RESUMO
To develop and evaluate an ELISA kit for Anti-PLA2R IgG. Recombinant M-type phospholipase A2 receptor (PLA2R) protein expressed in HEK293 was taken as coating antigen, HRP-labeled rabbit anti-human IgG was taken as a tracer, to test the anti-PLA2R IgG on the basis of the principle of ELISA. The detection linear range, accuracy, linear correlation, repeatability, and stability were evaluated. In addition, we made a comparison with enrolled anti-PLA2R IgG kit. The detection linear range of the kit is no more than 2 RU/mL. The relative deviation of the kit accuracy is in -15%-15%. There is a linear correlation coefficient of higher than 0.990 0 within 2-500 RU/mL range. The CV of the repeatable test is lower than 15% when the kit was put in 37 ℃ one week, 2-8 ℃ one year, the performance remains. The consistency of testing with comparison in enrolled anti-PLA2R IgG kit is 98.9% (positive: 97.2%, negative: 100%). The Anti-PLA2R IgG ELISA Kit which we developed is nearly identical to the reference standard in specific and sensitive of clinics. It's successfully used to determine anti-PLA2R titer and help clinical diagnosis.
