11508H - 2.

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REF 11508H Latex immunoassay for the determination of the

C-Reactive Protein (CRP) concentration in serum and
plasma
EN

CRP Ultra REAGENT 1: 2 x 20 mL - REAGENT 2: 2 x 20 mL

STANDARD/CALIBRATOR: the term refers to the standard / the calibrator

REAGENT: the term refers to the single reagent CONTROL: the term refers to the control

SUMMARY IMPORTANT NOTE

CRP (C-Reactive Protein) is an acute phase protein whose 1) Standard Method: use the CRP Calibrator Set 0.5-1-2-4-
concentration is seen to increase as a result of the 8-16-32 mg/dL, REF 11532.
inflammatory process, most notably in response to 2) Ultrasensitive Method: use the CRP Calibrator Set 0.5-1-
pneumococcal (bacterial) infection, histolytic disease and a 2-4-8-16-32 mg/dL, REF 11532, by substituting the
variety of other disease states. CRP is used as a marker or calibrator 32 mg/dL with the calibrator 0.25 mg/dL
general diagnostic indicator of infections and inflammation, in
addition to serving as a monitor of patient response to contained in the kit CRP Calibrator US, REF 11533.
pharmacological therapy and surgery. STANDARDIZATION
PRINCIPLE CRM 470 (Certified Reference Material) from BCR (EG
CRP Ultra is a latex immunoassay developed to accurately Community Bureau of Reference), corresponding to RPPHS
and reproducibly measure blood CRP levels in serum. When (Reference Preparation for Protein in Human Serum) lot
91/0619. CRP concentration is indicated on the package
an antigen-antibody reaction occurs between CRP in a insert included in each calibrator or control kit.
sample and anti-CRP antibody, which has been absorbed to
latex particles, agglutination results. This agglutination is SAMPLE
detected as an absorbance change, with the change in Serum, plasma (heparin, EDTA). Collect samples in
accordance 1 with the NCCLS procedure reported in
agglutination being proportional to the quantity of CRP in the bibliography .
sample.
STABILITY OF THE SAMPLE
REAGENTS 7 days at 2-8 °C or 12 months at -20 °C.
The components of the kit, stored at 2-8 °C in unopened vials,
are stable up to the expiry date indicated on the package. WARNING AND PRECAUTIONS
Components of the kit and concentration of reactive ·For in vitro diagnostic use.
ingredients: ·Do not use components beyond the expiration date.
REAGENT 1 ·Do not mix materials from different kit lot numbers.
glycine buffer pH 7.0, sodium azide < 0.1% ·Safety Data Sheets are available at
REAGENT 2 www.sentineldiagnostics.com or contact your local
anti-CRP polyclonal antibodies absorbed on latex particles in representative.
a 0.2% suspension, sodium azide < 0.1%
· CAUTION: This product requires the handling of
PREPARATION OF REAGENT SOLUTIONS
human specimens. It is recommended that all human
REAGENT 1 and REAGENT 2: Ready to use.
sourced materials be considered potentially infectious and
STABILITY be handled in accordance with the OSHA Standard on
2 3
On Board: 60 days, if contamination is avoided. Bloodborne Pathogens , Biosafety Level 2 or other
4,5
Calibration: 14 days. Repeat the calibration at any variation in appropriate biosafety practices should be used for
the reagent lot. materials that contain or are suspected of containing
CALIBRATION infectious agents.
· This product contains sodium azide; for a specific listing,
For the calibration, use the following material:
Standard Method refer to the REAGENTS section of this package insert.
Contact with acids liberates very toxic gas. This material
CRP Calibrator Set
and its container must be disposed of in a safe way.
0.5-1-2-4-8-16-32 mg/dL REF 11532 7x2mL
Ultrasensitive Method
CRP Calibrator US INSTRUMENTATION AND MATERIALS
[ CRP ] ≈ 0.25 mg/dL REF 11533 1x2mL REQUIRED BUT NOT PROVIDED
Liquid calibration sera. For use, follow the instructions · General laboratory equipment.
contained in the kit. ANALYTICAL PROCEDURE
QUALITY CONTROL Wavelength: 570 nm (main)
Use the following control materials to verify test accuracy: 800 nm (reference)
Standard Method Pathlength: 1 cm
Immuno Control Set (2 lev) REF 11211A 2x(2x1) mL Temperature: 37 °C
Sample/REAGENT 1/REAGENT 2: 1/50/50
Ultrasensitive Method
Reaction: Fixed Time (increase)
CRP Control US Allow reagents to reach working temperature before using.
[ CRP ] ≈ 0.05 mg/dL REF 11540 3x2mL A proportional variation of the indicated reaction volumes does not
Liquid control sera. For use, follow the instructions contained change the results.
in the kit.

REF 11508H CRP Ultra 1/2

 REF 11508H CRP Ultra EN
EXAMPLE OF ANALYTICAL PROCEDURE INTERFERENCES:
ON AUTOMATED INTRUMENTS the test is not affected by the presence of bilirubin
Time 0 (conjugated and fetal) up to 30 mg/dL, lipids (intrafat) up to
Calibrator/Controls/Sample = 3 μL 1500 mg/dL rheumatoid factor (RF) up to 550 IU/mL and
REAGENT 1 = 150 µL haemoglobin up to 500 mg/dL.
After 300 sec ANALYTICAL RANGE:
Addition of REAGENT 2 = 150 μL 0.04 - 32 mg/dL (SM).
After 60 sec Samples with concentrations higher than 32 mg/dL must be
Reading 1 diluted 1:10 with normal saline and the result multiplied by 10.
0.01 - 16 mg/dL (UM).
After 180 sec
Reading 2
Samples with concentrations higher than 16 mg/dL must be
diluted 1:10 with normal saline and the result multiplied by 10.
CALCULATION
PROZONE EFFECT:
1. Plot a calibration curve on a graph paper by tracing
no prozone effect was observed up to a concentration of
absorbance (y axis) according to corresponding mg/dL 100 mg/dL.
concentration (x axis) for each Calibrator.
2. Indicate on the calibration curve the absorbance value WASTE MANAGEMENT
obtained for Samples and Controls. Reagents must be disposed of in accordance with local
3. Extrapolate the mg/dL value for Samples and Controls from regulations.
the calibration curve. BIBLIOGRAPHY
CONVERSION FACTOR 1) NCCLS Procedures for the Collection of Diagnostic Blood
CRP [ mg/dL ] x 10 = CRP [ mg/L ] Specimens by Venipuncture; Approved Standard - Fifth Edition
(H3-A5). Wayne, PA: The National Committee for Clinical
REFERENCE VALUES Laboratory Standards, 2003.
2) US Department of Labor, Occupational Safety and Health
Adults: < 0.5 mg/dL Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
It is recommended that each laboratory establish its own expected 3) US Department of Health and Human Services. Biosafety in
range. For diagnostic purposes, results obtained should always be Microbiological and Biomedical Laboratories, 5th ed.
evaluated taking into consideration the patient's history and all other Washington,DC: US Government Printing Office, January 2007.
clinical findings. 4) World Health Organization. Laboratory Biosafety Manual, 3rd
ed.Geneva: World Health Organization, 2004.
PERFORMANCES 5) Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
AUTOMATIC ANALYZER Workers from Occupationally Acquired Infections; Approved
Guideline — Third Edition (M29-A3). Wayne, PA: Clinical and
SM = Standard Method - UM = Ultrasensitive Method Laboratory Standards Institute, 2005.
6) Pesce, A.J., Kaplan, L.A.: “Methods in Clinical Chemistry”,
SENSITIVITY: Mosby Ed. (1987).
0.04 mg/dL (SM), 0.01 mg/dL (UM). Sensitivity was calculated 7) Burtis C.A., Ashwood E.R.: “Tietz Textbook of Clinical
Chemistry”, W.B. Saunders Company Ed. (3rd edition, 1999).
on 20 replicates x 3 runs of normal saline and reported as the 8) Guder W.G.: “The Quality of Diagnostic Sample”.
"mean zero value + 3 SD". Recommendations of the Working Group on Preanalytical Quality
of the German Society for Clinical Chemistry and the German
INTER-ASSAY PRECISION (SM):
Society for Laboratory Medicine. (1st Edition - 2001).
was determined from 5x2x4 tests (day x run x rep) on each 9) Jakobs, D.S., Kasten, Jr., B.L., DeMott, W.R., Wolfson, W.L.:
control (4 levels - L1/L2/L3/L4). The results were as follows: “Laboratory Test Handbook”, Lexi-Comp and Williams & Wilkins
Total Between Ed. (2nd Edition - 1990).
mean Repeatability 10) Dati F, Johnson AM, Whicher JT. The existing interim consensus
Imprecision Days
reference ranges and the future approach. Clin.Chem.Lab.Med.
mg/dL SD CV% SD CV% SD CV% 2001;39(11):1134-6.
L1 1.09 0.018 1.6 0.000 0.0 0.013 1.2 11) US Patent: 6,248,597 / 6,828,158
L2 2.87 0.028 1.0 0.000 0.0 0.028 1.0 Explanation of symbols
L3 4.12 0.033 0.8 0.009 0.2 0.032 0.8 In vitro Diagnostic Medical Device
L4 5.48 0.045 0.8 0.014 0.3 0.042 0.8 Catalogue number

INTER-ASSAY PRECISION (UM): Batch code

was determined from 5x2x4 tests (day x run x rep) on each Contents of kit
control (4 levels - L1/L2/L3/L4). The results were as follows:
Caution, consult accompanying documents
Total Between
mean Repeatability
Imprecision Days Consult instructions for use
mg/dL SD CV% SD CV% SD CV%
L1 0.046 0.0022 4.7 0.0000 0.0 0.0019 4.0 Use by (last day of the month)
L2 0.492 0.0043 0.9 0.0000 0.0 0.0035 0.7
L3 1.135 0.0183 1.6 0.0000 0.0 0.0148 1.3 XXX Contains sufficient for <n> tests
L4 4.588 0.0389 0.9 0.0219 0.5 0.0298 0.7
Temperature limitation
ACCURACY:
this test (y) was compared with a commercially available Manufacturer
method (x). The results were as follows: Note: changes in comparison to the previous version are indicated by a
N = 51, r = 0.999, y = 1.04x - 0.04 vertical bar in the text margin.

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