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10.1016/j.jim.2014.04.011

http://scihub22266oqcxt.onion/10.1016/j.jim.2014.04.011
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suck abstract from ncbi


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pmid24801479
      J+Immunol+Methods 2014 ; 409 (ä): 62-71
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  • Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays #MMPMID24801479
  • Lynch HE ; Sanchez AM ; D'Souza MP ; Rountree W ; Denny TN ; Kalos M ; Sempowski GD
  • J Immunol Methods 2014[Jul]; 409 (ä): 62-71 PMID24801479 show ga
  • 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 IFN?, TNF?, 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.
  • |Biomarkers/blood [MESH]
  • |Cooperative Behavior [MESH]
  • |Cytokines/*blood [MESH]
  • |Guideline Adherence/standards [MESH]
  • |High-Throughput Screening Assays/*standards [MESH]
  • |Humans [MESH]
  • |International Cooperation [MESH]
  • |Laboratories/*standards [MESH]
  • |Laboratory Proficiency Testing/*standards [MESH]
  • |Monitoring, Immunologic/*standards [MESH]
  • |Multicenter Studies as Topic/*standards [MESH]
  • |Observer Variation [MESH]
  • |Practice Guidelines as Topic/standards [MESH]
  • |Predictive Value of Tests [MESH]
  • |Program Development [MESH]
  • |Program Evaluation [MESH]
  • |Quality Control [MESH]
  • |Quality Improvement/standards [MESH]
  • |Quality Indicators, Health Care/standards [MESH]
  • |Reference Standards [MESH]
  • |Reproducibility of Results [MESH]
  • |Specimen Handling/standards [MESH]
  • |Time Factors [MESH]


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