Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays.

dc.contributor.author

Lynch, Heather E

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Sanchez, Ana M

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D'Souza, M Patricia

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Rountree, Wes

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Denny, Thomas N

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Kalos, Michael

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Sempowski, Gregory D

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Netherlands

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2017-06-01T19:20:15Z

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2017-06-01T19:20:15Z

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2014-07

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Luminex bead array assays are widely used for rapid biomarker quantification due to the ability to measure up to 100 unique analytes in a single well of a 96-well plate. There has been, however, no comprehensive analysis of variables impacting assay performance, nor development of a standardized proficiency testing program for laboratories performing these assays. To meet this need, the NIH/NIAID and the Cancer Immunotherapy Consortium of the Cancer Research Institute collaborated to develop and implement a Luminex assay proficiency testing program as part of the NIH/NIAID-sponsored External Quality Assurance Program Oversight Laboratory (EQAPOL) at Duke University. The program currently monitors 25 domestic and international sites with two external proficiency panels per year. Each panel includes a de-identified commercial Luminex assay kit with standards to quantify human IFNγ, TNFα, IL-6, IL-10 and IL-2, and a series of recombinant cytokine-spiked human serum samples. All aspects of panel development, testing and shipping are performed under GCLP by EQAPOL support teams. Following development testing, a comprehensive site proficiency scoring system comprised of timeliness, protocol adherence, accuracy and precision was implemented. The overall mean proficiency score across three rounds of testing has remained stable (EP3: 76%, EP4: 75%, EP5: 77%); however, a more detailed analysis of site reported results indicates a significant improvement of intra- (within) and inter- (between) site variation, suggesting that training and remediation for poor performing sites may be having a positive impact on proficiency. Through continued proficiency testing, identification of variables affecting Luminex assay outcomes will strengthen efforts to bring standardization to the field.

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https://www.ncbi.nlm.nih.gov/pubmed/24801479

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S0022-1759(14)00128-8

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1872-7905

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https://hdl.handle.net/10161/14683

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eng

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Elsevier BV

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Journal of Immunological Methods

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10.1016/j.jim.2014.04.011

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Cytokines

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GCLP

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Luminex

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Multiplex

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Proficiency

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Biomarkers

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Cooperative Behavior

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Cytokines

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Guideline Adherence

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High-Throughput Screening Assays

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Humans

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International Cooperation

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Laboratories

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Laboratory Proficiency Testing

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Monitoring, Immunologic

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Multicenter Studies as Topic

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Observer Variation

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Practice Guidelines as Topic

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Predictive Value of Tests

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Program Development

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Program Evaluation

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Quality Control

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Quality Improvement

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Quality Indicators, Health Care

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Reference Standards

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Reproducibility of Results

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Specimen Handling

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Time Factors

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Workflow

dc.title

Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays.

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Journal article

duke.contributor.orcid

Sempowski, Gregory D|0000-0003-0391-6594

pubs.author-url

https://www.ncbi.nlm.nih.gov/pubmed/24801479

pubs.begin-page

62

pubs.end-page

71

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Clinical Science Departments

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Duke

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Duke Human Vaccine Institute

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Institutes and Centers

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Medicine

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Medicine, Duke Human Vaccine Institute

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Pathology

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School of Medicine

pubs.publication-status

Published

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409

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