PMID- 24456626
OWN - NLM
STAT- MEDLINE
DCOM- 20141009
LR  - 20211021
IS  - 1872-7905 (Electronic)
IS  - 0022-1759 (Print)
IS  - 0022-1759 (Linking)
VI  - 409
DP  - 2014 Jul
TI  - Statistical methods for the assessment of EQAPOL proficiency testing: ELISpot, 
      Luminex, and Flow Cytometry.
PG  - 72-81
LID - S0022-1759(14)00017-9 [pii]
LID - 10.1016/j.jim.2014.01.007 [doi]
AB  - In September 2011 Duke University was awarded a contract to develop the National 
      Institutes of Health/National Institute of Allergy and Infectious Diseases 
      (NIH/NIAID) External Quality Assurance Program Oversight Laboratory (EQAPOL). 
      Through EQAPOL, proficiency testing programs are administered for Interferon-gamma 
      (IFN-gamma) Enzyme-linked immunosorbent spot (ELISpot), Intracellular Cytokine 
      Staining Flow Cytometry (ICS) and Luminex-based cytokine assays. One of the 
      charges of the EQAPOL program was to apply statistical methods to determine 
      overall site performance. We utilized various statistical methods for each 
      program to find the most appropriate for assessing laboratory performance using 
      the consensus average as the target value. Accuracy ranges were calculated based 
      on Wald-type confidence intervals, exact Poisson confidence intervals, or via 
      simulations. Given the nature of proficiency testing data, which has repeated 
      measures within donor/sample made across several laboratories; the use of mixed 
      effects models with alpha adjustments for multiple comparisons was also explored. 
      Mixed effects models were found to be the most useful method to assess laboratory 
      performance with respect to accuracy to the consensus. Model based approaches to 
      the proficiency testing data in EQAPOL will continue to be utilized. Mixed 
      effects models also provided a means of performing more complex analyses that 
      would address secondary research questions regarding within and between 
      laboratory variability as well as longitudinal analyses.
CI  - Copyright (c) 2014 Elsevier B.V. All rights reserved.
FAU - Rountree, Wes
AU  - Rountree W
AD  - Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA. 
      Electronic address: wes.rountree@dm.duke.edu.
FAU - Vandergrift, Nathan
AU  - Vandergrift N
AD  - Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
FAU - Bainbridge, John
AU  - Bainbridge J
AD  - Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
FAU - Sanchez, Ana M
AU  - Sanchez AM
AD  - Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
FAU - Denny, Thomas N
AU  - Denny TN
AD  - Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
LA  - eng
GR  - HHSN272201000045C/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20140120
PL  - Netherlands
TA  - J Immunol Methods
JT  - Journal of immunological methods
JID - 1305440
RN  - 0 (Biomarkers)
RN  - 0 (Cytokines)
SB  - IM
MH  - Biomarkers/blood
MH  - Cytokines/*blood
MH  - Data Interpretation, Statistical
MH  - Enzyme-Linked Immunospot Assay/*standards/statistics & numerical data
MH  - Flow Cytometry/*standards/statistics & numerical data
MH  - Guideline Adherence/standards
MH  - Humans
MH  - Interferon-gamma Release Tests/*standards/statistics & numerical data
MH  - Laboratories/*standards/statistics & numerical data
MH  - Laboratory Proficiency Testing/*standards/statistics & numerical data
MH  - *Models, Statistical
MH  - Monitoring, Immunologic/*standards/statistics & numerical data
MH  - Observer Variation
MH  - Practice Guidelines as Topic/standards
MH  - Predictive Value of Tests
MH  - Program Development
MH  - Program Evaluation
MH  - Quality Control
MH  - Quality Indicators, Health Care/standards
MH  - Reproducibility of Results
MH  - Specimen Handling/standards
PMC - PMC4104253
MID - NIHMS562543
OTO - NOTNLM
OT  - ELISpot
OT  - Flow Cytometry
OT  - Luminex
OT  - Mixed effects models
OT  - Poisson
OT  - Proficiency testing
EDAT- 2014/01/25 06:00
MHDA- 2014/10/10 06:00
PMCR- 2015/07/01
CRDT- 2014/01/25 06:00
PHST- 2013/09/06 00:00 [received]
PHST- 2013/11/20 00:00 [revised]
PHST- 2014/01/10 00:00 [accepted]
PHST- 2014/01/25 06:00 [entrez]
PHST- 2014/01/25 06:00 [pubmed]
PHST- 2014/10/10 06:00 [medline]
PHST- 2015/07/01 00:00 [pmc-release]
AID - S0022-1759(14)00017-9 [pii]
AID - 10.1016/j.jim.2014.01.007 [doi]
PST - ppublish
SO  - J Immunol Methods. 2014 Jul;409:72-81. doi: 10.1016/j.jim.2014.01.007. Epub 2014 
      Jan 20.