The Biotime DengueIgG/IgM Antibody Rapid Testis intended to qualitatively detect the dengue IgG/IgM antibody in human serum, plasma or whole blood samples on Biotime FIA Analyzer byfluorescent immunoassay. The test is used asthe early aid diagnosis and screening of dengue virus infection.
For in vitro diagnostic use only.
For professional use only.
|
Specimen Types |
WB/S/P |
|
Sample |
Whole Blood:25μL; Serum/Plasma:20μL |
|
Reaction Time |
15 min |
|
Cut-off value |
≥95% |
Clinical Significance:
1. Determination of Infection Stage
IgM antibody becomes detectable 3–5 days after fever onset and persists for 30–90 days. A positive IgM result indicates recent or current infection.
IgG antibody appears later. In primary infections, IgG levels rise slowly; in secondary infections, IgG levels are already high early in the illness.
This test allows simultaneous detection of IgM and IgG, helping to differentiate between acute, recent, and past infections.
2. Differentiation Between Primary and Secondary Infection
In endemic regions, most dengue patients experience secondary infections.
Primary infection: IgM positive with low or negative IgG in the acute phase.
Secondary infection: High levels of specific IgG present prior to or simultaneously with IgM response.
Distinguishing primary from secondary infection is clinically important because secondary infection with a heterologous serotype carries a higher risk of severe dengue.
3. Complementary Role in Diagnosis
While NS1 antigen testing is optimal for very early diagnosis (days 1–5), antibody testing becomes valuable after the first few days of illness.
This test is particularly useful for patients presenting later in the disease course when NS1 may no longer be detectable.
4. Utility in Endemic Settings
Due to the high prevalence of secondary infections in endemic areas, the combination of IgM and IgG results helps clinicians quickly assess immune status and make decisions regarding patient monitoring and management.
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