The Biotime Dengue NS1 Antigen Rapid Test is intended to qualitatively detect the dengue NS1 antigen in human serum, plasma, or whole blood samples on the Biotime FIA Analyzer by fluorescent immunoassay. The test is used asthe earlyaid 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 |
|
Coincidence Rate |
99.0% |
Clinical Significance:
1. Early Diagnosis
NS1 antigen is secreted in high concentrations during the early stage of dengue virus infection (days 1–5 after symptom onset).
This test enables rapid qualitative detection of NS1 antigen in the early phase, allowing for early diagnosis before antibodies (IgM/IgG) become detectable, thereby avoiding delays in clinical management.
2. Differentiation of Infection Phase and Disease Severity
Dengue is divided into common dengue and severe dengue; early identification helps guide timely intervention.
A positive NS1 result indicates acute infection. When combined with clinical presentation, it aids in assessing the risk of progression to severe disease, especially in patients at higher risk (e.g., those with heterotypic secondary infection).
3. Identification of Secondary Infection Risk
As noted in the background, secondary infection with a different serotype (DENV‑1–4) can trigger an enhanced immune response, leading to more severe clinical manifestations.
NS1 testing, when used together with antibody (IgM/IgG) assays, helps rapidly identify possible secondary infections, supporting risk stratification and early intervention to prevent severe outcomes.
4. Suitability and Public Health Utility
The test is well‑suited for use in tropical and subtropical regions where dengue is endemic, particularly in outpatient, emergency, and primary care settings.
Fluorescence immunoassay offers high sensitivity and rapid results (typically 15–30 minutes), facilitating early case identification, isolation, and outbreak control—critical given the rapid transmission of the disease.
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