Aids in the diagnosis of an early
acute infection, including primary
or secondary infection
Compatible with human serum, plasma,
or whole blood specimens
Simple assay procedure yields
results in 15 minutes
This antigen detection test is a noninvasive diagnostic method and can be performed in 15 minutes without using laboratory equipment.
Product Features
- Detects NS1 antigen from all four dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) in human serum, plasma or whole blood specimen
- Simple assay procedure yields results in 15 minutes
- No equipment required
- Shelf Life: 24 months
- Storage Temperature: 2-30°C
Clinical Performance
Relative Sensitivity: 96.93% (95% CI: 93.02%-98.68%)
Relative Specificity: 99.35% (95% CI: 96.39%-99.88%)
Overall Agreement: 98.10% (95% CI: 95.92%-99.13%)
Strain Reactivity: Strain reactivity of the OnSite Dengue Ag Rapid Test was evaluated using a total of 65 strains (11 Type 1 strains, 27 Type 2 strains, 19 Type 3 strains, and 8 Type 4 strains). A detection rate of 100% was achieved for all strains tested.
Cross-Reactivity: No cross-reactivity or microbial interference was observed with any of the following diseases/conditions:
Chikungunya, Zika, Malaria, Yellow Fever virus, West Nile Virus, Leishmania, Japanese encephalitis virus, St. Louis encephalitis virus, HAV, HBsAg, HCV, HIV, T. pallidum, COVID-19, Influenza A, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, ANA, HAMA, Pregnancy specimen.
Interference: No interference was observed with any of the substances tested at the following concentrations:
Albumin (60 g/L), Glucose (55 mM), Aspirin (60 mg/dL), Hemoglobin (10 mg/mL), Acetamidophenol (0.7 mg/mL), Heparin (3000 U/L), Acetaminophen (0.2 mg/mL), Homeopathic Allergy Medicine (20 mg/mL), Alcohol (5% (v/v)), Human IgG (1,000 mg/dL), Beclomethasone (10% (v/v)), Ibuprofen (20 mg/mL), Bilirubin (0.4 mg/mL), Naproxen (0.5 mg/mL), Bilirubin conjugated (0.4 mg/mL), Oseltamiv (5 mg/mL), Biotin (200 ng/dL), RF (2,000 IU/mL), Budesonide (6.3 ng/mL), Ribavirin (1 mg/mL), Caffeine (58 μg/mL), Rimantadine (500 ng/mL), Chlorpheniramine (5 mg/mL), Salicylic acid (4.34 mM), Cholesterol (4 mg/mL), Sodium citrate (3.80%), Creatinine (442 μM), Tobramycin (24 μg/mL), Diphenhydramine (5% (v/v)), Triamcinolone (500 ng/mL), EDTA (3.4 μM), Triglycerides (15 mg/mL), Emergen-C (0.06 mg/mL), White blood cells (15% (v/v)), Ethanol (4 mg/mL), Fluticasone (5% (v/v)), and Zanamivir (282 ng/mL).
Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 31,000 times the assay’s Limit of Detection (LOD).
Please contact tech@ctkbiotech.com for further details about pathogens and substances tested for cross-reactivity/interference.
Support
- Product Brochures: Version 1 | Version 2
- Instructions for Use: Revision F4.1
ORDERING INFORMATION
| Catalog # | Product | Quantity | Specimen |
|---|---|---|---|
| R0063C | OnSite® Dengue Ag Rapid Test CE | 30 T/Kit | Serum/Plasma/Whole Blood |
| R0063C-10T | OnSite® Dengue Ag Rapid Test CE | 10 T/Kit | S/P/WB |
| R0063C-20T | OnSite® Dengue Ag Rapid Test CE | 20 T/Kit | S/P/WB |
| R0063C-25T | OnSite® Dengue Ag Rapid Test CE | 25 T/Kit | S/P/WB |
| R0063C-50T | OnSite® Dengue Ag Rapid Test CE | 50 T/Kit | S/P/WB |
Product Features
- Detects NS1 antigen from all four dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) in human serum, plasma or whole blood specimen
- Simple assay procedure yields results in 15 minutes
- No equipment required
- Shelf Life: 24 months
- Storage Temperature: 2-30°C
Clinical Performance
Relative Sensitivity: 96.93% (95% CI: 93.02%-98.68%)
Relative Specificity: 99.35% (95% CI: 96.39%-99.88%)
Overall Agreement: 98.10% (95% CI: 95.92%-99.13%)
Strain Reactivity: Strain reactivity of the OnSite Dengue Ag Rapid Test was evaluated using a total of 65 strains (11 Type 1 strains, 27 Type 2 strains, 19 Type 3 strains, and 8 Type 4 strains). A detection rate of 100% was achieved for all strains tested.
Cross-Reactivity: No cross-reactivity or microbial interference was observed with any of the following diseases/conditions:
Chikungunya, Zika, Malaria, Yellow Fever virus, West Nile Virus, Leishmania, Japanese encephalitis virus, St. Louis encephalitis virus, HAV, HBsAg, HCV, HIV, T. pallidum, COVID-19, Influenza A, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, ANA, HAMA, Pregnancy specimen.
Interference: No interference was observed with any of the substances tested at the following concentrations:
Albumin (60 g/L), Glucose (55 mM), Aspirin (60 mg/dL), Hemoglobin (10 mg/mL), Acetamidophenol (0.7 mg/mL), Heparin (3000 U/L), Acetaminophen (0.2 mg/mL), Homeopathic Allergy Medicine (20 mg/mL), Alcohol (5% (v/v)), Human IgG (1,000 mg/dL), Beclomethasone (10% (v/v)), Ibuprofen (20 mg/mL), Bilirubin (0.4 mg/mL), Naproxen (0.5 mg/mL), Bilirubin conjugated (0.4 mg/mL), Oseltamiv (5 mg/mL), Biotin (200 ng/dL), RF (2,000 IU/mL), Budesonide (6.3 ng/mL), Ribavirin (1 mg/mL), Caffeine (58 μg/mL), Rimantadine (500 ng/mL), Chlorpheniramine (5 mg/mL), Salicylic acid (4.34 mM), Cholesterol (4 mg/mL), Sodium citrate (3.80%), Creatinine (442 μM), Tobramycin (24 μg/mL), Diphenhydramine (5% (v/v)), Triamcinolone (500 ng/mL), EDTA (3.4 μM), Triglycerides (15 mg/mL), Emergen-C (0.06 mg/mL), White blood cells (15% (v/v)), Ethanol (4 mg/mL), Fluticasone (5% (v/v)), and Zanamivir (282 ng/mL).
Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 31,000 times the assay’s Limit of Detection (LOD).
Please contact tech@ctkbiotech.com for further details about pathogens and substances tested for cross-reactivity/interference.
Support
- Product Brochures: Version 1 | Version 2
- Instructions for Use: Revision F4.1
ORDERING INFORMATION