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Qualisa Dengue IgM

The RecombiLISA Dengue IgG ELISA is a solid-phase, IgG 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 IgG antibody
2) Recombinant dengue antigen
3) HRP-anti-dengue conjugates
This test is intended to be used for the qualitative detection of IgG 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 IgG 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 IgG antibody response is often observed. - IgG 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, IgG antibodies rise to levels higher than during primary infection. Importantly, anti-dengue IgG 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 IgG 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 μmol/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 IgG coated microwells
- Lyophilized dengue antigen
- HRP-anti-dengue conjugates (100X concentrate)
- Enzyme diluent
- Dengue IgG positive control
- Dengue IgG negative control
- Sample diluent
- Wash buffer (30X concentrate)
- TMB substrate A
- TMB substrate B
- Stop solution
- ELISA working sheet
- Product insert


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

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