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A candidate reference method using ICP-MS for sweat chloride quantification.

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.

journal_name

Clin Chem Lab Med

journal_title

Clinical chemistry and laboratory medicine

authors

Collie JT,Massie RJ,Jones OA,Morrison PD,Greaves RF

doi

10.1515/cclm-2015-0506

subject

Has Abstract

pub_date

2016-04-01 00:00:00

pages

561-7

issue

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2015-0506/cclm-2015-05

journal_volume

pub_type

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A candidate reference method using ICP-MS for sweat chloride quantification.