Description

Dengue IgM Elisa 96T pack

Dengue IgM Elisa

ELISA INTENDED USE

TRUSTwell Dengue IgM ELISA Kit 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 active infection with dengue viruses, including secondary infection. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care 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 become detectable by the end of the first week of illness. They increase slowly to peak around 14-21 days, and then decrease to low levels, persisting for the duration of life. During secondary infection, a strong and rapid IgM antibody response is often observed. IgM levels are detectable as early as 3 days after the onset of symptoms, with the peak detection window being 1-2 weeks after symptom onset. In secondary infection, IgM antibodies rise to levels higher than during primary infection. Importantly, anti-dengue IgM antibodies increase earlier than or simultaneously with IgM antibodies, and at much higher levels during secondary infection.

Sensitivity:96.4%
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 HCV, Syphilis, HBsAg, ANA, HIV, HAMA, H. pylori, RF, Malaria
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 ?mol/L
Intra Assay Precision: CV < 7%
Inter Assay Precision: CV < 6%
Shelf life: 18 months
Open vial stability: 8 weeks, or until the expiration date

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

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