Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research

an EORTC-NCI working group report.

F. C. Sweep, Herbert A. Fritsche, Massimo Gion, George G. Klee, Manfred Schmitt

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

A major dilemma associated with immuno(metric) assays for biomarkers is that various kits employing antibodies with differing specificities and binding affinities may generate non-equivalent test results. Also, variation in sample processing and the use of different standards (reference material) may result in discordant test results. Therefore, assays and procedures should be standardized and the quality of biomarker assay results should be monitored by continuous between-laboratory proficiency testing of performance. External quality control requires an established network of expert laboratories in which the investigators interact freely and where technical issues are discussed. Although such networking is more often praised than practiced, we strongly endorse and advocate between-laboratory exchange of experience and information. The present study discusses analytical aspects of immuno(metric) biomarker assays and presents recommendations of the Receptor and Biomarker Group of the EORTC (European Organisation for Research and Treatment of Cancer) how such tests should be validated for first time and day to day use. Moreover, a model for an appropriate quality assurance program is presented.

Original languageEnglish (US)
Pages (from-to)1715-1726
Number of pages12
JournalInternational Journal of Oncology
Volume23
Issue number6
StatePublished - Dec 2003
Externally publishedYes

Fingerprint

Quality Control
Biomarkers
Research
Laboratory Proficiency Testing
Neoplasms
Research Personnel
Antibodies

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research : an EORTC-NCI working group report. / Sweep, F. C.; Fritsche, Herbert A.; Gion, Massimo; Klee, George G.; Schmitt, Manfred.

In: International Journal of Oncology, Vol. 23, No. 6, 12.2003, p. 1715-1726.

Research output: Contribution to journalArticle

@article{2b63f86dfd9b4944ab0912495cf7cd20,
title = "Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research: an EORTC-NCI working group report.",
abstract = "A major dilemma associated with immuno(metric) assays for biomarkers is that various kits employing antibodies with differing specificities and binding affinities may generate non-equivalent test results. Also, variation in sample processing and the use of different standards (reference material) may result in discordant test results. Therefore, assays and procedures should be standardized and the quality of biomarker assay results should be monitored by continuous between-laboratory proficiency testing of performance. External quality control requires an established network of expert laboratories in which the investigators interact freely and where technical issues are discussed. Although such networking is more often praised than practiced, we strongly endorse and advocate between-laboratory exchange of experience and information. The present study discusses analytical aspects of immuno(metric) biomarker assays and presents recommendations of the Receptor and Biomarker Group of the EORTC (European Organisation for Research and Treatment of Cancer) how such tests should be validated for first time and day to day use. Moreover, a model for an appropriate quality assurance program is presented.",
author = "Sweep, {F. C.} and Fritsche, {Herbert A.} and Massimo Gion and Klee, {George G.} and Manfred Schmitt",
year = "2003",
month = "12",
language = "English (US)",
volume = "23",
pages = "1715--1726",
journal = "International Journal of Oncology",
issn = "1019-6439",
publisher = "Spandidos Publications",
number = "6",

}

TY - JOUR

T1 - Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research

T2 - an EORTC-NCI working group report.

AU - Sweep, F. C.

AU - Fritsche, Herbert A.

AU - Gion, Massimo

AU - Klee, George G.

AU - Schmitt, Manfred

PY - 2003/12

Y1 - 2003/12

N2 - A major dilemma associated with immuno(metric) assays for biomarkers is that various kits employing antibodies with differing specificities and binding affinities may generate non-equivalent test results. Also, variation in sample processing and the use of different standards (reference material) may result in discordant test results. Therefore, assays and procedures should be standardized and the quality of biomarker assay results should be monitored by continuous between-laboratory proficiency testing of performance. External quality control requires an established network of expert laboratories in which the investigators interact freely and where technical issues are discussed. Although such networking is more often praised than practiced, we strongly endorse and advocate between-laboratory exchange of experience and information. The present study discusses analytical aspects of immuno(metric) biomarker assays and presents recommendations of the Receptor and Biomarker Group of the EORTC (European Organisation for Research and Treatment of Cancer) how such tests should be validated for first time and day to day use. Moreover, a model for an appropriate quality assurance program is presented.

AB - A major dilemma associated with immuno(metric) assays for biomarkers is that various kits employing antibodies with differing specificities and binding affinities may generate non-equivalent test results. Also, variation in sample processing and the use of different standards (reference material) may result in discordant test results. Therefore, assays and procedures should be standardized and the quality of biomarker assay results should be monitored by continuous between-laboratory proficiency testing of performance. External quality control requires an established network of expert laboratories in which the investigators interact freely and where technical issues are discussed. Although such networking is more often praised than practiced, we strongly endorse and advocate between-laboratory exchange of experience and information. The present study discusses analytical aspects of immuno(metric) biomarker assays and presents recommendations of the Receptor and Biomarker Group of the EORTC (European Organisation for Research and Treatment of Cancer) how such tests should be validated for first time and day to day use. Moreover, a model for an appropriate quality assurance program is presented.

UR - http://www.scopus.com/inward/record.url?scp=1642413093&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=1642413093&partnerID=8YFLogxK

M3 - Article

VL - 23

SP - 1715

EP - 1726

JO - International Journal of Oncology

JF - International Journal of Oncology

SN - 1019-6439

IS - 6

ER -