ISE REAGENTS
For the OLYMPUS Instruments
Olympus is a trademark of Olympus Optical Company of Japan
| Catalog numbers: | ||
| ISE 800 | 6 x 1000 mL | ISE Buffer |
| ISE 810 | 6 x 1000 mL | ISE Mid-Standard |
| ISE 820 | 6 x 500 mL | ISE Reference |
| 911 Packaging - Contact Synermed | ||
The Synermed® ISE reagents are intended for use in the
quantitative determination of sodium, potassium and chloride
concentrations in human serum and urine using the Olympus®
AU800™ and AU5200™ ISE modules.
Methodology
The Olympus AU800 and AU5200 ISE module for Na+, K+,
and Cl- employs crown ether membrane electrodes for
sodium and potassium and a molecular oriented PVC membrane for
chloride that are specific for each ion of interest in the sample. An
electrical potential is developed according to the Nernst Equation
for a specific ion. When compared to the Reference Solution, this
electrical potential is translated into voltage and then into the ion
concentration of the sample.
The Synermed ISE reagents are designed as direct
replacements. Check Operators' Manual for parameters.
Analytical Range
The Synermed ISE reagents tested with the AU800/AU5200 ISE Module are linear with
serum samples within the following limits:
The Synermed ISE reagents tested with the AU800 ISE Module are linear with urine samples within the following limits:
Na+ 70 - 180 mEq/L K+ 2.0 - 10.2 mEq/L Cl- 70 - 180 mEq/L
Expected Values
Na+ 10 - 400 mEq/L K+ 2.0 - 300 mEq/L Cl- 25 - 400 mEq/L
Performance Characteristics
Serum Urine Na+ 136 - 145 mEq/L 40 - 220 mEq/L K+ 3.5 - 5.1 mEq/L 25 - 125 mEq/L Cl- 98 - 107 mEq/L 110 - 250 mEq/L
The performance characteristics have been generated in a commercial laboratory using Synermed reagents on the AU5200 and AU800.
Specific Performance Characteristics (Sodium)
1. The Synermed Sodium ISE methodology was correlated to the Olympus Sodium ISE method on an AU5200 analyzer. The calculated linear regression on 44 serum patient samples and controls ranging from 101 to 153 mEq/L with Synermed results on the Y axis was: Y= 0.97X + 3.5 with a correlation coefficient of 0.966.
2. The Synermed Sodium ISE methodology was correlated to the Olympus Sodium ISE method on an AU800 analyzer. The calculated linear regression on 46 urine patients and controls ranging from 23 to 228 mEq/L with Synermed results on the Y axis was: Y= 0.99X + 0.1 with a correlation coefficient of 0.999.
3. The average within run precision of the method was determined by assaying samples of control material at two levels of sodium:
4. The run to run reproducibility of the method was determined from replicate data points obtained on quality control material assayed over a 20 batch period.
N Sample Mean SD CV 32 Serum 139.5 mEq/L 1.2 0.9% 32 Serum 151.9 mEq/L 1.2 0.8% 33 Urine 34.2 mEq/L 0.4 1.3% 33 Urine 129.5 mEq/L 0.8 0.6%
Specific Performance Characteristics (Potassium)
N Sample Mean SD CV 64 Serum 140.0 mEq/L 1.2 0.9% 64 Serum 150.0 mEq/L 1.3 0.9% 73 Urine 34.2 mEq/L 0.6 1.8% 73 Urine 128.0 mEq/L 0.9 0.7%
1. The Synermed Potassium ISE methodology was correlated to the Olympus Potassium ISE method on an AU5200 analyzer. The calculated linear regression on 44 serum patient samples and controls ranging from 2.3 mEq/L to 7.1 mEq/L with Synermed results on the Y axis was: Y= 1.05X - 0.37 with a correlation coefficient of 0.991.
2. The Synermed Potassium ISE methodology was correlated to the Olympus Potassium ISE method on an AU800 analyzer. The calculated linear regression on 46 urine patient samples and controls ranging from 2.6 mEq/L to 109 mEq/L with Synermed results on the Y axis was: Y= 0.96 X -0.08 with a correlation coefficient of 0.999.
3. The average within run precision of the method was determined by assaying samples of control material at two levels of potassium.
4. The run to run reproducibility of the method was determined from replicate data points obtained on quality control material assayed over a 20 batch period.
N Sample Mean SD CV 32 Serum 3.8 mEq/L 0.05 1.3% 32 Serum 7.3 mEq/L 0.10 1.3% 33 Urine 15.0 mEq/L 0.09 0.6% 33 Urine 67.0 mEq/L 0.67 1.0%
Specific Performance Characteristics (Chloride)
N Sample Mean SD CV 64 Serum 3.9 mEq/L 0.09 2.2% 64 Serum 7.1 mEq/L 0.10 1.4% 73 Urine 15.0 mEq/L 0.10 0.7% 73 Urine 66.3 mEq/L 0.41 0.6%
1. The Synermed Chloride ISE methodology was correlated to the Olympus Chloride ISE method on an AU5200 analyzer. The calculated linear regression on 44 serum patient samples and controls ranging from 66 to 128 mEq/L with Synermed results on the Y axis was: Y= 0.99X + 1.8 with a correlation coefficient of 0.951.
2. The Synermed Chloride ISE methodology was correlated to the Olympus Chloride ISE method on an AU800 analyzer. The calculated linear regression on 48 urine patient sample and controls ranging from 32 to 264 mEq/L with Synermed results on the Y axis was: Y= 0.99X + 0.1 with a correlation coefficient of 0.999.
3. The average within run precision of the method was determined by assaying samples of control material at two levels of chloride.
4. The run to run reproducibility of the method was determined from replicate data points obtained on quality control material assayed over a 20 batch period.
N Sample Mean SD CV 32 Serum 104.4 mEq/L 0.8 0.8% 32 Serum 117.3 mEq/L 1.0 0.8% 33 Urine 42.1 mEq/L 0.2 0.6% 33 Urine 166.7 mEq/L 1.0 0.6%
N Sample Mean SD CV 64 Serum 105.9 mEq/L 1.2 1.2% 64 Serum 119.4 mEq/L 1.5 1.3% 73 Urine 42.8 mEq/L 1.0 2.3% 73 Urine 166.0 mEq/L 1.4 0.8%