Dengue Ag ELISA CE

The RecombiLISA Dengue Ag ELISA is a solid-phase, enzyme linked immunosorbent assay that was developed using the antibody sandwich technique.  The two main kit components are:

1) A 96 breakable well plate with the solid microwells pre-coated with rabbit anti- Pan Dengue NS1 antibody

2) A conjugate solution composed of antibodies against Dengue NS1 antigen conjugated with horseradish peroxidase (HRP-anti-dengue NS1 conjugates)

This test is intended for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum or plasma. It is intended to be used by professionals as an aid in the early detection of dengue virus infection .  Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of healthcare providers.

Recommended for use:

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

Dengue NS1 antigen is released into the blood during viral replication in an infected patient, and is detectable from the first day after the onset of fever up to Day 9. NS1 antigen can be identified before the formation of antibodies, thus making it a beneficial biomarker for early detection of dengue infection, allowing for prompt management of dengue fever.

  • Analytic sensitivity: Detects recombinant Dengue type 2 NS1 at a level as low as 0.3 ng/mL.
  • Sensitivity: 100%
  • Specificity:  97.8%
  • SeraCare Dengue Early Infection AccuSet Performance Panel: 100% agreement with PanBio Dengue Early ELISA
  • Cross Reactivity: No cross reaction with HCV, Syphilis, HBsAg, ANA, HIV, HAMA, H. pylori, RF, Malaria
  • Hook Effect: No hook effect up to 0.1 mg/mL
  • Interference: No interference with Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 1.3 %;Heparin: 3,000 U/L;  Creatinine:  5 mmol/L; Bilirubin:  10 mg/dL; EDTA: 3.4 μmol/L
  • Intra Assay Precision: CV < 10% 
  • Inter Assay Precision: CV <  7%
  • Shelf life: 18 months
  • Open vial stability:  8 weeks  at 2-8°C, or until the expiration date
  • Anti-dengue NS1 Ab coated microwells
  • HRP–anti-dengue NS1 conjugates
  • Dengue NS1 Antigen positive control
  • Dengue NS1 Antigen negative control
  • Wash buffer (30X Concentrate)
  • Sample diluent
  • TMB substrate A
  • TMB substrate B
  • Stop solution
  • ELISA working sheet
  • Product insert

Catalog #

Product

Quantity

Specimen

E0312

Dengue Ag ELISA Kit CE

96/kit

S,P

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