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Qualisa Dengue IgG

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.

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


Specifitions

- 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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Merlin Medic Sdn Bhd was incorporated in 2015. The corporate and manufacturing facility is based in Subang (8500 Square feet) We are manufacturer of IVD for medical industry ISO 13485 Certified Registered with Medical Device Authority Malaysia (MDA)

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  Merlin Medic Sdn Bhd

37, 1st Floor, Jln Bulan BL U5/BL,
Seksyen U5, Shah Alam,
40150, Selangor, Malaysia

Tel : 03-7842 2676
Mail : info@merlinmedic.com