CRP FS*

Diagnostic reagent for quantitative in vitro determination of C-reactive protein (CRP) in serum or plasma on
photometric systems

Order Information 5. Please refer to the safety data sheets and take the necessary
Cat. No. Kit size precautions for the use of laboratory reagents. For diagnostic
1 7002 99 10 021 R1 5 x 25 mL + R2 1 x 25 mL purposes, the results should always be assessed with the
1 7002 99 10 023 R1 1 x 1000 mL + R2 1 x 200 mL patient’s medical history, clinical examinations and other
1 7002 99 10 704 R1 8 x 50 mL + R2 8 x 10 mL findings.
1 7002 99 10 917 R1 8 x 60 mL + R2 8 x 12 mL 6. For professional use only!
1 7002 99 10 930 R1 4 x 20 mL + R2 2 x 8 mL Waste Management
1 7002 99 10 935 R1 2 x 20 mL + R2 1 x 8 mL Please refer to local legal requirements.
1 7000 99 10 039 5x 2 mL TruCal CRP:
Calibrator set with 5 different levels Reagent Preparation
The reagents are ready to use.
Summary [1-4]
Materials required but not provided
C-reactive protein (CRP) is the best known among the acute-phase
NaCl solution 9 g/L
proteins, a group of proteins whose concentration increases in
General laboratory equipment
blood as a response to inflammatory disorders (acute-phase
response). CRP is normally present in low concentration in blood of Specimen
healthy individuals (< 5 mg/L). It is elevated up to 500 mg/L in acute
inflammatory processes associated with bacterial infections, post- Serum, heparin plasma or EDTA plasma
operative conditions or tissue damage already after 6 hours Stability [5]: 15 days at 20 – 25°C
reaching a peak at 48 hours. The measurement of CRP represents 2 months at 4 – 8°C
a useful laboratory test for detection of acute infection as well as for 3 years at –20°C
monitoring inflammatory processes also in acute rheumatic and Only freeze once! Discard contaminated specimens.
gastrointestinal diseases. CRP testing shows various advantages in
comparison to the erythrocyte sedimentation rate (ESR) and the
Assay Procedure for Analyzers
leukocyte count. In fact, it is more sensitive, the increase occurs Application sheets for automated systems are available on
earlier and its levels return to the reference range more rapidly after request.
healing. Wavelength 340 nm, Hg 334 nm
Optical path 1 cm
Method
Temperature 37°C
Immunoturbidimetric test Measurement Against reagent blank
Principle
Blank Sample or calibrator
Determination of CRP concentration by photometric measurement Sample or calibrator - 15 µL
of the antigen-antibody reaction of antibodies to human CRP with Dist. Water 15 µL -
CRP present in the sample. Reagent 1 250 µL 250 µL
Mix, incubate for 5 min. at 37 °C and read absorbance (A1) , then
Reagents add:
Components and Concentrations Reagent 2 50 µL 50 µL
Mix, incubate for 5 min. at 37°C and read absorbance (A2).
R1: TRIS pH 7.5 100 mmol/L
R2: TRIS pH 8.0 100 mmol/L A = (A2–A1) sample or calibrator
Anti-human CRP antibodies (goat) < 1%
Storage Instructions and Reagent Stability Calculation
The reagents are stable up to the end of the indicated month of The CRP concentration of unknown samples is derived from a
expiry, if stored at 2 – 8°C and contamination is avoided. Do not calibration curve using an appropriate mathematical model such as
freeze the reagents and protect them from light! logit/log. The calibration curve is obtained with five calibrators at
different levels and NaCl solution (9 g/L) for determination of the
Warnings and Precautions zero value.
1. Reagent 1: Warning. H319 Causes serious eye irritation. P280 Stability of calibration: 4 weeks
Wear protective gloves/protective clothing/eye protection/face
protection. P305+P351+P338 If in eyes: Rinse cautiously with Calibrators and Controls
water for several minutes. Remove contact lenses, if present For the calibration of automated photometric systems, DiaSys
and easy to do. Continue rinsing. P337+P313 If eye irritation TruCal CRP calibrator set is recommended. The assigned values of
persists: Get medical advice/attention. TruCal CRP have been made traceable to the ERM®-DA474/IFCC
2. The reagents contain sodium azide (0.95 g/L) as preservative. reference material. For internal quality control, DiaSys TruLab CRP
Do not swallow! Avoid contact with skin and mucous or TruLab Protein control should be assayed. Each laboratory
membranes. should establish corrective action in case of deviations in control
3. Reagent 2: contains animal material. Handle the product as recovery.
potentially infectious according to universal precautions and
Cat. No. Kit size
good clinical laboratory practices.
TruLab CRP Level 1 5 9600 99 10 045 3 x 2 mL
4. In very rare cases, samples of patients with gammopathy
TruLab CRP Level 2 5 9610 99 10 045 3 x 2 mL
might give falsified results [9].
TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL
TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

CRP FS - Page 1 * fluid stable

Performance Characteristics Literature
Measuring Range 1. Thompson D, Milford-Ward A, Whicher JT. The value of acute
phase protein measurements in clinical practice. Ann Clin
The measuring range is from 2 mg/L up to the concentration of the Biochem 1992; 29: 123-31.
highest calibrator, at least up to 250 mg/L. 2. Gabay C, Kushner I. Acute-phase proteins and other systemic
When values exceed these ranges, samples should be diluted 1 + 1 responses to inflammation. N Engl J Med 1999; 340: 448-54.
with NaCl solution (9 g/L) and the result multiplied by 2. 3. Hansson LO, Lindquist L. C-reactive protein: its role in the
Prozone Limit diagnosis and follow-up of infectious diseases. Curr Opin
No prozone effect was observed up to a CRP concentration of Infect Diseases 1997; 10:196-201.
2000 mg/L. 4. Sipe JD. Acute-phase proteins in osteoarthritis. Semin Arthritis
Rheum 1995; 25: 75–86.
Specificity/Interferences 5. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
Due to its antibodies, DiaSys CRP FS is a specific immunoassay for 1st ed. Darmstadt: GIT Verlag; 2001. p. 24-5.
human CRP. No interference was observed by ascorbic acid up to 6. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S,
30 mg/dL, bilirubin up to 40 mg/dL, hemoglobin up to 500 mg/dL Bienvenu J et al. Consensus of a group of professional
and lipemia up to 2000 mg/dL triglycerides as well as by societies and diagnostic companies on guidelines for interim
anticoagulants in usual concentrations. For further information on reference ranges for 14 proteins in serum based on the
interfering substances refer to Young DS [8]. standardization against the IFCC/BCR/CAP reference material
Sensitivity/Limit of Detection (CRM 470). Eur J Clin Chem Clin Biochem 1996; 34: p.
517-20.
The lower limit of detection is 2 mg/L. 7. Schlebusch H, Liappis N, Klein G. High sensitive CRP and
Precision (n = 20) creatinine: reference intervals from infancy to childhood.
Intra-assay precision Mean SD CV Poster presented at AACC/CSCC; July/August 2001, Chicago,
[mg/L] [mg/L] [%] Illinois.
Sample 1 6.6 0.3 4.7 8. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
Sample 2 20.4 0.6 3.0 ed. Volume 1 and 2. Washington, DC: The American
Sample 3 88.5 3.1 3.5 Association for Clinical Chemistry Press 2000.
9. Bakker AJ, Mücke M. Gammopathy interference in clinical
chemistry assays: mechanisms, detection and prevention.
Inter-assay precision Mean SD CV
ClinChemLabMed 2007;45(9):1240–1243.
(daily calibration) [mg/L] [mg/L] [%]
Sample 1 7.3 0.4 5.9 Manufacturer
Sample 2 22.1 0.6 2.6
Sample 3 95.0 1.2 1.3 DiaSys Diagnostic Systems GmbH
IVD Alte Strasse 9 65558 Holzheim Germany
Inter-assay precision Mean SD CV
(single calibration) [mg/L] [mg/L] [%]
Sample 1 7.2 0.4 5.7
Sample 2 22.2 0.4 1.8
Sample 3 97.8 2.4 2.5
Method Comparison
A comparison of DiaSys CRP FS (y) to a commercially available
test (x) using 65 samples gave following results:
y = 0.99 x +0.00 mg/L; r = 0.997

Reference Range [6,7]

Adults < 5 mg/L
Newborn up to 3 weeks < 4.1 mg/L
Infants and children < 2.8 mg/L
Each laboratory should check if the reference ranges are
transferable to its own patient population and determine own
reference ranges if necessary.

CRP FS - Page 2 844 7002 10 02 00 January 2023/22