SYNCHRON System(s) GLUCm

Chemistry Information Glucose

Sheet 472500

For In Vitro Diagnostic Use

Rx Only

ANNUAL REVIEW

Reviewed by Date Reviewed by Date

PRINCIPLE

INTENDED USE

GLUCm reagent, when used in conjunction with UniCel ® DxC 600/800 System(s) and SYNCHRON®
Systems AQUA CAL 1 and 2, is intended for the quantitative determination of glucose concentration in
human serum, plasma, urine or cerebrospinal fluid (CSF).

CLINICAL SIGNIFICANCE

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders
including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell
carcinoma.

METHODOLOGY

The SYNCHRON System(s) determines GLUCm concentration by an oxygen rate method employing a
Beckman Coulter Oxygen electrode.1,2
A precise volume of sample (10 microliters) is injected in a reaction cup containing a glucose oxidase
solution. The ratio used is one part sample to 76 parts reagent. The peak rate of oxygen consumption is
directly proportional to the concentration of GLUCm in the sample. 3

CHEMICAL REACTION SCHEME

Oxygen is consumed at the same rate as glucose reacts to form gluconic acid.

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Because oxygen consumption rather than peroxide formation is measured, the only requirement for
peroxide is that it must be destroyed by a path not leading back to oxygen. The addition of ethanol to the
reagent causes peroxide to be destroyed in the presence of catalase without yielding oxygen, according
to the following reaction:

To ensure complete destruction of the peroxide, iodide and molybdate are added to the enzyme reagent,
causing the following reaction:

The reaction is effective even after the catalase activity has diminished with length of storage.

SPECIMEN

TYPE OF SPECIMEN

Biological fluid samples should be collected in the same manner routinely used for any laboratory test. 4
Freshly drawn serum, plasma, CSF or properly collected urine (random/timed) are the preferred
specimens. Acceptable anticoagulants are listed in the PROCEDURAL NOTES section of this chemistry
information sheet. Whole blood is not recommended for use as a sample. The use of fluoride as a
glycolysis inhibitor is recommended.

SPECIMEN STORAGE AND STABILITY

1. Tubes of blood are to be kept closed at all times and in a vertical position. It is recommended that the
serum or plasma be physically separated from contact with cells within two hours from the time of
collection.5
2. Separated serum or plasma should not remain at room temperature longer than 8 hours. If assays are
not completed within 8 hours, serum or plasma should be stored at +2°C to +8°C. If assays are not
completed within 48 hours, or the separated sample is to be stored beyond 48 hours, samples should
be frozen at -15°C to -20°C. Frozen samples should be thawed only once. Analyte deterioration may
occur in samples that are repeatedly frozen and thawed. 5
3. It is recommended that urine assays be performed within 2 hours of collection. For timed specimens,
the collection container should be kept in the refrigerator or on ice during the timed period. No
preservative is required.6
4. CSF specimens should be centrifuged and analyzed without delay.

ADDITIONAL SPECIMEN STORAGE AND STABILITY CONDITIONS AS DESIGNATED BY THIS LABORATORY:

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SAMPLE VOLUME

A filled 0.5 mL sample cup is the optimum volume. For optimum primary sample tube volumes in primary
tube samples and minimum volumes, refer to the Primary Tube Sample Template for your system.

CRITERIA FOR UNACCEPTABLE SPECIMENS

Refer to the PROCEDURAL NOTES section of this chemistry information sheet for information on
unacceptable specimens.

CRITERIA FOR SAMPLE REJECTION AS DESIGNATED BY THIS LABORATORY:

PATIENT PREPARATION

SPECIAL INSTRUCTIONS FOR PATIENT PREPARATION AS DESIGNATED BY THIS LABORATORY:

SPECIMEN HANDLING

SPECIAL INSTRUCTIONS FOR SPECIMEN HANDLING AS DESIGNATED BY THIS LABORATORY:

REAGENTS

CONTENTS

Each kit contains the following items:

Two Glucose Reagent Bottles (2 x 2 L)

VOLUMES PER TEST

Sample Volume 10 µL
ORDAC Sample Volume 5 µL
Total Reagent Volume 765 µL

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REACTIVE INGREDIENTS
REAGENT CONSTITUENTS
Glucose Oxidase 150 U/mL
Denatured Ethanol 5%
Potassium Iodide 0.04 mol/L
Ammonium Molybdate 0.03 mol/L
Also non-reactive chemicals necessary for optimal system performance.

GHS HAZARD CLASSIFICATION

Glucose Reagent (Glucose DANGER
Oxidase)

H226 Flammable liquid and vapour.

H334 May cause allergy or asthma symptoms or breathing
difficulties if inhaled.
P210 Keep away from heat, hot surfaces, and sparks. No
smoking.
P261 Avoid breathing vapours.
P284 In case of inadequate ventilation, wear respiratory
protection.
P304+P340 IF INHALED: Remove person to fresh air and keep at rest in
a position comfortable for breathing.
P342+P311 If experiencing respiratory symptoms: Call a POISON
CENTER or doctor/physician.
Glucose Oxidase 1 - 10%
Ethyl Alcohol 1 - 10%

Safety Data Sheet is available at techdocs.beckmancoulter.com

EUROPEAN HAZARD CLASSIFICATION

Glucose Reagent (Glucose Oxidase) Xn;R10-42
R10 Flammable.
R42 May cause sensitization by inhalation.
S16 Keep away from sources of ignition - No smoking.
S36 Wear suitable protective clothing.
S7 Keep container tightly closed.

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MATERIALS NEEDED BUT NOT SUPPLIED WITH REAGENT KIT
SYNCHRON® Systems AQUA CAL 1 and 2
At least two levels of control material
Saline

REAGENT PREPARATION

Prior to use, allow the glucose reagent to equilibrate to room temperature for at least 8 hours. A +25°C
water bath may be used to warm reagent. Invert reagent 5 times to mix.
Inspect for crystals and if present, see instructions for frozen reagent in Reagent Storage and Stability.

ACCEPTABLE REAGENT PERFORMANCE

The acceptability of a reagent is determined by successful calibration and by ensuring that quality control
results are within your facility's acceptance criteria.

REAGENT STORAGE AND STABILITY

GLUCm reagent stored unopened at +2°C to +8°C is stable until the expiration date indicated on each
bottle. The reagent is stable on instrument for 30 days or until the expiration date, if sooner.
If reagent is frozen in transit, thaw completely, warm to room temperature and mix thoroughly by gently
inverting bottle a least 10 times.

REAGENT STORAGE LOCATION:

CALIBRATION

CALIBRATOR REQUIRED

SYNCHRON® Systems AQUA CAL 1 and 2

CALIBRATOR PREPARATION

No preparation is required.

CALIBRATOR STORAGE AND STABILITY

1. If unopened, the calibrators should be stored at +2°C to +8°C until the expiration date printed on the
calibrator bottle. Once opened, the calibrators are stable at room temperature for 30 days.
2. Repetitive refrigeration of the aqueous calibrators may facilitate crystal formation. Once removed from
refrigerated storage, these calibrators should remain at room temperature.

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CALIBRATOR STORAGE LOCATION:

CALIBRATION INFORMATION

1. The system must have a valid calibration in memory before controls or patient samples can be run.
2. Under typical operating conditions the GLUCm assay must be calibrated every 48 hours or with each
new bottle of reagent and also with certain parts replacements or maintenance procedures, as defined
in the UniCel DxC 600/800 Systems Instructions for Use (IFU) manual. Calibration may be required if
the system is powered down for more than five minutes.
3. For detailed calibration instructions, refer to the UniCel DxC 600/800 System Instructions For Use
(IFU) manual.
4. The system will automatically perform checks on the calibration and produce data at the end of
calibration. In the event of a failed calibration, the data will be printed with error codes and the system
will alert the operator of the failure. For information on error codes, refer to the UniCel DxC 600/800
System Instructions For Use (IFU) manual.

TRACEABILITY

For Traceability information refer to the Calibrator instructions for use.

QUALITY CONTROL
At least two levels of control material should be analyzed daily. In addition, these controls should be run
with each new calibration, with each new bottle of reagent, and after specific maintenance or
troubleshooting procedures as detailed in the appropriate system manual. More frequent use of controls
or the use of additional controls is left to the discretion of the user based on good laboratory practices or
laboratory accreditation requirements and applicable laws.
The following controls should be prepared and used in accordance with the package inserts. Discrepant
quality control results should be evaluated by your facility.
NOTICE
Do not use controls containing diethylamine HCl.

TABLE 1 QUALITY CONTROL MATERIAL

CONTROL NAME SAMPLE TYPE STORAGE

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TESTING PROCEDURE(S)
1. If necessary prepare reagent as defined in the Reagent Preparation section of this chemistry
information sheet and load the reagent onto the system.
2. After reagent load is completed, calibration is required.
3. Program samples and controls for analysis.
4. After loading samples and controls onto the system, follow the protocols for system operations.

CALCULATIONS
The SYNCHRON System(s) performs all calculations internally to produce the final reported result. The
system will calculate the final result for sample dilutions made by the operator when the dilution factor is
entered into the system during sample programming.

REPORTING RESULTS
Equivalency between the SYNCHRON LX and UniCel DxC 600/800 Systems has been established.
Chemistry results between these systems are in agreement and data from representative systems may
be shown.

REFERENCE INTERVALS

Each laboratory should establish its own reference intervals based upon its patient population. The
reference intervals listed below were taken from literature and a study performed on SYNCHRON
Systems.7

TABLE 2 REFERENCE INTERVALS

INTERVALS SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS
Literature Serum or Plasma 74 – 106 mg/dL 4.1 – 5.9 mmol/L
Urinea 1 – 15 mg/dL 0.06 – 0.83 mmol/L
Urine (timed)a < 0.5 g/24 hrs < 2.8 mmol/24 hrs
CSF 40 – 70 mg/dL 2.2 – 3.9 mmol/L
SYNCHRON Serum or Plasma 74 – 118 mg/dL 4.1 – 6.6 mmol/L

INTERVALS SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS

Laboratory

Refer to References (8,9,10) for guidelines on establishing laboratory-specific reference intervals.

ADDITIONAL REPORTING INFORMATION AS DESIGNATED BY THIS LABORATORY:

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PROCEDURAL NOTES

ANTICOAGULANT TEST RESULTS

If plasma is the sample of choice, the following anticoagulants were found to be compatible with this
method:

TABLE 3 COMPATIBLE ANTICOAGULANTS

ANTICOAGULANT LEVEL TESTED FOR IN VITRO AVERAGE PLASMA-SERUM BIAS
INTERFERENCE (mg/dL)
Ammonium Heparin 14 Units/mL NSIb
Lithium Heparin 14 Units/mL NSI

Sodium Heparin 14 Units/mL NSI

Potassium Oxalate/Sodium Fluoride 2.0 / 2.5 mg/mL NSI

LIMITATIONS

1. If sodium fluoride is used as a preservative, a decrease of 9 mg/dL is seen during the first 2 hours. 7
2. If urine or CSF samples are cloudy or turbid or if CSF samples are visibly contaminated with blood, it is
recommended that they be centrifuged before transfer to a sample cup.
3. Freshly prepared D-glucose solutions or commercial controls spiked with D-glucose must be allowed
to mutarotate before analysis for accurate results.
4. Oxygenated samples will cause low results. Dilute samples 1:1 with saline or use the hexokinase
cartridge method.

INTERFERENCES

1. The following substances were tested for interference with this methodology:

TABLE 4 INTERFERENCES
SUBSTANCE SOURCE LEVEL TESTED OBSERVED EFFECT
Bilirubin (unconjugated) Bovine 30 mg/dL NSIc
Hemoglobin RBC hemolysate 500 mg/dL NSI

Lipemia Intralipidd 500 mg/dL NSI

2. Lipemic samples with visual turbidity >3+, or with a Lipemia Serum Index >8, should be
ultracentrifuged and the analysis performed on the infranate.
3. Refer to References (11,12,13) for other interferences caused by drugs, disease and preanalytical
variables.

PERFORMANCE CHARACTERISTICS

Analytic Range

The SYNCHRON System(s) method for the determination of this analyte provides the following analytical
ranges:

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TABLE 5 ANALYTICAL RANGE
SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS
Serum/Plasma/Urine/CSF 10 – 600 mg/dL 0.56 – 33.3 mmol/L

Serum/Plasma/Urine/CSF 300 – 1200 mg/dL 16.7 – 66.7 mmol/L

(ORDAC)

Samples with concentrations exceeding the high end of the analytical range should be diluted with saline
and reanalyzed.

REPORTABLE RANGE (as determined on site):

TABLE 6 REPORTABLE RANGE

SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS

SENSITIVITY

Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with
95% confidence. Sensitivity for GLUCm determination is 10 mg/dL (0.56 mmol/L).

EQUIVALENCY

Equivalency was assessed by Deming regression analysis of patient samples to accepted clinical
methods.
Serum or Plasma (in the range of 10 to 571 mg/dL):
Y (UniCel DxC Systems) = 1.005X - 0.165
N = 187
MEAN (UniCel DxC Systems) = 119.3
MEAN (SYNCHRON LX Systems) = 118.8
Correlation Coefficient(r) = 1.000

Urine (in the range of 10 to 628 mg/dL):

Y (UniCel DxC Systems) = 1.014X + 0.385
N = 96
MEAN (UniCel DxC Systems) = 211.0
MEAN (SYNCHRON LX Systems) = 208.5
Correlation Coefficient(r) = 1.000

CSF (in the range of 22 to 552 mg/dL):

Y (UniCel DxC Systems) = 0.982X + 0.43
N = 93
MEAN (UniCel DxC Systems) = 215
MEAN (SYNCHRON LX Systems) = 219

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 CSF (in the range of 22 to 552 mg/dL):
Correlation Coefficient(r) = 1.000

Refer to References (14) for guidelines on performing equivalency testing.

PRECISION

A properly operating SYNCHRON System(s) should exhibit imprecision values less than or equal to the
maximum performance limits in the table below. Maximum performance limits were derived by an
examination of the imprecision of various methods, proficiency test summaries, and literature sources.

TABLE 7 MAXIMUM PERFORMANCE LIMITS

TYPE OF SAMPLE TYPE 1 SD CHANGEOVER VALUEe % CV
PRECISION
mg/dL mmol/L mg/dL mmol/L
Within-run Serum/Plasma/Urine/CSF 2.0 0.1 100.0 5.6 2.0

Total Serum/Plasma/Urine/CSF 3.0 0.2 100.0 5.6 3.0

Within-run Serum/Plasma/Urine/CSF NA f NA NA NA 5.0

(ORDAC)
Total Serum/Plasma/Urine/CSF NA NA NA NA 7.5
(ORDAC)
Comparative performance data for a SYNCHRON LX® System evaluated using the NCCLS Proposed
Guideline EP5-T2 appears in the table below.15 Each laboratory should characterize their own instrument
performance for comparison purposes.

TABLE 8 NCCLS EP5-T2 PRECISION ESTIMATE METHOD

TYPE OF SAMPLE TYPE No. No. Data Test Mean EP5-T2 Calculated
IMPRECISION Systems Pointsg Value Point Estimates
(mg/dL) SD %CV
Within-run Serum Control 1 1 80 43.7 1.3 2.9
Serum Control 2 1 80 397.1 1.7 0.4
Urine Control 1 1 80 37.1 1.0 2.8
Urine Control 2 1 80 289.7 1.8 0.6
CSF Control 1 1 80 35.6 0.8 2.2
CSF Control 2 1 80 111.4 1.1 1.0
Total Serum Control 1 1 80 43.7 1.7 3.9
Serum Control 2 1 80 397.1 4.7 1.2
Urine Control 1 1 80 37.1 1.5 4.0
Urine Control 2 1 80 289.7 8.2 2.8
CSF Control 1 1 80 35.6 1.3 3.6
CSF Control 2 1 80 111.4 1.9 1.7
NOTICE
These degrees of precision and equivalency were obtained in typical testing procedures on a
SYNCHRON LX® System and are not intended to represent the performance specifications for
this reagent.

ADDITIONAL INFORMATION
For more detailed information on UniCel DxC Systems, refer to the appropriate system manual.
Beckman Coulter, the Beckman Coulter Logo, Synchron, UniCel and DxC are trademarks of Beckman
Coulter, Inc and are registered in the USPTO.

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SHIPPING DAMAGE

If damaged product is received, notify your Beckman Coulter Clinical Support Center.

Revision History

REVISION AF

Updated corporate address; updated European Hazard Classification and removed EDTA as an
Acceptable Anticoagulant claim.

REVISION AG

Revised Equivalency examples, and changed sensitivity and low end of analytical range to 10 mg/dL.

REVISION AH

Added Revision History.

REVISION AJ

Added new language requirement: Czech, and Korean.

REVISION AK

Removed references to CX and LX systems as they are discontinued effective 12/2013.

Added Beckman Coulter trademark statement and disclaimer.

REVISION AL

Revised Interferences section.

REVISION AM

Added GHS Classification information

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REFERENCES

1. Kadish, A. H., Hall, D. A., "A New Method for the Continuous Monitoring of Blood Glucose by
Measurement of Dissolved Oxygen", Clin. Chem., 11:869 (1965).

2. Kadish, A. H., Little, R. L., Sternberg, J. C., "A New and Rapid Method for the Determination of
Glucose by Measurement of Rate Oxygen Consumption", Clin. Chem., 144:116 (1968).

3. Morrison, B., "Use of the Beckman Glucose Analyzer for Low and High Glucose Values", Clin.
Chem. Acta, 42:192 (1972).

4. Tietz, N. W., "Specimen Collection and Processing; Sources of Biological Variation", Textbook of
Clinical Chemistry, 5th Edition, W. B. Saunders, Philadelphia, PA (2005).

5. National Committee for Clinical Laboratory Standards, Procedures for the Handling and
Processing of Blood Specimens Approved Guideline, NCCLS publication H18-A, Villanova, PA
(1990).

6. National Committee for Clinical Laboratory Standards, Routine Urinalysis and Collection,
Transportation and Preservation of Urine Specimens Tentative Guideline, NCCLS publication
GP16-T, Villanova, PA (1992).

7. Tietz, N. W., Clinical Guide to Laboratory Tests, 3rd Edition, W. B. Saunders Company,
Philadelphia, PA (1995).

8. National Committee for Clinical Laboratory Standards, How to Define, Determine, and Utilize
Reference Intervals in the Clinical Laboratory Approved Guideline, NCCLS publication C28-A,
Villanova, PA (1995).

9. Tietz, N. W., ed., Fundamentals of Clinical Chemistry, 6th Edition, W. B. Saunders, Philadelphia,
PA (2007).

10. Henry, J. B., Clinical Diagnosis and Management by Laboratory Methods, 22nd Edition, W. B.
Saunders Company, Philadelphia, PA (2006).

11. Young, D. S., Effects of Drugs on Clinical Laboratory Tests, 5th Edition, AACC Press,
Washington, D. C. (2000).

12. Friedman, R. B., Young, D. S.,Effects of Disease on Clinical Laboratory Tests, 4th Edition, AACC
Press, Washington, D.C. (2001).

13. Young, D. S., Effects of Preanalytical Variables on Clinical Laboratory Tests, 3rd Edition, AACC
Press, Washington, D. C. (2007).

14. National Committee for Clinical Laboratory Standards, Method Comparison and Bias Estimation
Using Patient Samples Approved Guideline, NCCLS publication EP9-A, Villanova, PA (1995).

15. National Committee for Clinical Laboratory Standards, Precision Performance of Clinical
Chemistry Devices Tentative Guideline, 2nd Edition, NCCLS publication EP5-T2, Villanova, PA
(1992).

Beckman Coulter Eurocenter S.A., 22, rue Juste-Olivier. Case Postale 1044, CH - 1260 Nyon 1,
Switzerland Tel: +41 (0)22 365 36 11

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 Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, CA 92821 U.S.A.

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ENDNOTES
a In a healthy patient, the normal urine glucose value is zero.
b NSI = No significant Interference (within ±4.0 mg/dL or 4%).
c NSI = No significant Interference (within ±4.0 mg/dL or 4%).
d Intralipid is a registered trademark of KabiVitrum, Inc., Clayton, NC 27250.
e When the mean of the test precision data is less than or equal to the changeover value, compare the
test SD to the SD guideline given above to determine the acceptability of the precision testing. When
the mean of the test precision data is greater than the changeover value, compare the test % CV to
the guideline given above to determine acceptability. Changeover value = (SD guideline/CV guideline)
x 100.
f NA = Not applicable.
g The point estimate is based on the pooled data from one system, run for twenty days, two runs per
day, two observations per run on an instrument operated and maintained according to the
manufacturer's instructions.

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