CTK Biotech, USA Dengue IgM ELISA Kit  96 Test

The 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 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.

• 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:  442µmol/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
• 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

TEST PRINCIPLE  The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay based on the principle of the capture immunoassay methodology for the detection of IgM anti-dengue virus in human serum or plasma.    The Dengue IgM ELISA Kit is composed of two key components:  1) Solid microwells pre-coated with mouse monoclonal anti-human IgM antibody. 2) Conjugate working solution composed of dengue antigen and HRP-anti-dengue conjugates.   During the assay, the test specimen is first incubated in the coated microwell. IgM antidengue, if present in the specimen, binds to the anti-human IgM antibodies coated on the microwell surface, and any unbound specimen is then removed by a wash step. During a second incubation with HRP-anti-dengue conjugate working solution, the IgM anti-dengue absorbed on the surface of microwell binds to the conjugate through dengue antigen, forming a conjugate complex. Unbound conjugates are then removed by washing. After addition of the TMB substrate, the presence of the conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. This reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm.