CTK Biotech, USA HEV IgM ELISA Kit  96 Test

The RecombiLISA HEV IgM ELISA is a solid phase enzyme-linked immunosorbent assay for the qualitative detection of anti-hepatitis E virus IgM in human serum or plasma.

• Microwells coated with anti-human IgM antibody
• HEV IgM negative control
• HEV IgM positive control
• Sample diluent
• HRP-HEV conjugates
• Wash buffer (30 x concentrate)
• TMB substrate A
• TMB substrate B
• Stop solution
• ELISA working sheet
• Product insert
• Detection of IgM antibodies in serum and plasma specimen
• Comparable performance v.s. EIA: relative sensitivity: 98.1%,  relative specificity: 99.2%,  overall agreement:  98.1%
• 24 month shelf life at 2-30°C

TEST PRINCIPLE The RecombiLISA HEV IgM ELISA Test is a solid-phase enzyme-linked immunosorbent assay based on the principle of the IgM capture technique for the detection of anti-HEV IgM in human serum or plasma.  The RecombiLISA HEV IgM ELISA Test is composed of two key components: 1)   Solid microwells pre-coated with polyclonal anti-human IgM antibody. 2) Liquid conjugate composed of HEV antigen conjugated with horseradish   peroxidase (HRP-HEV conjugate).  During the assay, the test specimen is first incubated in the coated microwells. AntiHEV IgM, if present in the specimen, binds to the antibody coated on the microwell surface. Any unbound specimen is then removed by a wash step.  During a second incubation with the HRP-HEV conjugate, the anti-HEV IgM antibody is absorbed on the microwell surface which binds to the HRP-HEV conjugate, forming a conjugate complex.  Unbound conjugate is then removed by washing. After addition of the TMB substrate, the presence of conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. The reaction is then quenched by addition of the Stop Solution, amd the absorbance value for each microwell is determined using a spectrophotometer at 450 /620-690 nm