Potassium FS*

Diagnostic reagent for quantitative in vitro determination of potassium in serum or plasma on photometric
systems
Order Information
Materials required but not provided
Cat. No.
General laboratory equipment
1 5221 99 10 021 R1 5 x 20 mL + R2 1 x 25 mL

Summary [1-2] Specimen

Serum or lithium heparin plasma
Potassium (K+) is the major cation in the intracellular space (ICS)
and is essential for many body functions, mainly the Stability [3]: 1 week at 20 – 25°C
neuromuscular excitability. The potassium gradient between ICS 1 week at 4 – 8°C
and extracellular space (ECS) is built up by a Na+/K+ pump and 1 year at –20°C
contributes considerably to the electrical potential difference at the Separate from cellular contents within 1 hour after blood collection.
cell membrane. K+ balance is regulated by the kidneys under Do not use hemolytic samples. [4]
hormonal control of the renin-angiotensin-aldosteron system. Discard contaminated specimens. Freeze only once!
Potassium levels in serum are mainly affected by acute and
chronic renal failure, severe diarrhea and vomiting, some Assay Procedure
medication (e. g. ACE inhibitors, angiotensin receptor blockers,
diuretics), disorders of acid balance and massive cell lysis or Application sheets for automated systems are available on
hemolysis after injury, surgery or burns. Furthermore, potassium request.
values are used for monitoring cardiovascular insufficiency, Wavelength 340 nm
changes in blood pH or diuretic therapies. Optical path 1 cm
Temperature 37°C
Method Measurement Against reagent blank
Enzymatic photometric test
Blank Sample or calibrator
Principle
Sample or calibrator - 100 µL
Pyruvate kinase is activated by K+ ions in the sample and Dist. Water 100 µL -
subsequently catalyzes the dephosphorylation of Reagent 1 1000 µL 1000 µL
phosphoenolpyruvate to pyruvate. In a second step pyruvate is Mix, incubate for 5 min. at 37°C
transformed to lactate under consumption of a NADH analogue. Reagent 2 250 µL 250 µL
The signal decrease measured at 340 nm is proportional to the Mix, incubate at 37°C, read absorbance A1 after 2 min. and
amount of potassium in the sample. start stopwatch. Read absorbance A2 after 1 min., absorbance
Reagents A3 after 2 min. and absorbance A4 after 3 min. at 37 °C and
calculate ∆A/min.
Components and Concentrations
ΔA/min. Sample
R1: Buffer pH 8.25 40 mmol/L Potassium [mmol/L] = x Conc. Calibrator [mmol/L]
ΔA/min. Calibrator
NADH analogue 0.4 mmol/L
Phosphoenolpyruvate (PEP) 2.5 mmol/L Calculation
ADP 2.5 mmol/L The concentration of potassium in unknown samples is derived
Lactate dehydrogenase (LDH) > 5 kU/L from a calibration curve using an appropriate mathematical model
R2: Buffer pH 7.0 200 mmol/L such as cubic spline. The calibration curve is obtained with the
Pyruvate kinase (PK) > 0.5 kU/L levels 1 - 4 of the electrolyte calibrator TruCal E.
Storage Instructions and Reagent Stability
Conversion factor
The reagents are stable up to the end of the indicated month of
expiry, if stored at 2 - 8°C, protected from light and contamination Potassium [mmol/L] = Potassium [mEq/L]
is avoided. Do not freeze the reagents! Potassium [mmol/L] x 3.91 = Potassium [mg/dL]

Warnings and Precautions Calibrators and Controls

1. The potassium test is very susceptible to potassium For calibration, DiaSys TruCal E calibrator is recommended. The
contamination. The sole use of ultrapure glass ware and assigned values of TruCal E have been made traceable to the
disposable materials is strongly recommended. NIST Standard Reference Material® SRM 956. DiaSys TruLab N
2. Reagents contain biological material. Handle the product as and P controls should be assayed for internal quality control. Each
potentially infectious according to universal precautions and laboratory should establish corrective action in case of deviations
good laboratory practice. in control recovery.
3. In very rare cases, samples of patients with gammopathy
Cat. No. Kit size
might give falsified results [8]. TruCal E 1 9310 99 10 079 4 x 3 mL
4. Please refer to the safety data sheets and take the necessary TruLab N 5 9000 99 10 062 20 x 5 mL
precautions for the use of laboratory reagents. For diagnostic 5 9000 99 10 061 6 x 5 mL
purposes, the results should always be assessed with the TruLab P 5 9050 99 10 062 20 x 5 mL
patient’s medical history, clinical examinations and other 5 9050 99 10 061 6 x 5 mL
findings.
5. For professional use only!
Waste Management
Please refer to local legal requirements.
Reagent Preparation
The reagents are ready to use.

Potassium FS – Page 1 * Fluid stable

Performance Characteristics
Reference Range
Measuring range
In Plasma
The test has been developed to determine potassium
concentrations within a measuring range from Adults [2] 3.6 – 4.8 mmol/L
2 to 8 mmol/L. Children [6]
0 – 7 days 3.2 – 5.5 mmol/L
Specificity/Interferences 8 – 31 days 3.4 – 6.0 mmol/L
Interfering Substance Interferences Potassium 1 – 6 month(s) 3.5 – 5.6 mmol/L
≤ 4.5% concentration 6 months – 1 year 3.5 – 6.1 mmol/L
Ascorbate up to 60 mg/dL 3.24 mmol/L > 1 year 3.3 – 4.6 mmol/L
up to 60 mg/dL 4.90 mmol/L
Bilirubin, conjugated up to 40 mg/dL 3.26 mmol/L In Serum [7]
up to 50 mg/dL 5.30 mmol/L Adults 3.5 – 5.1 mmol/L
Bilirubin, unconjugated up to 60 mg/dL 3.26 mmol/L Children
up to 60 mg/dL 5.27 mmol/L
Newborn 3.7 – 5.9 mmol/L
Lipemia (Triglyceride) up to 1000 mg/dL 3.09 mmol/L
up to 800 mg/dL 4.84 mmol/L Infant 4.1 – 5.3 mmol/L
Hemoglobin up to 500 mg/dL 2.89 mmol/L Child 3.4 – 4.7 mmol/L
up to 500 mg/dL 5.02 mmol/L
Hemolysis interferes because potassium is released by erythrocytes.
Each laboratory should check if the reference ranges are
Sodium 135 - 180 mmol/L 3.35 mmol/L transferable to its own patient population and determine own
106 - 206 mmol/L 5.34 mmol/L reference ranges if necessary.
Ammonia up to 250 µmol/L 4.61 mmol/L
Calcium 1.8 - 10.0 mmol/L 3.01 mmol/L Literature
2.2 - 10.0 mmol/L 5.02 mmol/L
1. Külpmann WR, Stumvoll HK, Lehmann P. Electrolytes –
Magnesium up to 3.0 mmol/L 4.94 mmol/L
Manganese up to 200 nmol/L 3.03 mmol/L
Clinical and Laboratory Aspects. 1st ed. Wien: Springer-
up to 200 nmol/L 5.16 mmol/L Verlag; 1996. p. 32–41.
Phosphate up to 7.0 mmol/L 3.22 mmol/L 2. Thomas L ed. Clinical Laboratory Diagnostics. 1st ed.
up to 7.0 mmol/L 5.22 mmol/L Frankfurt: TH-Books Verlagsgesellschaft, 1998: p. 306–313.
Zinc up to 500 µmol/L 3.08 mmol/L 3. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
up to 500 µmol/L 4.97 mmol/L 1st ed. Darmstadt: GIT Verlag; 2001; p. 40-1.
Iron up to 1000 µmol/L 3.11 mmol/L 4. Einer G, Zawta B. Präanalytikfibel. 2. Auflage. Heidelberg:
up to 1000 µmol/L 5.14 mmol/L Johann Ambrosius Barth Leipzig; 1991; p. 219–220, 238
Copper up to 500 µmol/L 3.33 mmol/L 5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th.
up to 500 µmol/L 5.28 mmol/L
For further information on interfering substances refer to Young DS [5].
ed. Volume 1 and 2. Washington, DC: The American
Association for Clinical Chemistry Press, 2000.
Limit of Detection 6. Soldin SJ, Brugnara C, Wong EC. Pediatric Reference
The lower limit of detection is 0.4 mmol/L. Intervals. 6th ed. Washington DC: AACC Press, 2007: p. 162-
3.
Precision 7. Tietz textbook of clinical chemistry and molecular diagnostics.
Intra-assay Mean SD CV 4th ed. St. Louis: Elsevier Saunders; 2006. p. 2291.
n = 20 [mmol/L] [mmol/L] [%] 8. Bakker AJ, Mücke M. Gammopathy interference in clinical
Sample 1 4.40 0.05 1.03 chemistry assays: Mechanism, detection and prevention. Clin
Sample 2 4.83 0.05 1.08 Chem Lab Med 2007; 45(9): 1240–1243.
Sample 3 7.05 0.08 1.17
Manufacturer
Inter-assay Mean SD CV DiaSys Diagnostic Systems GmbH
n = 20 [mmol/L] [mmol/L] [%] IVD Alte Strasse 9 65558 Holzheim Germany
Sample 1 3.26 0.07 1.99
Sample 2 4.33 0.16 3.73
Sample 3 7.06 0.16 2.20
Method Comparison
A comparison of DiaSys Potassium FS (y) to the reference method
Flame Atomic Emission Spectrometry (FAES, x) using 108
samples gave following results:
y = 0.962 x + 0.118 mmol/L; r = 0.991.

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