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
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.
CRPLX
C-Reactive Protein (Latex) Specific proteins
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.
CRPLX
C-Reactive Protein (Latex) Specific proteins