CRP-ULTRA

CRP-ultrasensitive
Latex turbidimetry

Quantitative determination of low levels of C-Reactive Protein SPIN 800 APPLICATION

IVD
Store 2 - 8ºC.
PRINCIPLE OF THE METHOD EDIT PARAMETERS
The CRP-ultrasensitive is a quantitative turbidimetric test for the measurement of
Test CRPu No. **
low levels of C- reactive protein (CRP) in human serum or plasma.
Latex particles coated with specific anti- human CRP are agglutinated when Full name CRPu Print name CRPu
mixed with samples containing CRP. The agglutination causes an absorbance
change, dependent upon the CRP contents of the patient sample that can be
quantified by comparison from a calibrator of known CRP concentration. Reac. Type End Point Direction Increase
CLINICAL SIGNIFICANCE Pri. Wave. 546 Sec. Wave.
CRP is an acute-phase protein present in normal serum, which increases
significantly after most forms of tissue injuries, bacterial and virus infections, Unit mg/L Decimal 0.1
inflammation and malignant neoplasia. CRP may be also useful in detecting
atherosclerotic process and providing important prognostic information about Reagent Blank - React. Time 18 - 31
patients with asymptomatic heart disease, unstable angina, and myocardial
infarction. Recent studies in apparently healthy people show that CRP Vol. Sample 3 ul Increas. Decrease Sample blank
concentration in serum rise long before traditional symptoms of heart and
vascular diseases are noticed.
REAGENTS R1 240 ul R2 60 ul R3 R4

Diluent-ultra (R1) Tris buffer 20 mmol/L, pH 8,2. Preservative.

Latex particles coated with goat IgG anti- human CRP,
Latex-ultra (R2)
pH 7,3. Preservative. CALIBRATION Spline Water 0 Vol aspirated Vol net Vol dil
Liquid Calibrator. C-Reactive protein concentration is
U-CRP CAL Calibrator *0.0625 3 10 150
stated on the vial label.
Optional Ref: 43036 CRP Ultra Control. Calibrator *0.125 3 25 175
Calibrator *0.25 3 30 90
PRECAUTIONS Calibrator *0.4951 6 30 90
Components from human origin have been tested and found to be negative for
the presence of HBsAg, HCV, and antibody to HIV (1/2). However handle Calibrator * 3 -- --
cautiously as potentially infectious. CAL AUTO DILUTIONS
CALIBRATION
Use CRP Ultra Calibrator Reference 43035.
The sensitivity of the assay and the target value of the calibrator have been The Calibration is stable until 31 days. After this period the Calibration must
standardized against the Reference Material ERM-DA 474/IFCC. be performed again in order to obtain good results.
Recalibrate when control results are out of specified tolerances, when using
PERFORMANCE CHARACTERISTICS
different lot of reagent and when the instrument is adjusted.
1. Linearity limit: Up to 10 mg/L, under the described assay conditions.
PREPARATION Samples with higher concentrations should be diluted 1/3 in NaCl 9 g/L and
Ready for use. re-tested again. The linearity limit depends on the sample / reagent ratio. It
CRP Calibrator: Ready for use. will be higher by decreasing the sample volume, although the sensitivity of
the test will be proportionally decreased.
STORAGE AND STABILITY 2. Detection limit: Values less than 0,05 mg/L give non-reproducible results.
All the components of the kit are stable until the expiration date on the label when 3. Prozone effect: No prozone effect was detected upon 800 mg/L.
stored tightly closed at 2-8ºC and contaminations are prevented during their use. 4. Sensitivity: ∆ 44 mA.mg/L.
Reagents should not be left inside the analyzer after use, they must be stored 5. Precision: The reagent has been tested for 20 days, using three different
refrigerated at 2-8ºC. Latex may sediment. Mix reagents gently before use. Do CRP concentrations in a EP5-based study.
not use reagents over the expiration date. EP5 CV (%)
Reagent deterioration: Presence of particles (R1, R2) and turbidity (R1). +/- 0,28 mg/L +/- 3,09 mg/L +/- 5,95 mg/L
Total 7,7% 2,7% 3,0%
Do not freeze; frozen Latex or Diluent could change the functionality of the test. Within Run 4,5% 1,7% 1,4%
ADDITIONAL EQUIPMENT Between Run 4,7% 1,9% 2,7%
- SPIN 800 autoanalyzer. Between Day 4,1% 0,7% 0,0%
- Laboratory equipment.. 6. Accuracy: Results obtained using this reagent (y) were compared to those
obtained using a commercial reagent (x) with similar characteristics. 23
SAMPLES samples of different concentrations of CRP were assayed. The correlation
Fresh serum. Stable 7 days at 2-8ºC or 3 months at –20ºC. coefficient (r) was 0,99 and the regression equation y=1,0028x-0,0625.
The samples with presence of fibrin should be centrifuged before testing. The results of the performance characteristics depend on the analyzer used.
Do not use highly hemolized or lipemic samples.
NOTES
REFERENCE VALUES Clinical diagnosis should not be made on findings of a single test result, but
Below 3 mg/L is considered normal. should integrate both clinical and laboratory data.
Each laboratory should establish its own reference range. BIBLIOGRAPHY
1. Thomas A et al. IVD Technology 2000; March/April: 27-35.
QUALITY CONTROL 2. Macy E M et al. Clinical Chemistry 1997; 43: 52-58.
Control Sera are recommended to monitor the performance of manual and 3. Pearson TA et al. Circulation 2003;107:499-511.
automated assay procedures. It should be used the SPINREACT CRP Ultra 4. Haverkate F et al. Fibrinolysis and Proteolysis 1007; 11: 1331-134.
Control (Ref.:43036). Each laboratory should establish its own Quality Control 5. Ronald D et al. Journal of Clinical Ligand Assay 1997; 313-315.
scheme and corrective actions if controls do not meet the acceptable tolerances. 6. Ridker PM et al. The New England Journal of Medicine 2000; 23: 836-843.
7. Koening W at al. Circulation 1999; 99: 237-242.
8.Young DS. Effects of drugs on clinical laboratory test, 4th ed. AACC Press, 1995.
BARCODED REAGENTS LOAD MUST BE PRECEDED OF A SPINREACT
“DATABASE” COPY INTO THE ANALYZER SOFTWARE. IT IS AVAILABLE PACKAGING
UNDER REQUEST TO SPINREACT. Ref.: MX43134
Cont.
R1. Diluent: 2 x 40 mL
R2. Latex :1 x 20 mL
U-CRP-CAL :1 x 2 mL

MXTLIS46-I 26/01/21 SPINREACT,S.A./S.A.U. Ctra.Santa Coloma, 7 E-17176 SANT ESTEVE DE BAS (GI) SPAIN
Tel. +34 972 69 08 00 Fax +34 972 69 00 99 e-mail: spinreact@spinreact.com