Dengue IgM ELISA CE

The RecombiLISA Dengue IgM ELISA is a solid-phase, IgM capture enzyme linked immunosorbent assay. The three main kit components are:

1) A 96 breakable well plate with the solid microwells pre-coated with mouse monoclonal anti-human IgM antibody

2) Recombinant dengue antigen

3) HRP-anti-dengue conjugates

This test is intended to be used for the qualitative detection of IgM anti-dengue viruses (DEN1,2,3,4) in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of acute dengue 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.

During primary infection, anti-dengue IgM antibodies start to appear approximately 4-6 days after the onset of fever, peak at about 2 weeks, and remain in circulation for about 2-3 months. During secondary infection, IgM antibodies increase simultaneously with, or after the IgG antibody response, in general at a titer lower than IgG. Importantly, IgM antibody levels during secondary infection are significantly lower in comparison with primary infection.

Product features

Product specifications

Product features

Sensitivity: 96.6%
Specificity: 98.1%
SeraCare AccuSet Performance Panel (0845-0051): 100% agreement with a market leading Dengue IgM Capture ELISA
Cross Reactivity: No cross reaction with CHIK, HCV, Syphilis, HBsAg, ANA, HIV, HAMA, H. pylori, RF, Malaria
Interference: No interference with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 1.3 %;Heparin: 3,000 U/L; Creatinine: 442 μmol/L; Bilirubin: 10 mg/dL; EDTA: 3.4 μmol/L
Intra Assay Precision: CV: <7%
Inter Assay Precision: CV: <10%
Shelf life: 18 months
Open vial stability: 8 weeks at 2-8°C, or until the expiration date

Product specifications

Anti-human IgM coated microwells
Lyophilized dengue antigen
HRP-anti-dengue conjugates (100X concentrate)
Enzyme diluent
Dengue IgM positive control
Dengue IgM negative control
Sample diluent
Wash buffer (30X concentrate)
TMB substrate A
TMB substrate B
Stop solution
ELISA working sheet
Product insert