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A new method of sweat testing: the CF Quantum®sweat test.

ABSTRACT: Conventional methods of sweat testing are time consuming and have many steps that can and do lead to errors. This study compares conventional sweat testing to a new quantitative method, the CF Quantum® (CFQT) sweat test. This study tests the diagnostic accuracy and analytic validity of the CFQT.Previously diagnosed CF patients and patients who required a sweat test for clinical indications were invited to have the CFQT test performed. Both conventional sweat testing and the CFQT were performed bilaterally on the same day. Pairs of data from each test are plotted as a correlation graph and Bland-Altman plot. Sensitivity and specificity were calculated as well as the means and coefficient of variation by test and by extremity. After completing the study, subjects or their parents were asked for their preference of the CFQT and conventional sweat testing.The correlation coefficient between the CFQT and conventional sweat testing was 0.98 (95% confidence interval: 0.97-0.99). The sensitivity and specificity of the CFQT in diagnosing CF was 100% (95% confidence interval: 94-100%) and 96% (95% confidence interval: 89-99%), respectively. In one center in this three center multicenter study, there were higher sweat chloride values in patients with CF and also more tests that were invalid due to discrepant values between the two extremities. The percentage of invalid tests was higher in the CFQT method (16.5%) compared to conventional sweat testing (3.8%) (p < 0.001). In the post-test questionnaire, 88% of subjects/parents preferred the CFQT test.The CFQT is a fast and simple method of quantitative sweat chloride determination. This technology requires further refinement to improve the analytic accuracy at higher sweat chloride values and to decrease the number of invalid tests.

SUBMITTER: Rock MJ

PROVIDER: S-EPMC4510978 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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A new method of sweat testing: the CF Quantum®sweat test.

Rock Michael J MJ Makholm Linda L Eickhoff Jens J

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society 20140523 5

<h4>Background</h4>Conventional methods of sweat testing are time consuming and have many steps that can and do lead to errors. This study compares conventional sweat testing to a new quantitative method, the CF Quantum® (CFQT) sweat test. This study tests the diagnostic accuracy and analytic validity of the CFQT.<h4>Methods</h4>Previously diagnosed CF patients and patients who required a sweat test for clinical indications were invited to have the CFQT test performed. Both conventional sweat te ...[more]

PMID: 24862724

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Project description:ObjectiveTo conduct a descriptive analysis of the sweat test (ST), associating ST results with epidemiological data, CFTR (cystic fibrosis transmembrane conductance regulator) mutations and reasons to indicate the ST, as well as correlating sweat sodium and sweat chloride concentrations in subjects.MethodsRetrospective survey and descriptive analysis of 5,721 ST at a university referral center.ResultsThe inclusion of the subjects was based on clinical data related with cystic fibrosis (CF) phenotype. The samples were grouped by (i) sweat chloride concentrations (mEq/L): <30: 3,249/5,277 (61.6%); ≥30 to <60: 1,326/5,277 (25.1%); ≥60: 702/5,277 (13.3%) and (ii) age: (Group A--GA) 0 to <6 months; (Group B--GB) ≥6 months to <18 years; (Group C--GC) ≥18 years. Digestive symptoms showed higher prevalence ratio for the CF diagnosis as well as association between younger age and higher values of sweat chloride, sweat sodium, and chloride/sodium ratio. The indication of ST due to respiratory symptoms was higher in GB and associated with greater age, lower values of sweat chloride, sweat sodium, and chloride/sodium ratio. There was higher prevalence of ST with sweat chloride levels <30 mEq/L in GB, ≥60 mEq/L in GC, and with borderline level in GB. There was positive correlation between sweat sodium and sweat chloride. Sweat chloride/sweat sodium and sweat sodium-sweat chloride indexes showed association with sex, reason for ST indication, and CFTR mutations. Sex alters some values presented in the ST. The number of ST/year performed before and after the newborn screening implementation was the same; however, we observed a higher number of borderlines values. A wide spectrum of CFTR mutation was found. Severe CFTR mutations and F508del/F508del genotype were associated with highest probability of ST chloride levels ≥60 mEq/L, and the absence of CFTR mutations identified was associated with borderline ST and respiratory symptoms.ConclusionsST data showed wide variability dependent on age, sex, reason for examination indication, CFTR mutations, and weight of the collected sweat sample. Sweat sodium concentration is directly correlated with sweat chloride levels and it could be used as a quality parameter.

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A new method of sweat testing: the CF Quantum®sweat test.

Publications

A new method of sweat testing: the CF Quantum®sweat test.

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