A candidate reference method using ICP-MS for sweat chloride quantification
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Jake T. Collie
Abstract
Background: The aim of the study was to develop a method for sweat chloride (Cl) quantification using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) to present to the Joint Committee for Traceability in Laboratory Medicine (JCTLM) as a candidate reference method for the diagnosis of cystic fibrosis (CF).
Methods: Calibration standards were prepared from sodium chloride (NaCl) to cover the expected range of sweat Cl values. Germanium (Ge) and scandium (Sc) were selected as on-line (instrument based) internal standards (IS) and gallium (Ga) as the off-line (sample based) IS. The method was validated through linearity, accuracy and imprecision studies as well as enrolment into the Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP) for sweat electrolyte testing.
Results: Two variations of the ICP-MS method were developed, an on-line and off-line IS, and compared. Linearity was determined up to 225 mmol/L with a limit of quantitation of 7.4 mmol/L. The off-line IS demonstrated increased accuracy through the RCPAQAP performance assessment (CV of 1.9%, bias of 1.5 mmol/L) in comparison to the on-line IS (CV of 8.0%, bias of 3.8 mmol/L). Paired t-tests confirmed no significant differences between sample means of the two IS methods (p=0.53) or from each method against the RCPAQAP target values (p=0.08 and p=0.29).
Conclusions: Both on and off-line IS methods generated highly reproducible results and excellent linear comparison to the RCPAQAP target results. ICP-MS is a highly accurate method with a low limit of quantitation for sweat Cl analysis and should be recognised as a candidate reference method for the monitoring and diagnosis of CF. Laboratories that currently practice sweat Cl analysis using ICP-MS should include an off-line IS to help negate any pre-analytical errors.
Acknowledgments
The Authors would like to thank Ross Wenzel, Royal North Shore Hospital, for providing their ICP-MS SOP for sweat Cl testing, Jeff Hughes (Program Leader, Chemistry, School of Applied Science, RMIT University) for all his advice and guidance on statistical matters and to PM Separations for their generous provision of the internal quality control materials.
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 organisation(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. Elborn JS, Shale DJ, Britton JR. Cystic fibrosis: current survival and population estimates to the year 2000. Thorax 1991;46:881–5.10.1136/thx.46.12.881Suche in Google Scholar
2. Cystic Fibrosis Foundation. Clinical and Functional Translation of CFTR. [cited 2015 30th June]; Available from: http://www.cftr2.org/.Suche in Google Scholar
3. Mishra A, Greaves R, Massie J. The relevance of sweat testing for the diagnosis of cystic fibrosis in the genomic era. Clin Biochem Rev 2005;26:135–53.Suche in Google Scholar
4. Gibson LE, Cooke RE. A test for concentration of electrolytes in sweat in cystic fibrosis of the pancreas utilizing pilocarpine by iontophoresis. Pediatrics 1959;23:545–50.10.1542/peds.23.3.545Suche in Google Scholar
5. ChemPath. Sweat Electrolyte Program. RCPA Quality Assurance Programs, 2014 Contract No.: 17th Novermber.Suche in Google Scholar
6. Collie JT, Massie J, Jones OA, LeGrys VA, Greaves RF. 65 years since the New York heat wave: advances in sweat testing for cystic fibrosis. Pediatr Pulmonol 2014;49:106–17.10.1002/ppul.22945Suche in Google Scholar
7. Massie J, Curnow L, Glazner J, Armstrong DS, Francis I. Lessons learned from 20 years of newborn screening for cystic fibrosis. Med J Aust 2012;16:67–70.10.5694/mja11.10686Suche in Google Scholar
8. Mishra A, Greaves R, Massie J, Smith K, Wootton A, Sterling R, et al. The diagnosis of cystic fibrosis by sweat test: Age specific reference intervals. J Pediatr 2008;153:758–63.10.1016/j.jpeds.2008.04.067Suche in Google Scholar
9. Multi Disciplinary Working Group. Guidelines for the performance of the sweat test for the investigation of cystic fibrosis in the UK 2nd version, Birmingham, http://www.acb.org.uk, 2014.Suche in Google Scholar
10. Sermet-Gaudelus I, Munck A, Rota M, Roussey M, Feldmann D. Recommandations rrançaises pour la réalisation et l’Interprétation du test de la sueur dans le cadre du dépistage néonatal de la mucoviscidose. Arch Fr Pediatr 2010;17:1349–58.10.1016/j.arcped.2010.06.021Suche in Google Scholar
11. CLSI. Sweat testing: sample collection and quantitative analysis: approved guideline, 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2009.Suche in Google Scholar
12. The AACB Sweat Test Working Party. Australian guidelines for the performance of the sweat test for the diagnosis of cystic fibrosis. Clin Biochem Rev 2006;27:S1–7.Suche in Google Scholar
13. Bureau International des Poids et Mesures. JCTLM database: Laboratory medicine and in vitro diagnostics. [cited 2015 13th March]; Available from: http://www.bipm.org/jctlm/.Suche in Google Scholar
14. Thomas R. Practical Guide to ICP-MS. New York: Marcer Dekker Inc, 2004.10.1201/9780203027073Suche in Google Scholar
15. May TW, Wiedmeyer RH. A table of polyatomic interferences in ICP-MS. At Spectrosc 1998;19:150–5.Suche in Google Scholar
16. Tanner SD, Baranov VI, Bandura DR. Reaction cells and collision cells for ICP-MS: a turorial review. Spectrochim Acta B 2002;57:1361–452.10.1016/S0584-8547(02)00069-1Suche in Google Scholar
17. Pullen NJ, Thurston V, Barber S. Evaluation of an inductively coupled plasma mass spectrometry method for the analysis of sweat chloride and sodium for use in the diagnosis of cystic fibrosis. Ann Clin Biochem 2013;50:267–70.10.1177/0004563212474565Suche in Google Scholar PubMed
18. Westgard JO. Basic method validation, 3rd ed. Madison, Wisconsin, USA: Westgard Quality Corporation, 2008.Suche in Google Scholar
19. Shrivastava A, Bupte VB. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chron Young Sci 2011;2:21–5.10.4103/2229-5186.79345Suche in Google Scholar
20. RCPAQAP. Personal Communication. Alice Gesmundo, 2015.Suche in Google Scholar
21. Hsiung C, Andrade JD, Costa C, Ash OA. Minimizing interferences in the quantitative multielement analysis of trace elements in biological fluids by inductively coupled plasma mass spectrometry. Clim Chem 1997;43:2303–11.10.1093/clinchem/43.12.2303Suche in Google Scholar
22. Sandberg S, Fraser CG, Rita Horvath A, 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-2015-0067Suche in Google Scholar PubMed
23. Kenny D, Fraser CG, Hoyltoft Petersen P, Kallner A. Consensus agreement. Scand J Clin Lab Invest 1999;59:585.10.1080/00365519950185409Suche in Google Scholar
24. Stöckl D, Sluss PM, Theinpont LM. Specifications for truness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin Chem Acta 2009;408:8–13.10.1016/j.cca.2009.06.027Suche in Google Scholar PubMed
25. Royal North Shore Hospital. Personal communication. Ross Wenzel, 2013.Suche in Google Scholar
26. Doorn J, Stortebeem TT, Mulder AM, De Jong WH, Rottier BL, Kema IP. Ion chromatography for the precise analysis of chloride and sodium in sweat for the diagnosis of cystic fibrosis. Ann Clin Biochem 2015;52:421–7.10.1177/0004563214549642Suche in Google Scholar PubMed
©2016 by De Gruyter
Artikel in diesem Heft
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Macroprolactin: searching for a needle in a haystack?
- Review
- Laboratory medicine in the new healthcare environment
- Opinion Paper
- Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies
- EFLM Survey
- Accreditation process in European countries – an EFLM survey
- Genetics and Molecular Diagnostics
- HB Puerta del Sol [HBA1:c.148A>C], HB Valdecilla [HBA2:c.3G>T], HB Gran Vía [HBA2:c.98T>G], HB Macarena [HBA2:c.358C>T] and HB El Retiro [HBA2:c.364_366dupGTG]: description of five new hemoglobinopathies
- General Clinical Chemistry and Laboratory Medicine
- A candidate reference method using ICP-MS for sweat chloride quantification
- Quantification of hemoglobin A1c by off-line HPLC separation and liquid chromatography-tandem mass spectrometry: a modification of the IFCC reference measurement procedure
- Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial
- Evaluation of a hand-held blood gas analyzer for rapid determination of blood gases, electrolytes and metabolites in intensive care setting
- Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms
- A possible cause of the variable detectability of macroprolactin by different immunoassay systems
- A multicenter comparison of whole blood vitamin B6 assays
- Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays
- Development and validation of a 2nd tier test for identification of purine nucleoside phosphorylase deficiency patients during expanded newborn screening by liquid chromatography-tandem mass spectrometry
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- Development of reference intervals for serum alkaline phosphatase among adults in Southern China traced to the new IFCC reference measurement procedure
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- A standardised FACS assay based on native, receptor transfected cells for the clinical diagnosis and monitoring of β1-adrenergic receptor autoantibodies in human heart disease
- Infectious Diseases
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- Letters to the Editor
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- Pre-analytical phase in cryoglobulin (CRG) detection: an alternative method for sample transport
- The efficacy of an internet-based e-learning system using the CellaVision Competency Software for continuing professional development
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