Elecsys® Immunosuppressive Drug Assay Panel

Roche is the only company offering the full immunosuppressive drug menu on one automated and integrated system, ensuring an efficient laboratory workflow and providing reliable and consistent patient results for lifelong monitoring.

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 window1, the use of immunosuppressive drugs (ISDs) requires both precise and consistent measurement of their concentration in whole blood during life-long monitoring.

The Elecsys ISD panel includes Tacrolimus, Cyclosporine, Sirolimus and Everolimus.

  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 30-2000 ng/mL 0.5-30 ng/mL 0.5-30 ng/mL
Total Imprecision
cobas e 411 analyzer
cobas e 601/e 602 modules


2.1 - 14.2 %

2.4 - 10.4 %


4.2 - 9.2 %

3.1 - 6.4 %


2.8 - 10.9 %

3.4 - 9.5 %


2.7 - 8.1 %

3.9 - 6.7 %

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

 

Consolidation for optimized workflow

The new Elecsys Sirolimus and Everolimus assays complete the ISD menu and are an important addition to the cobas TDM menu making it the most complete ISD product offering.

  • The full ISD menu now available on one automated and integrated Roche SWA platform:
    • Best-in-class automated MPA available on cobas c modules2 
    • Elecsys Cyclosporine and Tacolimus now completed with Elecsys Sirolimus and Everolimus on cobas e modules
  • One universal pre-treatment procedure for all ISD assays to increase workflow efficiency 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
  • Superior performance confirmed in routine customer laboratories3

Consistent results for life-long monitoring

  • Consistent patient results across all cobas ® platforms due to universal reagent concept
  • Low variability across different customer labs proven in external quality schemes
  • High comparability to well established and validated LC-MS/MS

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. Source: Package inserts, 2015

3. Source: IPT scheme, Analytical Services International Ltd, UK [including data reports from June 2014 to August 2015]

4. Shipkova, M., et al, (2014). “Multi-center analytical evaluation of a novel automated tacrolimus immunoassay”, Clin Biochem, 47(12):1069-77

5. Vogeser, M., et al., (2014). “Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine.” Ther Drug Monit, 36(5):640-50.