You are on page 1of 4

0020764930322COINV11.

CRPLX
C-Reactive Protein (Latex) Specific proteins
Order information
Analyzer(s) on which cobasc pack(s) can be used
COBASINTEGRA 400 plus
20764930 322 C-Reactive Protein (Latex) (300 tests) System-ID 0764930
COBAS INTEGRA 800
11355279 216 Calibrator f.a.s. Proteins (5 1 mL) System-ID 0765570
11355279 160 Calibrator f.a.s. Proteins (5 1 mL, for USA) System-ID 0765570
10557897 122 Precinorm Protein (3 1 mL) System-ID 0791059
10557897 160 Precinorm Protein (3 1 mL, for USA) System-ID 0791059
11333127 122 Precipath Protein (3 1 mL) System-ID 0791067
11333127 160 Precipath Protein (3 1 mL, for USA) System-ID 0791067
05117003 190 PreciControl ClinChem Multi 1 (20 5 mL) System-ID 0774693
05947626 160 PreciControl ClinChem Multi 1 (4 5 mL, for USA) System-ID 0774693
05117216 190 PreciControl ClinChem Multi 2 (20 5 mL) System-ID 0774707
05947774 160 PreciControl ClinChem Multi 2 (4 5 mL, for USA) System-ID 0774707
20756350 322 NaCl Diluent 9 % (6 22 mL) System-ID 0756350

English Reagent handling


System information COBASINTEGRA 400plus systems
Test CRPL2 Mix all brand new (nonpunctured) cobasc packs for 1minute on a
Test ID 0293 on COBASINTEGRA400plus analyzers cassette mixer before loading on the analyzer.
Test ID 0393 on COBASINTEGRA800analyzers COBASINTEGRA800 systems
Intended use Ready for use
In vitro test for the quantitative immunological determination of Creactive After cobasc pack puncture, the analyzer automatically mixes the reagent
protein in human serum and plasma on COBASINTEGRA systems. for 1minute.
Summary1,2 Storage and stability
Most tissuedamaging processes such as infections, inflammatory diseases
and malignant neoplasms are associated with a major acute phase Shelf life at 28C See expiration date on
response of the Creactive protein (CRP) and other acute phase reactants cobasc pack label
(e.g. AAT, AAGP, C3C, C4, HAPT). The CRP response frequently precedes
clinical symptoms, including fever. In normal healthy individuals CRP is a COBASINTEGRA400plus system
trace protein with a range up to 5mg/L. After onset of an acute phase On-board in use at 1015C 12weeks
response the serum CRP concentration rises rapidly and extensively.
Alterations are detectable within 6 to 8hours and the peak value is reached COBASINTEGRA800 system
within 24 to 48hours. Levels of up to thousandfold the normal value are On-board in use at 8C 12weeks
associated with severe stimuli such as myocardial infarction, major trauma,
surgery, or malignant neoplasms. CRP activates the classical complement Specimen collection and preparation
pathway. CRP has a halflife of only a few hours, making it an ideal tool for For specimen collection and preparation only use suitable tubes or
clinical monitoring. Postoperative monitoring of CRP levels of patients collection containers.
indicates either the normal recovery process (decreasing levels to normal) Only the specimens listed below were tested and found acceptable.
or unexpected complications (persisting high levels). Measuring changes in Serum
the concentration of CRP provides useful diagnostic information about how Plasma: Liheparin, EDTA, fluoride or citrate plasma.
acute and how serious a disease is. It also allows the assessment of
complications during the disease and judgements about the disease The sample types listed were tested with a selection of sample collection
genesis. Persistence of a high serum CRP concentration is usually a grave tubes that were commercially available at the time of testing, i.e. not all
prognostic sign which generally indicates the presence of an uncontrolled available tubes of all manufacturers were tested. Sample collection systems
infection. CRP determination may replace the classical determination of from various manufacturers may contain differing materials which could
Erythrocytes Sedimentation Rate (ESR), due to its prompt response to affect the test results in some cases. When processing samples in primary
changes in disease activity and its good correlation to ESR. tubes (sample collection systems), follow the instructions of the tube
Test principle3,4,5 manufacturer.
Particle enhanced turbidimetric assay Centrifuge samples containing precipitates before performing the assay.
Human CRP agglutinates with latex particles coated with monoclonal Stability:6 11days at 1525C
antiCRP antibodies. The precipitate is determined turbidimetrically at
552nm. 2months at 28C
Reagents - working solutions 3years at (-15)(-25)C

R1 TRIS buffer with bovine serum albumin and immunoglobulins Materials provided
(mouse); preservative See Reagents working solutions section for reagents.
SR Latex particles coated with antiCRP (mouse) in glycine buffer; Materials required (but not provided)
preservative NaClDiluent9%, Cat.No.20756350 322, systemID0756350 for
automatic postdilution and standard serial dilutions. NaClDiluent9% is
R1 is in position B and SR is in position C. placed in its predefined rack position and is stable for 4weeks onboard
Precautions and warnings COBASINTEGRA400plus/800analyzers.
Pay attention to all precautions and warnings listed in
Section1/Introduction of this Method Manual.
For USA: For prescription use only.

2016-02, V 11.0 English 1/4 CRPLX


0020764930322COINV11.0

CRPLX
C-Reactive Protein (Latex) Specific proteins

Assay Calibration interval Each lot and as required following quality


For optimum performance of the assay follow the directions given in this control procedures
document for the analyzer concerned. Refer to the appropriate operators
manual for analyzerspecific assay instructions. Enter the assigned lotspecific CRP value for all 6calibrator points indicated
in the package insert for Calibratorf.a.s. Proteins.
Application for serum and plasma Traceability: This method has been standardized with regard to the
COBAS INTEGRA 400plus test definition IFCC/BCR/CAP reference preparation CRM470 (RPPHS91/0619) for
14serum proteins.7
Measuring mode Absorbance
Quality control
Abs. calculation mode Kinetic
Reaction mode R1-S-SR Reference range Precinorm Protein or PreciControl
ClinChem Multi1
Reaction direction Increase
Pathological range Precipath Protein or PreciControl
Wavelength A 552nm ClinChem Multi2
Calc. first/last 35/48 Control interval 24hours recommended
Typical prozone effect >3100mg/L (>29512nmol/L or Control sequence User defined
>310mg/dL)
Control after calibration Recommended
Antigen excess check No
For quality control, use control materials as listed in the Order information
Unit mg/L section. In addition, other suitable control material can be used.
Pipetting parameters The control intervals and limits should be adapted to each laboratorys
individual requirements. Values obtained should fall within the defined
Diluent (H2O) limits. Each laboratory should establish corrective measures to be taken if
R1 82L 48L values fall outside the defined limits.
Follow the applicable government regulations and local guidelines for
Sample 2.5L 30L quality control.
SR 28L 14L Calculation
Total volume 204.5L COBASINTEGRAanalyzers automatically calculate the analyte
COBASINTEGRA800 test definition concentration of each sample. For more details, please refer to Data
Analysis in the Online Help (COBASINTEGRA400plus/800 analyzers).
Measuring mode Absorbance
Conversion factors: mg/L9.52=nmol/L
Abs. calculation mode Kinetic
mg/L0.1=mg/dL
Reaction mode R1-S-SR
Limitations - interference
Reaction direction Increase
Criterion: Recovery within 10% of initial value.
Wavelength A 552nm Serum, plasma
Calc. first/last 46/69 Icterus:8 No significant interference up to an Iindex of 60 for conjugated
Typical prozone effect >3100mg/L (>29512nmol/L or and unconjugated bilirubin (approximate conjugated and unconjugated
bilirubin concentration: 1026mol/L or 60mg/dL).
>310mg/dL)
Hemolysis:8 No significant interference up to an Hindex of 1000
Antigen excess check No (approximate hemoglobin concentration: 621mol/L or 1000mg/dL).
Unit mg/L Lipemia (Intralipid):8
COBASINTEGRA400plus analyzers:
Pipetting parameters No significant interference up to an Lindex of 1500 in the lower
Diluent (H2O) concentration range (3mg/L or 28.6nmol/L). No significant interference up
to an Lindex of 623 in the higher concentration range (80mg/L or
R1 82L 48L 762nmol/L).
COBASINTEGRA800 system:
Sample 2.5L 30L No significant interference up to an Lindex of 1094 in the lower
SR 28L 14L concentration range (3mg/L or 28.6nmol/L). No significant interference up
to an Lindex of 797 in the higher concentration range (80mg/L or
Total volume 204.5L 762nmol/L).
Calibration There is poor correlation between the Lindex (corresponds to turbidity) and
triglycerides concentration. Turbid samples exceeding 0.1Absorbance are
Calibrator Calibrator f.a.s. Proteins recognized by the High Activity check. Correct results can be obtained
after postdilution.
Calibration dilution ratio COBASINTEGRA400plus analyzers:
Rheumatoid factors: No significant interference.
1:0.5, 1:1, 1:1.5, 1:2.86, 1:10, and 0mg/L HAMA: Although measures were taken to minimize interference caused by
performed automatically by the instrument. human antimouse antibodies, erroneous findings may be obtained from
COBASINTEGRA800 analyzers: samples taken from patients who have been treated with monoclonal
mouse antibodies or have received them for diagnostic purposes.
1:0.5, 1:0.74, 1:1, 1:2.86, 1:10, and 0mg/L Drugs: No interference was found at therapeutic concentrations using
performed automatically by the instrument. common drug panels.9,10
Calibration mode Linear interpolation Exception: Significantly decreased CRP values may be obtained from
samples taken from patients who have been treated with carboxypenicillins.
Calibration replicate Duplicate recommended
In very rare cases, gammopathy, in particular type IgM (Waldenstrms
macroglobulinemia), may cause unreliable results.11

CRPLX 2/4 2016-02, V 11.0 English


0020764930322COINV11.0

CRPLX
C-Reactive Protein (Latex) Specific proteins

For diagnostic purposes, the results should always be assessed in Lin. regression y=1.014x-0.55mg/L
conjunction with the patients medical history, clinical examination and other
findings. Passing/Bablok13 y=1.011x-0.12mg/L
ACTION REQUIRED The sample concentrations were between 0.56 to 357mg/L (5.33 to
Special Wash Programming: The use of special wash steps is mandatory 3399nmol/L or 0.056 to 35.7mg/dL).
when certain test combinations are run together on COBASINTEGRA References
analyzers. Refer to the CLEAN Method Sheet for further instructions and for
the latest version of the Extra wash cycle list. 1 Pepys MB, Baltz MC. Acute phase proteins with special reference to C-
Where required, special wash/carry-over evasion programming must reactive protein and related proteins (pentaxins) and serum amyloid A
be implemented prior to reporting results with this test. protein Adv Immunol 1983;34:141-212.
2 Bowman BH. In: Hepatic Plasma Proteins. San Diego: Academic Press
Limits and ranges 1993:47-95.
Measuring range
3 Senju O, Takagi Y, Gomi K, et al. The quantitative determination of
1.0200mg/L (9.521904nmol/L or 0.120mg/dL) CRP by latex agglutination photometric assay. Jap J Clin Lab
The upper and lower limits of the measuring range depend on the actual Automation 1983;8:161-165.
calibrator value.
4 Price CP, Trull AK, Berry D, et al. Development and validation of a
Determine samples having higher concentrations via the rerun function. particle-enhanced turbidimetric immunoassay for C-reactive protein. J
Dilution of samples via the rerun function is a 1:10 dilution. Results from Immunol Methods 1987;99:205-211.
samples diluted using the rerun function are automatically multiplied by a
factor of 10. 5 Eda S, Kaufmann J, Roos W, et al. Development of a New
Microparticle-Enhanced Turbidimetric Assay for C-reactive Protein with
Lower limits of measurement Superior Features in Analytical Sensitivity and Dynamic Range. J Clin
Lower detection limit of the test Lab Anal 1998;12:137-144.
1.0mg/L (9.52nmol/L or 0.1mg/dL) 6 Use of Anticoagulants in Diagnostic Laboratory Investigations. WHO
The lower detection limit represents the lowest measurable analyte level Publication WHO/DIL/LAB/99.1 Rev. 2. Jan. 2002.
that can be distinguished from zero. It is calculated as the value lying 7 Johnson AM. A new international reference preparation for proteins in
3standard deviations above that of a zero sample (zero sample+3SD, human serum. Arch Pathol Lab Med 1993;117:29-31.
repeatability, n=30).
8 Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of
Expected values Interferences in Clinical Chemistry Instrumentation. Clin Chem
1986;32:470-475.
Adults12 <5mg/L (<47.6nmol/L or <0.5mg/dL)
9 Breuer J. Report on the Symposium Drug effects in Clinical Chemistry
Each laboratory should investigate the transferability of the expected values Methods. Eur J Clin Chem Clin Biochem 1996;34:385-386.
to its own patient population and if necessary determine its own reference
ranges. 10 Sonntag O, Scholer A. Drug interference in clinical chemistry:
recommendation of drugs and their concentrations to be used in drug
Specific performance data interference studies. Ann Clin Biochem 2001;38:376-385.
Representative performance data on the analyzers are given below. 11 Bakker AJ, Mcke M. Gammopathy interference in clinical chemistry
Results obtained in individual laboratories may differ. assays: mechanisms, detection and prevention.
Precision ClinChemLabMed2007;45(9):1240-1243.
Precision was determined using human samples and controls in an internal 12 Schumann G, Dati F. Vorlufige Referenzbereiche fr 14 Proteine im
protocol with repeatability and intermediate precision (2aliquots per run, Serum (fr Erwachsene) nach Standardisierung immunchemischer
2runs per day, 20days). The following results were obtained: Methoden unter Bezug auf das internationale Referenzmaterial CRM
470. Lab Med 1995;19:401-403.
Level 1 Level 2
13 Bablok W, Passing H, Bender R, et al. A general regression procedure
Mean 6.2mg/L 142mg/L for method transformation. Application of linear regression procedures
for method comparison studies in clinical chemistry, Part III. J Clin
(59.0nmol/L or (1352nmol/L or Chem Clin Biochem 1988 Nov;26(11):783-790.
0.62mg/dL) 14.2mg/dL)
A point (period/stop) is always used in this Method Sheet as the decimal
CV repeatability 1.8 % 1.5 % separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
CV intermediate precision 2.9 % 2.7 %
Symbols
Method comparison Roche Diagnostics uses the following symbols and signs in addition to
CRP values for human serum and plasma samples obtained on a those listed in the ISO 152231 standard.
COBASINTEGRA400 analyzer using the COBASINTEGRA CReactive
Protein (Latex) reagent(y) were compared with those determined using the Contents of kit
same reagent on a COBASINTEGRA700 analyzer(x) and with a Volume after reconstitution or mixing
commercially available alternative automated system(x). Sample size(n)
represents all replicates. GTIN Global Trade Item Number
COBASINTEGRA700 analyzer FOR US CUSTOMERS ONLY: LIMITED WARRANTY
Sample size (n) 140 Roche Diagnostics warrants that this product will meet the specifications
Corr. coefficient (r) 0.999 stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
Lin. regression y=0.981x+0.50mg/L
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
Passing/Bablok13 y=0.986x+0.11mg/L OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
Alternative system
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
Sample size (n) 140 FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
Corr. coefficient (r) 0.998 DAMAGES.

2016-02, V 11.0 English 3/4 CRPLX


0020764930322COINV11.0

CRPLX
C-Reactive Protein (Latex) Specific proteins

COBAS, COBASC, COBASINTEGRA, PRECICONTROL, PRECINORM and PRECIPATH are trademarks of


Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
2015, Roche Diagnostics

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim


www.roche.com
Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

CRPLX 4/4 2016-02, V 11.0 English