Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patientsVeenhof, H., Koster, R. A., Alffenaar, J-W. C., van den Berg, A. P., de Groot, M. R., Verschuuren, E. A. M., Berger, S. P., Bakker, S. J. L. & Touw, D. J., Dec-2019, In : Clinical chemistry and laboratory medicine. 57, 12, p. 1854-1862 9 p.
Research output: Contribution to journal › Article › Academic › peer-review
- Microbes in Health and Disease (MHD)
- Groningen Institute for Organ Transplantation (GIOT)
- Groningen Kidney Center (GKC)
- Lifestyle Medicine (LM)
- Biopharmaceuticals, Discovery, Design and Delivery (BDDD)
- Groningen Research Institute for Asthma and COPD (GRIAC)
- Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE)
- Pharmaceutical Analysis
Background: Monitoring of immunosuppressive drugs such as everolimus and sirolimus is important in allograft rejection prevention in transplant patients. Dried blood spots (DBS) sampling gives patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail.
Methods: A total of 39 sirolimus and 44 everolimus paired fingerprick DBS and whole blood (WB) samples were obtained from 60 adult transplant patients for method comparison using Passing-Bablok regression. Bias was assessed using Bland-Altman. Two validation limits were pre-defined: limits of analytical acceptance were set at >67% of all paired samples within 20% of the mean of both samples and limits of clinical relevance were set in a multidisciplinary team at >80% of all paired samples within 15% of the mean of both samples.
Results: For both sirolimus and everolimus, Passing-Bablok regression showed no differences between WB and DBS with slopes of 0.86 (95% CI slope, 0.72-1.02) and 0.96 (95% CI 0.84-1.06), respectively. Only everolimus showed a significant constant bias of 4%. For both sirolimus and everolimus, limits of analytical acceptance were met (76.9% and 81.8%, respectively), but limits or clinical relevance were not met (77.3% and 61.5%, respectively).
Conclusions: Because pre-defined limits of clinical relevance were not met, this DBS sampling method for sirolimus and everolimus cannot replace WB sampling in our center at this time. However, if the clinical setting is compatible with less strict limits for clinical relevance, this DBS method is suitable for clinical application.
|Number of pages||9|
|Journal||Clinical chemistry and laboratory medicine|
|Publication status||Published - Dec-2019|
- dried blood spots, immunosuppressants, microsampling, validation, CYCLOSPORINE-A, REGRESSION PROCEDURES, TACROLIMUS, VALIDATION, MS/MS, HEMATOCRIT, CREATININE, SAMPLES