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Evaluation of a cystic fibrosis screening system incorporating a miniature sweat stimulator and disposable chloride sensor

Clinical Chemistry 32(5): 850-853

Evaluation of a cystic fibrosis screening system incorporating a miniature sweat stimulator and disposable chloride sensor

A new sweat test (CF Indicator; Medtronic, Inc.) for cystic fibrosis (CF) features a compact, portable configuration of electrodes that dispense pilocarpine for iontophoresis. A disposable chloride sensor patch absorbs a specified volume of sweat, in which the chloride concentration is immediately determined as less than 40, 40-60, or greater than 60 mmol/L. We assessed the performance of the system in a five-center study, in relation to the clinical diagnosis and to the Gibson-Cooke sweat test (GCST) as a control test. With sweat chloride concentrations of less than or equal to 40 mmol/L defined as normal and greater than 40 mmol/L as indicating persons at risk for CF, the new system showed 91% specificity and 100% sensitivity for CF, as compared with 92.8% and 100%, respectively, for the GCST. When we used sweat chloride concentrations of less than or equal to 60 mmol/L as probably normal and greater than 60 mmol/L as probably indicative of CF, the new system showed a 99.1% specificity and 98.6% sensitivity, vs 97.8% specificity and 97.9% sensitivity for the GCST test. In both procedures, occasionally insufficient sweat was collected, and this appeared related to the age of the subject. We conclude that the new sweat test system is potentially useful in physicians' offices, in clinics, and similar settings.

Accession: 005395046

PMID: 3698274

Related references

Steinrud, J.; Winkel, S.; Flensborg, E.W., 1974: Screening for cystic fibrosis with chloride electrode. An investigation of sweat chloride with chloride electrode orion 417 in normal persons and in patients with cystic fibrosis. Danish Medical Bulletin 21(6): 251-255

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Warwick, W.J.; Hansen, L.G.; Werness, M.E., 1990: Quantification of chloride in sweat with the Cystic Fibrosis Indicator System. We examined the relation between chloride concentration and the area of complexed chloride of Medtronic's Cystic Fibrosis Indicator System, using a high-resolution x-y coordinated digitizer to measure the circumference of the chloride precipi...

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