Version：A/6

Instruction for Electrolyte Reagents (ISE, Pressure Method)

【Product Name】 Please refer to the labels for production date.

Electrolyte Reagents 【Applicable Instruments】

【Package Specification】 Applicable instruments Test item

Packaging specifications are shown in Table 1 (Unit: mL) : GE200, GE300, GE310,

Table 1 GE330, GE340, GE350, K+, Na+, Cl-, Ca2+, Li+, pH

Type STD A STD B STD C CO2 STD Buffer REF GE360

DS-Ⅰ (NO.1) 400 90 0 0 0 42033001 GE320 K+, Na+, Cl-, Ca2+, Li+, pH, TCO2

DS-Ⅰ (NO.2) 390 160 0 0 0 42034001 GE500 K+, Na+, Cl-, Ca2+, Li+, Mg2+, pH,

DS-Ⅰ (NO.3) 390 160 0 0 0 42035001 【Sample Requirements】

DS-Ⅰ(AB buffer) 390 80 0 0 80 42036001 The optimum sample is non-hemolyzed fresh serum. Samples should be analyzed within 5 hour at

DS-Ⅱ (NO.1) 400 90 0 0 0 42037001 room temperature.

Whole blood: it is recommed to use no-additive evacuated or sodium heparin evacuated specimen
DS-Ⅱ (NO.2) 390 160 0 0 0 42038001
collection tubes for whole blood or plasma samples, Whole blood samples should be analyzed within 60
DS-Ⅱ(NO.3) 390 160 0 0 0 42039001
minutes at room temperature and avoid hemolysis.
DS-Ⅱ(AB buffer) 390 80 0 0 80 42040001
Urine sample: it is required to dilute the fresh urine samples with urine diluent at 1:10 before testing.
DS-Ⅲ (NO.3) 390 80 80 0 0 42041001
【Test Methods】
DS-Ⅳ (NO.3) 390 80 80 0 0 42042001
1. Open the electrolyte analyzer’s reagent room, carefully put in the corresponding reagent, connect
DS-Ⅴ 0 0 0 50 0 42043001
the tubes of Standard A & B or Reagent package, and then close the reagent room.
DS-C 0 0 400 0 0 42044001
2. Turn on the power, the system enters the main menu, select “Calibrate”, the instrument
GE-1 750 250 700 0 0 42047001
automatically aspirates Standard A & B and establishes the calibration curve. After calibration, click
GE-2 750 250 0 0 0 42048001
“Measure” to aspirate sample. After calculating the concentration, the instrument displays and
GE-3 600 200 0 0 0 42049001
prints it out. It is recommended to leave the analyzer on for 24 hours.
GE-4 600 200 600 0 0 42050001
3. When using reagents at room temperature, it takes about 30-60 seconds to test one sample, if the
GE-5 500 150 0 0 0 42051001
sample is refrigerated, bring it to room temperature before analysis.
GE-6 500 150 500 0 0 42052001
4. Use Standard A and Standard B to perform two-point calibration.
GE-7 400 120 0 0 0 42053001 5. Test QC to do quality control before testing samples every day to ensure the reliability of test
GE-8 400 120 400 0 0 42054001 results. QC must not contain substances that interfere with ion selective electrodes and must be
GE-9 300 90 0 0 0 42055001 accurately diluted. Mean value of test results of the QC must be within the allowable range.
GE-10 300 90 300 0 0 42056001 6. For more instrument operations, please see the operation manual of electrolyte analyzer.

DS-ISE 0 0 0 0 0 42045001 【Reference Range】

DS-Ref 0 0 0 0 0 42046001 Item Serum or Blood Urine

【Intended Use】 K+ 3.5-5.3 mmol/L 25-125 mmol/L

It can be used with Electrolyte Analyzers by professionals, for the detection of potassium (K+), sodium Na+ 135-148 mmol/L 130-260 mmol/L
+ - 2+ 2+ +
(Na ), chloride (Cl ), calcium (Ca ), magnesium (Mg ), lithium (Li ), pH (pH value) and TCO2 Cl- 98-107 mmol/L 170-255 mmol/L
concentration in human serum. In addition, GE-1 and GE-2 also can concentration in human blood and Ca2+ 1.10-1.30 mmol/L 2.7-7.5 mmol/L
urine. Li+ 0-0.7 mmol/L N/A
【Test Principle】 2+
Mg 0.7-1.1 mmol/L 3.0-4.5 mmol/L
ISE method: Use ISE (Ion Selective Electrode) technology to measure K+, Na+, Cl-, Ca2+, Li+, Mg2+ and
TCO2 22-29 mmol/L N/A
pH in the sample. Test Standard A and B respectively to obtain two electrode potentials of known
pH 7.35-7.45 N/A
concentrations, and establish a calibration curve in the instrument programmed by these two potentials.
【Interpretation of Test Results】
Measure the electrode potential of sample with unknown concentration and then calculate ion
1. Results are for clinicians’ reference only. To draw a clinical conclusion, please also consider the
concentration (mmol/L) of unknown samples from the established calibration curve.
patient’s clinical symptoms and other test results.
Pressure method: Compare the pressure value obtained by the reaction of Standard C and sample with
2. Select calibrators and controls manufactured by qualified companies (such as Randox) to do
that of Standard C and TCO2 solution, to obtain TCO2 content in the sample by calculation.
calibration and quality control.
【Main Compositions】
【Limitations of Test Method】
Standard A: K+ : 1.1%, Na+ : 57.0%, Cl- : 40.5%, Ca2+ : 0.5%, Li+ : 0.4%, Mg2+ : 0.5%.
1. Using plasma that contains EDTA, heparin, sodium citrate and oxalate will result in increased
Standard B: K+ : 4.0%, Na+ : 57.5%, Cl- : 36.5%, Ca2+ : 1.3%, Li+ : 0.3%, Mg2+ : 0.4%.
sodium concentration and decreased calcium concentration in test results.
Standard C (weak acid) and TCO2 solution (carbonate).
2. Sodium azide, salicylic acid and other drugs can cause increase in the chlorine concentration in
Components of test kits with different batches cannot be interchanged for use
test results.
【Accessories Required But Not Provided】
3. ISE method can be used to measure ionized calcium only, total calcium cannot be measured
None.
directly (as concluded by test summary and technical exchange meeting). Diagnosis and treatment
【Storage and Transportation】
cannot rely on this test result only, but need to take the clinical history and other laboratory test
Storage: Ambient temperature of 2-30 ℃, relative
-85%, avoidhumidity of 20
direct sunlight.
results into account.
Validity period: 24 months (sealed), 1 month (after opening).
【Performance Indicators】
GE-1&GE-2: 24 months (sealed), 50 days (after opening).
1. Analytical sensitivity

Genrui Biotech Inc. -1-

Web: www.genrui-bio.com

P04.04.020170-06
 Version：A/6
Minimum detection limit of Standard C ≤ 1.41mmol/L 3. Nephrology Dialysis Transplantation (Impact Factor: 3.37). 07/2003, 18(6): 1217-9.

2. Linearity range 4. REN Biqiong, XU Guofeng, ZOU Guoying, ZHANG Yu, YU Qihua. Department of Clinical

Linear regression coefficient of Standard A, B, C: r≥0.990 Laboratory, Hunan Province Second People's Hospital, Assessment of the effect of self-made

Linearity shall comply with requirements in Table 2. electrolyte reagent in the electrolyte system of Dimension AR analyzer. Hunan Changsha 410007,

3. Measurement range China. Laboratory medicine 2006.06.

Testing diluented urine range shall comply with requirements in Table 3. 5. United States Patent 6387646. Inventors: Kimata, Shinsuke (Tsuruga, JP), Mizuguchi, Katsuhiko

4. Precision, Accuracy, Difference between batches (Tsuruga, JP), Kawamura, Yoshihisa (Tsuruga, JP). Reagent compositions for measuring

When testing control material, calibrator, certified reference serum with electrolyte reagents, the electrolyte. Publication Date. 05.14.2002.

precision, accuracy, difference between batches of each item should be consistent with 6. National Guide to Clinical Laboratory Procedures (Third Edition). Department of Medical

requirements in Table 2&3. Administration in People's Republic of China. Ye Yingwu, etc., 2006.11.

Table 2 Performance for serum and whole blood 【Manufacturer】

Difference Genrui Biotech lnc.
Item Linearity range Accuracy (B) Precision between
batches Address: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen,

≤2.0%or CV ≦1.5% o China

K+ 1.5-7.5mmol/L ≤0.5mmol/L
≦0.15mmol/L SD ≦0.08 Web: www.genrui-bio.com
≤2.0%or CV ≦1.5% or
Na +
100-180mmol/L ≤10mmol/L 【Medical Device Manufacturing Enterprise Permit Number】
≦0.15mmol/L SD ≦1.5m
GuangDong SFDA(State Food and Drug Administration) authorized Medical Device Manufacturing
≤2.0%or CV ≦1.5% or
Cl- 80-160mmol/L ≤10mmol/L Permit No. 20041046.
≦0.15mmol/L SD ≦1.5
mmol/L
≤2.5%or CV ≦1.5% or 【Guarantee and Technical Support】
iCa2+ 0.5-2.5mmol/L ≤0.3mmol/L
≦0.12mmol/L SD ≦0.06 If invalid message repeats or need technical support, please contact Genrui Customer Service and
≤2.5%or CV ≦1.5% or Support Center.
Li+
0.5-2.5mmol/L ≤0.3mmol/L
≦0.12mmol/L SD ≦0.06
【Instruction Approved and Revised Dates】
≤2.5%or CV ≦1.5% or
Mg2+ 0.5-2.5mmol/L ≤0.3mmol/L Approved date: November 6th 2015
≦0.12mmol/L SD ≦0.06
Revised date: October 20th 2017
pH 6.8-7.6 ≤2.0% ≤1.5% ≤0.15
CO2 10-60mmol/L ≤2.0% ≤1.5% ≤3.0

Table 3 Performance for diluented urine

Difference
Measurement
Item Accuracy (B) Precision (CV) between
range
batches
K+ 1-500 mmol/L ≤10.0% ≤5.0% ≤10mmol/L
Consult Instructions for use Main component
Na+ 25-1000 mmol/L ≤10.0% ≤5.0% ≤20mmol/L
Cl -
25-500 mmol/L ≤10.0% ≤5.0% ≤20mmol/L
Batch code Catalogue number
iCa2+ 0.5-40.0 mmol/L ≤10.0% ≤5.0% ≤1.5mmol/L
Mg2+ 0.5-40.0 mmol/L ≤10.0% ≤5.0% ≤1.5mmol/L
Temperature limit Humidity limit
【Precautions】

1. The product should be used within its validity period, not mixed up with toxic, corrosive or

contaminated goods. Stop using it if the package is damaged, or the solution is cloudy, moldy or Date of manufacture Use-by date

precipitated.
Manufacturer
CE Marking
2. Ensure that all electrodes are immersed in Standard A & B when perform the calibration.

3. Keep remaining reagents under seal for the pH and ions may change when exposed to the air. Authorized representative in the In vitro diagnostic
4. Avoid skin contact. Wear gloves when operating. European Community medical device
5. If the reagent is carelessly spattered onto the skin, eyes, etc., flush with clean water immediately,

and if mistakenly swallowed, seek medical advice.

Keep away from sunlight Keep dry
6. Waste from clinical use of this product should be disposed of in accordance with the relevant

provisions of medical wastes.

Contains sufficient for <n>tests Volume
7. Do not mix different batches of reagents.

8. Do not use the solution when package is damaged.

Biological risks
【Icon Illustration】

【Training information】

Please refer to the training manual.

【Help information】

If you need help please contact after sales.

【Trouble shooting】

Please contact after sales.

【References】

1. Huang Ziqing. Introduction to the theory of electrolyte solution. Science press, 1983.08.

2. Adrian Schreiber. Charite Universitats medizin Berlin. Solving electrolyte disturbances with the

Ehrlich reagent. HELIOS Klinikum Berlin, Franz Volhard Clinic, Berlin, Germany.

Genrui Biotech Inc. -2-

Web: www.genrui-bio.com

P04.04.020170-06