Elecsys® Immunosuppressive Drug Assay Panel

Trusted and consistent results for organ transplant patients

Elecsys Immunosuppressive Drug Assay Panel

Trusted and consistent results for organ transplant patients

Optimal immunosuppressive therapy, ­defined clinically and by therapeutic drug monitoring (TDM), is essential to prevent acute rejection and ensure long-term survival of both the patient and the allograft. Characterized by a narrow therapeutic window, the use of immunosuppressive drugs (ISDs) requires both precise and consistent measurement of their concentration in whole blood during life-long monitoring.1

 

Consolidation for optimized workflow

 

The full ISD menu available on one automated and integrated Roche SWA platform:

  • Best-in-class automated MPA (Mycophenolic Acid) available on cobas c modules2
  • Elecsys Cyclosporine and Tacolimus now completed with Sirolimus and Everolimus on cobas e modules

One universal pre-treatment procedure for all ISD assays increase efficiency, ensure high quality results for every product and reduce handling errors in the lab

Outstanding possibilities for consolidation with >230 parameters on one cobas® platform

 

High precision for confidence in results

 

  • High precision at low drug concentrations and across a wide measuring range
  • Excellent performance confirmed in routine customer laboratories3

 

Consistent results for life-long monitoring

 

  • Excellent lot-to-lot comparability and traceability
  • Consistent patient results across all cobas® platforms due to universal reagent concept
  • Low variability across different customer labs proven in external quality schemes3
  • High comparability to well established and validated LC-MS/MS
Elecsys Immunosuppressive Drug Assay Panel

Elecsys® Immunosuppressive Drug Assay Panel

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Elecsys® Immunosuppressive Drug Assay Panel

  Tacrolimus
Cyclosporine
Sirolimus
Everolimus
Assay time

18 min.

18 min.

18 min.

18 min.

Sample material

EDTA whole blood

EDTA whole blood

EDTA whole blood

EDTA whole blood

Sample volume

300 µL

300 µL

300 µL

300 µL

Sample pretreatment

Identical sample pretreatment

Identical sample pretreatment

Identical sample pretreatment

Identical sample pretreatment

Sensitivity    
LoB *
LoD *
LoQ *


0.3 ng/ml
0.5 ng/mL
1.0 ng/mL


20 ng/mL
30 ng/mL
50 ng/mL


0.4 ng/mL
0.5 ng/mL
1.5 ng/mL


0.4 ng/mL
0.5 ng/mL
1.0 ng/mL

Measuring range

0.5 – 40 ng/mL

30 – 2,000 ng/mL

0.5 – 30 ng/mL

0.5 – 30 ng/mL

Total imprecision
cobas e 411 analyzer



2.1–14.2 %


4.2 – 9.2 %


2.8 – 10.9 %


2.7 – 8.1 %

cobas e 601/e 602 modules

2.4 –10.4 %

3.1– 6.4 %

3.4 – 9.5 %

3.9 – 6.7 %

* LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation

References

 

  1. De Jonge, H., Naesens, M., Kuypers, D.R. (2009). New insights into the pharmacokinetics and pharmacodynamics of the calcineurin inhibitors and mycophenolic acid: possible consequences for therapeutic drug monitoring in solid organ transplantation. Ther Drug Monit: 31, 416–435.
  2. Method sheets cobas c, Siemens EMIT, Siemens Dimension and ThermoFisher, status 2015
  3. IPT (International Proficiency Testing) scheme, Analytical Services International Ltd, UK (including data reports from June 2014 to August 2015; data on file).