ISE Reagents for the Hitachi Instruments
Hitachi is a trademark of Nissei Sangyo Co. Ltd. of Japan
Principles of the Reaction
Ion selective electrodes for sodium, potassium and chloride utilize permeable membranes that are specific for each ion of interest in the sample solution. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to a reference solution, this electrical potential is translated into voltage and then into the ion concentration of the sample solution.
Analytical Range
The measuring ranges of the Boehringer Mannheim Diagnostics/Hitachi ISE Modules are reported to be:
Na+ 80 - 180 mEq/L
K+ 1.5 - 10.0 mEq/L
Cl- 60 - 140 mEq/L
Intended Use
The Synermed® ISE reagents are intended for use in the quantitative determination of sodium, potassium, and chloride in human serum on the Hitachi® 705, 704, 737, 747 and 717 clinical chemistry analyzers.
Expected Values
The adult normal range for electrolytes is reported to be:
Na+ 135 - 148 mEq/L
K+ 3.5 - 5.3 mEq/L
Cl- 98 - 109 mEq/L
Performance Characteristics (Sodium)
- The Synermed Sodium ISE methodology was correlated to the Boehringer Mannheim Diagnostics Sodium ISE method on an Hitachi 737 analyzer. The calculated linear regression on 59 samples ranging from approximately 116 mEq/L to 143 mEq/L with Synermed results on the Y-axis was: Y = 1.02X - 2.9 with a correlation coefficient of 0.991.
- The average within run precision of the method was determined by assaying 30 samples of control material at two levels of sodium which provided the following results:
Mean SD CV 127.2 mEq/L 0.61 0.5% 140.9 mEq/L 0.48 0.3% - The run to run reproducibility of the method was determined from the values obtained from 5 replicate analyses of quality control material assayed over a 23 batch period. The following results were obtained:
Mean SD CV 130.0 mEq/L 1.47 1.1% 143.0 mEq/L 1.58 1.1%
Performance Characteristics (Sodium)
- The Synermed Potassium ISE methodology was correlated to the Boehringer Mannheim Diagnostics Potassium ISE method on an Hitachi 737 analyzer. The calculated linear regression on 60 samples ranging from approximately 2.4 mEq/L to 6.3 mEq/L with Synermed results on the Y-axis was: Y = 1.02X - 0.1 with a correlation coefficient of 0.998.
- The average within run precision of the method was determined by assaying 30 samples of control material at two levels of potassium which provided the following results:
Mean SD CV 4.1 mEq/L 0.05 1.1% 6.3 mEq/L 0.03 0.5% - The run to run reproducibility of the method was determined from the values obtained from 5 replicate analyses of quality control material assayed over a 24 batch period. The following results were obtained:
Mean SD CV 3.1 mEq/L 0.07 2.3% 4.7 mEq/L 0.10 2.2%
Performance Characteristics (Sodium)
- The Synermed ISE chloride was correlated to the Boehringer Mannheim ISE method. The calculated linear regression on samples ranging from approximately 60 to 130 mmol/L with Synermed results on the Y-axis was: Y = 0.99X + 2.4 with a correlation coefficient of 0.99.
- The average within run precision of the method as applied to the Hitachi 737 analyzer was determined by assaying 30 samples of quality control material at two levels of chloride concentration with following results:
Mean SD CV 109 mEq/L 0.9 0.8% 127 mEq/L 1.0 0.8% - The run to run reproducibility of the method as applied to the Hitachi 737 analyzer was determined from the values obtained by 5 replicate analyses of quality control material assayed over a 22 batch period. The following results were obtained:
Mean SD CV 90.4 mEq/L 1.7 2.0% 125.1 mEq/L 2.6 2.1%
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