AU CO2
Instructions For Use BICARBONATE
© 2021 Beckman Coulter, Inc. All rights reserved.
OSR6190 4 x 25 mL R1
OSR6290 4 x 50 mL R1
For in vitro diagnostic use only.
PRINCIPLE
INTENDED USE
System reagent for the quantitative determination of bicarbonate in human serum and plasma on Beckman Coulter
analysers.
SUMMARY AND EXPLANATION
Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated
with changes in body acid-base balance. The determination of bicarbonate (HCO3-) is used in conjunction with other
clinical and laboratory information for the evaluation of acid-base status. An elevation of the HCO3- level may be observed
in compensated respiratory acidosis and metabolic alkalosis. Low HCO3- levels may be observed in compensated
respiratory alkalosis and metabolic acidosis.1 Additional laboratory determinations will permit differentiation between
metabolic and respiratory conditions.
METHODOLOGY
The Bicarbonate reagent utilizes an enzymatic method to measure bicarbonate in human serum and plasma. In this
procedure bicarbonate (HCO3-) and phosphoenolpyruvate (PEP) are converted to oxaloacetate and phosphate in the
reaction catalyzed by phosphoenolpyruvate carboxylase (PEPC). Malate dehydrogenase (MD) catalyzes the reduction
of oxaloacetate to malate with the concomitant oxidation of a reduced nicotinamide adenine dinucleotide (NADH). This
oxidation of the NADH results in a decrease in absorbance of the reaction mixture measured bichromatically at 380/410
nm proportional to the HCO3- content of the sample.
CHEMICAL REACTION SCHEME
PEPC
PEP + HCO3- Oxaloacetate + H2PO4-
Magnesium
MD
Oxaloacetate + NADH + H+ Malate + NAD+
SPECIMEN
TYPE OF SPECIMEN
Serum and heparinised plasma samples free from haemolysis are the recommended specimens. Separate serum or
plasma from cells promptly to minimise haemolysis.
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Once separated from cells, HCO3- in serum is stable for several hours when stored at 2...8°C and protected from
exposure to air.2
REAGENTS
WARNING AND PRECAUTIONS
Exercise the normal precautions required for handling all laboratory reagents.
Dispose of all waste material in accordance with local guidelines.
This product contains material of animal origin. The product should be considered as potentially capable of transmitting
infectious diseases.
REACTIVE INGREDIENTS
Final concentration of reactive ingredients:
MD (microbial) > 2,000 U/L
PEPC (microbial) > 572 U/L
NADH 1.6 mmol/L
PEP 8.2 mmol/L
Magnesium 2.8 mmol/L
Also contains preservatives.
CAUTION
Sodium azide preservative may form explosive compounds in metal drain lines.
See NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
To avoid the possible build-up of azide compounds, flush wastepipes with
water after the disposal of undiluted reagent. Sodium azide disposal must be in
accordance with appropriate local regulations.
GHS HAZARD CLASSIFICATION
Not classified as hazardous
Safety Data Sheet is available at [Link]/techdocs
REAGENT PREPARATION
The reagent is ready for use and can be placed directly on board the instrument.
STORAGE AND STABILITY
The reagent is stable unopened, up to the stated expiry date when stored at 2…8°C. Once open, reagent stored on
board the instrument is stable for 7 days.
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CALIBRATION
CALIBRATOR REQUIRED
Bicarbonate Calibrator Cat No. ODC0019.
The calibrator bicarbonate value is traceable to the National Institute of Standards and Technology (NIST) Standard
Reference Material (SRM) 351.
Recalibrate the assay every day, or when the following occur:
Change in reagent lot number or significant shift in control values;
Major preventative maintenance was performed on the analyser or a critical part was replaced.
Absorption of atmospheric CO2 by the reagent on board the analyzer can impair calibration stability. This effect will
vary depending upon the rate of use. Consequently each laboratory should set a calibration frequency in the instrument
parameters appropriate to their usage pattern.
QUALITY CONTROL
Control materials with values determined by this Beckman Coulter system may be used.
Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be
tested each day patient samples are tested and each time calibration/blanking is performed.
The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that
each laboratory generates analyte specific control target values and intervals based on multiple runs according to their
requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product
literature.
If any trends or sudden shifts in values are detected, review all operating parameters.
Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified
limits.
TESTING PROCEDURE(S)
Refer to the appropriate Beckman Coulter AU analyser User Guide/Instructions For Use (IFU) for analyser-specific assay
instructions for the sample type as listed in the Intended Use statement. The paediatric application is suitable for use
with small volume serum/plasma samples.
CALCULATIONS
The Beckman Coulter analysers automatically compute the bicarbonate concentration of each sample.
REPORTING RESULTS
REFERENCE INTERVALS
Reference3,4
Adult 21 − 31 mmol/L
Newborn 17 − 24 mmol/L
Infant 19 − 24 mmol/L
2 months − 2 years 16 − 24 mmol/L
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Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify
the transferability of the expected values to its own population, and if necessary determine its own reference interval
according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with
the patient's medical history, clinical examinations and other findings.
PROCEDURAL NOTES
INTERFERENCES
Interfering Substances5
Results of studies conducted to evaluate the susceptibility of the method to interference were as follows:
AU600/AU640
Lipemia: Interference less than 5% up to 1,000 mg/dL Intralipid.
Haemolysis: Interference less than 10% up to 500 mg/dL haemoglobin
Icterus: Interference less than 5% up to 40 mg/dL billirubin
Refer to Young6 for further information on interfering substances.
PERFORMANCE CHARACTERISTICS
PERFORMANCE CHARACTERISTICS
Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your
laboratory may differ from these values.
LIMITATIONS
Visible signs of a crystalline precipitate which settles out upon storage may be evident in the reagent bottle. Reagent with
crystalline precipitate may be used without affecting results. However, if any trends or sudden shifts in control values
are detected, which are not corrected by recalibration then an alternative vial of reagent should be used.
LINEARITY
The test is linear within a concentration range of 2.0 to 45.0 mmol/L.
SENSITIVITY
The lowest detectable level on an AU640 analyser was estimated at 0.71 mmol/L.
The lowest detectable level represents the lowest measurable level of bicarbonate that can be distinguished from zero.
It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.
METHODS COMPARISON
Patient samples were used to compare this Bicarbonate Reagent OSR6190 on an AU640 to a blood gas analyzer
method.
y = 0.999x – 1.207 r = 0.98 n = 102 Sample range = 9.4 – 32.2 mmol/L
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PRECISION
The following data was obtained7 on an AU640 using 3 serum pools analysed over 20 days.
n = 80 Within-run Total
Mean mmol/L SD CV% SD CV%
9.0 0.37 4.15 0.63 7.02
25.1 0.29 1.15 0.58 2.31
34.9 0.37 1.05 0.71 2.02
ADDITIONAL INFORMATION
DxC 700 AU requires that each reagent application has a standard format of abbreviated Closed Test Name. This Closed
Test Name is required to allow automated loading of the calibrator information for each application as part of the DxC
700 AU Closed System. Refer to the table below for the Closed Test Name assigned to each application for this assay.
Test Name Description
CO21N Bicarbonate (Serum)
CO21NP Bicarbonate (Serum Paediatric)
Setting Sheet Footnotes
# User defined
† Bicarbonate Calibrator Catalogue Number ODC0019
* Values set for working in mmol/L
‡ Depends on usage pattern in the laboratory.
REVISION HISTORY
Added new languages
Preceding version revision history
IFU updated to add Ukrainian language
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REFERENCES
1. Tietz, N.W., Hg., Fundamentals of Clinical Chemistry, 3rd edition, W.B. Saunders Company, 1999.
2. WHO/DIL/LAB/99.1 Rev.2; Use of anticoagulants in diagnostic laboratory investigations, 2002.
3. Kaplan, L.A. and Pesce, A.J. Clinical Chemistry Theory, Analysis, Corelation 3rd Edition, CV Mosbey, 1996.
4. Painter PC, Cope JY, Smith JL. Reference information for the clinical laboratory. In: Burtis CA, Ashwood ER, eds.
Tietz textbook of clinical chemistry. Philadelphia:WB Saunders Company, 1999;1803pp.
5. NCCLS, Interference Testing in Clinical Chemistry EP7-P, 1986.
6. Young DS. Effects of Drugs on Clinical Laboratory Tests, AACC, 5th ed. AACC Press, 2000.
7. NCCLS, Evaluation Protocol EP5-A, 1999.
Beckman Coulter Ireland Inc., Lismeehan, O’Callaghan’s Mills, Co. Clare, Ireland +(353) (0) 65 683 1100
[Link]
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