IMMAGE ®Immunochemistry Systems CCRP Chemistry Information Sheet ©Copyright 2010Beckman Coulter,Inc.
H i g h S e n s i t i v i t y C a r d i a c C -R e a c t i v e P r o t e i n
REF A38656
reactive materials studiesFor In Vitro Diagnostic Use
This document is for use with IMMAGE ®800Immunochemistry System only
ANNUAL REVIEW Reviewed by:
Date
Reviewed by:
Date
PRINCIPLE
INTENDED USE
High Sensitivity Cardiac C-Reactive Protein (CCRP)reagent,when used in conjunction with IMMAGE ®800Immunochemistry Systems and Calibrator 5Plus,is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry.CLINICAL SIGNIFICANCE
Measurement of C-Reactive protein (CRP)aids in evaluation of stress,trauma,infection,inflammation,surgery,and associated diseases.Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease.When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes,CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.SUMMARY AND EXPLANATION
Blood levels of C-Reactive Protein are known to rise rapidly from normal baseline levels of <0.3mg/dL to as high as 50mg/dL as part of the body‘s non-specific inflammatory response to infection or injury.1,2,3,4,5,6In more recent years,the utility of measuring CRP has expanded from its historical use as a sensitive marker of acute inflammation to include assessment of cardiac events and risk.
A prognostic value for measuring CRP has been determined from studies with cardiac patients where elevated levels of CRP were associated with a higher risk of having a future cardiac event.7,8,9,10Elev
ated levels of CRP have been associated with poor prognosis in cases of stable angina,unstable angina and myocardial infarction.7,8,9,10
Cardiac disease is believed to be the end result of interplay between minor changes in the cardiovascular endothelium and the corresponding inflammatory response to these changes.11The ability to measure CRP at extremely low concentrations has raised the possibility of using CRP to detect early inflammatory responses and potentially detect cardiac disease in the preclinical stages.Recent evidence supporting this potential application has shown that high baseline values of CRP in individuals without a history of cardiac disease were associated with an increased incidence of subsequent cardiac events.12,13
The Centers for Disease Control and the American Heart Association (CDC/AHA)recommends the following cardiovascular disease risk assessment guidelines for CRP.14,15
Table1.0CARDIOVASCULAR RISK CLASSIFICATION
RISK LEVEL CRP(mg/L)CRP(mg/dL)
Low<1.0<0.10
Average  1.0–3.00.10–0.30
High>3.0>0.30
It is important to note that baseline CRP values are known to be influenced by various non-pathological factors(age, gender,obesity,hormone replacement therapy,smoking)and a single measurement may lead to an erroneous assessment of early cardiac inflammation.16,17,18,19,20Increases in CRP levels are non-specific and should not be interpreted without a complete clinical history.It is recommended,therefore,that any estimations of inflammation be based on changes in CRP values from multiple measurements and be used in conjunction with the values of other cardiac risk ,HDL,cholesterol,etc.).
METHODOLOGY
The IMMAGE®800Immunochemistry Systems CCRP reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology.An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity.The rate of aggregate formation is directly proportional to the concentration of CRP in the sample.
CHEMICAL REACTION SCHEME
SPECIMEN
TYPE OF SPECIMEN
Serum samples are recommended.Plasma samples(EDTA,Lithium Heparin,and Sodium Heparin)can be used. Serum or plasma samples should be collected in the manner routinely used for any clinical laboratory test.6Freshly drawn serum or plasma from a fasting individual is preferred.Anticoagulants tested are listed in the PROCEDURAL NOTES section of this chemistry information sheet.
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.21
2.If serum samples are not assayed within8hours,samples should be stored at+2°C to+8°C.If samples are not
assayed within72hours,samples should be stored frozen at-15°C to-20°C.Frozen samples should be th
awed only once.Analyte deterioration may occur in samples that are repeatedly frozen and thawed.21
3.Plasma samples can be stored at+2°C to+8°C for up to72hours.Plasma samples should not be frozen. Additional specimen storage and stability conditions as designated by this laboratory:
SAMPLE VOLUME
For sample volumes refer to the Sampling Template.
CRITERIA FOR UNACCEPTABLE SPECIMENS
Refer to the PROCEDURAL NOTES section of this chemistry information sheet. 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:
KIT COMPONENTS QUANTITY
CCRP Cartridge2
Antibody
Evaporation Caps4
CCRP Reagent Bar Code Card1
INITIAL VOLUMES OF SAMPLE AND REAGENTS IN THE CUVETTE
Sample Volume  4.5µL
Total Reagent Volume209µL Antibody-coated particle42µL
Buffer4125µL
Diluent42µL REACTIVE INGREDIENTS
REAGENT CARTRIDGE CONSTITUENTS VOLUME CRP Antibody(particle bound goat and mouse anti-CRP
antibody)
7.8mL Diluent7.8mL Sodium Azide(used as a preservative)<0.1%(w/w) Bovine Serum Albumin0.1%(w/v) Also non-reactive chemicals necessary for optimal system performance.
EUROPEAN HAZARD CLASSIFICATION
High Sensitivity Cardiac C-Reactive Protein Reagent(Compartment B)N;R51/53Toxic to aquatic organisms,may cause long-term adverse effects in aquatic environment.
MATERIALS NEEDED BUT NOT SUPPLIED WITH REAGENT KIT IMMAGE Immunochemistry Systems Wash Solution
IMMAGE Immunochemistry Systems Diluent1
IMMAGE Immunochemistry Systems Buffer4
Calibrator5Plus
Centrifuge capable of90,000x g
At least two levels of control material
REAGENT PREPARATION
1.Invert cartridge gently before removing screw caps.
2.Remove screw caps from reagent cartridges.Check each cartridge for bubbles and remove any bubbles present.
3.Place evaporation caps on both reagent cartridge compartments before loading the cartridge on the i
nstrument.
See Appendices for evaporation cap directions.
4.Reagent cartridges should be stored upright and can be removed from the refrigerator and used immediately.
5.Mix all buffers and diluents thoroughly by inversion.Remove screw cap from container.Check each container for
bubbles and remove any bubbles present.Place evaporation cap on container before loading the container on the instrument.See Appendices for evaporation cap directions.
ACCEPTABLE REAGENT PERFORMANCE
Acceptability of a reagent is determined from the successful performance of quality control testing,as defined in the QUALITY CONTROL section of this chemistry information sheet.
REAGENT STORAGE AND STABILITY
Storage conditions other than those recommended may cause erroneous results.
Reagent Cartridges
1.Return all reagent cartridges to the refrigerator(+2°C to+8°C)upon completion of the daily workload.
2.The CCRP reagents are stable for30days with the evaporation caps in place.Alternatively,reagent life can be
maximized by replacing evaporation caps with screw caps and storing at+2°C to+8°C upon completion of the daily workload.
3.The CCRP reagent is stable until the expiration date on the label if stored at+2°C to+8°C with the screw caps in
place.
Diluent1and Buffer4
1.Diluent1and Buffer4are stable on the system for30days with the evaporation cap in place.
2.Diluent1and Buffer4are stable until the expiration date on the label if stored at room temperature with the screw
cap in place.
Reagent storage location:
CALIBRATION
CALIBRATOR REQUIRED
Calibrator5Plus
CALIBRATOR PREPARATION
No preparation is required.
CALIBRATOR STORAGE AND STABILITY
The calibrator is stable until the expiration date printed on the calibrator bottle if stored capped in the original container at+2°C to+8°C.

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