Objectives: Sweat chloride testing is the gold standard for diagnosis of cystic fibrosis (CF). Our objectives were to: 1) describe variables that determine sweat rate; 2) determine the analytic and diagnostic capacity of sweat chloride analysis across the range of observed sweat rates; and 3) determine the biologic variability of sweat chloride concentration.
Methods: A retrospective analysis was performed using data from all sweat chloride tests performed at St. Louis Children's Hospital over a 21-month period.
Results: A total of 1397 sweat chloride tests (1155 sufficient [≥75 mg], 242 insufficient [<75 mg]), were performed on 904 individuals. The sweat weight collected from forearms was statistically greater than that collected from legs. There was a negligible correlation between sweat weight and chloride concentration (r=-0.06). The mean individual biologic CV calculated from individuals with two or more sweat collections ≥75 mg was 13.1% (95% CI: 11.3-14.9%; range 0-88%) yielding a reference change value of 36%. Using 60 mmol/L as the diagnostic chloride cutoff, 100% of CF cases were detected whether a minimum sweat weight of 75, 40, or 20 mg was required.
Conclusions: 1) Collection of sweat from forearms is preferable to upper legs, particularly in very young infants; 2) sweat chloride concentrations are not highly dependent upon sweat rate; 3) a change in sweat chloride concentration exceeding 36% may be considered a clinically significant response to cystic fibrosis transmembrane receptor targeted therapy, and 4) sweat collections of less than 75 mg provide clinically accurate information.
Keywords: Biological variability; Cystic fibrosis; Limit of quantitation; Sweat chloride; Sweat rate.
Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.