SYNCHRON System(s) CRP

Chemistry Information Sheet C-Reactive Protein

© 2020 Beckman Coulter, Inc. All rights reserved.
465131 (200 tests/cartridge)

For In Vitro Diagnostic Use

Rx Only

ANNUAL REVIEW
Reviewed by Date Reviewed by Date

PRINCIPLE
INTENDED USE

CRP reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is
intended for quantitative determination of c-reactive protein concentration in human serum or plasma.

CLINICAL SIGNIFICANCE

C-reactive protein measurements are useful in the clinical evaluation of stress, trauma, infection, inflammation, and
surgery.

METHODOLOGY

CRP reagent is used to measure the c-reactive protein concentration by a turbidimetric method.1,2 In the reaction,
c-reactive protein combines with specific antibody to form insoluble antigen-antibody complexes.
The SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into a cuvette. The
ratio used is one part sample to 26 parts reagent. The system monitors the change in absorbance at 340 nanometers.
This change in absorbance is proportional to the concentration of C-reactive protein in the sample and is used by the
System to calculate and express C-reactive protein concentration based upon a single-point adjusted, pre-determined
calibration curve.

CHEMICAL REACTION SCHEME

Chemistry Information Sheet A18484 AN English CRP

FEBRUARY 2020 Page 1 of 12
SPECIMEN
TYPE OF SPECIMEN

Biological fluid samples should be collected in the same manner routinely used for any laboratory test.3 Freshly drawn
serum or plasma are the preferred specimens. Acceptable anticoagulants are listed in the PROCEDURAL NOTES
section of this chemistry information sheet. Whole blood or urine are not recommended for use as a sample.

SPECIMEN STORAGE AND STABILITY

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.4
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.4
Additional specimen storage and stability conditions as designated by this laboratory:

SAMPLE VOLUME

The optimum volume, when using a 0.5 mL sample cup, is 0.3 mL of sample. For optimum primary sample tube volumes
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:

CRP English Chemistry Information Sheet A18484 AN

Page 2 of 12 FEBRUARY 2020
SPECIMEN HANDLING

Special instructions for specimen handling as designated by this laboratory:

REAGENTS
CONTENTS

Each kit contains the following items:

Two CRP Reagent Cartridges (2 x 200 tests)
One lot-specific Parameter Card

VOLUMES PER TEST

Sample Volume 10 µL
ORDAC Sample Volume 4 µL
Total Reagent Volume 260 µL
Cartridge Volumes
A 250 µL
B – –
C 10 µL

REACTIVE INGREDIENTS

REAGENT CONSTITUENTS
Polyclonal anti-CRP Antibody (Goat) 3.5 mL
Reaction Buffer 63.4 mL
Also non-reactive chemicals necessary for optimal system performance.

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.

Chemistry Information Sheet A18484 AN English CRP

FEBRUARY 2020 Page 3 of 12
GHS HAZARD CLASSIFICATION

Not classified as hazardous

Safety Data Sheet is available at techdocs.beckmancoulter.com

MATERIALS NEEDED BUT NOT SUPPLIED WITH REAGENT KIT

SYNCHRON Systems CAL 5 Plus

At least two levels of control material
Saline

REAGENT PREPARATION

No preparation is required.

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

CRP reagent when stored unopened at +2°C to +8°C, will obtain the shelf-life indicated on the cartridge label. Once
opened, the reagent is stable for 60 days at +2°C to +8°C unless the expiration date is exceeded. DO NOT FREEZE.
Reagent storage location:

CALIBRATION
CALIBRATOR REQUIRED

SYNCHRON Systems CAL 5 Plus

CALIBRATOR PREPARATION

No preparation is required.

CALIBRATOR STORAGE AND STABILITY

SYNCHRON Systems CAL 5 Plus is stable until the expiration date printed on the calibrator bottle if stored capped in
the original container at +2°C to +8°C.

CRP English Chemistry Information Sheet A18484 AN

Page 4 of 12 FEBRUARY 2020
 CAUTION
Because this product is of human origin, it should be handled as though capable
of transmitting infectious diseases. Each serum or plasma donor unit used
in the preparation of this material was tested by United States Food and Drug
Administration (FDA) approved methods and found to be negative for antibodies
to HIV and HCV and nonreactive for HbsAg. Because no test method can offer
complete assurance that HIV, hepatitis B virus, and hepatitis C virus or other
infectious agents are absent, this material should be handled as though capable
of transmitting infectious diseases. This product may also contain other human
source material for which there is no approved test. The FDA recommends such
samples to be handled as specified in Centers for Disease Control's Biosafety
Level 2 guidelines.5

Calibrator storage location:

CALIBRATION INFORMATION

1. The system must have a lot-specific parameter card and a valid calibration adjustment in memory before controls
or patient samples can be run.
2. Under typical operating conditions the CRP reagent cartridge must be calibrated every 30 days and also with certain
parts replacements or maintenance procedures, as defined in UniCel DxC 600/800 System Instructions For Use
(IFU) manual. This assay has within-lot calibration available. Refer to the UniCel DxC 600/800 System Instructions
For Use (IFU) manual for information on this feature.
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 reagent cartridge, 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.

Chemistry Information Sheet A18484 AN English CRP

FEBRUARY 2020 Page 5 of 12
Table 1.0 Quality Control Material
CONTROL NAME SAMPLE TYPE STORAGE

TESTING PROCEDURE(S)
1. If necessary, load the reagent onto the system.
2. After reagent load is completed, calibration may be required.
3. Program samples and controls for analysis.
4. After loading samples and controls onto the system, follow the protocols for system operations.
For detailed testing procedures, refer to the UniCel DxC 600/800 System Instructions For Use (IFU) manual.

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 following reference
intervals were taken from literature and a study performed on SYNCHRON Systems.6

Table 2.0 Reference intervals

INTERVALS SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS
Literature Serum or Plasma < 1.0 mg/dL < 10.0 mg/L
SYNCHRON Serum or Plasma < 1.0 mg/dL < 10.0 mg/L

INTERVALS SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS

Laboratory
Refer to References (7,8,9) for guidelines on establishing laboratory-specific reference intervals.

CRP English Chemistry Information Sheet A18484 AN

Page 6 of 12 FEBRUARY 2020
Additional reporting information as designated by this laboratory:

PROCEDURAL NOTES
ANTICOAGULANT TEST RESULTS

The following anticoagulants were assessed by Deming regression analysis with 50 paired human serum and plasma
samples. Values of serum (X) ranging from 0.7 mg/dL to 14.9 mg/dL were compared with the values for plasma (Y)
yielding the following results.

Table 3.0 Anticoagulant Test Resultsa

DEMING REGRESSION ANALYSIS
ANTICOAGULANT LEVEL OF ANTICOAGULANT TESTED (mg/dL)
Lithium Heparin 14 Units/mL Y = 1.042X - 0.45; r = 0.977
Sodium Heparin 14 Units/mL Y = 0.994X - 0.07; r = 0.989
a Data shown was collected using SYNCHRON CX Systems. Equivalency between SYNCHRON LX Systems has been established by Deming
regression analysis to SYNCHRON CX Systems.

LIMITATIONS

Neonatal samples should not be tested using the SYNCHRON CRP turbidimetric assay.10, 11

INTERFERENCES

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

Table 4.0 Interferencesa

SUBSTANCE SOURCE LEVEL TESTED OBSERVED EFFECT
Hemoglobin RBC hemolysate 500 mg/dL NSIb
Bilirubin Porcine 30 mg/dL NSI
Lipemia Human 1+ NSI
Rheumatoid Factor Human 400 IU/mL NSI
a Data shown was collected using SYNCHRON CX Systems. Equivalency between SYNCHRON LX Systems has been established by Deming
regression analysis to SYNCHRON CX Systems.
b NSI = No Significant Interference (within ± 0.4 mg/dL or 10%).

2. Lipemic specimens should be delipidated by ultra centrifugation (90,000 x g for 10 minutes) prior to determination
of CRP concentration.
3. Refer to References (12,13,14) for other interferences caused by drugs, disease and preanalytical variables.

Chemistry Information Sheet A18484 AN English CRP

FEBRUARY 2020 Page 7 of 12
PERFORMANCE CHARACTERISTICS
ANALYTIC RANGE

The SYNCHRON System(s) method for the determination of c-reactive protein provides the following analytical range:

Table 5.0 Analytical Range

SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS
Serum or Plasma 0.5 – 20.0 mg/dL 5.0 – 200.0 mg/L
Serum or Plasma (ORDAC) 15.0 – 48.8 mg/dL 150.0 – 488.0 mg/L
Samples with concentrations outside of the analytical range will be reported as "<0.5 mg/dL" ("<5.0 mg/L") or ">20
mg/dL" (">200.0 mg/L"). (ORDAC "<15.0 mg/dL" or ">48.8 mg/dL")
Samples reported out as greater than the analytical range should be confirmed by enabling ORDAC, or diluting with
saline, and reanalyzing. If manual dilution is used the appropriate dilution factor should be applied to the reported result.
Samples reported out as "SUPPRESSED" due to RXN ERROR should be reanalyzed.

REPORTABLE RANGE (AS DETERMINED ON SITE):

Table 6.0 Reportable Range

SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS

Samples flagged as "Results Suppressed, Blank Rate-High" should NOT be diluted and re-assayed. It is
recommended an alternate method be used.

SENSITIVITY

Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with 95% confidence.
Sensitivity for CRP determination is 0.5 mg/dL (5.0 mg/L).

EQUIVALENCY

Equivalency was assessed by Deming regression analysis of patient samples to accepted clinical methods.

Serum or plasma (in the range of 0.6 to 15.0 mg/dL):

Y (SYNCHRON LX Systems) = 0.982X - 0.04
N = 77
MEAN (SYNCHRON LX Systems) = 3.4
MEAN (SYNCHRON CX7 DELTA) = 3.5
CORRELATION COEFFICIENT (r) = 0.9987

Y (SYNCHRON LX Systems) = 0.958X - 0.03

N = 77

CRP English Chemistry Information Sheet A18484 AN

Page 8 of 12 FEBRUARY 2020
 Serum or plasma (in the range of 0.6 to 15.0 mg/dL):
MEAN (SYNCHRON LX Systems) = 3.4
MEAN (IMMAGE) = 3.6
CORRELATION COEFFICIENT (r) = 0.9959
Refer to References (15) for guidelines on performing equivalency testing.

PRECISION

A properly operating SYNCHRON System(s) should exhibit precision values less than or equal to the following:

Table 7.0 Precision Values

1 SD CHANGEOVER VALUEa
TYPE OF
PRECISION SAMPLE TYPE mg/dL mg/L mg/dL mg/L % CV
Within-run Serum/Plasma 0.2 2.0 4.0 40.0 5.0
Serum/Plasma (ORDAC) NAb NA NA NA 10.0
Total Serum/Plasma 0.3 3.0 4.0 40.0 7.5
Serum/Plasma (ORDAC) NA NA NA NA 15.0
a 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.
b NA = Not applicable.
Comparative performance data for a SYNCHRON LX System evaluated using the NCCLS Proposed Guideline EP5-T2
appears in the table below.16 Each laboratory should characterize their own instrument performance for comparison
purposes.

Table 8.0 NCCLS EP5-T2 Precision Estimate Method

EP5-T2 Calculated
Test Mean
Point Estimates
TYPE OF No. No. Data Value
IMPRECISION SAMPLE TYPE Systems Pointsa (mg/dL) SD %CV
Within-run Serum Control 1 1 80 1.33 0.05 3.46
Serum Control 2 1 80 4.85 0.05 1.11
Serum Control 3 1 80 7.49 0.06 0.79
Total Serum Control 1 1 80 1.33 0.05 3.96
Serum Control 2 1 80 4.85 0.07 1.40
Serum Control 3 1 80 7.49 0.10 1.32
a The point estimate is based on the 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.

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.

Chemistry Information Sheet A18484 AN English CRP

FEBRUARY 2020 Page 9 of 12
ADDITIONAL INFORMATION
For more detailed information on UniCel DxC Systems, refer to the appropriate system manual.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are
trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
May be covered by one or more pat. -see www.beckmancoulter.com/patents.

SHIPPING DAMAGE

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

REVISION HISTORY

Revision AE
Revised Quality Control section

Revision AF
Updated corporate address; removed EDTA as an Acceptable Anticoagulant claim.

Revision AG
Added Revision History

Revision AH
Added new language requirement: Czech, and Korean.

Revision AJ
Removed references to CX and LX systems as they are discontinued effective 12/2013.
Added Beckman Coulter trademark statement and disclaimer.

Revision AK
Added GHS Classification information

Revision AL
Updates to comply with requirements per Beckman Coulter Global Labeling Policy.

Revision AM
Additional changes to comply with requirements per Beckman Coulter Global Labeling Policy.

Revision AN
Added new language requirement: Bulgarian, Romanian, Serbian, and Vietnamese. Additional changes to comply with
requirements per Beckman Coulter Global Labeling Policy.

CRP English Chemistry Information Sheet A18484 AN

Page 10 of 12 FEBRUARY 2020
SYMBOLS KEY

Table 9.0

Catalogue Number In Vitro Diagnostic

Contents Temperature limit

Manufacturer Expiration Date

Lot Number Safety Data Sheet

CE Mark Consult Instructions for Use

Authorized Representative in the Date of Manufacture

European Community
Caution Biological risks

Reagent Cartridges Bar Code Card

Do Not Freeze Do not reuse

Made in USA of US and Foreign Components

Chemistry Information Sheet A18484 AN English CRP

FEBRUARY 2020 Page 11 of 12
REFERENCES
1. Boyden, A., Button, E., Germerog, D., "Precipitin Testing With Special Reference to the Measurement of Turbidity",
J. Immunol., 57:211 (1947).

2. Hellsing, K., "The Effects of Different Polymers for Enhancement of the Antigen-Antibody Reaction as Measured
with Nephelometry", Protides of the Biological Fluids, 23:579 (1973).

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

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

5. CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, (Washington, D.C.: U.S.
Government Printing Office, 2009). (CDC 21-1112)

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

7. 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 (1994).

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

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

10. Ishibashi, M., et al., Clinical Chemistry, 48:7 pp 1103 1106 (2002).

11. Ng, P.C. "Diagnostic Markers of Infection in Neonates Arch Dis Child Fetal Neonatal Ed. 2004 May; 89(3):F229-35.

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

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

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

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

16. 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

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

CRP English Chemistry Information Sheet A18484 AN

Page 12 of 12 FEBRUARY 2020