Dengue Ag Rapid Test 4.0 CE

Dengue Ag Rapid Test 4.0 CE

The OnSite Dengue Ag rapid Test CE is a lateral flow chromatographic immunoassay for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood.

The test is designed to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with dengue virus.

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

Recommended for use:

Any person presenting with clinical signs or symptoms within 9 days consistent with acute dengue infection or dengue fever including: high fever, severe headaches, severe pain behind the eyes, severe joint and muscle pain, fatigue, nausea, vomiting, and/or skin rash.

Dengue NS1 antigen is detectable in human blood from the first day after the onset of fever up to 9 days, which allows early detection and prompt treatment of infection with dengue virus.

As mild dengue fever symptoms can overlap with acute clinical manifestations of other arbovirus infections, such as Zika virus and chikungunya virus infections, correct diagnosis of dengue infection during early disease onset is critical for guiding clinical patient management.

  • In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection
  • Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen
  • Simple assay procedure yields results within 20-25 minutes

Clinical performance:

  • Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)
  • Sensitivity: 100%
  • Specificity: 98.75% comparing to a commercial ELISA
  • Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others
  • No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0063, 5 mL/bottle)
  • One package insert (instruction for use)

Catalog #

Product

Quantity

Specimen

R0063C

Dengue Ag Rapid Test 4.0 CE

30/kit

S, P & WB

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To learn about distribution opportunities or for additional product information, please contact <http://www.privatedaddy.com?q=c3FrM1ldeQltNA0uV0pULwNOQVduWjA-3D_19>

Product Features
  • In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection
  • Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen
  • Simple assay procedure yields results within 20-25 minutes

Clinical performance:

  • Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)
  • Sensitivity: 100%
  • Specificity: 98.75% comparing to a commercial ELISA
  • Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others
  • No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)
Kit Components
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0063, 5 mL/bottle)
  • One package insert (instruction for use)
Support
Order Information

Catalog #

Product

Quantity

Specimen

R0063C

Dengue Ag Rapid Test 4.0 CE

30/kit

S, P & WB

Other Products You Might Be Interested In..

Catalog #

Product

Quantity

Specimen

R0061C

Dengue IgG/IgM Combo Rapid Test CE

30/kit

S, P & WB

R0062C

Duo Dengue Ag-IgG/IgM Rapid Test CE

30/kit

S, P & WB

R0069C

Duo Dengue IgG/IgM-CHIK IgM Rapid Test CE

30/kit

S, P & WB

E0310

Dengue IgM ELISA Kit

96/kit

S, P

E0311

Dengue IgG ELISA Kit

96/kit

S, P

E0312

Dengue Ag ELISA Kit

96/kit

S, P

C0063

Dengue Ag Rapid Test Control Kit

 

 

To learn about distribution opportunities or for additional product information, please contact <http://www.privatedaddy.com?q=c3FrM1ldeQltNA0uV0pULwNOQVduWjA-3D_19>

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