OnSite™ Dengue Ag Rapid Test Kit, CE, 30 Tests

The OnSite® Dengue Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of dengue NS1 antigen from all four known dengue virus serotypes (DENV-1, DENV-2, DENV-3, DENV-4) in human serum, plasma, or whole blood. This non-invasive rapid diagnostic test provides results in just 15 minutes, requiring no laboratory equipment, making it ideal for point-of-care and field-based testing.

By targeting the NS1 antigen, a highly conserved marker of acute dengue infection, this assay enables early detection and helps clinicians manage patients promptly.

Key Features

• Broad Serotype Coverage: Detects NS1 antigen from DENV-1, DENV-2, DENV-3, and DENV-4.
• Rapid Results: Clear results available in 15 minutes.
• High Clinical Accuracy:
  • Sensitivity: 96.93% (95% CI: 93.02–98.68%)
  • Specificity: 99.35% (95% CI: 96.39–99.88%)
  • Overall Agreement: 98.10% (95% CI: 95.92–99.13%)
• Strain Reactivity: Achieved 100% detection across 65 tested strains of all four serotypes.
• No Cross-Reactivity: Confirmed negative against related pathogens and conditions (e.g., chikungunya, Zika, malaria, yellow fever, COVID-19, influenza, HIV, HAV, HCV, syphilis, pregnancy samples, autoimmune factors).
• Interference-Free: Robust performance despite common interfering substances (e.g., hemoglobin, bilirubin, aspirin, ibuprofen, anticoagulants, antivirals, alcohol, etc.).
• Hook Effect Resistant: No hook effect observed at NS1 antigen levels up to 31,000x above the LOD.

Kit Contents

• Individually sealed foil pouches containing cassette + desiccant
• Plastic droppers
• Sample diluent (where applicable)
• Instructions for use

Applications

• Clinical Diagnosis: Early detection of acute dengue infection.
• Hospitals & Clinics: Rapid triage of febrile patients in dengue-endemic regions.
• Public Health Programs: Outbreak surveillance and rapid screening in communities.
• Field Testing: Reliable results in resource-limited or decentralized settings.
• Research & Epidemiology: Monitoring dengue seroprevalence and strain reactivity.

The OnSite® Dengue Ag Rapid Test (R0063C) is a fast, reliable, and highly accurate diagnostic tool for the detection of dengue NS1 antigen across all four serotypes. With excellent sensitivity and specificity, no cross-reactivity, and strong interference resistance, it ensures dependable results in just 15 minutes. This makes it a critical tool for clinicians, public health authorities, and field teams engaged in dengue diagnosis and outbreak control.