Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients.

Abstract:

: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.

journal_name

Clin Chem Lab Med

authors

Veenhof H,Koster RA,Alffenaar JC,van den Berg AP,de Groot MR,Verschuuren EAM,Berger SP,Bakker SJL,Touw DJ

doi

10.1515/cclm-2019-0053

subject

Has Abstract

pub_date

2019-11-26 00:00:00

pages

1854-1862

issue

12

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2019-0053/cclm-2019-00

journal_volume

57

pub_type

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