Abstract
Background: Therapeutic drug monitoring of immunosuppressant drugs are used to monitor drug efficacy and toxicity and to prevent organ transplantation rejection. This study evaluates the analytical performance of semi-automated electrochemiluminescence immunoassays (ECLIA) for cyclosporine (CSA), tacrolimus (TAC) and sirolimus (SRL) on the Roche cobas e 411 analyzer at a major transplant hospital to identify method suitability and limitations. Methods: Residual whole blood samples from patients undergoing immunosuppressant therapy were used for evaluation. Experiments included imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot assessments. Results: Total imprecision ranged from 3.3 to 7.1% for CSA, 3.9 to 9.4% for TAC, and 4.6 to 8.2% for SRL. Linearity was verified from 30.0 to 960.9 μg/L for CSA, from 1.1 to 27.1 μg/L for TAC, and from 0.5 to 32.3 µg/L for SRL. The functional sensitivity met the manufacturer's claims and was determined to be <6.5 μg/L for CSA, 1.1 μg/L for TAC, and <0.1 µg/L for SRL (CV≤20%). Deming regression analysis of method comparisons with the ARCHITECT immunoassay yielded slopes of 0.917 (95%CI: 0.885-0.949) and r of 0.985 for CSA, 0.938 (95%CI: 0.895-0.981) and r of 0.974 for TAC, and 0.842 (0.810-1.110) and r of 0.982 for SRL. Deming regression analysis of comparisons with the LC-MS/MS method yielded slopes of 1.331 (95%CI: 1.167-1.496) and r of 0.969 for CSA, 0.924 (95%CI: 0.843-1.005) and r of 0.984 for TAC, and 0.971 (95%CI: 0.913-1.030) and r of 0.993 for SRL. Conclusions: The cobas e 411 ECLIA for CSA, TAC, and SRL have acceptable precision, linearity, and functional sensitivity. The method comparisons correlated well with the ARCHITECT immunoassay and LC-MS/MS and is fit for therapeutic drug monitoring.
Highlights
Immunosuppressive drugs (ISD), such as the calcineurin inhibitors (cyclosporine (CSA) and tacrolimus (TAC)) and mammalian target of rapamycin inhibitors (sirolimus (SRL) and everolimus), are critical to the maintenance of solid organ transplantation[1]
We evaluated the analytical performance of electrochemiluminescence immunoassays (ECLIA) method for CSA, TAC, and SRL on the Roche cobas e411 analyzer and compared to the commonly used chemiluminescent microparticle immunoassay (CMIA) method on the Abbott ARCHITECT i2000 analyzer (Abbott Laboratories, Abbott Park, IL, USA)
Residual EDTA whole blood specimens from 300 patients undergoing immunosuppressant therapy at the University Health Network, and CAP proficiency testing samples were used in this evaluation
Summary
Immunosuppressive drugs (ISD), such as the calcineurin inhibitors (cyclosporine (CSA) and tacrolimus (TAC)) and mammalian target of rapamycin (mTOR) inhibitors (sirolimus (SRL) and everolimus), are critical to the maintenance of solid organ transplantation[1]. SRL ( known as rapamycin) is a 31-membered macrolide antibiotic that binds to FKBP-12 and allosterically targets the mTOR pathway, inhibiting cell cycle progression, T-cell proliferation and differentiation[2]. We evaluated the analytical performance of ECLIA method for CSA, TAC, and SRL on the Roche cobas e411 analyzer and compared to the commonly used chemiluminescent microparticle immunoassay (CMIA) method on the Abbott ARCHITECT i2000 analyzer (Abbott Laboratories, Abbott Park, IL, USA). This is the first report on the evaluation of ECLIA SRL, and compares the performance of all three ISDs together
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