24 hours urine sample:

CHLORIDE SYMBOLS
chloride meq/24h = Ax/As x 100 x 2 x urine volume
CL 0100 CH 2 x 50 ml (standard value, dilution factor and diuresis in decilitres) in vitro diagnostic medical device

CL 0500 CH 4 x 125 ml EXPECTED VALUES batch code

serum/plasma: 98 - 110 meq/l catalogue number

INTENDED USE urine: 110 - 250 meq/24h temperature limit
Reagent for quantitative in vitro determination of chloride (dietary variations are possible)
in biological fluids. sweat: up to 30 meq/l use by date
caution
SUMMARY OF TEST Each laboratory should establish appropriate reference
Chloride is the major extracellular anion. Sodium and intervals related to its population. consult instructions for use
chloride together represent the majority of the osmotically
active constituents of plasma. Chloride is therefore signifi- QUALITY CONTROL AND CALIBRATION
cantly involved in maintenance of water distribution, osmo-
tic pressure and anion-cation balance in the extracellular It is suggested to perform an internal quality control. For
fluid compartment. this purpose the following human based control sera are
available:
PRINCIPLE OF THE METHOD QUANTINORM CHEMA
with normal or close to normal control values
Chloride ions react with mercuric ions, giving available an QUANTIPATH CHEMA
equal quantity of tiocyanate ions. Tiocyanate ions react with pathological control values.
with trivalent ferric ions present in solution to form a red If required, a multiparametric, human based calibrator is
colored complex with an absorbance peak at 480 nm. available:
AUTOCAL H
KIT COMPONENTS
For in vitro diagnostic use only. Please contact Customer Care for further information.
The components of the kit are stable until expiration date
on the label. TEST PERFORMANCE
Keep away from direct light sources. Linearity
the method is linear up to 200 meq/l.
CL R1 0100: 2 x 50 ml (liquid) blue cap If the limit value is exceeded, it is suggested to dilute
0500: 4 x 125 ml (liquid) blue cap sample 1+9 with distilled water and to repeat the test, mul-
tiplying the result by 10.
Composition: mercury(II) tiocyanate 2.2 mM, mercury(II)
chloride 0.7 mM, iron (III) nitrate 19 mM. Sensitivity/limit of detection (LOD)
the limit of detection is 1.5 meq/l.
Standard: chloride solution 100 meq/l - 5 ml
Interferences
Store all components at 15-25°C. no interference was observed by the presence of:
hemoglobin ≤ 500 mg/dl
MATERIALS REQUIRED BUT NOT SUPPLIED bilirubin ≤ 32 mg/dl
lipids ≤ 500 mg/dl
Current laboratory instrumentation. Spectrophotometer
UV/VIS with thermostatic cuvette holder. Automatic micro- Precision
pipettes. Glass or high quality polystyrene cuvettes. Deio- intra-assay (n=10) mean (meq/l) SD (meq/l) CV%
nized water. sample 1 114.80 1.48 1.30
sample 2 111.00 1.41 1.30
REAGENT PREPARATION
Use reagent ready to use. inter-assay (n=20) mean (meq/l) SD (meq/l) CV%
Stability: up to expiration date on labels at 15-25°C. sample 1 117.03 2.95 2.50
Stability since first opening of vials: preferably within 60 sample 2 113.44 3.26 2.90
days at 15-25°C.
Methods comparison
PRECAUTIONS a comparison between Chema and a commercially availa-
ble product gave the following results:
Reagent may contain some non-reactive and preservative
components. It is suggested to handle carefully it, avoiding Chloride Chema = x
contact with skin and swallow. Chloride competitor = y
Perform the test according to the general “Good Labora- n = 83
tory Practice” (GLP) guidelines.

SPECIMEN y = 0.869x + 14.402 meq/l r2 = 0.927

Serum, plasma heparinate. Separation of cells from plasma WASTE DISPOSAL

should be prompt. Sweat is a suitable sample. This product is made to be used in professional labora-
Use 24 hours urine. tories.
Dilute sample urine 1:2 with redistilled water and multiply P501: Dispose of contents according to national/interna-
results by two. tional regulations.
TEST PROCEDURE
REFERENCES
Wavelenght: 480 nm (allowed 460 ÷ 500 nm) Levinson S.S., Direct determination of serum chloride with
Lightpath: 1 cm a semiautomated discrete analyzer, Clin.Chem. 22:273-
Temperature: 25, 30 or 37°C 274, 1976
Tietz Textbook of Clinical Chemistry, Second Edition,
dispense: blank standard sample Burtis-Ashwood (1994).
reagent 1 ml 1 ml 1 ml
MANUFACTURER
water 5 µl - -
standard - 5 µl - Chema Diagnostica
Via Campania 2/4
sample - - 5 µl
60030 Monsano (AN) - ITALY - EU
Mix, incubate at 25, 30 or 37°C for 5 minutes. phone +39 0731 605064
Read absorbances of standard (As) and samples (Ax) fax +39 0731 605672
against reagent blank. e-mail: [email protected]
website: http://www.chema.com
RESULTS CALCULATION
Serum/plasma sample:

chloride meq/l = Ax/As x 100 (standard value)

Random urine sample:

chloride meq/l = Ax/As x 100 x 2 (standard value and dilu-

tion factor) IUS-7.5 IT rev. 01/06/2015 ©