0005883962001c501V12.

ISE indirect Na-K-Cl for Gen.2

ISE indirect Na-K-Cl for Gen.2
Order information
Analyzer(s) on which cobas c pack(s) can be used
11360981216 ISE Reference Electrolyte (5 x 300 mL) cobas c 311, cobas c 501
04522320190 ISE Internal Standard Gen.2 (5 x 600 mL)
04522630190 ISE Diluent Gen.2 (5 x 300 mL)
11298500316 ISE Cleaning Solution (5 x 100 mL)
10825468001 Sodium electrode (1 electrode)
10825441001 Potassium electrode (1 electrode)
03246353001 Chloride electrode (1 electrode)
03149501001 Reference electrode (1 electrode)
04663632190 Activator (9 x 12 mL)
11183974216 ISE Standard Low (10 x 3 mL) Code 502
11183982216 ISE Standard High (10 x 3 mL) Code 503 / 763
05979854190 Internal Standard Insert ‑ ISE (Set of 20)
12149435122 Precinorm U Plus (10 x 3 mL) Code 300
12149435160 Precinorm U Plus (10 x 3 mL, for USA) Code 300
12149443122 Precipath U Plus (10 x 3 mL) Code 301
12149443160 Precipath U Plus (10 x 3 mL, for USA) Code 301
05117003190 PreciControl ClinChem Multi 1 (20 x 5 mL) Code 391
05947626190 PreciControl ClinChem Multi 1 (4 x 5 mL) Code 391
05117216190 PreciControl ClinChem Multi 2 (20 x 5 mL) Code 392
05947774190 PreciControl ClinChem Multi 2 (4 x 5 mL) Code 392

English concentration. Because of the particular nature of the membrane, the test
ions will closely associate with the membrane on each side. The membrane
Intended use and Test principle EMF is determined by the difference in concentration of the test ion in the
Intended use test solution and the internal filling solution. The EMF develops according to
the Nernst equation for a specific ion in solution:
The ISE module of the Roche/Hitachi cobas c systems is intended for the
quantitative determination of sodium, potassium and chloride in serum, (1) E = E0 + RT / nF · In (f · Ct ) / (f · Ci )
plasma or urine using ion‑selective electrodes.
Summary Where:
Physiological significance:1 E = electrode EMF
Electrolytes are involved in most major metabolic functions in the body. E0 = standard EMF
Sodium, potassium and chloride are amongst the most important
physiological ions and the most often assayed electrolytes. They are R = constant
supplied primarily through the diet, absorbed in the gastrointestinal tract, T = temperature
and excreted via the kidneys.
Sodium is the major extracellular cation and functions to maintain fluid n = charge of the ion
distribution and osmotic pressure. Some causes of decreased levels of F = Faraday's constant
sodium include prolonged vomiting or diarrhea, diminished reabsorption in
the kidney and excessive fluid retention. Common causes of increased In = natural logarithm (base e)
sodium include excessive fluid loss, high salt intake and increased kidney f = activity coefficient
reabsorption.
Potassium is the major intracellular cation and is critical to neural and Ct = ion concentration in test solution
muscle cell activity. Some causes of decreased potassium levels include Ci = ion concentration in internal filling solution
reduced intake of dietary potassium or excessive loss of potassium from the
body due to diarrhea, prolonged vomiting or increased renal excretion. For sodium, potassium and chloride, which all carry a single charge, R, T,
Increased potassium levels may be caused by dehydration or shock, severe n, and F are combined into a single value representing the slope (S). For
burns, diabetic ketoacidosis, and retention of potassium by the kidney. determination on a cobas c 311/501 analyzer where the sample is diluted
1:31, the ionic strength and therefore the activity coefficients are essentially
Chloride is the major extracellular anion and serves to regulate the balance constant.
of extracellular fluid distribution. Similarly to the other ions, common causes
of decreased chloride include reduced dietary intake, prolonged vomiting The concentration of the test ion in the internal filling solution is also
and reduced renal reabsorption as well as some forms of acidosis and constant. These constants may be combined into the E0 term. The value of
alkalosis. Increased chloride values are found in dehydration, kidney failure, E0 is also specific for the type of reference electrode used. Equation (1) can
some forms of acidosis, high dietary or parenteral chloride intake, and hence be rewritten to reflect these conditions:
salicylate poisoning.
(2) E = E|0 + S · In (Ct )
Test principle
The complete measurement system for a particular ion includes the ISE, a
An Ion‑Selective Electrode (ISE) makes use of the unique properties of reference electrode and electronic circuits to measure and process the EMF
certain membrane materials to develop an electrical potential (electromotive to give the test ion concentration.
force, EMF) for the measurements of ions in solution. The electrode has a
selective membrane in contact with both the test solution and an internal The sodium2,3 and potassium4 electrodes are based on neutral carriers and
filling solution. The internal filling solution contains the test ion at a fixed the chloride5 electrode is based on an ion exchanger.

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ISE indirect Na-K-Cl for Gen.2

Precautions and warnings ISE Diluent 2 weeks

For in vitro diagnostic use. ISE Internal Standard 2 weeks
Exercise the normal precautions required for handling all laboratory
reagents. If always closed immediately after usage and stored at 2‑8 °C the ISE
Disposal of all waste material should be in accordance with local guidelines. Cleaning Solution can be used up to the expiration date.
Safety data sheet available for professional user on request. For daily maintenance use only fresh cleaning solution.
For USA: Caution: Federal law restricts this device to sale by or on the NOTE: If one of the reagent bottles is nearly empty do not just refill the
order of a physician. bottle with new reagent. Discard the old reagent bottle, including any
04522320190/04522630190: remaining reagent.
This kit contains components classified as follows in accordance with the NOTE: Dissolved gases can cause performance problems if present in high
Regulation (EC) No. 1272/2008: amounts in the Diluent, Internal Standard or Reference Electrolyte. In this
Contains mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and case mix the contents of the bottle gently before use.
2-methyl-2H-isothiazol-3-one (3:1). NOTE: Customers using cobas c 311/501 analyzers: in case of proven or
potential ISE Internal Standard evaporation use Internal Standard Insert –
EUH 208 May produce an allergic reaction. ISE (Cat. No. 05979854 190) to reduce the potential for evaporation.
Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336
Product safety labeling follows EU GHS guidance. Electrodes
Handle patient samples and human‑based controls as potentially infectious Sodium, Potassium, Chloride, Reference
specimens. Storage and Stability
As with any diagnostic test procedure, results should be interpreted taking Store electrodes at 7‑40 °C.
all other test results and the clinical status of the patient into consideration. See label for expiration date.
In addition, pay attention to all precautions and warnings listed in the
Operator’s Manual of the analyzer. On‑board stability

ISE calibrators, auxiliary reagents and electrodes Sodium 2 months or 9000 tests

Calibrators S1, S2 and S3 Potassium 2 months or 9000 tests

S1: ISE Standard Low Chloride 2 months or 9000 tests
120 mmol/L Na+, 3 mmol/L K+, 80 mmol/L Cl- Reference at least 6 months
S2: ISE Standard High The electrodes should be replaced after this time period has expired.
160 mmol/L Na+, 7 mmol/L K+, 120 mmol/L Cl- For replacement refer to instructions in the Operator’s Manual.
S3: ISE Standard High
160 mmol/L Na+, 7 mmol/L K+, 120 mmol/L Cl- Slope ranges
Storage and stability Sodium 50 to 68 mV/dec
Store S1, S2 and S3 at 15‑25 °C. Potassium 50 to 68 mV/dec
See label for expiration date. Chloride -40 to -68 mV/dec
On‑board stability
The slope ranges for newly installed electrodes should be in the upper half
Calibrators S1, S2 and S3: to be used for one calibration only. of the recommended electrode slope range (excluding chloride).
Auxiliary reagents ISE solution summary
ISE Reference Electrolyte Solution Usage
1 mol/L potassium chloride S1 Full calibration
ISE Diluent (ready for use) S2 Full calibration
HEPES buffer: 10 mmol/L
S3 Full calibration (Compensation)
Triethanolamine: 7 mmol/L
Preservative Reference Provides a reference potential.
ISE Internal Standard (ready for use) Electrolyte
HEPES buffer: 10 mmol/L Diluent For dilution.
Triethanolamine: 7 mmol/L Internal Standard Monitoring of Electrode potential.
Sodium chloride: 3.06 mmol/L Cleaning Solution Cleans the ion‑selective electrodes, dilution vessel
Sodium acetate: 1.45 mmol/L and tubing.
Potassium chloride: 0.16 mmol/L CAUTION: The above‑mentioned ISE calibrators, auxiliary reagents and
Preservative electrodes are required to calibrate and calculate results for the ISE
ISE Cleaning Solution module. Use of any other products may result in inaccurate measurements
Sodium hydroxide solution: of routine samples and/or damage to the electrodes.
12 % with sodium hypochloride solution < 2 % active Cl Specimen collection and preparation6
Storage and Stability Specimen
Store Reference Electrolyte, Internal Standard, Diluent at 15‑25 °C. Only the specimens listed below were tested and found acceptable.
Store ISE Cleaning Solution at 2‑8 °C. Serum separation tube: Use serum free of hemolysis and gross lipemia,
See label for expiration date. collected by standard venipuncture technique.
On‑board stability Plasma: Use only lithium heparin.
Urine:7 Collect 24‑hour urine without additives. Store refrigerated during
ISE Reference Electrolyte 4 weeks collection.

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Stability in serum, plasma and urine samples kept in tightly closed tubes ▪ after replacing any electrode
are given in the table below.8 ▪ as required following quality control procedures
15‑25 °C 2‑8 °C -20 °C Quality control
Sodium 14 days 14 days stable For serum/plasma quality control, use control materials as listed in the
“Order information” section.
Potassium 14 days 14 days stable In addition, other suitable control material can be used.
Chloride 7 days 7 days stable For urine quality control, use commercially available urine controls.
Preparation Quality controls should be performed daily and after every additional
Do not allow serum to remain on the cells after centrifugation. As described calibration.
in the literature, potassium values in serum are increased compared to The control intervals and limits should be adapted to each laboratory’s
plasma. Serum potassium is released from platelets during clotting. The individual requirements. Values obtained should fall within the defined
higher the platelet count, the greater the error.9 While serum is susceptible limits. Each laboratory should establish corrective measures to be taken if
to preanalytic handling (hemolysis) and leakage from erythrocytes, plasma values fall outside the defined limits.
is preferable to serum as sample material for potassium determination. Follow the applicable government regulations and local guidelines for
The chloride content of serum or plasma is stable for several days when the quality control.
sample is separated from erythrocytes and stored in a tightly closed Refer to appropriate value sheets/package inserts for additional information.
container.7
Expected values1
Gross lipemia causes pseudohyponatremia.10 Grossly lipemic specimens
should be cleared by ultracentrifugation. Turbid urine samples should be Serum Sodium 136‑145 mmol/L
cleared by centrifugation.
(Adults) Potassium 3.5‑5.1 mmol/L
Potassium: For certain types of hematological neoplasias, (severe)
pseudohyperkalemia using lithium heparin samples has been Chloride 98‑107 mmol/L
reported.11,12,13
CAUTION:
Plasma Sodium 136‑145 mmol/L
Serum separator tubes containing acrylic, ester, styrene, urethane or olefin
based gels may be used for sample collection as long as they are used in (Adults) Potassium 3.4‑4.5 mmol/L
accordance with the manufacturer’s recommended procedures. It is
especially important that storage temperature, adequate mixing, clotting Chloride 98‑107 mmol/L
times and centrifugation at sufficient g‑forces for sufficient time periods are Plasma potassium levels are reported to be lower than serum levels.
respected. Ensure also correct filling levels and ensure a minimum of 1 cm
sample above gel layer. If these precautions are not taken, it is possible to
accidentally coat the sample probe with gel (interfering with proper sample Urine (24 h) Sodium 40‑220 mmol/24 h
level detection), or even to aspirate gel into the ISE system (resulting in a
clogged system). Inadequate mixing of plasma tubes can cause (Adults) Potassium 25‑125 mmol/24 h
interference with micro fibrin clots. It is strongly recommended to avoid Chloride 110‑250 mmol/24 h
silicone‑type gels, due to risk of silicon oil contaminations. In addition, tubes
that exhibit a layer of clear liquid, which rises to the top of the serum after The urinary excretion of sodium, potassium and chloride varies significantly
centrifugation, should not be used for direct sample aspiration, in order to with dietary intake. The values given here are typical of people on an
prevent coating the sample probes and interfering with ISE system. average diet.
Pipetting parameters: NOTE: It is recommended that each laboratory establishes and maintains
The sample volume pipetted by cobas c 311/501 systems is 9.7 µL (as well its own reference ranges. The values given here are only to be used as a
as for automatic rerun). Another 6.5 µL is pipetted for the urine manual guideline.
rerun.
Maintenance
NOTE: Each laboratory should establish guidelines for determining
acceptability of specimens and the corrective action to be taken if a The system maintenance procedures and frequencies stated in the
specimen is considered unacceptable. Compile a laboratory‑specific Operator’s Manual must be performed each day at the end of the daily
guideline. sample run or after an elevated sample throughput.
The system recognizes the wash rack and switches automatically to
Procedure of ISE measurements cleaning mode.
Assay cobas c 501 maintenance:
Refer to the Operator’s Manual of the analyzer. The specially labeled wash rack (green) is used.
Calibration Position 1: Multiclean (not necessary when only the ISE is cleaned)
Full calibration for Na+, K+ and Cl- requires the following 3 calibrator Position 2: ISE Cleaning Solution
solutions: ISE Standard Low, ISE Standard High, and ISE Standard High Position 3: Activator (The ISE system requires conditioning after cleaning
(compensated). The slope of the calibration curve is calculated from and prior to calibration.)
Standards 1 and 2. ISE Compensation affects the intercept, not the slope.
An internal standard is also measured during calibration and between Note: Always use fresh solutions for cleaning.
samples to compensate for any system deviations. cobas c 311 maintenance:
Refer to the Operator’s Manual of the analyzer for detailed calibration The specially designated positions on the sample disk are used. The ISE
instructions. Wash procedure has to be manually selected out of maintenance items.
Traceability: This method has been standardized against primary calibrators Position W1: ISE Cleaning Solution.
prepared gravimetrically from purified salts. Position W2: Activator. (The ISE system requires conditioning after cleaning
Calibration frequency and prior to calibration.)
Perform a full calibration Note: Always use fresh solutions for cleaning.
▪ every 24 hours Limitations ‑ interference
▪ after ISE cleaning and maintenance Criterion: Recovery within ± 10 % of initial value.
▪ after changing the reagent bottles Hemolysis ‑ serum

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ISE indirect Na-K-Cl for Gen.2

Sodium and chloride L‑Dopa 1000 mg/L

Hemoglobin does not interfere in the tested concentration range up to Methyldopa 2000 mg/L
1000 mg/dL (621 μmol/L) hemoglobin (approximate H index 1000).
Na‑Cefoxitin 12000 mg/L
Potassium
Do not use hemolyzed samples. Ofloxacine 900 mg/L
Potassium concentration in erythrocytes is 25 times higher than in normal Phenazopyridine 300 mg/L
plasma. The level of interference may be variable depending on the exact Salicyluric acid 6000 mg/L
content of erythrocytes. An H‑index of ≤ 20 equals an increase of the
potassium concentration of ≤ 0.1 mmol/L.14 ACTION REQUIRED
Icterus ‑ serum Special Wash Programming: The use of special wash steps is mandatory
when certain test combinations are run together on cobas c systems. The
Bilirubin (conjugated/unconjugated) does not interfere in the tested latest version of the carry‑over evasion list can be found with the NaOHD-
concentration range up to 60 mg/dL (1026 μmol/L) bilirubin (approximate SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the
I index 60). operator’s manual. cobas c 502 analyzer: All special wash programming
Icterus ‑ urine necessary for avoiding carry‑over is available via the cobas link, manual
Bilirubin (conjugated) does not interfere in the tested concentration range input is required in certain cases.
up to 60 mg/dL (1026 μmol/L) bilirubin (approximate I index 60). Where required, special wash/carry‑over evasion programming must
Lipemia ‑ serum be implemented prior to reporting results with this test.
Intralipid does not interfere in the tested concentration range up to Limits and ranges
2000 mg/dL Intralipid (corresponding to an approximate L index of 2000). Measuring range
There is poor correlation between the L index (corresponds to turbidity) and Measuring mode ISE indirect:
the triglycerides concentration. Pseudohyponatremia may be seen with
lipemic specimens as a result of fluid displacement.10 Application for serum and plasma:
Sodium: Altered protein‑/lipid levels may falsely shift sodium results into the Na+ 80‑180 mmol/L
opposite direction; i.e. elevated protein level = pseudohyponatremia,
decreased protein level = pseudohypernatremia.15,16 K+ 1.5‑10.0 mmol/L
Drugs Cl- 60‑140 mmol/L
The following drugs have been tested and caused no significant Application for urine:
interference when added to aliquots of pooled normal human serum or
pooled urine up to the indicated concentration. Na+ 20‑250 mmol/L
Falsely high chloride values have been reported from patients receiving K+ 3‑100 mmol/L
perchlorate medication. This is due to an interference of perchlorate ions
with chloride ISE determination. Cl- 20‑250 mmol/L
Serum panel: NOTE: All results falling outside the measuring ranges for urine will be
reported with a <> / < Test data alarm due to the fact that the results are
Acetaminophen (paracetamol) 200 mg/L evaluated independently of sample volume. Results for the manual rerun of
Acetylcysteine 150 mg/L urine samples with both a reduced sample volume, and the data alarm
<> / < Test , must be checked against the manual rerun urine sample
Acetylsalicylic acid 1000 mg/L ranges (see below). When running samples with reduced sample volumes
Ampicillin‑Na 1000 mg/L the results of such samples must be assessed on an individual basis. The
reason for this is that matrix effects cannot be excluded for such samples.
Ascorbic acid 300 mg/L Manual rerun of urine samples with reduced sample volume:
Cefoxitin 2500 mg/L
Na+ 250‑375 mmol/L
Cyclosporin 5 mg/L
K+ 100‑150 mmol/L
Doxycyclin 50 mg/L
Cl- 250‑375 mmol/L
Heparin 5000 U
NOTE: All results outside the following ranges Na+ 20‑250 mmol/L, K+
Ibuprofen 500 mg/L 3‑100 mmol/L, Cl- 20‑250 mmol/L will always have a <> / < Test data alarm
Intralipid 10000 mg/L attached. Urine rerun results with reduced sample volume with this alarm
need to be checked against the ranges for rerun urine samples case by
L‑Dopa 20 mg/L case.
Methyldopa 20 mg/L Determine urine samples having higher concentrations via the rerun
function. Dilution of urine samples via the rerun function is a 1:1.5 dilution.
Metronidazol 200 mg/L Results from urine samples diluted using the rerun function are
Phenylbutazone 400 mg/L automatically multiplied by a factor of 1.5.
Rifampicin 60 mg/L Analysis of sodium on a cobas c system with serum and plasma
specimens should yield a linear relationship from 80‑180 mmol/L with a
Theophylline 100 mg/L deviation from the linear line of less than 5 %.
Urine panel: Analysis of potassium on a cobas c system with serum and plasma
specimens should yield a linear relationship from 1.5‑10.0 mmol/L with a
Acetaminophen (paracetamol) 3000 mg/L deviation from the linear line of less than 5 %.
Acetylcysteine 10 mg/L Analysis of chloride on a cobas c system with serum and plasma
specimens should yield a linear relationship from 60‑140 mmol/L with a
Ascorbic acid 4000 mg/L deviation from the linear line of less than 5 %.
Doxycyclin 300 mg/L Specific performance data
Gentamycin sulfate 400 mg/L Representative performance data on the analyzers are given below.
Ibuprofen 4000 mg/L Results obtained in individual laboratories may differ.

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ISE indirect Na-K-Cl for Gen.2

Data contained within this section are representative of typical performance Method comparison
for cobas c 501 ISE systems and are not be viewed as test specifications. ISE values for human plasma and urine samples obtained on cobas c 501
Precision analyzers (y) using Standard High (compensated) as S3 Calibrator, were
compared to those determined with the corresponding reference method (x)
Repeatability and intermediate precision were determined using human and with a cobas c 501 analyzer using ISE Compensator as S3 Calibrator.
samples and controls in accordance with the CLSI (Clinical and Laboratory
Standards Institute) EP5 requirements (2 aliquots per run, 2 runs per day, The reference methods used are: Flame Photometer IL 943 for Sodium and
21 days). The following results were obtained: Potassium, Chloride Analyzer 926S for Chloride.
Sodium
Sodium
Repeatability Intermediate precision Instruments Sample Min.x Max.x P/B Regression17 Coeff.
Type/ N (r)
Sample (on a Mean SD CV Mean SD CV
cobas c 501) mmol/L mmol/L % mmol/L mmol/L % x: flame Plasma/103 86.7 178 y = 1.000x + 0.300 0.999
photom.
Plasma low 84.8 0.2 0.3 84.8 1 1.1
y: cobas c 501
Plasma medium 121.4 0.3 0.3 121.4 0.8 0.6 (S3 = Standard
Plasma high 176.7 0.3 0.2 176.7 0.6 0.4 High)
Precinorm U 126 0.2 0.2 126.0 0.7 0.6 Bias at 135 mmol/L = 0.03 (0.2 %)
Precipath U 148.2 0.3 0.2 148.2 0.5 0.4 Bias at 150 mmol/L = 0.03 (0.2 %)
Urine low 30.6 0.1 0.2 30.6 0.9 3.0 x: cobas c 501 Plasma/103 87.6 176 y = 1.014x - 1.176 1.000
Urine medium 131.7 0.2 0.2 131.7 0.6 0.5 (S3 = ISE
Urine high 236.7 0.4 0.2 236.7 1.3 0.6 Compensator)
Liquichek 1 81.6 0.2 0.2 81.6 1.3 1.6 y: cobas c 501
(S3 = Standard
Liquichek 2 172.3 0.2 0.1 172.3 2.6 1.5 High)
Potassium Bias at 135 mmol/L = 0.714 (0.5 %)
Repeatability Intermediate precision Bias at 150 mmol/L = 0.924 (0.6 %)
Sample (on a Mean SD CV Mean SD CV x: flame Urine/100 23.5 250 y = 0.964x + 4.032 1.000
cobas c 501) mmol/L mmol/L % mmol/L mmol/L % photom.
Plasma low 1.62 0.01 0.7 1.62 0.03 1.6 y: cobas c 501
Plasma medium 4.97 0.04 0.7 4.97 0.04 0.8 (S3 = Standard
High)
Plasma high 9.46 0.06 0.6 9.46 0.07 0.7
Bias at 20 mmol/L = 3.312 (16.6 %)
Precinorm U 3.57 0.03 0.8 3.57 0.04 1.0
Bias at 220 mmol/L = -3.888 (-1.8 %)
Precipath U 6.59 0.04 0.6 6.59 0.05 0.7
Urine low 5.12 0.03 0.6 5.12 0.04 0.7 x: cobas c 501 Urine/100 25.1 245 y = 0.995x + 0.687 1.000
(S3 = ISE
Urine medium 52.08 0.32 0.6 52.08 0.67 1.3 Compensator)
Urine high 90.34 0.67 0.7 90.34 1.38 1.5 y: cobas c 501
Liquichek 1 31.48 0.19 0.6 31.48 0.53 1.7 (S3 = Standard
Liquichek 2 70.56 0.43 0.6 70.56 1.17 1.7 High)
Bias at 20 mmol/L = 0.587 (2.9 %)
Chloride
Bias at 220 mmol/L = -0.413 (-0.2 %)
Repeatability Intermediate precision
Potassium
Sample (on a Mean SD CV Mean SD CV
cobas c 501) mmol/L mmol/L % mmol/L mmol/L % Instruments Sample Min.x Max.x P/B Regression17 Coeff.
Plasma low 68.5 0.2 0.3 68.5 0.6 0.8 Type/ N (r)
Plasma medium 129.0 0.4 0.3 129.0 0.6 0.5 x: flame Plasma/106 1.59 9.56 y = 1.007x - 0.019 1.000
photom.
Plasma high 139.0 0.3 0.2 139.0 0.6 0.4
y: cobas c 501
Precinorm U 86.2 0.2 0.3 86.2 0.5 0.6 (S3 = Standard
Precipath U 119.2 0.3 0.2 119.2 0.5 0.4 High)
Urine low 25.8 0.1 0.2 25.8 0.6 2.3 Bias at 3.0 mmol/L = 0.002 (0.1 %)
Urine medium 131.4 0.3 0.2 131.4 0.7 0.5 Bias at 5.8 mmol/L = 0.022 (0.4 %)
Urine high 243.4 0.6 0.2 243.4 1.8 0.7
Liquichek 1 97.5 0.2 0.2 97.5 1.6 1.6
Liquichek 2 198.2 0.4 0.2 198.2 2.3 1.2

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x: cobas c 501 Plasma/106 1.52 9.45 y = 1.006x + 0.024 1.000 Bias at 60 mmol/L = 0.009 (0.0 %)
(S3 = ISE Bias at 170 mmol/L = -1.201 (-0.7 %)
Compensator)
Bias at the medical decision level (MDL) was calculated as follows:
y: cobas c 501
Bias [mmol/L] = intercept + (slope x MDL) - MDL
(S3 = Standard
High) Bias [%] = (Bias [mmol/L] x 100) / MDL
References
Bias at 3.0 mmol/L = 0.042 (1.4 %)
1 Tietz NW. Fundamentals of Clinical Chemistry, 5th ed. Burtis CA,
Bias at 5.8 mmol/L = 0.059 (1.0 %) Ashwood ER, eds. WB Saunders Co 2001:970,1004,1009.
x: flame Urine/105 4.00 97.2 y = 1.018x - 0.397 1.000 2 Shono T, Okahara M, Ikeda I, et al. Sodium‑selective PVC Membrane
photom. Electrodes Based on Bis(12‑crown‑4)s. J Electroanal Chem
1982;132:99-105.
y: cobas c 501
3 Shibata Y, Maruizume T, Miyage H. Journal of the Chemical Society of
(S3 = Standard Japan. Chemistry and Industrial Chemistry 1992;9:961-967.
High)
4 Lavinia A, Pioda R, Stankova V, et al. Highly selective potassium ion
Bias at 20 mmol/L = 0.757 (3.8 %) responsive liquid-membrane electrode. Analytical Letters
1969;2(12):665-674.
Bias at 80 mmol/L = 1.837 (2.3 %)
5 Hartman K, Luterotti S, Osswald HF, et al. Chloride‑selective
x: cobas c 501 Urine/105 4.05 97.4 y = 0.997x + 0.062 0.999 liquid‑membrane electrodes based on lipophilic
(S3 = ISE methyl‑tri‑N‑alkyl‑ammonium compounds and their applicability to blood
Compensator) serum measurements. Microchimica Acta 1978;70(3-4):235-246.
y: cobas c 501 6 Tietz NW. Clinical Guide to Laboratory Tests. Philadelphia: WB
Saunders Co 1983;110:398, 446.
(S3 = Standard
High) 7 Kaplan LA, Pesce AJ. Clinical Chemistry, Theory, Analysis and
Correlation. Ladig D, Kasper R (ed), St Louis, CV Mosby Co
Bias at 20 mmol/L = 0.002 (0.0 %) 1984;1061-1077.
Bias at 80 mmol/L = -0.178 (-0.2 %) 8 Young DS. Effects of Preanalytical Variables on Clinical Laboratory
Tests, AACC Press 1997;2(4):493-503.
Chloride
9 Lum G, Gambino SR. A Comparison of serum versus heparinized
Instruments Sample Min.x Max.x P/B Regression17 Coeff. plasma for routine chemistry tests. Am J Clin Pathol 1974
Type/ N (r) Jan;61(1):108-113.
10 Tietz NW. Fundamentals of Clinical Chemistry, 5th ed. Burtis CA,
x: coulometry Plasma/105 62.0 136 y = 1.033x - 1.800 0.998 Ashwood ER, eds. WB Saunders Co 2001:726-728.
y: cobas c 501 11 Yu HYE, Kellogg M. Hyperkalemia or Hypokalemia? Clinical Chemistry
(S3 = Standard 2009;55:11:2068.
High) 12 Cao J, Karger AB. Critically evaluated potassium in a 55-year-old
Bias at 90 mmol/L = 1.170 (1.3 %) female with chronic lymphocytic leukemia. Laboratory Medicine
2018;49:3:280-283.
Bias at 112 mmol/L = 1.896 (1.7 %)
13 Theparee T, Benirschke RC, Lee HK. Variable potassium
x: cobas c 501 Plasma/105 61.4 138 y = 1.000x + 0.500 0.999 concentrations: Which is right and which is wrong? Laboratory
(S3 = ISE Medicine 2017;48:2:183-187.
Compensator) 14 Martinez-Morillo E, Alvarez FV. Management of potassium results in
haemolysed plasma samples at the emergency department laboratory.
y: cobas c 501 Clin Chem Lab Med 2019;57(11):e271-e273.
(S3 = Standard
High) 15 Virk MS, Dean NP, Wong ECC. Severe Underestimation of Serum Na
following IVIG Treatment. Laboratory Medicine 2018;49:4:372-376.
Bias at 90 mmol/L = 0.500 (0.6 %) 16 Stove V, et al. How to Solve the Underestimated Problem of
Bias at 112 mmol/L = 0.500 (0.4 %) Overestimated Sodium Results in the Hypoproteinemic Patient. Crit
Care Med 2016;44 (2):e83-e88.
x: coulometry Urine/105 22.0 248 y = 1.020x - 1.700 0.999
17 Bablok W, Passing H, Bender R, et al. A general regression procedure
y: cobas c 501 for method transformation. Application of linear regression procedures
(S3 = Standard for method comparison studies in clinical chemistry, Part III. J Clin
High) Chem Clin Biochem 1988 Nov;26(11):783-790.
A point (period/stop) is always used in this Method Sheet as the decimal
Bias at 60 mmol/L = -0.500 (-0.8 %) separator to mark the border between the integral and the fractional parts of
Bias at 170 mmol/L = 1.700 (1.0 %) a decimal numeral. Separators for thousands are not used.
x: cobas c 501 Urine/105 21.2 250 y = 0.989x + 0.669 1.000 Symbols
(S3 = ISE Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
Compensator) definition of symbols used):
y: cobas c 501
(S3 = Standard Contents of kit
High) Volume after reconstitution or mixing
GTIN Global Trade Item Number

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0005883962001c501V12.0

ISE indirect Na-K-Cl for Gen.2

ISE indirect Na-K-Cl for Gen.2

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

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stated in the labeling when used in accordance with such labeling and will
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