INSTRUCTIONS FOR USE K+

VITROS Chemistry Products K+ Slides Potassium

815 7596

Rx ONLY

Intended Use
For in vitro diagnostic use only.
VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine
using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

Summary and Explanation of the Test

Potassium is the major cation of the intracellular fluid. Measurement of serum potassium is used for evaluation of
electrolyte imbalance, cardiac arrhythmias, muscular weakness, hepatic encephalopathy, and renal failure and for the
monitoring of ketoacidosis in diabetes mellitus and intravenous fluid replacement therapy.
More than 90% of hypertensive patients with aldosteronism have a low K+; a low K+ is also common in vomiting, diarrhea,
alcoholism, and folic acid deficiency. High K+ values occur in rapid K+ infusion, end stage renal failure, hemolysis, trauma,
Addison’s disease, metabolic acidosis, acute starvation, dehydration, and acute medical emergency.
Normally, K+ is freely filtered by the glomerulus but tends to be conserved if the serum K+ is low. Urinary potassium may be
elevated with dietary increase, hyperaldosteronism, renal tubular acidosis, and at the onset of alkalosis. 1

Principles of the Procedure

The VITROS K+ Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for
measurement of ionic potassium. The slide consists of two ion-selective electrodes, each containing valinomycin (an
ionophore for potassium), a reference layer, and a silver and a silver chloride layer coated on a polyester support.
A drop of patient sample and a drop of VITROS Electrolyte Reference Fluid on separate halves of the slide results in
migration of both fluids toward the center of the paper bridge. A stable liquid junction is formed connecting the reference
electrode to the sample indicator electrode.
Each electrode produces an electrical potential in response to the activity of potassium applied to it. The potential difference
poised between the two electrodes is proportional to the potassium concentration in the sample.

Test Type and Conditions

Approximate
Incubation Reaction Reference Fluid
Test Type VITROS System Time Temperature Sample Volume Drop Volume
5600, 4600, 5,1 FS,
Potentiometric 250/350, XT 7600, 2 minutes 37 °C (98.6 °F) 10 μL 10 μL
XT 3400
Not all products and systems are available in all countries.

Warnings and Precautions

For in vitro diagnostic use only.
WARNING: Take care when handling materials and samples of human origin. Since no test
method can offer complete assurance that infectious agents are absent, consider
all clinical specimens, controls, and calibrators potentially infectious. Handle
specimens, solid and liquid waste, and test components in accordance with local
regulations and CLSI Document M29 2 or other published biohazard safety
guidelines.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the
Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.

Version 9.0 Pub. No. J32746_EN 1 of 13

 K+ INSTRUCTIONS FOR USE
Potassium Reagents

Reagents
Slide Diagram
Slide Ingredients 1. Upper frame
2. Paper Bridge
3. Ion-selective membrane:
Reactive Ingredients per cm2 valinomycin
Silver 0.4 mg; silver chloride 0.2 mg; sodium chloride 0.2 mg; 4. Reference layer: KCl and
potassium chloride 63 µg and valinomycin 55 µg. NaCl
5. Silver, silver chloride layer
Other Ingredients 6. Support layer
7. Lower frame
Binders, plasticizers, stabilizer, surfactants and nickel-chromium.

Reagent Handling
Caution: Do not use slide cartridges with damaged or incompletely sealed packaging.
• Inspect the packaging for signs of damage.
• Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product
packaging.

Reagent Preparation
IMPORTANT: The slide cartridge must reach room temperature, 18–28 °C (64–82 °F), before it
is unwrapped and loaded into the slide supply.

1. Remove the slide cartridges from storage.

2. Warm the wrapped cartridge at room temperature for 30 minutes when taken from the refrigerator or 60 minutes when
taken from the freezer.
3. Unwrap and load the cartridge into the slide supply.
Note: Load the cartridges within 24 hours after they reach room temperature, 18–28 °C
(64–82 °F).

Reagent Storage and Stability

VITROS K+ Slides are stable until the expiration date on the carton when they are stored and handled as specified. Do not
use beyond the expiration date.

Reagent Storage Condition Stability

Unopened Refrigerated 2–8 °C (36–46 °F) Until expiration date
Frozen ≤-18 °C (≤0 °F) Until expiration date
Opened On-analyzer System turned on ≤ 2 weeks
On-analyzer System turned off ≤ 2 hours
Verify performance with quality control materials:
• If the system is turned off for more than 2 hours.
• After reloading cartridges that have been removed from the slide supply and stored for later use.

Specimen Collection, Preparation and Storage

Specimens Recommended
• Serum
• Plasma 3: Heparin
• Urine
IMPORTANT: Certain collection devices have been reported to affect other analytes and tests. 4
Owing to the variety of specimen collection devices available, Ortho Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible
with this test.

2 of 13 Pub. No. J32746_EN Version 9.0

 INSTRUCTIONS FOR USE K+
Specimen Collection, Preparation and Storage Potassium

Specimens Not Recommended

• Do not use hemolyzed specimens. Lysis of only 0.5% of the erythrocytes can increase potassium levels by 0.5 mmol/L. 5
• Plasma: 6
– EDTA
– Citrate
– Fluoride oxalate
• Urine: Boric acid with sodium formate as a preservative

Serum and Plasma

Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 7 8

Note: For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
The patient should avoid any exercise of the arm or hand before or during collection because opening and closing the fist
increases potassium concentration by 10% to 20%. 5
Special Precautions
• Do not draw specimen from an arm receiving an intravenous transfusion.
• Fibrin clots may cause incomplete sampling of the specimen. 9
– Allow specimens to clot completely in order to prevent fibrin clots.
– Inspect plasma specimens for fibrin clots.
• Do not refrigerate the specimen prior to centrifugation because potassium will leak from the red blood cells. 6
• Centrifuge specimens and remove the serum or plasma from the cellular material within 2 hours of collection. 6
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.
• Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.

Specimen Storage and Stability for Serum and Plasma 6

Storage Temperature Stability
Room temperature 18–28 °C (64–82 °F) ≤ 6 weeks
Refrigerated 2–8 °C (36–46 °F) ≤ 6 weeks
Frozen ≤-18 °C (≤0 °F) ≤ 1 year

Urine
Specimen Collection and Preparation
• Collect specimens using standard laboratory procedures. 10
• Keep refrigerated until analysis.
Note: For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
Urine specimens must be pretreated prior to processing. Refer to “Specimen Pretreatment” for instructions.
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.
• Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.

Specimen Storage and Stability for Urine 6

Storage Temperature Stability
Room temperature 18–28 °C (64–82 °F) ≤ 4 days
Refrigerated 2–8 °C (36–46 °F) ≤ 7 days
Frozen ≤-18 °C (≤0 °F) ≤ 6 months

Version 9.0 Pub. No. J32746_EN 3 of 13

 K+ INSTRUCTIONS FOR USE
Potassium Specimen Pretreatment

Specimen Pretreatment
Urine
Predilution
Pretreatment is managed by the analyzer, no operator intervention is required.

Testing Procedure
Materials Provided
VITROS Chemistry Products K+ Slides

Materials Required but Not Provided

• VITROS Chemistry Products Calibrator Kit 2 or VITROS Chemistry Products Calibrator Kit 32*.
• Quality control materials, such as VITROS Chemistry Products Performance Verifier I and II for serum and plasma, and
VITROS Chemistry Products Liquid Performance Verifier I and II for urine
• VITROS Chemistry Products Urine Electrolyte Diluent
• Electrolyte Reference Fluid appropriate for your VITROS Chemistry or Integrated System
• Reagent-grade water
• VITROS Chemistry Products FS Diluent Pack 1 (Apo Diluent/Urine Electrolyte Diluent) (for on-analyzer dilution of urine
samples)
*Not all products and systems are available in all countries.

Operating Instructions
• Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload.
• For additional information, refer to the operating instructions for your system.
IMPORTANT: Bring all fluids and samples to room temperature, 18–28 °C (64–82 °F), prior to
analysis.

Sample Dilution
Serum and Plasma
Potassium concentrations outside the measuring (reportable or dynamic) range are not expected. Diluted samples should
not be analyzed with VITROS K+ Slides because dilution changes the concentration of solids in plasma and the ionic
strength of the sample.

Urine
If potassium concentrations exceed the system’s measuring (reportable or dynamic) range:
On-Analyzer Sample Dilution (VITROS 5600/XT 7600 Integrated and VITROS 250/350, 5,1 FS/4600/XT 3400
Chemistry Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS 5600/XT 7600 Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS
Diluent Pack 1 for the dilution.
For VITROS 250/350 and VITROS XT 3400 Chemistry Systems, use reagent-grade water for the dilution.
Manual Sample Dilution
1. Manually dilute 1 part of the original urine sample with an equal volume of reagent-grade water.
2. Reanalyze.
3. Multiply the results by 2 to obtain an estimate of the potassium concentration in the original urine sample.

Calibration
Required Calibrators
VITROS Chemistry Products Calibrator Kit 2 or VITROS Chemistry Products Calibrator Kit 32.
Note: The same VITROS Calibrator Kit is used to calibrate both serum and urine
potassium. However, specific supplementary assigned values (SAVs) are applied
for each body fluid.

4 of 13 Pub. No. J32746_EN Version 9.0

 INSTRUCTIONS FOR USE K+
Quality Control Potassium

Calibrator Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Chemistry Calibrator Kit 2 or VITROS Chemistry Products Calibrator Kit 32.

Calibration Procedure
Refer to the operating instructions for your system.

When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
• When the VITROS Electrolyte Reference Fluid lot number changes.
The VITROS K+ test may also need to be calibrated:
• If quality control results are consistently outside acceptable range.
• After certain service procedures have been performed.
For additional information, refer to the operating instructions for your system.

Calculations
The VITROS Chemistry and Integrated Systems measure the potential difference in millivolts between the two electrodes of
a potentiometric slide—one in contact with the sample to be analyzed and the other in contact with the electrolyte reference
fluid. A linear relationship exists between the measured potential difference observed on the slide and the logarithm of
potassium concentration, i.e., the Nernst equation for ion-selective electrodes. Once the calibration has been established
for each slide lot, unknown potassium concentrations for a given sample can be determined using the software-resident
math model and the measured potential difference.

Validity of a Calibration
Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the
Coefficients and Limits screen on VITROS 250/350 Systems (for the VITROS 5600/XT 7600 Integrated and VITROS 5,1
FS/4600/XT 3400 Chemistry Systems, see the Review Assay Data screen). Failure to meet any of the pre-defined quality
parameters results in a failed calibration. The calibration report should be used in conjunction with quality control results to
determine the validity of a calibration.
Measuring (Reportable or Dynamic) Range

Conventional and SI Units

(mmol/L)
Serum/Plasma 1.00–14.00
Urine 2.50–175.00*
*After multiplying by a 5x dilution factor.
For out-of-range samples, refer to “Sample Dilution.”

Traceability of Calibration
Values assigned to the VITROS Chemistry Products Calibrator Kit 2 and VITROS Chemistry Products Calibrator Kit 32 for
potassium are traceable to the Certified NIST (National Institute of Standards and Technology) Reference Material, SRM®
(Standard Reference Material) 918. The Ortho Clinical Diagnostics calibration laboratory uses SRM® 918 to calibrate the
flame atomic emission spectroscopy method 11 to support potassium value assignment for VITROS Chemistry Products
Calibrator Kit 2 and VITROS Chemistry Products Calibrator Kit 32.

Quality Control
Quality Control Material Selection
IMPORTANT: VITROS Performance Verifiers are recommended for use with the VITROS
Chemistry and Integrated Systems. Evaluate the performance of other
commercial control fluids for compatibility with this test before using for quality
control.
• Control materials other than VITROS Performance Verifiers may show a difference when compared with other potassium
methods if they:
– Depart from a true human matrix.
– Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.

Version 9.0 Pub. No. J32746_EN 5 of 13

 K+ INSTRUCTIONS FOR USE
Potassium Results

• Do not use control materials stabilized with ethylene glycol.

Urine
• Use urine controls and dilute in the same manner as for patient samples.
• Select urine as the fluid when programming the system to run controls. Multiply the result by 5.
IMPORTANT: If using a VITROS 250/350, 5,1 FS/4600/XT 3400 Chemistry Systems or
VITROS 5600/XT 7600 Integrated Systems in On-Analyzer Dilution Mode, do not
manually dilute samples for analysis and do not multiply by a dilution factor after
analysis. Refer to the operating instructions for your system for more information
on the On-Analyzer Dilution Procedure.

Quality Control Procedure Recommendations

• Choose control levels that check the clinically relevant range.
• Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
• To verify system performance, analyze control materials:
– After calibration.
– According to local regulations or at least once each day that the test is being performed.
– After specified service procedures are performed. Refer to the operating instructions for your system.
• If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient
results.
• For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements:
Principles and Definitions; Approved Guideline –Third Edition 12 or other published guidelines.
• For additional information, refer to the operating instructions for your system.

Quality Control Material Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Chemistry Products Performance Verifier I and II, VITROS Chemistry Products
Liquid Performance Verifier I and II, or to other manufacturer's product literature.

Results
Reporting Units
The VITROS Chemistry and Integrated Systems may be programmed to report K+ results in conventional or SI units.

Conventional and SI Units

mmol/L

Limitations of the Procedure

Known Interferences
None have been identified.

Other Limitations
Certain drugs and clinical conditions are known to alter potassium concentration in vivo. For additional information, refer to
one of the published summaries. 13 14

Expected Values
Reference Interval
These reference intervals are based on external studies. 15

Conventional and SI Units

Serum 15 3.5–5.1 mmol/L
Plasma 5 0.1–0.7 mmol/L lower than serum range
Urine (24-hour)* 25.0–125.0 mmol/day (diet dependent)
*Potassium concentration (mmol/L) x 24-hour volume (L) = mmol/day
Each laboratory should confirm the validity of these intervals for the population it serves.

6 of 13 Pub. No. J32746_EN Version 9.0

 INSTRUCTIONS FOR USE K+
Performance Characteristics Potassium

Performance Characteristics
Detection Capability
The Limit of Quantitation (LoQ) is 1.00 mmol/L for serum/plasma and 2.50 mmol/L for urine. The total number of LoQ
determinations was 480. The LoQ was established consistent with CLSI EP17. 16

LoQ*
Fluid Type
(mmol/L)
Serum/Plasma 1.00
Urine 2.50
* The Total Error goal used to accept the LoQ was ≤ 0.28 mmol/L for serum and ≤ 0.75 mmol/L for urine.

Method Comparison
The plots and tables show the results of a comparison of serum and urine samples analyzed on the VITROS 950 System
with those analyzed using the flame photometry comparative method. 11
The tables, for serum and urine respectively, summarize the results of regression analyses of data obtained from
measurements with both the VITROS 250 and 5,1 FS Systems compared to measurements with the VITROS 950 System.
In addition, the tables for serum and urine summarize the regression analysis of comparisons of results for serum, plasma
and urine samples measured on the VITROS 5600 Integrated System and the VITROS 5,1 FS Chemistry System following
NCCLS Protocol EP9. 17

Serum
Conventional and SI Units
VITROS 950 System (mmol/L)

Comparative Method: Flame Photometry

(mmol/L)

Conventional and SI Units

(mmol/L)
Correlation Range of
n Slope Coefficient Sample Conc. Intercept Sy.x
950 vs. comparative
method 78 0.96 0.997 2.7–13.0 +0.17 0.12
250 vs. 950 79 1.00 1.000 2.5–13.6 -0.03 0.02
5,1 FS† vs. 950 79 1.00 1.000 2.5–13.6 -0.05 0.02
5600†† vs. 5,1 FS† 110 1.00 1.000 1.4–13.8 +0.02 0.04
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Version 9.0 Pub. No. J32746_EN 7 of 13

 K+ INSTRUCTIONS FOR USE
Potassium Performance Characteristics

Urine
Conventional and SI Units
VITROS 950 System (mmol/L)

Comparative Method: Flame Photometry

(mmol/L)

Conventional and SI Units

(mmol/L)
Correlation Range of
n Slope Coefficient Sample Conc. Intercept Sy.x
950 vs. comparative
method 79 0.99 0.997 12.4–170.6 +1.62 2.63
250 vs. 950 79 1.00 1.000 13.7–130.7 -0.15 0.31
5,1 FS† vs. 950 79 1.00 1.000 13.7–130.7 -0.09 0.29
5600†† vs. 5,1 FS† 110 1.01 1.000 6.0–170.8 +0.06 0.47
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Precision
Precision was evaluated with quality control materials on VITROS 250 and 5,1 FS Chemistry Systems and the VITROS
5600 Integrated System following NCCLS protocol EP5. 18
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.

Serum
Conventional and SI Units
(mmol/L)
Mean Within Within Lab Within Lab No.
Conc. Day SD* SD** CV%** Observ. No. Days
2.8 0.02 0.02 0.71 88 22
250 5.1 0.04 0.05 0.98 88 22
5.8 0.03 0.04 0.69 88 22
2.7 0.02 0.02 0.74 88 22
5,1 FS† 5.1 0.03 0.03 0.59 88 22
5.8 0.04 0.04 0.69 88 22
2.8 0.02 0.03 1.07 100 25
5600††
5.3 0.03 0.05 0.94 100 25
* Within Day precision was determined using two runs/day with two replications per run.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Note: Urine control samples were prepared daily following the protocol given in the
urine specimen preparation section.

8 of 13 Pub. No. J32746_EN Version 9.0

 INSTRUCTIONS FOR USE K+
Performance Characteristics Potassium

Urine
Conventional and SI Units
(mmol/L)
Mean Within Within Lab Within Lab No.
Conc. Day SD* SD** CV%** Observ. No. Days
9.7 0.08 0.10 1.03 84 21
250 49.7 0.44 0.57 1.15 84 21
100.2 0.87 1.09 1.09 84 21
10.2 0.10 0.12 1.18 84 21
5,1 FS† 54.2 0.51 0.55 1.05 84 21
105.9 1.03 1.20 1.13 84 21
9.6 0.08 0.14 1.46 100 25
5600††
49.7 0.47 0.91 1.83 100 25
* Within Day precision was determined using two runs/day with two replications per run.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Specificity
Substances that Do Not Interfere: Serum/Plasma
The substances listed in the table below were tested with the VITROS K+ Slides at a potassium concentration of 4.1 mmol/L
following CLSI Protocol EP7 19 and found not to interfere, bias <0.26 mmol/L at the concentration shown.
Compound Concentration Compound Concentration
acetaminophen 20 mg/dL 1.3 mmol/L ibuprofen 70 mg/dL 3.4 mmol/L
acetylsalicylic acid 35 mg/dL 1.9 mmol/L intralipid 800 mg/dL 8 g/L
alprazolam 20 µg/dL 648 nmol/L isoniazid 0.4 mg/dL 29.2 µmol/L
para-aminosalicylic acid 23 mg/dL 1.7 mmol/L L-dopa 0.6 mg/dL 30.4 µmol/L
5‑aminosalicylic acid 23 mg/dL 1.5 mmol/L levothyroxine 375 µg/dL 4.8 µmol/L
amitriptyline 1 µg/mL 3.6 µmol/L lithium 1 mEq/L 1 mmol/L
amoxicillin 1500 µg/mL 4.1 mmol/L loratadine 100 ng/mL 261 nmol/L
ascorbic acid 3 mg/dL 170 µmol/L magnesium 4.5 mg/dL 1.85 mmol/L
atenolol 20 µg/mL 75.1 µmol/L meprobamate 2 mg/dL 91.6 µmol/L
bilirubin 40 mg/dL 684 µmol/L 6‑mercaptopurine 1.5 mg/dL 98.5 µmol/L
calcium 16 mg/dL 4 mmol/L naproxen 900 µg/mL 3.9 mmol/L
carbamazepine 60 µg/mL 254 µmol/L nifidepine 0.2 mg/dL 5.8 µmol/L
cephalexin 400 µg/mL 1.2 mmol/L omeprazole 20 mg/dL 579 µmol/L
ciprofloxacin 5 mg/dL 151 µmol/L phenobarbital 3 mg/dL 129 µmol/L
clarithromycin 25 mg/dL 334 µmol/L phenytoin 10 mg/dL 396 µmol/L
codeine 4 µg/mL 13.4 µmol/L phospholipids as lecithin 500 mg/dL 5 g/L
dextran 3000 mg/dL 750 µmol/L prednisone 0.1 mg/dL 2.8 µmol/L
dextromethorphan 3.8 µg/mL 14.0 µmol/L propoxyphene 0.4 mg/dL 11.8 µmol/L
digoxin 3 µg/dL 38.4 nmol/L pseudoephedrine 20 µg/mL 121 µmol/L
diltiazem 5 µg/mL 12.1 µmol/L ranitidine 20 µg/mL 63.8 µmol/L
diphenhydramine 10 µg/mL 39.1 µmol/L simvastatin 500 mg/L 1.2 mmol/L
enalapril 1.2 µg/mL 3.2 µmol/L sulfamethoxazole 330 mg/dL 13.0 mmol/L
ethanol 394 mg/dL 85.7 mmol/L sulfathiazole 6 mg/dL 235 µmol/L
fluoxetine 0.8 mg/dL 25.9 µmol/L terazosin 1 mg/dL 25.8 µmol/L
furosemide 10 mg/dL 302 µmol/L tolbutamide 22 mg/dL 814 µmol/L
gentisic acid 0.5 mg/dL 32.4 µmol/L total protein 4–10 g/dL 40–100 g/L
glucose 600 mg/dL 33.3 mmol/L triamterene 6 mg/dL 237 µmol/L
glutathione 1 mg/dL 32.5 µmol/L triglycerides 800 mg/dL 9 mmol/L
glyburide 6.4 µg/mL 13.0 µmol/L trimethoprim 25 mg/dL 861 µmol/L
guaifenesin 100 mg/dL 5 mmol/L tyrosine 24 mg/dL 1.3 mmol/L

Version 9.0 Pub. No. J32746_EN 9 of 13

 K+ INSTRUCTIONS FOR USE
Potassium References

Compound Concentration Compound Concentration

hydrochlorothiazide 2 mg/dL 67.2 µmol/L urea 214 mg/dL 35.7 mmol/L
hydrocodone 250 ng/mL 835 nmol/L warfarin 10.7 mg/dL 347 µmol/L
Substances that Do Not Interfere: Urine
The substances listed in the table below were tested with the VITROS K+ Slides at a potassium concentration of 60 mmol/L
following CLSI Protocol EP7 19 and found not to interfere, bias <6.5 mmol/L at the concentration shown.
Compound Concentration Compound Concentration
amphotericin B 3.5 mg/dL 38 µmol/L glyburide 6.4 µg/mL 13 µmol/L
ampicillin 200 mg/dL 5.7 mmol/L hydrochlorthiazide 2 mg/dL 67.2 µmol/L
atenolol 20 µg/mL 75.1 µmol/L ibuprofen 70 mg/dL 3.4 mmol/L
azathioprine 1 mg/dL 36 µmol/L ketoconazole 3 mg/dL 56.5 µmol/L
bumetanide 20 mg/dL 549 µmol/L lead 1 mg/dL 48.3 µmol/L
captopril 2 mg/dL 92 µmol/L methylprednisolone 43 mg/dL 1.15 mmol/L
ceftriaxone 250 mg/dL 4.5 mmol/L metolazone 1 mg/dL 27.3 µmol/L
chlorpropamide 45 mg/dL 1.6 mmol/L naproxen 900 µg/mL 3.9 mmol/L
cisplatin 24 mg/dL 800 µmol/L nifedipine 0.2 mg/dL 5.8 µmol/L
clonidine 2 µg/dL 87 nmol/L nitrofurantoin 2 mg/dL 84 µmol/L
cyclophosphamide 25 mg/dL 958 µmol/L prednisone 0.1 mg/dL 2.8 µmol/L
cyclosporin 1 mg/dL 8.3 µmol/L propranolol 0.5 mg/dL 19 µmol/L
diltiazem 5 µg/mL 12.1 µmol/L sulfamethoxazole 330 mg/dL 13 mmol/L
doxycycline 24 mg/dL 519 µmol/L tobramycin 12 mg/dL 257 µmol/L
fluconazole 40 mg/dL 1.3 mmol/L trimethoprim 25 mg/dL 861 µmol/L
furosemide 10 mg/dL 302 µmol/L vancomycin 30 mg/dL 207 µmol/L
gentamicin 12 mg/dL 256 µmol/L verapamil 90 µg/mL 198 µmol/L
glipizide 10 mg/dL 224 µmol/L
The urine preservatives listed below were tested with the VITROS K+ Slides at a potassium concentration of 60 mmol/L
following CLSI Protocol EP7 19 and found not to interfere, bias <6.5 mmol/L at the concentration shown.
• boric acid – 5.3 g/L
• glacial acetic acid – 10 mL/L
• 12N HCl – 6.7 mL/L
• 10% thymol in isopropanol – 3.3 mL/L
• toluene – 1.3 mL/L

References
1. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 616–618; 1987.
2. CLSI. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition.
CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
3. Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR
Analyzer, and Evaluation of “Plasma Separator Tubes (PST).”Clin. Chem. 35:151–153; 1989.
4. Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
5. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 617; 1987.
6. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical
Microscopy. Northfield, IL: College of American Pathologists; 1992.
7. CLSI. Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI standard GP41. Wayne, PA: Clinical and
Laboratory Standards Institute; 2017.
8. NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—
Fifth Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA, 2004.
9. Slockbower JM, Blumenfeld TA (ed.). Collection and Handling of Laboratory Specimens. Philadelphia: Lippincott Co;
201; 1983.
10. NCCLS. Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS
Document GP16. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898; 1995.
11. Velapoldi R.A., et al. A reference method for the determination of potassium in serum. National Institute of Standards
and Technology Special Publication 260-63. Gaithersburg, MD, 1978.

10 of 13 Pub. No. J32746_EN Version 9.0

 INSTRUCTIONS FOR USE K+
Glossary of Symbols Potassium

12. CLSI.Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline – Third
Edition. CLSI document C24-A3 [ISBN 1-56238-613-1]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2006.
13. Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
14. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
15. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 4. Philadelphia: WB Saunders; 809; 1996.
16. CLSI. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second
Edition. CLSI document EP 17-A2 (IBSN 1-56238-796-0). Clinical and Laboratory Standards Institute, 950 West Valley
Road, Suite 2500, Wayne Pennsylvania 19087 USA, 2012.
17. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document
EP9-A2 [ISBN 1-56238-472-4]. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA;
2002.
18. NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second
Edition. NCCLS document EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA, 2004.
19. CLSI. Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition. CLSI document EP7-A2 [ISBN
1-56238-584-4], CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2005.

Glossary of Symbols

Version 9.0 Pub. No. J32746_EN 11 of 13

 K+ INSTRUCTIONS FOR USE
Potassium Revision History

Revision History
Date of Revision Version Description of Technical Changes*
2019-09-06 9.0 • Added information for the VITROS XT 3400 Chemistry System
• Glossary of Symbols: updated
• Updated EC Representative address
• Removed statement: “for Coatings 800 and above”
• Detection Capability: Section Added
• Added Reference
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.

Signature Obsolete Date

12 of 13 Pub. No. J32746_EN Version 9.0

 INSTRUCTIONS FOR USE K+
Revision History Potassium

Ortho-Clinical Diagnostics
1500 Boulevard Sébastien Brant
B.P. 30335
67411 Illkirch
CEDEX, France

Ortho-Clinical Diagnostics, Inc.

100 Indigo Creek Drive
Rochester, NY 14626
USA

VITROS is a registered trademark of Ortho Clinical Diagnostics.

© Ortho Clinical Diagnostics, 2007–2019

Version 9.0 Pub. No. J32746_EN 13 of 13