INSTRUCTIONS FOR USE

CRP
C-Reactive Protein

VITROS Chemistry Products CRP Slides

192 6740
809 7990

Intended Use

For in vitro diagnostic use only.

VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma
using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Summary and Explanation of the Test

C-reactive protein is synthesized by the liver and is one of the acute phase proteins. In the acute phase response, increased
concentrations of a number of plasma proteins, including CRP, are observed.1
CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and
infections.2, 3

Principles of the Procedure

The VITROS CRP Slide method is performed using the VITROS CRP Slides and the VITROS Chemistry Products Calibrator
Kit 7 on VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The VITROS CRP Slide is a multilayered, analytical element coated on a polyester support.
The immuno-rate format for CRP is based on an enzymatic heterogeneous, sandwich immunoassay format. In this format a
derivative of phosphorylcholine (PC) is covalently bound to polystyrene polymer beads and in the presence of calcium serves
as a capture agent. Monoclonal anti-CRP antibody conjugated to horseradish peroxidase (HRP) serves as a signal generator.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers.
CRP in the sample binds to PC-linked capture beads and anti-CRP antibody labeled with horseradish peroxidase to form an
insoluble sandwich complex in Incubation 1. The subsequent addition of 12 L of VITROS Immuno-Wash Fluid to the slide
removes unbound materials from the read area, while also providing the hydrogen peroxide required for the enzyme-mediated
oxidation of leuco dye.
The reflection density of the dye is measured after the addition of VITROS Immuno-Wash Fluid at the end of Incubation 2.
This reflection density is directly proportional to the concentration of CRP in the sample. To determine if an adequate wash
has occurred, the wash detection dye is read at 540 nm immediately after Incubation 2.

Test Type and Conditions

Test Type
Fixed-point
immuno-rate

VITROS System
5600, 4600,
5,1 FS, 950,
250/350

Approximate
Incubation Time
Incubation 1: 5
minutes
Incubation 2: 2.5
minutes

Temperature

Wavelength

Reaction Sample
Volume

37 C (98.6 F)

670 nm

11 L

Not all products and systems are available in all countries.

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C-Reactive Protein

Warnings and Precautions

Reaction Scheme
CRP + PC* + AbHRP

Ca2+

PC*-CRP-AbHRP + AbHRP

Immuno-Wash + PC*-CRP-AbHRP + AbHRP

wash

H2O2 + leuco dye + PC*-CRP-AbHRP

PC*-CRP-AbHRP
dye + 2 H2O

PC* = phosphorylcholine beads

AbHRP = anti-CRP monoclonal antibody labeled with horseradish peroxidase

Warnings and Precautions

For in vitro diagnostic use only.

WARNING:

Take care when handling materials and samples of human origin. Since no test
method can offer complete assurance that infectious agents are absent, consider all
clinical specimens, controls, and calibrators potentially infectious. Handle specimens,
solid and liquid waste, and test components in accordance with local regulations and
CLSI Guideline M294 or other published biohazard safety guidelines.

For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the Instructions
for Use for the appropriate VITROS product, or to other manufacturers product literature.

Reagents
Slide Diagram

Slide Ingredients
Reactive Ingredients per cm2

Immobilized phosphorylcholine 0.07 mg; mouse anti-CRP

antibody labeled with horseradish peroxidase 0.0006 U; calcium
chloride 0.08 mg; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis
(4-dimethylaminophenyl) imidazole (leuco dye) 0.04 mg.

Other Ingredients

1. Upper slide mount

2. Spreading layer (beads)

CaCl2
wash detection dye
immobilized phosphorylcholine
anti-CRP antibody horseradish
peroxidase conjugate
leuco dye

3. Buffer layer: buffer, pH 7.0

4. Support layer
5. Lower slide mount

Binders, buffer, surfactants, cross-linking agent, polymer beads,

proteins, stabilizers and wash detection dye.

Reagent Handling
Caution:

Do not use slide cartridges with damaged or incompletely sealed packaging.

Inspect the packaging for signs of damage.

Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product
packaging.

Reagent Preparation
IMPORTANT:

The slide cartridge must reach room temperature, 1828 C (6482 F), before it is
unwrapped and loaded into the slide supply.

1. Remove the slide cartridges from storage.

2. Warm the wrapped cartridge at room temperature for 60 minutes.
3. Unwrap and load the cartridge into the slide supply.
Note:

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Load the cartridges within 24 hours after they reach room temperature, 1828 C
(6482 F).

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Reagent Storage and Stability

C-Reactive Protein

Reagent Storage and Stability

VITROS CRP Slides are stable until the expiration date on the carton when they are stored and handled as specified. Do not
use beyond the expiration date.
Reagent
Unopened
Opened

Frozen
On-analyzer
On-analyzer

Storage Condition
-18 C (0 F)
System turned on
System turned off

Stability
Until expiration date
48 hours
2 hours

Verify performance with quality control materials:

If the system is turned off for more than 2 hours.
After reloading cartridges that have been removed from the slide supply and stored for later use.

Specimen Collection, Preparation and Storage

Serum
Plasma:
EDTA
Heparin

Specimens Recommended
IMPORTANT:

Certain collection devices have been reported to affect other analytes and tests.5
Owing to the variety of specimen collection devices available, Ortho-Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible with
this test.

Specimens Not Recommended

Plasma:
Citrate
Fluoride oxalate

Serum and Plasma

Specimen Collection and Preparation
Collect specimens using standard laboratory procedures.6, 7
Note:

For details on minimum fill volume requirements, refer to the operating instructions
for your system.

Patient Preparation
No special patient preparation is necessary.
Special Precautions
Centrifuge specimens and remove the serum or plasma from the cellular material within 4 hours of collection.8

Specimen Handling and Storage

Handle and store specimens in stoppered containers to avoid contamination and evaporation.
Mix samples by gentle inversion and bring to room temperature, 1828 C (6482 F), prior to analysis.

Specimen Storage and Stability8

Storage
Room temperature
Refrigerated
Frozen

Temperature
1828 C (6482 F)
28 C (3646 F)
-18 C (0 F)

Stability
4 hours
3 days
6 months

Testing Procedure
Materials Provided

VITROS Chemistry Products CRP Slides

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C-Reactive Protein

Calibration

Materials Required but Not Provided

VITROS Chemistry Products Calibrator Kit 7

Quality control materials, such as VITROS Chemistry Products CRP Performance Verifier I and II
VITROS Chemistry Products Specialty Diluent
VITROS Chemistry Products Immuno-Wash Fluid
VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water) (for on-analyzer dilution)

Operating Instructions

Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload.
For additional information, refer to the operating instructions for your system.

IMPORTANT:

Bring all fluids and samples to room temperature, 1828 C (6482 F), prior to
analysis.

Sample Dilution
Serum and Plasma

If C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range:
1. Dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial
threefold dilution is recommended.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original samples C-reactive protein concentration.
On-Analyzer Sample Dilution (VITROS Integrated, VITROS 5,1 FS/4600 and VITROS 250/350 Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For VITROS
Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS Diluent Pack 3 for the dilution.

Calibration
Required Calibrators

VITROS Chemistry Products Calibrator Kit 7

Calibrator Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Calibrator Kit 7.

Calibration Procedure

Refer to the operating instructions for your system.

When to Calibrate

Calibrate:
When the slide lot number changes.
When critical system parts are replaced due to service or maintenance.
When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
When the VITROS Immuno-Wash Fluid lot number changes.
The VITROS CRP test may also need to be calibrated:
If quality control results are consistently outside acceptable range.
After certain service procedures have been performed.
For additional information, refer to the operating instructions for your system.

Calculations

Based on sequential readings of the slides reflectance at 670 nm taken at the end of the incubation period, an end-point
reflectance is determined. This value is used in the software-resident endpoint colorimetric math model to compute the Creactive protein concentration. Once a calibration has been performed for each slide lot, CRP concentration in unknown
samples can be determined from the reflectance calculated for each unknown test slide.

Validity of a Calibration

Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the
Coefficients and Limits screen on VITROS 250/350/950 Systems (on the VITROS Integrated and VITROS 5,1 FS/4600
Systems, see the Review Assay Data screen). Failure to meet any of the pre-defined quality parameters results in a failed

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Quality Control

C-Reactive Protein

calibration. The calibration report should be used in conjunction with quality control results to determine the validity of a
calibration.

Measuring (Reportable or Dynamic) Range

Conventional Units
(mg/dL)
0.59.0

SI Units
(mg/L)
590

Alternate Units
(g/dL)
5009000

For out-of-range samples, refer to Sample Dilution.

Note:

For VITROS Integrated and VITROS 5,1 FS/4600 Chemistry Systems, the
Reporting Units information found under OptionsConfigure
AssaysCRPReview/Edit Configuration identifies the conventional unit for CRP
as mg/L and the SI unit as mg/dL. For VITROS 250/350/950 the same Reporting
Unit information can be found under OptionsTest/Fluid ConfigurationCRP.
Please confirm that you have selected the appropriate reporting units for your
laboratory on your analyzer.

Traceability of Calibration

Values assigned to the VITROS Chemistry Products Calibrator Kit 7 for CReactive Protein (CRP) are traceable to the
ERM DA470 reference material. The Ortho Clinical Diagnostics calibration laboratory uses ERM DA472/IFCC, traceable to
ERM DA470, to calibrate a nephelometric method for CRP9 to support value assignment for VITROS Calibrator Kit 7.

Quality Control
Quality Control Material Selection
IMPORTANT:

VITROS CRP Performance Verifiers are recommended for use with VITROS
Chemistry and Integrated Systems. Evaluate the performance of other commercial
control fluids for compatibility with this test before using for quality control.

Control materials other than VITROS CRP Performance Verifiers may show a difference when compared with other
Creactive protein methods if they:
Depart from a true human matrix.
Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
Do not use control materials stabilized with ethylene glycol.

Quality Control Procedure Recommendations

Choose control levels that check the clinically relevant range.

Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
To verify system performance, analyze control materials:
After calibration.
According to local regulations or at least once each day that the test is being performed.
After specified service procedures are performed. Refer to the operating instructions for your system.
If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient results.
For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements: Principles
and Definitions; Approved Guideline-Third Edition10 or other published guidelines.
For additional information, refer to the operating instructions for your system.

Quality Control Material Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Chemistry Products CRP Performance Verifier I and II or to other manufacturer's
product literature.

Results
Reporting Units and Unit Conversion

The VITROS Chemistry and Integrated Systems may be programmed to report CRP results in conventional, SI, and alternate
units.
Conventional Units
mg/dL

Version 8.0

SI Units
mg/L (mg/dL x 10)

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Alternate Units
g/dL (mg/dL x 1000)

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Limitations of the Procedure

Limitations of the Procedure

Known Interferences

Specimens with low total protein <4.9 g/dL (49 g/L) may give a positive bias of greater than +0.31 mg/dL (+3.1 mg/L) at a
CRP concentration of 2.0 mg/dL (20.0 mg/L).
Specimens with an elevated total protein >9.5 g/dL (95 g/L) may give a negative bias greater than -0.31 mg/dL (-3.1 mg/L)
at a CRP concentration of 2.0 mg/dL (20.0 mg/L).

Serum and Plasma

The VITROS CRP Slide method was screened for interfering substances following NCCLS Protocol EP7.12 The substances
listed in the table, when tested at the concentrations indicated, caused the bias shown.
For substances that were tested and did not interfere, refer to Specificity.
Interferent*
Ampicillin
Gentisic acid
Hemoglobin
*

Interferent
Concentration
200 mg/dL
(5.7 mmol/L)
5 mg/dL
(0.32 mmol/L)
400 mg/dL
(4 g/L)

Comments
Therapeutic
Therapeutic

CRP Concentration
Conv.
SI (mg/L)
(mg/dL)
2.4
24
2.5
25
2.0
20

Conv.
(mg/dL)
-0.52
-0.54
+0.24

Bias

SI
(mg/L)
-5.2
-5.4
+2.4

It is possible that other interfering substances may be encountered. These results are representative; however, your results may differ
somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Other Limitations

Certain drugs and clinical conditions are known to alter C-reactive protein concentration in vivo. For additional information,
refer to one of the published summaries.13, 14, 15

Expected Values
Reference Interval
This reference interval is based on an external study.11
Conventional Units
(mg/dL)
<1.0

SI Units
(mg/L)
<10

Alternate Units
(g/dL)
<1000

Each laboratory should confirm the validity of these intervals for the population it serves.

Performance Characteristics
Method Comparison

The plots and table show the results of a comparison of serum samples analyzed on the VITROS 950 System with those
analyzed using the Behring Latex Agglutination Nephelometric comparative method.9 Testing followed NCCLS Protocol
EP9.16
The table also shows the results of comparisons with serum samples of the VITROS 250 Systems with the VITROS 950
System and comparisons of the VITROS 5,1 FS System with the VITROS 950 System.
In addition, the table shows the results of comparisons with serum and plasma samples on the VITROS 5600 Integrated
System and the VITROS 5,1 FS Chemistry System. The testing followed NCCLS Protocol EP9.17

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Performance Characteristics

C-Reactive Protein

Serum
SI Units

VITROS 950 System (mg/L)

VITROS 950 System (mg/dL)

Conventional Units

Comparative Method: Behring Latex Agglutination Nephelometric

(mg/dL)

Comparative Method: Behring Latex Agglutination Nephelometric

(mg/L)

Conventional Units (mg/dL)

Slope

Correlation
Coefficient

Range of
Sample
Concentration

950 vs. comparative

method

91

1.03

0.985

0.59.0

-0.01

0.48

250 vs. 950

48

1.02

1.000

0.59.0

0.00

0.09

5,1 FS vs. 950

92

0.97

0.997

0.59.0

+0.10

92

0.99

0.999

0.78.9

-0.01

5600 vs. 5,1

FS

SI Units (mg/L)

Intercept

Sy.x

Range of
Sample
Concentration

Intercept

Sy.x

590

-0.15

4.84

590

+0.01

0.86

0.19

590

+1.00

1.90

0.12

789

-0.10

1.24

Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same specifications

as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been demonstrated to
be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are therefore applicable
to the VITROS 4600 System.

Precision

Precision was evaluated with quality control materials on VITROS 250, 950, and 5,1 FS Systems following NCCLS
Protocol EP5. 18 Precision was evaluated with quality control materials on VITROS 5600 Integrated System following NCCLS
protocol EP5.19
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.

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References

Conventional Units (mg/dL)

Mean
Conc.
250

950

5,1 FS
5600

SI Units (mg/L)

Within Day Within Lab

SD*
SD**

Within Day Within Lab Within Lab

SD*
SD**
CV%**

Mean
Conc.

No.
Observ.

No. Days

0.4

0.07

0.11

0.7

1.1

25.1

80

20

1.4

0.08

0.10

14

0.8

1.0

7.4

80

20

7.2

0.18

0.21

72

1.8

2.1

3.0

80

20

8.7

0.26

0.34

87

2.6

3.4

3.9

80

20

0.4

0.06

0.08

0.6

0.8

18.2

80

20

1.4

0.07

0.08

14

0.7

0.8

5.9

80

20

7.1

0.18

0.27

71

1.8

2.7

3.8

80

20

8.6

0.28

0.38

86

2.8

3.8

4.4

80

20

2.1

0.10

0.18

21

1.0

1.8

8.4

90

22

6.9

0.24

0.26

69

2.4

2.6

3.8

90

22

2.6

0.09

0.13

26

0.9

1.3

5.0

84

21

7.0

0.15

0.18

70

1.5

1.8

2.6

84

21

Within Day precision was determined using two runs/day with two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same specifications
as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been demonstrated to
be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are therefore applicable
to the VITROS 4600 System.

Specificity
Substances that Do Not Interfere

The substances listed in the table, and at the concentrations shown, were tested with VITROS CRP Slides at a C-reactive
protein concentration of 2.0 mg/dL (20 mg/L) or at a C-reactive protein concentration 2.0 to 3.0 mg/dL (20 to 30 mg/L), and
found not to interfere [bias <0.31 mg/dL (<3.1 mg/L) or <20%, respectively].
Compound

Concentration

Compound

Acetaminophen

20 mg/dL

1 mmol/L

N-acetylcysteine

100 mg/dL

6.13 mmol/L

Positive

Positive

Antinuclear Antibody (ANA)

Ascorbic acid

Indomethacin
Intralipid
Keflin

Concentration
10 g/mL

28 mol/L

800 mg/dL

8 g/L

1000 g/mL

2 mmol/L

3 mg/dL

171 mol/L

Lidocaine

Bilirubin

25 mg/dL

428 mol/L

Methotrexate

Captopril

20 g/mL

92 mol/L

Carbamazepine

120 g/mL

508 mol/L

Naproxen

1.2 mg/mL

5 mmol/L

Chloramphenicol

250 g/mL

1 mmol/L

Neomycin

120 g/mL

226 mol/L

Cholesterol

260 mg/dL

7 mmol/L

Phenytoin

100 g/mL

396 mol/L

Cimetidine

100 g/mL

397 mol/L

Procainamide

100 g/mL

368 mol/L

Codeine

30 g/mL

100 mol/L

Propranolol

Diazepam

20 g/mL

70 mol/L

Dipyrone

Morphine sulfate

Ranitidine

2.6 mol/L
10 mmol/L

2 mg/dL

30 mol/L

5 g/mL

19 mol/L

200 g/mL

637 mol/L

30 mg/dL

0.85 mmol/L

200 g/mL

273 mol/L

Ethamsylate

3.0 mg/dL

0.11 mmol/L

Theophylline

25 mg/dL

1 mmol/L

Ethanol

394 mg/dL

86 mmol/L

Total protein

4.99.5 g/dL

4995 g/L

Gentamicin

120 g/mL

251 mol/L

Triglycerides

360 mg/dL

4 mmol/L

Hypaque

500 mg/dL

8 mmol/L

Valproic acid

500 g/mL

3 mmol/L

Ibuprofen

400 g/mL

2 mol/L

Erythromycin

Rheumatoid Factor (RF)

60 g/mL
10 mmol/L

Salicylate

Positive

Positive

50 mg/dL

4 mmol/L

References
1.
2.
3.

8 of 12

Kushner I. The Phenomenon of the Acute Phase Response. Ann. NY Acad. Sci. 389:3948; 1982.
Pepys MB. C-Reactive Protein Fifty Years On. Lancet; March 21:653657; 1981.
Gambino R. C-Reactive Protein: An Underutilized Test. Lab Report for Physicians. 11:4143; 1989.

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References

4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.

Version 8.0

C-Reactive Protein

CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition.
CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA;
2005.
Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:8690; 1988.
CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard Sixth Edition.
CLSI document H3-A6 (ISBN 1-56238-650-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA;
2007.
NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard Fifth
Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA, 2004.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical Microscopy.
Northfield, IL: College of American Pathologists; 1992.
Dati F, et al. Referenzwerte fr 18 Plasmaproteine am Behring-Nephelometer-System. Lab. Med. 13:8790; 1989.
CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline Third
Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898
USA; 2006.
Tietz NW. Clinical Guide to Laboratory Tests. ed. 3. Philadelphia: WB Saunders; Section I General Clinical Tests, 178;
1995.
NCCLS. Interference Testing in Clinical Chemistry. NCCLS Document EP7. CLSI, 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898 USA; 1986.
Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
Tryding N, Tufvesson C, Sonntag O (eds). Drug Effects in Clinical Chemistry. ed. 7. Stockholm: The National Corporation
of Swedish Pharmacies, Pharmasoft AB, Swedish Society for Clinical Chemistry; 1996.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document EP9.
CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1995.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document
EP9A2 [ISBN 1-56238-472-4]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 2002.
NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1992.
NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline Second
Edition. NCCLS document EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2004.

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Glossary of Symbols

Glossary of Symbols

Revision History

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Date of Revision
2010-12-13

Version
8.0

2009-08-24
2008-11-05

7.0
6.0

2005-03-31

5.0

2004-11-19

4.0

2004-10-22

3.0 DA, DE,

EN, ES, FR, IT,
PT, SV only

Description of Technical Changes*

Added information for the VITROS 4600 Chemistry System
Limitations of the Procedure Bias: corrected data
Traceability of the Calibration Updated reference material
Added information for the VITROS 5600 Integrated System
Test Type and Conditions Added statement
Measuring (Reportable or Dynamic) Range Updated data, added note
Traceability of the Calibration Updated name of reference material
Method Comparison Added information on sample types; updated data
References Updated
Glossary of Symbols Updated
Minor wording and formatting changes
Removed Coatings 400 and above
Sample Dilution updated data
Reportable (Dynamic) Range updated data
Method Comparison updated values and plots
Specificity removed Hemoglobin
Precision corrected data

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Revision History

Date of Revision
2004-09-13

Version
2.0 DE, EN,
ES, FR, IT, PT
only

2004-04-30

1.0

C-Reactive Protein

Description of Technical Changes*

Added VITROS 5,1 FS Chemistry System
Specimen Requirements, Special Precautions wording update
Limitations of the Procedure added Hemoglobin
Specificity added Intralipid; updated Bilirubin
Glossary of Symbols updated data
New release for VITROS CRP Slides Coatings 400 and above
Reactive ingredients updated concentrations
Specimens Recommended removed citrate
Specimens Not Recommended added citrate
Reportable (Dynamic) Range updated values
Known Interferences Removed Ethamsylate, N-acetylcysteine, Hemoglobin;
added Ampicillin; updated values for Gentisic acid
Method Comparison updated all data and plots
Precision updated all data
Specificity Updated with new test conditions & data. Added N-acetylcysteine,
Ascorbic acid, Bilirubin (conjugated), Ethamsylate; removed Amphotericin B,
Ampicillin, Chlorpromazine (HCl), Creatinine, Lovastatin, Serum amyloid;
updated Dipyrone, Gentamicin, Hemoglobin, Lidocaine, Morphine sulfate,
Neomycin, Procainamide, Salicylate, Theophylline
References added 12

* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
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CRP

INSTRUCTIONS FOR USE

C-Reactive Protein

Ortho-Clinical Diagnostics
Johnson & Johnson
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom

Revision History

Brasil:
Johnson & Johnson do Brasil Ind. e Com. de Prod.
para Sade Ltda.
Diviso: Johnson & Johnson Medical Brasil
Rod. Presidente Dutra, Km 154, So Jos dos Campos - SP CEP: 12240-908 - Brasil
CNPJ: 54.516.661/0002-84
Resp. Tcnico.: Nancy M.R.B Lopes C.R.F.-SP N 10965
Somente Para Uso Diagnstico In Vitro
SAC: 08007075420

Ortho-Clinical Diagnostics, Inc.

100 Indigo Creek Drive
Rochester, NY 14626
VITROS is a registered trademark of Ortho-Clinical Diagnostics,
Inc.
Ortho-Clinical Diagnostics, Inc., 20032010.

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