ISA Reagents for Olympus

Olympus is a trademark of Olympus Optical Company of Japan

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:
Na+ 70 - 180 mEq/L
K+ 2.0 - 10.2 mEq/L
Cl- 70 - 180 mEq/L
The Synermed ISE reagents tested with the AU800 ISE Module are linear with urine samples within the following limits:
Na+ 10 - 400 mEq/L
K+ 2.0 - 300 mEq/L
Cl- 25 - 400 mEq/L

Special Performance Characteristics - Sodium

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.
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.
The average within run precision of the method was determined by assaying samples of control material at two levels of sodium:

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%
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

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%

Special Performance Characteristics - Potassium

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.
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.
The average within run precision of the method was determined by assaying samples of control material at two levels of potassium.

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%
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

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%

Special Performance Characteristics - Chloride

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.
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.
The average within run precision of the method was determined by assaying samples of control material at two levels of chloride.

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%
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

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%

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Cat No.	Product Name	Packaging	Package Volume (mL)	Storage
ISE800	ISE Buffer	6x1000 mL	6,000	20-25° C
ISE810	ISE Mid-Standard	6x1000 mL	6,000	20-25° C
ISE820	ISE Reference	6x500 mL	3,000	20-25° C

Methodology

Analytical Range

Expected Values

Performance Characteristics

Special Performance Characteristics - Sodium

Special Performance Characteristics - Potassium

Special Performance Characteristics - Chloride

SDS

Product Packaging and Storage

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%

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%

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