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Electrochemiluminescence Assays for Human Islet Autoantibodies
Published on: March 23, 2018
Analytic evaluation of the beta-human chorionic gonadotropin assay on the Abbott IMx and Elecsys2010 for its use in
Khurram Shahzad1, Dong-Hyun Kim, Min-Jung Kang
1Bioanalysis and Biotransformation Center, Korea Institute of Science and Technology, 130-650, Hawolgokdong 39-1, Seoul, Korea.
Objectives:
The principal objective of this study was to compare the analytical performance of the Elecsys2010 (Roche Diagnostics) system with the IMx (Abbott laboratories) system for beta-hCG assay in order to assess its possible utility as a confirmation test for the quantitative measurement of beta-hCG in urine for doping control purposes.
Design And Methods:
Urine samples with spiked standard known concentrations of beta-hCG and different urine samples from athletes were used in order to determine the calibration curve stability and linearity, detection limit, total, within-run and between-run precision, and method comparison for the IMx and Elecsys2010 systems for beta-hCG assay, along with the stability of samples, at room temperature and at 4 degrees C.
Results:
The IMx assay was linear up to 500 IU/L, whereas the Elecsys2010 assay was linear up to 1000 IU/L. The detection limit for the IMx and Elecsys2010 systems were 0.75 IU/L and 0.25 IU/L, respectively. The total precision of the IMx and Elecsys2010 systems were
Conclusions:
For doping control, the IMx and Elecys2010 may be used to screen and confirm the presence of beta-hCG in urine of athletes, respectively. Additional studies are needed to verify this finding. This study also underscores the need for beta-hCG assays standardization for doping control.
