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

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    Date
    2014-07
    Author
    Lynch, Heather
    Sanchez, AM
    D'Souza, MP
    Rountree, Wes
    Denny, Thomas Norton
    Kalos, M
    Sempowski, GD
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    Abstract
    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.
    Type
    Journal Article
    Subject
    Cytokines
    GCLP
    Luminex
    Multiplex
    Proficiency
    Biomarkers
    Cooperative Behavior
    Cytokines
    Guideline Adherence
    High-Throughput Screening Assays
    Humans
    International Cooperation
    Laboratories
    Laboratory Proficiency Testing
    Monitoring, Immunologic
    Multicenter Studies as Topic
    Observer Variation
    Practice Guidelines as Topic
    Predictive Value of Tests
    Program Development
    Program Evaluation
    Quality Control
    Quality Improvement
    Quality Indicators, Health Care
    Reference Standards
    Reproducibility of Results
    Specimen Handling
    Time Factors
    Workflow
    Permalink
    http://hdl.handle.net/10161/14683
    Published Version (Please cite this version)
    10.1016/j.jim.2014.04.011
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