Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays.
dc.contributor.author | Lynch, Heather E | |
dc.contributor.author | Sanchez, Ana M | |
dc.contributor.author | D'Souza, M Patricia | |
dc.contributor.author | Rountree, Wes | |
dc.contributor.author | Denny, Thomas N | |
dc.contributor.author | Kalos, Michael | |
dc.contributor.author | Sempowski, Gregory D | |
dc.coverage.spatial | Netherlands | |
dc.date.accessioned | 2017-06-01T19:20:15Z | |
dc.date.available | 2017-06-01T19:20:15Z | |
dc.date.issued | 2014-07 | |
dc.description.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. | |
dc.identifier | ||
dc.identifier | S0022-1759(14)00128-8 | |
dc.identifier.eissn | 1872-7905 | |
dc.identifier.uri | ||
dc.language | eng | |
dc.publisher | Elsevier BV | |
dc.relation.ispartof | Journal of Immunological Methods | |
dc.relation.isversionof | 10.1016/j.jim.2014.04.011 | |
dc.subject | Cytokines | |
dc.subject | GCLP | |
dc.subject | Luminex | |
dc.subject | Multiplex | |
dc.subject | Proficiency | |
dc.subject | Biomarkers | |
dc.subject | Cooperative Behavior | |
dc.subject | Cytokines | |
dc.subject | Guideline Adherence | |
dc.subject | High-Throughput Screening Assays | |
dc.subject | Humans | |
dc.subject | International Cooperation | |
dc.subject | Laboratories | |
dc.subject | Laboratory Proficiency Testing | |
dc.subject | Monitoring, Immunologic | |
dc.subject | Multicenter Studies as Topic | |
dc.subject | Observer Variation | |
dc.subject | Practice Guidelines as Topic | |
dc.subject | Predictive Value of Tests | |
dc.subject | Program Development | |
dc.subject | Program Evaluation | |
dc.subject | Quality Control | |
dc.subject | Quality Improvement | |
dc.subject | Quality Indicators, Health Care | |
dc.subject | Reference Standards | |
dc.subject | Reproducibility of Results | |
dc.subject | Specimen Handling | |
dc.subject | Time Factors | |
dc.subject | Workflow | |
dc.title | Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays. | |
dc.type | Journal article | |
duke.contributor.orcid | Sempowski, Gregory D|0000-0003-0391-6594 | |
pubs.author-url | ||
pubs.begin-page | 62 | |
pubs.end-page | 71 | |
pubs.organisational-group | Clinical Science Departments | |
pubs.organisational-group | Duke | |
pubs.organisational-group | Duke Human Vaccine Institute | |
pubs.organisational-group | Institutes and Centers | |
pubs.organisational-group | Medicine | |
pubs.organisational-group | Medicine, Duke Human Vaccine Institute | |
pubs.organisational-group | Pathology | |
pubs.organisational-group | School of Medicine | |
pubs.publication-status | Published | |
pubs.volume | 409 |