CRP U-hs*

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

Order Information Reference Range [6,7]

Cat. No. Kit size Adults < 5 mg/L
1 7045 99 10 930 R1 3x 20 mL + R2 3x 20 mL Newborns up to 3 weeks < 4.1 mg/L
Calibrator set for universal range (5 levels) Infants and children < 2.8 mg/L
1 7040 99 10 059 5x 1 mL TruCal CRP U
Calibrator set for high sensitive range (5 levels) Each laboratory should check if the reference ranges are transferable to its
1 7080 99 10 059 5x 1 mL TruCal CRP hs own patient population and determine own reference ranges if necessary.

Summary [1-4] Literature

C-reactive protein (CRP) is the best known among the acute-phase proteins, 1. Thompson D, Milford-Ward A, Whicher JT. The value of acute phase
a group of proteins whose concentration increases in blood as a response to protein measurements in clinical practice. Ann Clin Biochem
inflammatory disorders (acute-phase response). CRP is normally present in 1992;29:123-31.
low concentration in blood of healthy individuals (< 5 mg/L). It increases 2. Gabay C, Kushner I. Acute-phase proteins and other systemic
already after 6 hours in acute inflammatory processes associated with responses to inflammation. N Engl J Med 1999;340:448-54.
bacterial infections, post-operative conditions or tissue damage. During the 3. Hansson LO, Lindquist L. C-reactive protein: its role in the diagnosis
disease CRP concentration can get as high as 500 mg/L. The measurement and follow-up of infectious diseases. Curr Opin Infect Diseases 1997;
of CRP represents an important laboratory test for detection of acute infection 10:196–201.
as well as for monitoring inflammatory processes also in acute rheumatic and 4. Sipe JD. Acute-phase proteins in osteoarthritis. Semin Arthritis Rheum
gastrointestinal diseases. CRP testing shows various advantages in 1995;25: 75–86.
comparison to the erythrocyte sedimentation rate (ESR) and the leukocyte 5. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed.
count. In fact, it is more sensitive, the increase occurs earlier and its levels Darmstadt: GIT Verlag; 2001. p. 24-5.
return to the reference range more rapidly after healing. 6. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et al.
Consensus of a group of professional societies and diagnostic
Method companies on guidelines for interim reference ranges for 14 proteins in
Particle enhanced immunoturbidimetric test with two applications. The high serum based on the standardization against the IFCC/BCR/CAP
sensitive application is recommended for samples with concentrations lower reference material (CRM 470). Eur J Clin Chem Clin Biochem
than 20 mg/L and where high precision and extremely good sensitivity is 1996;34:517-20.
required (measuring range of hs application: 0.05 mg/L – 20 mg/L). The 7. Schlebusch H, Liappis N, Klein G. High sensitive CRP and creatinine:
universal application is characterized by extraordinary wide measuring range reference intervals from infancy to childhood. Poster presented at
(0.3 - 350 mg/L) and low sample volume. AACC/CSCC; July/August 2001, Chicago, Illinois.
8. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th ed.
Principle Volume 1 and 2. Washington, DC: The American Association for
Determination of the concentration of CRP by photometric measurement of Clinical Chemistry Press 2000.
antigen-antibody reaction of antibodies to human CRP bound to polystyrene 9. Bakker AJ, Mücke M. Gammopathy interference in clinical chemistry
particles with CRP present in the sample. assays: mechanisms, detection and prevention. ClinChemLabMed
2007;45(9):1240–1243.
Reagents
Universal application
Components and Concentrations
R1: HEPES pH 7.2 10 mmol/L Assay Procedure for Analyzers
R2: Borate buffer 4.6 mmol/L
Application sheets for automated systems are available on request.
Polyclonal (goat) and monoclonal (mouse) anti-human CRP
antibodies bound to carboxylated polystyrene particles Basic parameter for Hitachi 911
Storage Instructions and Reagent Stability Wavelength 800/505 nm (bi-chromatic)
The reagents are stable up to the end of the indicated month of expiry, if Temperature 37°C
stored at 2 – 8°C and contamination is avoided. Do not freeze the reagents Measurement 2-Point Test (Fixed Time Kinetics)
and protect them from light! Sample/calibrator 3 µL
Reagent 1 150 µL
Warnings and Precautions Reagent 2 150 µL
1. The reagents contain sodium azide (0.95 g/L) as preservative. Do not Addition Reagent 2 Cycle 16 (320 s)
swallow! Avoid contact with skin and mucous membranes. Absorbance 1 Cycle 19 (380 s)
2. In very rare cases, samples of patients with gammopathy might give Absorbance 2 Cycle 31 (620 s)
falsified results [9]. Calibration spline
3. Heterophile antibodies in patient samples may cause falsified results.
4. Please refer to the safety data sheets and take the necessary Calculation
precautions for the use of laboratory reagents. For diagnostic purposes, The CRP concentration of unknown samples is derived from a calibration
the results should always be assessed with the patient`s medical curve using an appropriate mathematical model such as spline. The
history, clinical examinations and other findings. calibration curve is obtained with five calibrators at different levels and NaCl
5. For professional use only! solution (9 g/L) for determination of the zero value. Stability of calibration:
Waste Management 4 weeks
Please refer to local legal requirements. Calibrators and Controls
Reagent Preparation For calibration the DiaSys TruCal CRP U calibrator set is recommended
The reagents are ready to use. Do not shake and avoid foaming. (order information see above). The assigned values of the calibrators have
®
been made traceable to the IFCC reference material ERM -DA474. DiaSys
Materials required but not provided TruLab CRP or TruLab Protein control should be assayed for internal quality
NaCl solution 9 g/L control. Each laboratory should establish corrective action in case of
General laboratory equipment deviations in control recovery.
Cat. No. Kit size
Specimen TruLab CRP level 1 5 9600 99 10 045 3 x 2 mL
Serum, heparin plasma or EDTA plasma TruLab CRP level 2 5 9610 99 10 045 3 x 2 mL
Stability [5]: 15 days at 20 – 25°C TruLab Protein 1 5 9500 99 10 046 3 x 1 mL
2 months at 4 – 8°C TruLab Protein 2 5 9510 99 10 046 3 x 1 mL
3 years at –20°C
Only freeze once!
Discard contaminated specimens.

CRP U-hs – Page 1 *U-hs: universal and high sensitive

Performance Characteristics Calculation
The CRP concentration of unknown samples is derived from a calibration
Measuring range curve using an appropriate mathematical model such as spline. The
The measuring range is from 0.3 mg/L up to the concentration of the highest calibration curve is obtained with five calibrators at different levels and NaCl
calibrator, at least up to 350 mg/L. When values exceed these ranges solution (9 g/L) for determination of the zero value. Stability of calibration:
samples should be diluted 1 + 1 with NaCl solution (9 g/L) and the result 4 weeks
multiplied by 2.
Calibrators and Controls
Prozone Limit
For calibration, the DiaSys TruCal CRP hs calibrator set is recommended
No prozone effect was observed up to a CRP concentration of 1000 mg/L.
(order information see above). The assigned values of the calibrators have
®
Specificity/Interferences been made traceable to the IFCC reference material ERM -DA474.
Due to its antibodies DiaSys CRP U-hs is a specific immunoassay for human For internal quality control, a DiaSys TruLab CRP hs control should be
CRP. At a CRP level of 1.0 mg/L interference by lipemia is < 10% up to assayed with each batch of samples. Each laboratory should establish
2000 mg/dL triglycerides (Intralipid). No interference has been observed up to corrective action in case of deviations in control recovery.
levels of 700 IU/mL RF, 40 mg/dL bilirubin and 1000 mg/dL hemoglobin. For Cat. No. Kit size
further information on interfering substances refer to Young DS [8]. TruLab CRP hs Level 1 5 9730 99 10 046 3 x 1 mL
Sensitivity/Limit of Detection TruLab CRP hs Level 2 5 9740 99 10 046 3 x 1 mL
The lower limit of detection is 0.3 mg/L. Performance Characteristics
Precision
Measuring range
Intra-assay precision Mean [mg/L] SD CV
n=20 [mg/L] [%] Multi-point calibration: The measuring range is from 0.05 mg/L up to the
concentration of the highest calibrator, at least up to 20 mg/L. When values
Sample 1 1.03 0.04 3.9
exceed these range samples should be diluted 1 + 1 with NaCl solution
Sample 2 2.08 0.05 2.5
(9 g/L); the result multiplied by 2.
Sample 3 222 4.35 2.0
Prozone Limit
Inter-assay precision Mean [mg/L] SD CV No prozone effect was observed up to a CRP concentration of 800 mg/L.
n=20 [mg/L] [%]
Sample 1 2.24 0.04 1.9 Specificity/Interferences
Sample 2 24.6 0.29 1.2 Due to its antibodies DiaSys CRP U-hs is a specific immunoassay for human
Sample 3 233 7.84 3.4 CRP. At a CRP level of 0.70 mg/L interference by lipemia is < 10 % up to
1200 mg/dL triglycerides (Intralipid). No interference has been observed up to
Total precision according to protocol EP-5 of the NCCLS (National Committee 700 IU/mL RF, up to 40 mg/dL bilirubin and up to 1000 mg/dL hemoglobin.
of Clinical Laboratory Standards): For further information on interfering substances refer to Young DS. [8].
Inter-assay precision Mean [mg/L] SD CV Sensitivity/Limit of Detection
n=80 [mg/L] [%] The lower limit of detection is 0.05 mg/L.
Sample 1 24.6 0.48 2.0
Sample 2 233 8.38 3.6 Precision
Intra-assay precision Mean [mg/L] SD CV
Method Comparison n=20 [mg/L] [%]
A comparison of DiaSys CRP U-hs FS with universal application (y) to a Sample 1 0.37 0.01 2.5
nephelometric test (x) using 111 samples gave following results: Sample 2 1.21 0.02 1.3
y = 1.06 x + 0.07 mg/L; r = 0.992 Sample 3 17.5 0.47 2.7
A comparison of DiaSys CRP U-hs with universal application (y) to a
Inter-assay precision Mean [mg/L] SD CV
commercially available immunoturbidimetric test (x) using 78 samples gave
n=20 [mg/L] [%]
following results: y = 1.03 x + 0.34 mg/L; r = 0.998
Sample 1 0.68 0.01 1.3
Sample 2 2.37 0.02 1.0
High sensitive application Sample 3 10.7 0.10 1.0
Assay Procedure for Analyzers Total precision according to protocol EP-5 of the NCCLS (National Committee
of Clinical Laboratory Standards):
Application sheets for automated systems are available on request. Inter-assay precision Mean [mg/L] SD CV
Basic parameter for Hitachi 911 n=80 [mg/L] [%]
Wavelength Sample 1 2.37 0.04 1.7
800/505 nm (bichromatic)
Temperature Sample 2 10.7 0.13 1.2
37°C
Measurement 2-Point Test (Fixed Time Kinetics) Method Comparison
15 µL A comparison of DiaSys CRP U-hs FS with high sensitive application (y) to a
Sample/calibrator
Reagent 1 150 µL nephelometric test (x) using 59 samples gave following results:
Reagent 2 150 µL y = 0.99 x + 0.01 mg/L; r = 0.990
Addition Reagent 2 Cycle 16 (320 s)
Absorbance 1 Cycle 19 (380 s) A comparison of DiaSys CRP U-hs FS with high sensitive application (y) to a
Absorbance 2 Cycle 31 (620 s) commercially available test (x) using 59 samples gave following results:
Calibration spline y = 0.99 x – 0.06 mg/L; r = 0.994

Manufacturer
DiaSys Diagnostic Systems GmbH
IVD Alte Strasse 9 65558 Holzheim Germany

CRP U-hs – Page 2 844 7045 10 02 00 February 2018/14