The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of anti-hepatitis E virus (HEV) IgM in human serum or plasma. It is intended for professional use only and to be used as an aid in the diagnosis of infection with HEV.
The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the IgM capture technique for the detection of antiHEV IgM in human serum or plasma. The RecombiLISA HEV IgM ELISA 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, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm.
A total of 400 specimens from susceptible subjects were tested by the RecombiLISA HEV IgM ELISA and by a Chinese State Drug Administration (SFDA) licensed reference EIA.
Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%.