Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system

Mark A. Cervinski; Show Hong Duh; Karl G. Hock; Jeffery Gray; Tie Q. Wei; Daniel C. Kilgore; Robert H. Christenson; Mitchell G. Scott

doi:10.1016/j.clinbiochem.2009.03.009

Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system

Mark A. Cervinski, Show Hong Duh, Karl G. Hock, Jeffery Gray, Tie Q. Wei, Daniel C. Kilgore, Robert H. Christenson, Mitchell G. Scott

Division of Laboratory and Genomic Medicine

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Objectives: Current therapeutic drug monitoring methods for sirolimus require a manual pre-treatment step and batch analysis. We describe and validate a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system from Siemens Healthcare Diagnostics Inc. Design and methods: Whole blood samples from renal transplant patients prescribed sirolimus were analyzed by the LC-MS/MS reference method, Abbott IMx and Dimension RxL methods in accordance with CLSI recommendations. Results: The Dimension sirolimus assay had a functional sensitivity of 2.0 ng/mL and repeatability and within-laboratory imprecision less than 12.6% at 3 ng/mL and less than 5% at 11-12 ng/mL. Least squares linear regression demonstrated the following relationships: RxL = 1.20(LC-MS/MS) - 0.70, r = 0.95 and RxL = 1.33(IMx) - 0.75, r = 0.96. Conclusions: The Dimension sirolimus assay correlates well with the LC-MS/MS reference and IMx immunoassay methods and has the advantage of random access analysis without a manual pre-treatment step.

Original language	English
Pages (from-to)	1123-1127
Number of pages	5
Journal	Clinical Biochemistry
Volume	42
Issue number	10-11
DOIs	https://doi.org/10.1016/j.clinbiochem.2009.03.009
State	Published - Jul 2009

Keywords

Dimension RxL
Random access
Sirolimus

Access to Document

10.1016/j.clinbiochem.2009.03.009

Cite this

@article{0c928acfc94942b094d4cdbfe600c826,

title = "Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension{\textregistered} RxL clinical chemistry system",

abstract = "Objectives: Current therapeutic drug monitoring methods for sirolimus require a manual pre-treatment step and batch analysis. We describe and validate a no-pretreatment, random access sirolimus assay for the Dimension{\textregistered} RxL clinical chemistry system from Siemens Healthcare Diagnostics Inc. Design and methods: Whole blood samples from renal transplant patients prescribed sirolimus were analyzed by the LC-MS/MS reference method, Abbott IMx and Dimension RxL methods in accordance with CLSI recommendations. Results: The Dimension sirolimus assay had a functional sensitivity of 2.0 ng/mL and repeatability and within-laboratory imprecision less than 12.6% at 3 ng/mL and less than 5% at 11-12 ng/mL. Least squares linear regression demonstrated the following relationships: RxL = 1.20(LC-MS/MS) - 0.70, r = 0.95 and RxL = 1.33(IMx) - 0.75, r = 0.96. Conclusions: The Dimension sirolimus assay correlates well with the LC-MS/MS reference and IMx immunoassay methods and has the advantage of random access analysis without a manual pre-treatment step.",

keywords = "Dimension RxL, Random access, Sirolimus",

author = "Cervinski, {Mark A.} and Duh, {Show Hong} and Hock, {Karl G.} and Jeffery Gray and Wei, {Tie Q.} and Kilgore, {Daniel C.} and Christenson, {Robert H.} and Scott, {Mitchell G.}",

note = "Funding Information: This study was supported by Siemens Healthcare Diagnostics Inc.",

year = "2009",

month = jul,

doi = "10.1016/j.clinbiochem.2009.03.009",

language = "English",

volume = "42",

pages = "1123--1127",

journal = "Clinical Biochemistry",

issn = "0009-9120",

number = "10-11",

}

Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system. / Cervinski, Mark A.; Duh, Show Hong; Hock, Karl G.; Gray, Jeffery; Wei, Tie Q.; Kilgore, Daniel C.; Christenson, Robert H.; Scott, Mitchell G.

In: Clinical Biochemistry, Vol. 42, No. 10-11, 07.2009, p. 1123-1127.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system

AU - Cervinski, Mark A.

AU - Duh, Show Hong

AU - Hock, Karl G.

AU - Gray, Jeffery

AU - Wei, Tie Q.

AU - Kilgore, Daniel C.

AU - Christenson, Robert H.

AU - Scott, Mitchell G.

N1 - Funding Information: This study was supported by Siemens Healthcare Diagnostics Inc.

PY - 2009/7

Y1 - 2009/7

N2 - Objectives: Current therapeutic drug monitoring methods for sirolimus require a manual pre-treatment step and batch analysis. We describe and validate a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system from Siemens Healthcare Diagnostics Inc. Design and methods: Whole blood samples from renal transplant patients prescribed sirolimus were analyzed by the LC-MS/MS reference method, Abbott IMx and Dimension RxL methods in accordance with CLSI recommendations. Results: The Dimension sirolimus assay had a functional sensitivity of 2.0 ng/mL and repeatability and within-laboratory imprecision less than 12.6% at 3 ng/mL and less than 5% at 11-12 ng/mL. Least squares linear regression demonstrated the following relationships: RxL = 1.20(LC-MS/MS) - 0.70, r = 0.95 and RxL = 1.33(IMx) - 0.75, r = 0.96. Conclusions: The Dimension sirolimus assay correlates well with the LC-MS/MS reference and IMx immunoassay methods and has the advantage of random access analysis without a manual pre-treatment step.

AB - Objectives: Current therapeutic drug monitoring methods for sirolimus require a manual pre-treatment step and batch analysis. We describe and validate a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system from Siemens Healthcare Diagnostics Inc. Design and methods: Whole blood samples from renal transplant patients prescribed sirolimus were analyzed by the LC-MS/MS reference method, Abbott IMx and Dimension RxL methods in accordance with CLSI recommendations. Results: The Dimension sirolimus assay had a functional sensitivity of 2.0 ng/mL and repeatability and within-laboratory imprecision less than 12.6% at 3 ng/mL and less than 5% at 11-12 ng/mL. Least squares linear regression demonstrated the following relationships: RxL = 1.20(LC-MS/MS) - 0.70, r = 0.95 and RxL = 1.33(IMx) - 0.75, r = 0.96. Conclusions: The Dimension sirolimus assay correlates well with the LC-MS/MS reference and IMx immunoassay methods and has the advantage of random access analysis without a manual pre-treatment step.

KW - Dimension RxL

KW - Random access

KW - Sirolimus

UR - http://www.scopus.com/inward/record.url?scp=67349130768&partnerID=8YFLogxK

U2 - 10.1016/j.clinbiochem.2009.03.009

DO - 10.1016/j.clinbiochem.2009.03.009

M3 - Article

C2 - 19303402

AN - SCOPUS:67349130768

VL - 42

SP - 1123

EP - 1127

JO - Clinical Biochemistry

JF - Clinical Biochemistry

SN - 0009-9120

IS - 10-11

ER -

Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension® RxL clinical chemistry system

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this