Section 1 - Introduction; Chlorochek Description - Elitech ChloroChek Chloridometer 3400 User Manual

SECTION 1
INTRODUCTION

1.1 ChloroChek Description

INDICATIONS FOR USE
The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of
chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in
the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The ChloroChek Chloridometer test
system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set.
The ChloroChek Reagent Set (REF: SS-248), is to be used on the ChloroChek. It is used as the titration matrix
during the titration process.
The 100 mmol/L NaCl/H O Standard Solution (REF: SS-251), is to be used on the ChloroChek. It is used as a
2
calibration verifier, and quality control solution.
ELITech Group Sweat Controls (REF: SS-150), levels #1, #2, and #3, are to be used on the ChloroChek. They are
used as quality control solutions.
SAMPLE INFORMATION
Specimen
®
Human sweat collected with ELITech Group's Macroduct Collector or by other means (see CLSI C34-A3 guideline
for more information).
Storage
Sweat is stable for at least 72 hours across a reasonable temperature range, 25-77 ˚F, (2-25˚C) without significant
evaporation when stored in 0.2-mL microcentrifuge tubes with snugly fitting caps (see CLSI C34-A3 guideline for
more information).
Interferences
Any salts containing chloride or other halides (halogens) such as fluoride, bromide, or iodide will interfere and
cause an elevated reading. CLSI acknowledges this in the C34-A3 guideline. "In addition to chloride, other halides
such as bromide and iodide are also detected using a chloridometer. Therefore, if a sweat sample contains other
(1)
halides in addition to chloride, they will be detected and can falsely elevate the sweat chloride result." . Halides
including chloride may be present in lotions or creams, so it is important that the patient's skin is properly
cleaned prior to collecting the sweat. Refer to the CLSI C34-A3 guidelines for cleaning the skin prior to pilocarpine
iontophoresis. Improperly cleaned skin prior to sweat collection can lead to higher than normal results, thus
leading to false intermediate or false positive results.
CAUTION!
It is critical that the skin is free of contamination before collecting a sweat sample to be used.
SPECIFICATION OF SAFE USE
Using this instrument in a manner not specified by ELITech Group may impair the safety protection designed into
the equipment and may lead to injury.
SAFE USE ENVIRONMENT
This device has been designed for indoor use only, between 41-104 °F, (5-40 C), maximum relative humidity
80%, at up to 87.8 °F (31 C). For use at altitudes up to 2000 meters.
For use with a supply voltage of 85 to 264 Volts AC @ 50 to 60 Hz, 10%. Transient Overvoltage Category II.
Pollution Degree 2 in accordance with IEC 664 (non-conductive pollution).
4