Validation Kits

International Everolimus Validation and Cross-Validation Support Program

The clinical use of drugs such as immunosuppressants in transplantation creates a major challenge whereby monitoring and proper validation, alongside ongoing external quality control checks of in- house tests, is important in order to support effective and safe use.

One program iC42 has initiated in 2012 is targeted towards laboratories in the United States and in participating countries throughout the world that are in the process of implementing everolimus therapeutic drug monitoring, with the aim of providing validation support for both LC‐MS/MS and immunoassay methods, providing the opportunity to cross-validate these assays with other laboratories. For LC‐ MS/MS this support is more comprehensive and includes both method optimization and validation support. This support is provided in the form of:

‐ LC‐MS/MS Validation Kits – provide comprehensive set of samples for LC‐MS/MS method validation
‐ Supplemental Patient Sample Kits – provide samples for immunoassay validation, or as an addition to the LC‐MS/MS Validation Kits.
‐ Monthly Cross‐Validation Kits – provide sample sets as monthly external QC check against other participating laboratories.

Whole blood samples are collected on EDTA from transplant patients receiving everolimus treatment. The individual samples are from patients: with different organ transplants, at different time periods following transplantation, of different ages, and with different ethnic backgrounds. These samples are pooled to create larger samples, at various everolimus concentrations, which form the basis of the samples provided in the kits.
Contained within the LC‐MS/MS validation kit are 67 blinded samples to be tested by the receiving center for external validation. The samples in the validation kit are spiked calibration samples within an appropriate analytical range for therapeutic drug monitoring of Everolimus, quality controls in 4 different levels covering the analytical range and controls for establish a reasonable lower limit of quantification. Twenty of these samples are pooled transplant patient samples.

For immunoassay validations blinded patient sample pools are provided as supplemental samples for your assay validation. These supplemental samples can also be provided for additional validation support for LC‐MS/MS assays.
Once the provided samples are run as part of your validation, the data obtained is provided to iC42 for analysis via the website. iC42 will carry out statistical analyses, and the results will be communicated back via the website as well.
This initial validation phase will be followed by a cross validation study whereby participating laboratories will receive smaller identical, kits containing three blinded samples, on a monthly, bi‐ monthly, or quarterly basis, as requested. As above, data will be shared between the laboratories and iC42 to study test performance over a longer period and to provide feedback.

To become involved in this program, please visit our Zortracker Website:

For more information about LC-MS/MS and Fisher QMS immunoassay Cross-Validation Results of our Zortracker Everolimus TDM Laboratory Support Program click the following link.

Feel free to contact our project manager Dr. Jost Klawitter if you have any questions.

Dr. Jost Klawitter
University of Colorado, School of Medicine
Bioscience II Building,
12705 E Montview Blvd
Suite 200
Aurora, Colorado 80045-7503

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