Challenges in implementing clinical liquid chromatography-tandem mass spectrometry methods - Seeing the light at the end of the tunnel

William Clarke, Jeanne M. Rhea, Ross Molinaro

Research output: Contribution to journalArticle

Abstract

The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the clinical setting is a relatively new application. One of the significant barriers hampering the transition of LC-MS/MS from the research lab into a clinical setting is the uncertainty of how to successfully develop and validate a method that meets guidelines for clinical applications. Here, we have taken this seemingly overwhelming process and broken it into five general stages for consideration: assessing the clinical validity of a new LC-MS/MS assay, determination of feasibility, assay development, assay validation and post-implementation monitoring. Although various publications are available and serve as resources for determining development processes and acceptability criteria for specific LC-MS/MS assays, many of them are general recommendations or are specific to research applications that may not translate either practically or clinically. In this perspective special feature article, a resource is compiled that describes key differences between LC-MS/MS methods for research use versus clinical use. In addition, the challenges facing the expanding role of this technique in the clinical setting are discussed, including instrumentation/automation challenges, potential regulation of laboratory developed tests by the US Food and Drug Administration and standardization and harmonization of MS methods through the use of traceable materials and availability of guidance documents.

Original languageEnglish (US)
Pages (from-to)755-767
Number of pages13
JournalJournal of Mass Spectrometry
Volume48
Issue number7
DOIs
StatePublished - Jul 2013

Fingerprint

Liquid chromatography
liquid chromatography
Tandem Mass Spectrometry
Liquid Chromatography
Mass spectrometry
Assays
mass spectroscopy
resources
Research
Automation
standardization
United States Food and Drug Administration
automation
recommendations
acceptability
Uncertainty
availability
Publications
Guidelines
Standardization

Keywords

  • challenges
  • clinical LC-MS/MS
  • guidance
  • implementation
  • regulations

ASJC Scopus subject areas

  • Spectroscopy

Cite this

Challenges in implementing clinical liquid chromatography-tandem mass spectrometry methods - Seeing the light at the end of the tunnel. / Clarke, William; Rhea, Jeanne M.; Molinaro, Ross.

In: Journal of Mass Spectrometry, Vol. 48, No. 7, 07.2013, p. 755-767.

Research output: Contribution to journalArticle

@article{61123d4898cc4c789c315da48272fed0,
title = "Challenges in implementing clinical liquid chromatography-tandem mass spectrometry methods - Seeing the light at the end of the tunnel",
abstract = "The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the clinical setting is a relatively new application. One of the significant barriers hampering the transition of LC-MS/MS from the research lab into a clinical setting is the uncertainty of how to successfully develop and validate a method that meets guidelines for clinical applications. Here, we have taken this seemingly overwhelming process and broken it into five general stages for consideration: assessing the clinical validity of a new LC-MS/MS assay, determination of feasibility, assay development, assay validation and post-implementation monitoring. Although various publications are available and serve as resources for determining development processes and acceptability criteria for specific LC-MS/MS assays, many of them are general recommendations or are specific to research applications that may not translate either practically or clinically. In this perspective special feature article, a resource is compiled that describes key differences between LC-MS/MS methods for research use versus clinical use. In addition, the challenges facing the expanding role of this technique in the clinical setting are discussed, including instrumentation/automation challenges, potential regulation of laboratory developed tests by the US Food and Drug Administration and standardization and harmonization of MS methods through the use of traceable materials and availability of guidance documents.",
keywords = "challenges, clinical LC-MS/MS, guidance, implementation, regulations",
author = "William Clarke and Rhea, {Jeanne M.} and Ross Molinaro",
year = "2013",
month = "7",
doi = "10.1002/jms.3214",
language = "English (US)",
volume = "48",
pages = "755--767",
journal = "Journal of Mass Spectrometry",
issn = "1076-5174",
publisher = "John Wiley and Sons Ltd",
number = "7",

}

TY - JOUR

T1 - Challenges in implementing clinical liquid chromatography-tandem mass spectrometry methods - Seeing the light at the end of the tunnel

AU - Clarke, William

AU - Rhea, Jeanne M.

AU - Molinaro, Ross

PY - 2013/7

Y1 - 2013/7

N2 - The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the clinical setting is a relatively new application. One of the significant barriers hampering the transition of LC-MS/MS from the research lab into a clinical setting is the uncertainty of how to successfully develop and validate a method that meets guidelines for clinical applications. Here, we have taken this seemingly overwhelming process and broken it into five general stages for consideration: assessing the clinical validity of a new LC-MS/MS assay, determination of feasibility, assay development, assay validation and post-implementation monitoring. Although various publications are available and serve as resources for determining development processes and acceptability criteria for specific LC-MS/MS assays, many of them are general recommendations or are specific to research applications that may not translate either practically or clinically. In this perspective special feature article, a resource is compiled that describes key differences between LC-MS/MS methods for research use versus clinical use. In addition, the challenges facing the expanding role of this technique in the clinical setting are discussed, including instrumentation/automation challenges, potential regulation of laboratory developed tests by the US Food and Drug Administration and standardization and harmonization of MS methods through the use of traceable materials and availability of guidance documents.

AB - The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the clinical setting is a relatively new application. One of the significant barriers hampering the transition of LC-MS/MS from the research lab into a clinical setting is the uncertainty of how to successfully develop and validate a method that meets guidelines for clinical applications. Here, we have taken this seemingly overwhelming process and broken it into five general stages for consideration: assessing the clinical validity of a new LC-MS/MS assay, determination of feasibility, assay development, assay validation and post-implementation monitoring. Although various publications are available and serve as resources for determining development processes and acceptability criteria for specific LC-MS/MS assays, many of them are general recommendations or are specific to research applications that may not translate either practically or clinically. In this perspective special feature article, a resource is compiled that describes key differences between LC-MS/MS methods for research use versus clinical use. In addition, the challenges facing the expanding role of this technique in the clinical setting are discussed, including instrumentation/automation challenges, potential regulation of laboratory developed tests by the US Food and Drug Administration and standardization and harmonization of MS methods through the use of traceable materials and availability of guidance documents.

KW - challenges

KW - clinical LC-MS/MS

KW - guidance

KW - implementation

KW - regulations

UR - http://www.scopus.com/inward/record.url?scp=84879906458&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879906458&partnerID=8YFLogxK

U2 - 10.1002/jms.3214

DO - 10.1002/jms.3214

M3 - Article

C2 - 23832931

AN - SCOPUS:84879906458

VL - 48

SP - 755

EP - 767

JO - Journal of Mass Spectrometry

JF - Journal of Mass Spectrometry

SN - 1076-5174

IS - 7

ER -