2021 Volume 70 Issue 3 Pages 443-447
We performed a basic study of serum Entamoeba histolytica Immunoglobulin Enzyme-linked immuno-sorbent assay (hereinafter referred to as this reagent) based on the enzyme-linked immunosorbent assay method to verify the accuracy, detection limit, dilution linearity, reference value of serum E. histolytica antibody titer, and the correlation with the control reagent (antibody measurement method using a fluorescent dye-labeled antibody). As a result, CVs of within-run precision were less than 3.5% and CVs of between-day precision were less than 7.5%. The antibody titer increased almost linearly up to 10 GWU and then plateaued above 10 GWU, but no decrease in antibody titer due to excess antibody was observed up to around 28 GWU. This reagent had a positive concordance rate of 42.9%, a negative concordance rate of 100.0%, and a judgment concordance rate of 69.2% with respect to the control reagent. The 14 negative samples for this reagent all showed 100 times the minimum dilution factor that was judged to be positive for the control reagent. This reagent showed a good correlation with the control reagent.
