CRP-latex

Slide agglutination
Qualitative determination of C-Reactive Protein (CRP)
IVD Store at 2-8ºC. REF: KCRP-004B

Reading and Interpretation:

Summary: Examine macroscopically the presence or absence of visible agglutination
CRP is an acute-phase protein present in normal serum, which increases immediately after removing the slide from the rotator.
significantly after most forms of tissue injuries, bacterial and virus The presence of agglutination indicates a CRP concentration equal or greater
infections, inflammation and malignant neoplasia. During tissue necrosis and than 6 mg/L (Note 2 and 3).
inflammation resulting from microbial infections, the CRP concentration can The titer, in semi-quantitative method, is defined as the highest dilution
rise up to 300 mg/L in 12-24 hours. showing a positive result.

Principle: Calculations:
The approximate CRP concentration in the patient sample is calculated as
The CRP-latex is a slide agglutination test for the qualitative and
follow:
semiquantitative detection of C- Reactive Protein (CRP) in human serum.
6 x CRP Titer = mg/L
Latex particles coated with goat IgG anti-human CRP are agglutinated when
mixed with samples containing CRP. Quality control:
Composition: All clinical laboratories should establish an Internal Quality Control program.
Check instrument and reagent performance with recommended controls
Latex: Latex particles coated with goat IgG anti-human CRP,
or similar. The values obtained for QC should fall within manufacturer’s
pH, 8,2. Preservative
acceptable ranges or should be established according to the Laboratory’s QC
Control + Red cap: Human serum with a CRP concentration > 20 mg/L,
program.
Preservative
Controls should be assayed:
Control - Blue cap: Animal serum, Preservative
- Prior reporting patient results.
- Following any maintenance procedure on the photometer used.
Precautions:
- At pre-established intervals following the Q.C. Laboratory recommandations.
Components from human origin have been tested and found to be negative
for the presence of HBsAg, HCV, and antibody to HIV (1/2). Reference values:
However handle cautiously as potentially infectious. Up to 6 mg/L. Each laboratory should establish its own reference range.
Calibration: Performance characteristics:
The CRP-latex sensitivity is calibrated to the Reference Material ERMDA
Prozone effect:
474/IFCC.
No prozone effect was detected up to 1600 mg/L.
Storage and stability:
Sensitivity:
All the kit components are ready to use, and will remain stable until the
6 (5-10) mg/L, under the described assay conditions
expiration date printed on the label, when stored tightly closed at 2-8ºC and
contaminations are prevented during their use. Do not freeze: frozen reagents
Diagnostic Sensitivity:
could change the functionality of the test.
95.6 %
Mix reagents gently before use.
Reagents deterioration: Presence of particles and turbidity.
Diagnostic specificity:
Samples: 96.2 %
Fresh serum. Stable 7 days at 2-8ºC or 3 months at –20ºC. Interferences:
Samples with presence of fibrin should be centrifuged before testing. Bilirubin (20 mg/dL), hemoglobin (10 g/L), and lipids (10 g/L), do not
Do not use highly hemolysed or lipemic samples. interfere. Rheumatoid factors (100 IU/mL), interfere. Other substances may
interfere.
Equipment:
- Mechanical rotator with adjustable speed at 80-100 r.p.m. Notes:
- Vortex mixer. 1. High CRP concentration samples may give negative results
- Pipettes 50 μL. (prozone effect). Re-test the sample again using a drop of 20 μL.
2. The strength of agglutination is not indicative of the CRP
Procedure:
concentration in the samples tested.
Qualitative method 3. Clinical diagnosis should not be made on findings of a single test
1. Allow the reagents and samples to reach room temperature. The sensitivity result, but should integrate both clinical and laboratory data.
of the test may be reduced at low temperatures.
2. Place 50 μL of the sample (Note 1) and one drop of each Positive and References:
Negative controls into separate circles on the slide test. 1. Lars-Olof Hanson et al. Current Opinion in Infectious diseases 1997; 10:
3. Mix the CRP-latex reagent vigorously or on a vortex mixer before using and 196-201.
add one drop (50 μL) next to the samples to be tested. 2. M.M. Pepys. The Lancet 1981; March 21: 653 – 656.
4. Mix the drops with a stirrer, spreading them over the entire surface of the 3. Chetana Vaishnavi. Immunology and Infectious Diseases 1996; 6: 139 –
circle. Use different stirrers for each sample. 144.
5. Place the slide on a mechanical rotator at 80-100 r.p.m. for 2 minutes. False 4. Yoshitsugy Hokama et al. Journal of Clinical Laboratory Status 1987; 1:
positive results could appear if the test is read later than two minutes. 15 – 27.
5. Yamamoto S et al. Veterinary Immunology and Immunopathology 1993;
Semi-quantitative method 36: 257 – 264.
1. Make serial two fold dilutions of the sample in 9 g/L saline solution. 6. Charles Wadsworth et al. Clinica Chimica Acta; 1984: 138: 309 – 318.
2. Proceed for each dilution as in the qualitative method. 7. Young DS. Effects of drugs on clinical laboratory test, 4th ed. AACC Press,
1995.

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