengue virus and dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood.

• Utilizes recombinant chimeric dengue virus licensed from the US CDC
• Detects all four dengue serotypes
• Duo test format minimizes processing time
• IgM detection indicates recent infection
• IgG detection indicates recent or previous infections
• Ag detection indicates a current infection
• 24 month shelf life at 2-30 °C storage

 Each kit contains :

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• 5 µL Capillary tubes (for Dengue IgG/IgM test)
• Plastic droppers (for Dengue Ag test)
• Sample diluent (5 mL/bottle)
• One package insert (instruction for use)

 TEST PRINCIPLE  : The OnSite Duo Dengue Ag-IgG/IgM Rapid Test contains two test strips (left side: Dengue IgG/IgM test; right side: Dengue Ag test).   The Dengue IgG/IgM Rapid Test on the left-side is a lateral flow chromatographic immunoassay. The test strip consists of: 1) a burgundy colored conjugate pad containing recombinant dengue envelope antigens conjugated with colloidal gold (dengue Ag conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The G line is pre-coated with antibodies for the detection of IgG anti-dengue virus, the M line is pre-coated with antibodies for the detection of IgM anti-dengue virus, and the C line is pre-coated with a control line antibody.   The Dengue Ag Rapid Test on the right-side is a lateral flow chromatographic immunoassay. The test strip consists of: 1) a burgundy colored conjugate pad containing antibodies to dengue NS1 antigen conjugated with colloidal gold (dengue Ab conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with antibodies to dengue NS1 antigen, and the C line is pre-coated with a control line antibody. The antibodies to dengue NS1 recognize the antigens from all four dengue virus serotypes.   When an adequate volume of specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Dengue NS1 antigen, if present in the specimen, will bind to the dengue Ab conjugates. The immunocomplex is then captured on the membrane by the pre-coated antibodies to dengue NS1 antigen forming a burgundy colored T line. IgG and/or IgM anti-dengue virus, if present in the specimen, will bind to the dengue Ag conjugates. The immunocomplex is then captured by the pre-coated reagent forming a burgundy colored G and/or M line, respectively.   Suggested result interpretation: Ag positive: Early acute primary or secondary infection. IgM positive: acute primary or secondary infection. IgG positive: secondary or past infection. IgM and IgG positive: Late primary or early secondary acute infection.   Absence of any G, M or T lines suggests a negative result. Each test contains an internal control (C lines) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies in both the left and right panels, regardless of color development on any of the test lines. If the C line does not develop in a panel, the test result is invalid and the specimen must be retested with another device. An invalid result in one panel does not invalidate the test result in the other panel. dengue,