Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays.
J Immunol Methods
; 409: 62-71, 2014 Jul.
Article
en En
| MEDLINE
| ID: mdl-24801479
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.
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Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Monitorización Inmunológica
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Estudios Multicéntricos como Asunto
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Citocinas
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Ensayos Analíticos de Alto Rendimiento
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Ensayos de Aptitud de Laboratorios
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Laboratorios
Tipo de estudio:
Clinical_trials
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Evaluation_studies
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Guideline
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Prognostic_studies
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Sysrev_observational_studies
Límite:
Humans
Idioma:
En
Revista:
J Immunol Methods
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos