TECNICAS CIENTIFICAS PARA LABORATORIO S.A. T620 Manuel D’Utilisation
ISEsweat
- User’s Manual 6
1.1 ISEsweat intended use
ISEsweat is intended for quantitative pilocarpine iontophoresis sweat chloride testing for the
diagnosis of cystic fibrosis.
ISEsweat should only be used by Doctors, nurses and trained laboratory personnel. It is
highly recommended that users gain prior experience before diagnosing Cystic Fibrosis.
The place for testing may be in laboratories, hospitals or clinics
In order to increase the possibility of collecting an adequate sweat sample, it is advisable to
conduct the first chloride sweat determination tests on individuals older than 2 weeks and
weighing above 2kg.
Sweat volumes are dependant on age, sex, corporal weight, race, skin condition and
sampling system.
ISEsweat
®
is a Sweat Chloride Analyzer intended for Cystic Fibrosis Diagnosis.
CAUTION: ISEsweat
®
is intended only as a supplement in a patients’ evaluation. It must
be used in conjunction with other signs and symptoms. Don’t take any clinical decision
based only on the sweat test evaluations.
based only on the sweat test evaluations.
1.2 Operating principles
Cystic fibrosis is a multisystem disorder that causes formation and accumulation of dense
mucus, that affects mainly lungs, intestines, pancreas, and liver. Cystic fibrosis is also
characterized by the presence of a high chloride (Cl
-
) concentration in sweat, which is the
basisi of this diagnosis: (commonly known as the sweat test). This test QUANTIFIES the
chloride levels excreted while sweating, and is indicative for CF diagnosis.
The ISEsweat
chloride levels excreted while sweating, and is indicative for CF diagnosis.
The ISEsweat
®
runs the sweat test in two different stages: IONTOPHORESIS or sweat
stimulation and MEASUREMENT of the chloride concentration.
The first phase is called IONTOPHORESIS because sweat stimulation is done using this
technique. Its purpose is to get a sweat stimulating drug, pilocarpine, through the skin, with
the help of an electrical potential difference. Pilocarpine excites the sweat glands and
stimulates sweat on the treated area. Once there is enough sweat, the second phase begins.
The amount of pilocarpine delivered varies directly in proportion to the current and time
according to the Faraday equation below:
The first phase is called IONTOPHORESIS because sweat stimulation is done using this
technique. Its purpose is to get a sweat stimulating drug, pilocarpine, through the skin, with
the help of an electrical potential difference. Pilocarpine excites the sweat glands and
stimulates sweat on the treated area. Once there is enough sweat, the second phase begins.
The amount of pilocarpine delivered varies directly in proportion to the current and time
according to the Faraday equation below:
The second phase is called the MEASUREMENT phase. Chloride ion (Cl
-
) concentration is
measured in the sweat produced by iontophoresis. The analysis is made without any need to
i
Intensity in mA
t
Iontophoresis time
Mw
Pilocarpine molecular weight
F
Faraday constant
P
mg of released pilocarpine