An assessment of clinical laboratory performance for the determination of manganese in blood and urine
-
Meredith L. Praamsma
, David Bisson
Abstract
Background:
Proficiency testing or external quality assessment schemes (PT/EQASs) are an important method of assessing laboratory performance. As each scheme establishes assigned values and acceptable ranges for the analyte according to its own criteria, monitoring of participant performance varies according to the scheme and can lead to conflicting conclusions.
Methods:
Standard deviations (SDs) for PT were derived from Thompson’s and biological variation models applied to blood and urine manganese (Mn) robust data from four EQASs from North America and Europe. The fitness for purpose was verified by applying these SDs to individual results.
Results:
Using Thompson characteristic function the relationship between SD and Mn concentration, expressed in nmol/L was the square root of [19.72+(0.07712×Mn concentration2)] for blood and the square root of [6.772+(0.09852×Mn concentration2)] for urine. While the biological variation model was not suitable for urine, it produced an acceptable range for blood as ±54.4 nmol/L (assigned value ≤320 nmol/L) or 17% (assigned value >320 nmol/L). For blood, individual performance evaluated by the two approaches led to similar conclusions.
Conclusions:
The biological variation model can be used to propose quality specifications for blood, however it could not be applied to urine. The Thompson characteristic function model could be applied to derive quality specifications for Mn in urine and, to a lesser extent in blood. The more lenient quality specifications for blood highlight the difficulty of determining Mn in this matrix. Further work is needed to harmonize PT, such as using assigned ranges for the specimens.
Acknowledgments:
We greatly thank Dr. Marissa G. Baker (University of Washington, WA, USA) for sharing the data presented in her paper on individual variability. We thank the members of the Network of Organisers of EQAS in Occupational and Environmental Laboratory Medicine who gave us the opportunity for fruitful discussions about trace element PT/EQAS. We particularly thank Dr. Cas W. Weykamp (Queen Beatrix hospital, Winterswijk, The Netherlands) for the preparation of OELM samples.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Michalke B, Fernsebner K. New insights into manganese toxicity and speciation. J Trace Elem Med Biol 2014;28:106–16.10.1016/j.jtemb.2013.08.005Search in Google Scholar PubMed
2. Santos D, Batoreu C, Mateus L, Marreilha Dos Santos AP, Aschner M. Manganese in human parenteral nutrition: considerations for toxicity and biomonitoring. Neurotoxicology 2014;43:36–45.10.1016/j.neuro.2013.10.003Search in Google Scholar PubMed PubMed Central
3. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833–5.10.1515/cclm-2015-0067Search in Google Scholar PubMed
4. Thompson M. Uncertainty functions, a compact way of summarising or specifying the behaviour of analytical systems. Trends Anal Chem 2011;30:1168–75.10.1016/j.trac.2011.03.012Search in Google Scholar
5. Horwitz W, Albert R. The Horwitz ratio (HorRat): a useful index of method performance with respect to precision. J AOAC Int 2006;89:1095–109.10.1093/jaoac/89.4.1095Search in Google Scholar
6. Côté I, Robouch P, Robouch B, Bisson D, Gamache P, LeBlanc A, et al. Determination of the standard deviation for proficiency assessment from past participant’s performances. Accred Qual Assur 2012;17:389–93.10.1007/s00769-012-0906-2Search in Google Scholar
7. Taylor A, Angerer J, Claeys F, Kristiansen J, Mazarrasa O, Menditto A, et al. Comparison of procedures for evaluating laboratory performance in external quality assessment schemes for lead in blood and aluminum in serum demonstrates the need for common quality specifications. Clin Chem 2002;48:2000–7.10.1093/clinchem/48.11.2000Search in Google Scholar
8. Arnaud J, Weber JP, Weykamp CW, Parsons PJ, Angerer J, Mairiaux E, et al. Quality specifications for the determination of copper, zinc, and selenium in human serum or plasma: evaluation of an approach based on biological and analytical variation. Clin Chem 2008;54:1892–9.10.1373/clinchem.2008.108142Search in Google Scholar PubMed
9. Arnaud J, Cote I, Parsons PJ, Patriarca M, Taylor A, Weykamp C. Harmonization and transferability of performance assessment: experience from four serum aluminum proficiency testing schemes. Accred Qual Assur 2014;19:169–74.10.1007/s00769-014-1049-4Search in Google Scholar
10. Horvath AR, Bossuyt PM, Sandberg S, John AS, Monaghan PJ, Verhagen-Kamerbeek WD, et al. Setting analytical performance specifications based on outcome studies – is it possible? Clin Chem Lab Med 2015;53:841–8.10.1515/cclm-2015-0214Search in Google Scholar PubMed
11. Fraser CG. General strategies to set quality specifications for reliability performance characteristics. Scand J Clin Lab Invest 1999;59:487–90.10.1080/00365519950185210Search in Google Scholar PubMed
12. ISO. ISO 13528:2015. Statistical methods for use in proficiency testing by interlaboratory comparisons. Available at: https://www.iso.org/obp/ui/#iso:std:iso:13528:ed-2:v1:en. Accessed: 28 July 2015.Search in Google Scholar
13. Parsons PJ, Reilly AA, Esernio-Jenssen D, Werk LN, Mofenson HC, Stanton NV, et al. Evaluation of blood lead proficiency testing: comparison of open and blind paradigms. Clin Chem 2001;47:322–30.10.1093/clinchem/47.2.322Search in Google Scholar
14. Wadsworth Center. Trace Elements Laboratory. Available at: http://www.wadsworth.org/programs/ehs/inorganic-analytical-chem/trace-elements. Accessed: 25 Feb 2016.Search in Google Scholar
15. OELM: Occupational and Environmental Laboratory Medicine. Available at: http://www.trace-elements.eu/. Accessed: 11 Dec 2015.Search in Google Scholar
16. INSPQ CTQ. The centre de toxicologie du Québec. External quality assessment schemes. Available at: https://www.inspq.qc.ca/en/ctq/eqas/. Accessed: 23 Dec 2015.Search in Google Scholar
17. UKNEQAS for Trace Elements EQA Scheme. Available at: http://www.surreyeqas.org.uk/trace-elements-teqas/. Accessed: 6 Mar 2015.Search in Google Scholar
18. NIST. SRM 955c Toxic Metals in Caprine Blood. Available at: http://www.nist.gov/mml/csd/inorganic/caprineblood.cfm. Accessed: 28 Jan 2015.Search in Google Scholar
19. NIST. SRM 2670a Toxic Elements in Urine (Freeze-Dried). Available at: https://www-s.nist.gov/m-srmors/view_detail.cfm?srm=2670a. Accessed: 1 Aug 2011.Search in Google Scholar
20. Baker MG, Simpson CD, Sheppard L, Stover B, Morton J, Cocker J, et al. Variance components of short-term biomarkers of manganese exposure in an inception cohort of welding trainees. J Trace Elem Med Biol 2015;29:123–9.10.1016/j.jtemb.2014.05.004Search in Google Scholar PubMed PubMed Central
21. ATSDR. Toxicological Profile for Manganese. Available at: http://www.atsdr.cdc.gov/toxprofiles/tp151.pdf. Accessed: 14 Dec 2015.Search in Google Scholar
22. Praamsma ML, Arnason JG, Parsons PJ. Monitoring Mn in whole blood and urine: a comparison between electrothermal atomic absorption and inorganic mass spectrometry. J Anal At Spectrom 2011;26:1224–32.10.1039/c1ja10039dSearch in Google Scholar
23. New York State. Trace elements. Available at: http://www.wadsworth.org/sites/default/files/WebDoc/858162172/TREL_June2014.pdf. Accessed: 25 Feb 2016.Search in Google Scholar
Supplemental Material:
The online version of this article (DOI: 10.1515/cclm-2015-1267) offers supplementary material, available to authorized users.
©2016 Walter de Gruyter GmbH, Berlin/Boston
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- Aberrant methylation of tumour suppressor genes WT1, GATA5 and PAX5 in hepatocellular carcinoma
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