C REACTIVE PROTEIN (CRP)

Qualitative and semiquantitative determination of C-reactive protein by agglutination to latex

TEST SUMMARY Area Area Area Area Area Area WASTE DISPOSAL
Reagents
C-reactive protein, contained in the serum, produces 1 2 3 4 5 6 Product is intended for professional laboratories. Waste
agglutination of latex particles coated with anti-CRP products must be handled as per relevant security cards
antibody. Physiologic 50 µl 50 µl 50 µl 50 µl 50 µl 50 µl and local regulations.
Sample 50 µl 50 µl 50 µl 50 µl 50 µl 50 µl
SAMPLES PACKAGING
from from from from from
Fresh serum. Stability 7 days at 2-8°C. For longer periods 1 2 3 4 5 CODE AK00110 (100 TESTS)
of time it is recommended to freeze samples at –20°C. Latex 1 x 5 ml
Frozen samples must be totally unfrozen and brought to Reject 50 µl from last area
room temperature before using. Samples in which Latex 50 µl 50 µl 50 µl 50 µl 50 µl 50 µl
CODE AK00111 (100 TESTS)
turbidity is observed must be cleared by centrifugation Latex 1 x 5 ml
before being analysed. 12 24 48 96 192 384 Positive control 1 x 0.5 ml
Titre
mg/l mg/l mg/l mg/l mg/l mg/l Negative control 1 x 0.5 ml
REAGENTS Slide black spot 3
Latex Stirrers 50
EXPECTED VALUES
Latex particles coated with anti-CRP antibody;
Generally CRP in healthy adults is below 5 mg/L, in a CODE AK00105 (CRP Controls)
conservative and stabilizer.
number of disease states these values often exceeded Positive control 1 x 0.5 ml
Positive control within 4 to 8 hours after an acute event and reach levels Negative control 1 x 0.5 ml
Human base stabilized solution having a CRP up to 500 mg/L. The average value of CRP on 143
concentration 30-50 mg/L. healthy adults is resulted 0.64 mg/L with an interval from
REFERENCES
Negative control 0.08 mg/L to 3.11 mg/L. (Clinical chemistry 43:1; 52-58:
1997). Lars-Olof Hanson et al.Current Opinion in Infectious
Protein solution not reactive with latex. diseases 1997; 10: 196-201.
Every laboratory should be establish own reference
All reagents contain 0.095% of sodium azide. intervals in relation to own population. M.M. Pepsy. The Lancet 1981; March 21 : 653 –656.
Chetana Vaishnavi. Immunology and Infectious Diseases
REAGENTS PREPARATION AND STORAGE CLINICAL SIGNIFICANCE 1996; 6: 139-144.
Yoshitsugy Hokama et al. Journal of Clinical Laboratory
Reagents are ready for the use. C-reactive protein is a protein present in normal serum,
Status 1987; 1 : 15-27.
The latex suspension must be resuspended with much which increases significantly after most forms of tissue
Charles Wadsworth et al. Clinica Chimica Acta; 1984 :
care. When the suspension becomes homogeneous by injuries, bacterial and virus infections, inflammation, and
138: 309-318.
sweet inversion, it is necessary to fill and to empty the malignant neoplasies. CRP contributes to non-specific Singer, J.M. et al., Am.J.Med.,21:888-892 (1956).
dosage’s pipette many times. defense by complement activation and accelerating Pepsy,M.B.,Lancet,1 :653-657 (1981).
Stability: the components of this kit will remain stable until phagocytosis. CRP testing has a high diagnostic value on Pepsy,M.B. et al., Adv.Immunol.,34 :141-142 (1983).
the expiration date stated on the label. a tentative diagnosis made on the basis of case history
Store at 2-8°C. Do not freeze. and clinical findings.
MANUFACTURER
MATERIAL REQUIRED BUT NOT SUPPLIED NOTE LTA s.r.l.
Physiologic solution. • If reaction’s times are bigger than 2 minutes, they may Via Milano 15/F
COD. AK00110 Slide and disposable stirrers. cause a over-estimation of samples concentrations. 20060 Bussero (Milan) ITALY
• Human sera used in controls have been found negative Tel: ++39 02 95409034
PRECAUTION in the reaction with HIV and HBsAg. However, they Fax: ++39 02 95334185
Reagent may contain not reactive and conservative should be handled with care. e-mail: info@ltaonline.it
components. It is opportune to avoid contacts with the • If the results are incompatible with clinical presentation, Website: http://www.ltaonline.it
skin and do not swallow. they have to be evaluated within a total clinical study.
Perform the test according to the general “Good SYMBOLS
Laboratory Practice” (GLP) guidelines. CALIBRATION
Positive and Negative control sera should be always used
QUALITATIVE PROCEDURE to distinguish an eventual background’s agglutination of F Only for IVD use
reactive.
C Lot of manufacturing
Positive Negative
Reagents Samples
Control Control TEST PERFORMANCE B Code number
Sensitivity
Sample 50 µl (1 gt) -- -- Test gives positive results as from concentrations of 6 I Storage temperature interval

Control +
Control -
--
--
50 µl (1 gt)
--
--
50 µl (1 gt)
mg/l (5-10 mg/l).
Not happened phenomenon of prozone in CRP
K Expiration date

Latex 50 µl (1 gt) 50 µl (1 gt) 50 µl (1 gt) concentrations studied until 1634 mg/dl. J Warning, read enclosed documents

Mix using disposable stirrers and spreading

Specificity L Read the directions
A comparison with an available commercial method gave
homogeneously the mixture on the slide, then, shake
slide for 2 minutes by a sweet rotating motion or by a
following results on 125 samples compared, giving a A Biological risk
specificity = 96.2%:
stirrer at 100 r.p.m., and observe eventual agglutination Mod. 01.06 (ver. 3.5 - 05/12/2005)
using artificial light. LTA srl

H
RESULTS INTERPRETATION + - TOT.
COMPETI TORS

POSITIVE: A clear agglutination within 2 minutes. 44 2

+ 46
NEGATIVE: No agglutination within 2 minutes. 95.6% 4.35%
In case of positivity it is opportune to titre 3 76
semiquantitatively the serum. - 79
3.8% 96.2%
TOT. 47 78 125
SEMIQUANTITATIVE PROCEDURE
Prearrange serial dilution of the serum, pipetting in six Interferences
slide areas, 50 µl of physiologic solution and 50 µl of Not happened interferences with:
sample in the first area. Using the same pipette (inspiring Haemoglobin ≤ 1000 mg/dl
and discharging many times) mix carefully contents of Bilirubin ≤ 20 mg/dl
first area and transfer 50 µl in the following area etc. Lipids ≤ 1000 mg/dl
Discharge 50 µl from last area. Dispense latex Rheumatoid factor interfere to concentration ≥ 100 UI/ml.
suspension, shake, and after 3 minutes observe
agglutination. The titre is given by last clear agglutination. Lipemic or turbid samples may give false positivity.
Procedure is in the scheme below .