Dengue IgG/IgM Rapid Test

The TRUSTline Dengue 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.

Features of Dengue IgG/IgM Rapid Test:

• Utilizes recombinant chimeric dengue virus licensed by the US CDC
• Detects all four dengue serotypes
• Test format minimizes processing time
• IgM detection indicates recent infection
• IgG detection indicates recent or previous infections
• Ag detection indicates a current infection

Intended use of Dengue IgG/IgM Rapid Test:

The TRUSTline Dengue IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-dengue virus (DEN1, 2, 3, and 4) in human serum, plasma, or whole blood. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with dengue viruses.

Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

Product Specifications:

• Individually sealed pouches containing:
  1. One cassette device
  2. One desiccant
• 5 µL capillary tubes
• Sample diluent (5 mL/bottle)
• One package insert (instruction for use)

TRUSTline Dengue IgG/IgM Rapid Test:

The Dengue IgG/IgM Rapid Test is a diagnostic assay designed for the rapid, qualitative, and differential detection of IgG and IgM antibodies to the dengue virus. Here are the key details about this test:

Purpose and Components Detected:

• The test aims to simultaneously detect and differentiate:
  • IgG antibodies: These antibodies develop in response to previous dengue infections.
  • IgM antibodies: These antibodies are produced during acute or recent dengue infections.
  • The test can also detect all four dengue serotypes using a mixture of recombinant dengue envelope proteins.

Sample Types:

• The Dengue IgG/IgM Rapid Test can be used with:
  • Human serum
  • Human plasma
  • Whole blood

Detection Method:

• The test utilizes a solid-phase immunochromatographic assay.
• When a specimen (serum, plasma, or whole blood) is added to the test device, specific antibodies react with dengue envelope proteins to form a complex.
• The presence of colored bands indicates positive results for IgG and/or IgM antibodies.

Clinical Utility:

• This test aids in the presumptive diagnosis of both primary and secondary dengue infections.
• It provides valuable information for patient management and helps differentiate between acute and past infections.