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Tél. : 71 182 500 - Fax : 71 182 250
www.biomaghreb.com
IVD
FT En 42 Date of updating : 10/ 2020 Version B
IN VITRO DIAGNOSTIC USE
Manufacturer Use by In Vitro Diagnostic Temperature
Limitation
Catalogue number See insert Keep away
from light
Sufcient
for < n > essais
Batch number
CLINICAL SIGNIFICANCE
CRP is an acute-phase protein present in normal serum, which increases significantly after most
forms of tissue injuries, bacterial and virus infections, inflammation and malignant neoplasia. During
tissue necrosis and inflammation resulting from microbial infections, the CRP concentration can rise
up to 300 mg/L in 12-24 hours.
PRINCIPLE
The CRP LATEX is a rapid latex test for the search for C Reactive Protein (CRP). Latex particles,
sensitized with antibodies specific for human CRP, are agglutinated in the presence of patient serum
containing CRP.
REAGENT COMPOSITION
Anti-CRP latex
(Ready to use)
Aqueous suspension of sensitized latex particles.
Dropper bottle: (1 drop = 50 µl)
Homogenize before use
Positive control
(Ready to use)
Dropper bottle:
(1drop :50µl)
Negative control
(Ready to use)
Dropper bottle
(1goutte = 50 µl)
Card Card for carrying out the test
Stirrers Disposable stirrers for mixing reagents and samples
SAFETY CAUTIONS
Biomaghreb reagents are intended for use by qualified personnel for in vitro use (do not pipette by
mouth).
• Refer to the current MSDS available on request or on www.biomaghreb.com.
• Check the integrity of the reagents before use.
• Disposal of waste: comply with applicable legislation.
For safety reasons, treat any specimen or reagent of biological origin as potentially infectious. Ob-
serve the applicable legislation.
SAMPLE PREPARATION
Sera fresh or stored at -20°C, showing complete coagulation.
Reject any lipemic or contaminated serum. Do not use plasma.
PRESERVATION AND STABILITY
Store at 2-8°C until the expiration date indicated on the box.
PROCEDURE
Bring reagents and test sera to room temperature (18-25°C).
1) Qualitative test
Place successively on the card :
• drop of the positive control
• 1 drop of negative control
• 1 drop of the serum to be tested
Next to each deposit; add, using the vertical dropper, 1 drop of well homogenized anti- CRP.
Mix with a stirrer.
Make a slow rotational movement to the card. Note the appearance of agglutination in exactly 3
minutes.
◊ RESULT
› Positive reaction (agglutination) :
Clear agglutination in 2 minutes. The sensitivity of the CRP LATEX test is 6 mg/l. Sera giving a posi-
tive reaction have a concentration higher than 6mg/l of CRP.
› Negative reaction (homogeneous suspension) :
Absence of antistreptolysin O antibodies or presence at a level lower than 200 Ul/ml.
2) Semi quantitative test
Prepare serial two-fold dilutions in physiological saline and observe the presence or absence of
agglutination.
The approximate C-Reactive protein level in serum sample can be calculated by the following formula:
CRP mg/l = Highest dilution with positive reaction X
reagent sensitivity (6 mg/l).
NORMAL VALUE
Up to 6-8 mg/l
INTERPRETATION
The CRP concentration increases in acute inflammatory diseases and malignant tumors.
Continuous monitoring of patients with high CRP concentrations provides a good indication of the
therapeutic response of these patients.
BIBLIOGRAPHIE
Hind. C.R.K. and M.B. Pepys nt. Med. 5-151 (1984).
Singer, J.M. et al.
Amer. J. Clin. Path. 28.611 (1957).
CRP LATEX
Serological detection on latex particles
of protein C Reactive
