ISE REAGENTS
For the HITACHI Instruments
| Catalog numbers: | ||
| ISE 7106 | 6 x 1000 mL | ISE Reference |
| ISE 7206 | 6 x 1000 mL | ISE Diluent |
| ISE 7306 | 6 x 500 mL | ISE KCI Reagent |
| 911 Packaging - Contact Synermed | ||
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.
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:
Limitations of the Procedure
Na+ 80 - 180 mEq/L K+ 1.5 - 10.0 mEq/L Cl- 60 - 140 mEq/L
See appropriate section of the Hitachi Operator’s Manual.
Expected Values
The adult normal range for electrolytes is reported to be:
Performance Characteristics (Sodium)
Na+ 135 - 148 mEq/L K+ 3.5 - 5.3 mEq/L Cl- 98 - 109 mEq/L
1. 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.
2. 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:
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 127.2 mEq/L 0.61 0.5% 140.9 mEq/L 0.48 0.3%
Performance Characteristics (Potassium)
Mean SD CV 130.0 mEq/L 1.47 1.1% 143.0 mEq/L 1.58 1.1%
1. 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.
2. 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:
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 24 batch period. The following results were obtained:
Mean SD CV 4.1 mEq/L 0.05 1.1% 6.3 mEq/L 0.03 0.5%
Performance Characteristics (Chloride)
Mean SD CV 3.1 mEq/L 0.07 2.3% 4.7 mEq/L 0.10 2.2%
1. 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.
2. 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:
3. TThe 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 109 mEq/L 0.9 0.8% 127 mEq/L 1.0 0.8%
Mean SD CV 90.4 mEq/L 1.7 2.0% 125.1 mEq/L 2.6 2.1%