2 x 30 mL
SODIUM 51014001
Intended Use Materials Required but Not Provided
This reagent is intended for in vitro quantitative determination of Sodium in serum. l Pipettes & Tips
l Test Tubes & racks
• Uranyl Acetate Method
l Timer
• Linearity up to 200 mmol/L l Incubator
Clinical Significance l Analyzer
Sodium is the principle cation of the extracel lular and intracel lular fluid. It plays Test Parameter
a central role in the maintenance of the normal distribution of water and the
Mode of Reaction End Point
osmotic pressure in the various fluid compartments.
Slope of Reaction Increasing
Increased Sodium levels are found in severe dehydration and excessive treatment
with sod ium salts. Decreased levels are found in servere polyurea, metabolic Wavelength 546 nm
acidosis, diarrhea & renal insufficiency. Temperature 30O C
Principle Standard Concentration 150 mmol/L
Sod ium is estimated by colorimetric method based on modified Maruna and Linearity 200 mmol/L
Trinders method. Sodium and proteins are precipitated together by Magnesium
uranyl acetate as Uranyl magnesium sodium acetate salt. Excess of uranyl salt reacts Blank Reagent
with potassium ferrocynide to produce a brownish color. The intensity of the color Incubation Time 5 min
is inversely proportional to the sodium concentration in the specimen and is
measured photometrical ly at 530 nm (500-546 nm). Sample Volume 10 µL
Uranyl ions + Mg ion + Na+ ———————> Uranyl Mg Na Precipitate Reagent Volume 1 mL + 1 mL
Cuvette 1 cm light path
Free Uranyl ions + K4 Fe (CN)6———————> Brown colored Complex.
Kit Components Calibration
Agappe Sod ium Standard is recommended for calibration of this assay.
Reagent/ Poduct Code Description
Component 51014001
Procedure Notes
Sodium R1 1 x 30 mL Uranyl acetate 19 mmol/L Step 1 - Precipitation Laboratory Procedure for Semi Auto Analyzer
Magnesium acetate 140 mmol/L Standard Sample
Sodium R2 1 x 30 mL Ammonium thioglycolate 550 mmol/L Sodium R1 (Precipitating Reagent) 1000 µL 1000 µL
Ammonia 550 mmol/L Sodium Standard 10 µL -
Sod ium 1 x 3 mL Sodium standard concentration Sample - 10 µL
Standard 150 mmol/L
Shake vigorously and incubate at room temperature for 5 minutes. Then centrifuge
at 2000 - 3000 RPM for 2 minutes to obtain a clear supernatent. Transfer the
supernatent immed iately after centrifugation for standard and test.
Risk & Safety
Material safety data sheets (MSDS) wil l be provided on request. Step 2 - Sod ium Estimation
Reagent Preparation Blank Standard Sample
Sodium R1, R2 and Standard are ready to use. Sodium R2 (Colour Reagent) 1000 µL 1000 µL 1000 µL
Reagent Storage and Stability Supernatent from Step 1 - 20 µL 20 µL
The sealed reagents are stable up to the expiry date stated on the label, when Sodium R1 20 µL - -
o
stored at 2 - 8 C and protected from light.
Mix wel l and allow it to stand at room temperature for 5 minutes. Measure the
Open Vial Stability
absorbance of standard and sample against reagent blank.
Once opened, the reagent is stable up to 4 weeks, if contamination is avoided.
Reagent Deterioration
Turbidity or precipitation in any kit component indicates deterioration and the Calculation
component must be d iscarded. Values outside the recommended acceptable range Sodium Concentration (mmol/L) =
for the control may also be an indication of reagent instability and associated
results are invalid. Sample should be retested, using a fresh vial of reagent. Absorbance of Blank - Absorbance of Sample
x 150
Precaution Absorbance of Blank - Absorbance of Standard
To avoid contamination, use clean laboratory wares. Use clean, dry disposable Note : Sodium Assay is an inverse reaction hence blank absorbance is higher than
pipette tips for dispensing. Close reagent bottles immediately after use. that of standard and test, and factor may come in negative in some instruments.
Avoid direct exposure of reagent to light.
Pipetting of Sod ium R1 (Precipitating Reagent) (in step 1) and transfer of
Do not blow into the reagent bottles. supernatant (in step 2) should be done quickly to avoid error to low density of
This reagent is only for IVD use and follow the normal precaution required for liquid.
hand ling all laboratory reagents.
Quality Control
Waste Management It is recommended to use control to verify the performance of the assay. Each
Reagents must be d isposed off in accordance with local regulations. laboratory has to establish its own internal quality control scheme and procedure
for corrective action, if control do not recover within the acceptable range.
Sample
Fresh Serum (free of haemolysis)
Materials Provided
Sodium R1, R2 and Sodium Standard
SYMBOLS USED ON THE LABELS
IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT
AGAPPE DIAGNOSTICS SWITZERLAND GmbH
Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11 ISO 9001:2015
[email protected] | www.agappeswiss.com REV. NO.: ADS/IFU/SOD/CHEM/R01 EN ISO 13485:2016
2 x 30 mL
SODIUM 51014001
Reference Range Precision
It is recommended that each laboratory should establish its own reference values.
Accuracy (mmol/L)
The fol lowing value may be used as guide line.
Serum /Plasma : 128 – 160 mmol/L Control Expected Value Measured Value
Results obtained for patient samples are to be correlated with clinical findings of Control Level 1 121 ± 15 127.98
patient for interpretation and diagnosis.
Control Level 2 155 ± 25 152
Performance
1. Linearity
Bibliography
This reagent is linear upto 200 mmol/L.
1. Maruna RFL (M58) Clin. Chem, acta. 2.1.581
If the concentration is greater than linearity (200 mmol/L), d ilute the sample with
normal sal ine and repeat the assay. Multiply the result with dilution factor. 2. Tietz N W Fundamentals of Clinical Chemistry W.B.Saunder Co. Phila, PA, P.874
3. Trinder, P., (1951) Analyst 76:596
SYMBOLS USED ON THE LABELS
IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT
AGAPPE DIAGNOSTICS SWITZERLAND GmbH
Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11 ISO 9001:2015
[email protected] | www.agappeswiss.com REV. NO.: ADS/IFU/SOD/CHEM/R01 EN ISO 13485:2016
