Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs

2017 ◽  
Vol 10 (1) ◽  
pp. 81-94 ◽  
Author(s):  
Yu Zhang ◽  
Rui Zhang
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Analytical Methods ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Recent Advances

scholarly journals Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1832
Author(s):  
Angela W.S. Fung ◽  
Michael J. Knauer ◽  
Ivan M. Blasutig ◽  
David A. Colantonio ◽  
Vathany Kulasingam
Keyword(s):  
Regression Analysis ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Transplant Rejection ◽  
Organ Transplant ◽  
Drug Efficacy ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Deming Regression ◽  
Roche Cobas

Background:  Therapeutic drug monitoring of immunosuppressant drugs are used to monitor drug efficacy and toxicity and to prevent organ transplant 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 assess method suitability and limitations. Methods: Residual whole blood samples from patients undergoing immunosuppressant therapy were used for evaluation. Imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot comparisons were assessed. 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

Long-term evaluation of analytical methods used in sirolimus therapeutic drug monitoring

2014 ◽  
Vol 28 (2) ◽  
pp. 243-251 ◽  
Author(s):  
David W. Holt ◽  
Didier A. Mandelbrot ◽  
Michael A. Tortorici ◽  
Joan M. Korth-Bradley ◽  
Debra Sierka ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Analytical Methods ◽  
Therapeutic Drug ◽  
Term Evaluation

scholarly journals Prospective investigations of concentration–clinical response for immunosuppressive drugs provide the scientific basis for therapeutic drug monitoring

1998 ◽  
Vol 44 (2) ◽  
pp. 381-387 ◽  
Author(s):  
Leslie M Shaw ◽  
Bruce Kaplan ◽  
Kenneth L Brayman
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Clinical Response ◽  
Drug Monitoring ◽  
Immunosuppressive Drugs ◽  
Scientific Basis ◽  
Therapeutic Drug ◽  
Controlled Clinical Trial ◽  
Target Drug ◽  
Drug Concentrations ◽  
The Individual

Abstract The performance of prospective concentration–clinical response investigations during the early stages of the development of new therapeutic agents can provide a more rigorous basis for therapeutic drug monitoring than the traditional retrospective review of drug concentrations vs clinical outcome. Here we discuss the application of the multicenter randomized concentration-controlled clinical trial study design, and related study designs, as applied to older commonly used and monitored drugs and to two new immunosuppressant drugs, mycophenolate mofetil and tacrolimus. Such studies can provide a more rigorous basis for assessing the risk/benefit associated with a target drug concentration in the individual patient and for designing future prospective pharmacokinetic and therapeutic drug monitoring investigations.

Knowledge of immunosuppressive drugs used in kidney transplants

2012 ◽  
Vol 21 (13) ◽  
pp. 795-800
Author(s):  
Mas Linda Mohamad ◽  
Li Yang ◽  
Xu Jin ◽  
Priscilla Tan Lee Eng ◽  
Terence Kee Yi Shern
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Kidney Transplant ◽  
Drug Monitoring ◽  
Education Programme ◽  
Immunosuppressive Drugs ◽  
Therapeutic Drug ◽  
Kidney Transplant Recipients ◽  
Transplant Patients ◽  
High Dependency ◽  
Kidney Transplant Patients

Aim: A key role of renal nurses is the correct and safe administration of immunosuppressive drug therapy (ImmRx) to kidney transplant recipients. The authors sought to examine the knowledge and competency of ImmRx in kidney transplant patients and whether an annual kidney transplant nurse education programme had any beneficial effects. Methods: The study population was comprised of 63.2% (n=50/79) of all nurses from renal wards (ward A (n=17/35), ward B (n=21/32)) and 12 nurses from a high-dependency urology ward (ward C (n=12)). Kidney transplant patients usually receive inpatient care in wards A, B or C only as these wards specialise in urology and renal care. Each nurse completed a 35-question test that covered ImmRx in areas of indication, identification, interaction, pharmcokinetics/pharmacodynamics, therapeutic drug monitoring, administration and adverse effects. A minimum score of 70% was required to pass the test. Results: Only 46% of participants passed the test. The proportion of nurses who passed was not significantly different with respect to years of nursing experience, professional rank, postgraduate nursing qualifications or ward location. Unexpectedly, a greater proportion of nurses who did not attend the education programme passed the test (63.6%; n=14/22) than those who did attend it (32.1%; n=9/28]; p=0.03). Notably, 24% (n=12/50), 4% (n=2/50) and 4% (n=2/50) were unable to correctly answer any of the identification, interaction and therapeutic drug monitoring questions. Conclusion: These findings suggest that the nurses' understanding and knowledge of ImmRx is insufficient and they need to update their knowledge on ImmRx continually.

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