Korean J Clin Pathol.
1997 Dec;17(6):1029-1037.
Evaluation of Elecsys 2010 Electrochemiluminescent Immunoassay System
Abstract
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BACKGROUND: Elecsys 2010 immunoassay system is based on the electrochemiluminescence immunoassay using a ruthenium (II) tris (bipyridyl) label. Since it was the first time to use the system in our laboratory, we would like to evaluate the analytical performances (precision, linearity and recovery rate) and correlation with radioimmunoassay (RIA) and microparticle enzyme immunoassay (MEIA) methods.
METHODS
We used precicontrol tumor marker (TM1, TM2) for alpha-fetoprotein (AFP), prostatic specific antigen (PSA) and carcinoembryonic antigen (CEA), Precicontrol universal (Ul, U2) for triiodothyronine (T3) and thyroxine (T4), Precicontrol-TSH for thyrotropin (TSH) and pooled serum for the evaluation of precision and recovery rate. Patients' sera were used for the linearity and comparison study.
RESULTS
The coefficients of variatron of Imprecision study were below; 4.0%, 8.7% and 10.2%, respectively in the within-run, within-day and between-day analysis. The recovery rates were 100.5%, 96.1% and 102.5%, respectively in T4, TSH, and AFP. The linearity were y=1.02x-0.182(r=0.99) for T4, y=1.01x+0.12 (r=0.99) for TSH and y=1.01x+0.54(r=1.00) for AFP. T3, T4, TSH, CEA and PSA results showed good correlation with RIA (r>0.90), but AFP showed r=0.88. Also, AFP, CEA and PSA results showed excellent correlation with AxSYM (r>0.99).
CONCLUSION
Elecsys 2010 immunoassay system showed excellent precision, recovery rate, clinically acceptable linearity and good correlation with the results obtained by RIA and MEIA methods.