CEDIA (R) sirolimus assay compared with HPLC-MS/MS and HPLC-UV in transplant recipient specimens

Westley, IS, Morris, RG, Taylor, PJ, Salm, P and James, MJ (2005) CEDIA (R) sirolimus assay compared with HPLC-MS/MS and HPLC-UV in transplant recipient specimens. Therapeutic Drug Monitoring, 27 3: 309-314. doi:10.1097/01.ftd.0000164394.47520.12

Author Westley, IS
Morris, RG
Taylor, PJ
Salm, P
James, MJ
Title CEDIA (R) sirolimus assay compared with HPLC-MS/MS and HPLC-UV in transplant recipient specimens
Journal name Therapeutic Drug Monitoring   Check publisher's open access policy
ISSN 0163-4356
Publication date 2005
Sub-type Article (original research)
DOI 10.1097/01.ftd.0000164394.47520.12
Volume 27
Issue 3
Start page 309
End page 314
Total pages 6
Editor S. J. Soldin
F. Sjoeqvist
Place of publication USA
Publisher Lippincott Williams & Wilkins
Collection year 2005
Language eng
Subject C1
320503 Clinical Pharmacology and Therapeutics
730305 Diagnostic methods
Abstract The role of the therapeutic drug monitoring laboratory in support of immunosuppressant drug therapy is well established, and the introduction of sirolimus (SRL) is a new direction in this field. The lack of an immunoassay for several years has restricted the availability of SRL assay services. The recent availability of a CEDIA (R) SRL assay has the potential to improve this situation. The present communication has compared the CEDIA (R) SRL method with 2 established chromatographic methods, HPLC-UV and HPLC-MS/MS. The CEDIA (R) method, run on a Hitachi 917 analyzer, showed acceptable validation criteria with within-assay precision of 9.1% and 3.3%, and bias of 17.1% and 5.8%, at SRL concentrations of 5.0 mu g/L and 20 mu g/L, respectively. The corresponding between-run precision values were 11.5% and 3.3% and bias of 7.1% and 2.9% at 5.0 mu g/L and 20 mu g/L, respectively, The lower limit of quantification was found to be 3.0 mu g/L. A series of 96 EDTA whole-blood samples predominantly from renal transplant recipients were assayed by the 3 methods for comparison. It was found that the CEDIA (R) method showed a Deming regression line of CEDIA = 1.20 X HPLC-MS/MS - 0.07 (r = 0.934, SEE = 1.47), with a mean bias of 20.4%. Serial blood samples from 8 patients included in this evaluation showed that the CEDIA (R) method reflected the clinical fluctuations in the chromatographic methods, albeit with the variable bias noted. The CEDIA (R) method on the H917 analyzer is therefore a useful adjunct to SRL dosage individualization in renal transplant recipients.
Keyword Medical Laboratory Technology
Pharmacology & Pharmacy
Therapeutic Drug Monitoring
Immunosuppressant Drug
Performance Liquid-chromatography
Whole-blood Concentrations
Tandem Mass-spectrometry
Ultraviolet Detection
Radioreceptor Assay
Consensus Panel
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2006 Higher Education Research Data Collection
School of Pharmacy Publications
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Created: Wed, 15 Aug 2007, 05:37:45 EST