BIOLABO

www.biolabo.fr SODIUM E n z ym a t i c me t h o d
MANUFACTURER: Reagent for quantitative determination of Sodium ions
BIOLABO SAS, in human serum and plasma.
Les Hautes Rives
02160, Maizy, France
R1 6 x 30 mL R2 6 x 15 mL
REF K2085
R3 1 x 3 mL R4 1 x 3 mL

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TECHNICAL SUPPORT AND ORDERS
Tel : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 IN VITRO DIAGNOSTIC USE
support@biolabo.fr

CLINICAL SIGNIFICANCE (1) REAGENTS PREPARATION

Sodium determination is used as an aid in diagnosis in case of
dehydratation, diabetes insipidus, loss of gastrointestinal hypotonic Ready for use.
fluids, salt poisoning, selective depression of the sense of thirst, loss of
skin, burns, sudation, hyperaldosteronism, CNS disturbances, STABILITY AND STORAGE
hyponatremia by dilution, depletion or delirium and syndrome of
Stored away from light, well caped in the original vial at 2-8°C,
inappropriate antidiuretic hormone secretion (SIADH) when stored and used as described, reagents are stable:
Unopened:
PRINCIPLE (4) · Until expiry date stated on the label of the kit.
The assay is based on the activation of b-galactosidase enzyme by the Once opened:
sodium present in the sample and the consequent enzymatic · Reagents are stable for at least 2 months.
transformation of o-nitropehnyl-b, D-galactopiranoside (o-NPG) into o-
niytrophenol and galactose, as shown in the following reaction scheme: SPECIMEN COLLECTION AND HANDLING (3)
+
Na Plasma (Lithium heparinate).
o-nitropehnyl-b- o-nitrophenol + galactose Unhemolysed serum:
D-galactopiranoside b-galactosidase
( o-NPG ) ü Centrifuge and test as soon as possible after collection.

The o-nitrophenol formed is kinetically measured at 405 nm. LIMITS (5)

For a more comprehensive review of factors affecting this assay refer to
REAGENTS the publication of Young D.S.
R1 Na+ Reagent 1
Good’s Buffer pH 8,5 MATERIAL REQUIRED BUT NOT PROVIDED
Cryptand > 0.4 mmol/L
1. Basic medical analysis laboratory equipment.
b-galactosidase < 8 UI/L 2. Biochemistry Clinical Analyzer Kenza One, Kenza 240TX/ISE or
Proclin 300 0,02 % Kenza 450TX/ISE
R2 Na+ Reagent 2
Good’s Buffer pH 8,5
o-NGP > 0,5 mmol/L
Proclin 300 0,02 %

R3 Na+ Cal 1
Sodium Choride approx. 110 mmol/L

R4 Na+ Cal 2
Sodium Choride approx. 170 mmol/L

Sodium aqueous primary standards (2 levels)

Specific batch value indicated on the label of the vial.
According to 1272/2008/EC Regulation, these reagents are not classified as
dangerous.

SAFETY CAUTIONS
BIOLABO reagents are designated for professional, in vitro diagnostic
use (do not pipette with mouth).
· Refer to current Material Safety Data Sheet available on request or on
www.biolabo.fr
· Verify the integrity of the contents before use.
· Waste disposal: Respect legislation in force in the country.
All specimens or reagents from biological origin should be handled as
potentially infectious. Respect legislation in force in the country.

Made in France Latest revision: www.biolabo.fr Revision: 10/11/2019

EXPECTED VALUES (3) CALIBRATION (7)

Serum or plasma mEq/L [mmol/L] · Cal1 and Cal 2 (Vial R3 and vial R4) traceable to SRM956

Premature, cord 116-140 [116-140] The calibration frequency depends on proper instrument functions and
on the preservation of reagent.
Premature, 48h 128-148 [128-148]
New born, in cord 126-166 Make a new calibration when changing reagent batch, if quality control
[126-166]
results are found out of the established range and after maintenance
New Born 133-146 [133-146] operations.
Infant 139-146 [139-146]
Child 138-145 [138-145] QUALITY CONTROL
Thereafter 136-145 [136-145]
· REF 95010 BIOLABO EXATROL-N Level I
> 90 years 132-146 [132-146] · REF 95011 BIOLABO EXATROL-P Level II
· External quality control program
Each laboratory should establish its own normal ranges for the It is recommended to control in the following cases:
population that it serves. · At least once a run
· At least once within 24 hours
PERFORMANCES at 37°C · When changing vial of reagent
· After maintenance operations on the instrument.
Performances studies on Hitachi 717 Analyzer:
If control is out of range, apply following actions:
Linearity Range: between 80 mmol/L and 180 mmol/L 1. Prepare a fresh control serum and repeat the test
Precision: 2. If control is still out of range, use a new vial of fresh calibrator
Within- Between
3. If control is still out of range, use a new vial of reagent and reassay
Level 1 Level 2 Level 1 Level 2 If control is still out of range, please contact BIOLABO technical support
run N = 20 Run N = 20
or your local Agent.
Mean (mmol/L) 129 156 Mean (mmol/L) 129 156
S.D. mmol/L 1.6 1.7 S.D. mmol/L 2.01 2.6
PROCEDURE
C.V. % 1.2 1.1 C.V. % 1.6 1.7
Refer to validated application of the Kenza Analyzer used
Comparison studies with Sodium ISE:
Automated Analyzer (specimens n=57) from 86.2 to 174.7 mmol/L CALCULATION
y =1,0881x -9,9478 r = 0,9814 The analyzer provides directly final result.
Refer to the instruction of use of Kenza analyzer.
Interferences:
Ascorbic acid No interference up to 10 mmol/L REFERENCES
Bilirubin Positive interference from 684 µmol/L (1) BERRY, M. N. et al., (1988) Clin. Chem. 34,2295
Triglycerides No interference up to 11,5 mmol/L (2) TIETZ N.W. Textbook of clinical chemistry, 3rd Ed. C.A. Burtis, E.R.
Ashwood, W.B. Saunders (1999) p. 1057, 1098-1101.
th
Hemoglobin No interference up to 238 µmol/L (3) Clinical Guide to Laboratory Test, 4 Ed., N.W. TIETZ (2006) p. 992.
(4) R. Quiles, J.M. Fernandez Romero, CLIN. CHEM. 39/3, (1993) p.500-503
Sodium When sodium and potassium are required, (5)
th
YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4 Ed. (1995) p.
Sodium should be tested immediately before 3-531 à 3-541
®
Potassium (6) SRM: Standard Reference Material

Other substances may interfere (see § Limits)

Performances and stability data on Kenza 240TX/ISE,

Kenza 450TX/ISE and Kenza One are available on request.

IVD H2O

Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

Made in France Latest revision: www.biolabo.fr Revision: 10/11/2019