BIOLABO
!
www.biolabo.fr
CRP Turbidimetric Immunoassay
Reagent for quantitative determination of C-Reactive Protein (CRP) in human serum
MANUFACTURER:
BIOLABO S.A.S
! Les Hautes Rives REF CRP050E R1 1 x 50 mL R2 1 x 5 mL
! 02160, Maizy, France
REF CRP620E R1 6 x 20 mL R2 1 x 10 mL
|
TECHNICAL SUPPORT AND ORDERS IVD
Tel: (33) 03 23 25 15 50
support@biolabo.fr Made in France
Latest revision : www.biolabo.fr I: corresponds to significant modifications!
!
INTENDED USE SAFETY CAUTIONS
This reagent is designated for professional use in laboratory (manual · Refer to current Material Safety Data Sheet available on request or
or automated method). on www.biolabo.fr
This quantitative test is to detect and measure C - reactive protein in · Verify the integrity of the contents before use.
human serum to assess the inflammatory status of the body. · Waste disposal: Respect legislation in force in the country.
· All specimens or reagents of biological origin should be handled as
potentially infectious. Respect legislation in force in the country.
GENERALITIES (1) (4) Any serious incident that has occurred in connection with the device is
notified to the manufacturer and the competent authority of the
C - reactive protein is one of the strongest acute phase reactants and Member State in which the user and/or patient is based.
help in non-specific host defence against infectious agents.
Its concentration increased after myocardial infarction, stress, trauma, REAGENTS PREPARATION
infection, inflammation, surgery or neoplastic proliferation. Ready for use.
PRINCIPLE (2) (3) STABILITY AND STORAGE
Turbidimetric Immunoassay (TIA): Photometric measurement of
Stored away from light, well cap in the original vial at 2-8°C,
turbidity, corresponding to antigen-antibody reaction, by the end-point reagent is stable when stored and used as described in the insert:
method at 340 nm.
Unopened,
· Until the expiry date stated on the label of the Kit.
REAGENTS Once opened:
· When free from contamination, 2 separated reagents are stable for :
R1 CRP Buffer
- 3 years at 2-8° C
Tris buffered saline pH 7.5
Polyethylene glycol 60 g/L
Sodium azide 0.95 g/L SPECIMEN COLLECTION AND HANDLING (5)
R2 CRP Anti-CRP Use fresh serum. Specimen without lipemia or haemolysis are
Tris buffered saline pH 7.5 preferred.
Polyclonal goat anti-human CRP (variable) If the test cannot be carried out on the same day, the serum may be
Sodium azide 0.95 g/L stored:
According to 1272/2008 regulation, these reagents are not classified · at 2-8°C for 72 hours
as dangerous. · at -20°C for 6 months
LIMITS (5) (6)
Excessive turbidity can affect nephelometric methods
For a more comprehensive review of factors affecting this assay refer
to the publication of Young D.S.
MATERIAL REQUIRED BUT NOT PROVIDED
1. Medical analysis laboratory equipment.
2. Spectrophotometer or Biochemistry Clinical Analyzer
3. Saline (NaCl 9 g/L)
!
IVD H2O !
Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk
REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with
CRP_220E_IFU_CRP050E-CRP620E_V06_20240417
QUALITY CONTROL CALIBRATION
· REF CRP CONTL1: CRP Control Low · REF CRP CALSET51: CRP Standard Set
· REF CRP CONTH1: CRP Control High Or
· REF TIA CONT21: Control Set · REF CRP CALSH1: CRP Standard Super High (successive 1:2
· External quality control program. dilutions in saline up to 6 different levels including zero point).
It is recommended to control in the following cases: · Use saline as zero point
· At least once a run. Calibration values are traceable to a reference material
· At least once within 24 hours. (RPPHS/CRM470) from the International Federation of Clinical
· When changing vial of reagent. Chemistry (IFCC).
· After maintenance operations on the instrument. The calibration frequency depends on proper instrument functions and
If control is out of range, apply following actions: on the preservation of the reagent.
1. Prepare a fresh control serum and repeat the test.
2. If control is still out of range, use a new vial of calibrator or a fresh
PROCEDURE
calibrator and repeat the test.
3. If control is still out of range, repeat the tests with a new vial of Let stand reagents, standards, control, assays at room temperature.
reagent. Before use, mix reagent R2 by gentle swirling.
If control is still out of range, please contact BIOLABO technical
support or your local Agent. Manual Procedure:
Generate standard curve (§ Calibration)
REFERENCE INTERVAL (1)
Pipette into well identified test Blank Calibration Assays
IFCC Value: < 0.5 mg/dL tubes:
These values are applicable only to adults between 20 and 60 years of Buffer (R1) 1000 µL! 1000 µL 1000 µL
age
Saline 60 µL
Each laboratory should establish its own normal ranges for the
population that it serves. Standards 60 µL
Specimen 60 µL
I PERFORMANCES
On Kenza 240TX, at 340 nm, 37°C Mix well. Record absorbance A1 against blank at 340 nm
Linearity Range: between 0.5 mg/dL and 24.8 mg/dL
Anti-CRP (R2) 100 µL 100 µL 100 µL
Precision:
Within-run Low Normal High Between run Low Normal High Mix and let stand for 5 minutes at room temperature.
N = 20 level level level N = 20 level level level Record absorbance A2 against blank at 340 nm.
Mean (mg/dL) 1.44 3.43 10.01 Mean (mg/dL) 1.50 3.65 11.21 1- With Manual Procedure on Spectrophotometer, performances and
S.D. mg/dL 0.09 0.08 0.159 S.D. mg/dL 0.075 0.099 0.267 stability data should be validated by user
C.V. % 6,3% 2,3% 1,6% C.V. % 5.0% 2,7% 2.4% 2- Applications proposal are available on request of other analysers
Prozone effect: from 60 mg/dL
I CALCULATION
Interferences:
Negative interference from 0.014 OD Manual procedure:
Turbidity Calculate DAbs (Abs A2 – Abs A1) for standards, controls and assays.
(eq. 1,2 mmol/L of triglycerides)
Plot a Standard Curve “Concentration = f(DAbs)”.
Total bilirubin Negative interference from 76 µmol/L
Read the concentration of controls and samples on the graph.
Direct bilirubin Negative interference from 95 µmol/L
Automatic Biochemistry analyzer:
Ascorbic acid No interference up to 2500 mg/dL
The analyzer provides directly final result.
Glucose No interference up to 969 mg/dL For more details about calibration and calculation of results, refer to
Haemoglobin Negative interference from 24 µmol/L User’s manual and specific application.
Other substances may interfere (see § Limits) Note: Results lower than 0.5mg/dL must be indicated as < 0.5 mg/dL
On the board stability: 2 months
Calibration Stability: at least 7 days REFERENCES
Make a new calibration when changing reagent batch, if quality control
(1) TIETZ N.W. Textbook of clinical chemistry, 3rd Ed. C.A. Burtis, E.R.
results are found out of the established range and after maintenance Ashwood, W.B. Saunders (1999) p.493, p.481.
operations. (2) Marrack, J.R. and Richards, CB., J. Immunol. 20, 1019 – 1040
Comparison study on Pentra 400: (1971)
50 human specimens between 0,5 and 37,53 mg/dL were analysed (3) Ritchie, RF., J. Lab. Clin. Med. 70, 512 - 517(1967)
with this method and compared to another commercially available (4) Pepys MB. et al., Ann. NY Acad. Sci, 389, 459 (1982)
(5) Clinical Guide to Laboratory Test, 4th Ed., N.W. TIETZ (2006) p.
reagent (same method): 190-192
(6) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed.
Y = 0.9905 x – 0.1234 R = 0.9993!! (1995) p. 3-511 to 3-512
CRP_220E_IFU_CRP050E-CRP620E_V06_20240417
