The NADAL® CRP Test is a rapid semi-quantitative immunoassay
for detection and monitoring of C-reactive protein (CRP) in whole and
capillary blood, plasma and serum.
Reagents and material supplied:
- 20 NADAL® CRP test strips (individually packaged)
- 20 plastic tubes containing buffer solution (1 mL)
- 20 end-to-end capillaries (10 μL)
- 1 workstation
- 1 package insert
Test time: 5 min
Performance characteristics:
The NADAL® CRP Test was calibrated against the international human CRP reference standard of the WHO 85/506. The detection limit of the NADAL® CRP Test is adjusted to 10 μg/ml.
Specificity and sensitivity of the NADAL® CRP Test were confirmed by EIA assay.
Sensitivity: 99,1%
Specificity: 98,7%
No Hook effect was observed was observed for concentrations up to 2000 μg/ml CRP.
Test principle:
The NADAL® CRP Test includes three test lines which
obtain red color depending on the concentration of CRP in the sample.
Thus it allows for semiquantitative detection of CRP in whole and
capillary blood, serum or plasma samples.
The tip of the test strip is dipped into the test sample which
is diluted with buffer solution. If the sample contains CRP it binds to
anti-CRP antibodies conjugated to colloidal gold particles and comples
CRP/anti-CRP antibodies/ gold particles is formed. Further this complex
migrates along the test strip and reaches lines of the test membrane
which are that is pre-dispensed with second anti-CRP antibody. Depending
on the concentration of CRP in the samples 1,2 or 3 red lines appear in
the test line region of the test.
One red line corresponds to concentration of at least 10 μg/ml CRP.
Two red lines – concentration higher than 40 μg/ml CRP
Three red lines - concentration higher than 80 μg/ml CRP.A
colored line should always appear in the control (C) line region of the
test strip. This is internal procedural control, indicating that enough
sample has been used and that the assay was run properly.
Clinical significance:
C-reactive protein (CRP) in patient samples has been found in association with acute infections, necrotic conditions and a variety of inflammatory disorders. There is a strong correlation between levels of CRP and the onset of the inflammatory process. Monitoring the levels of CRP in patient samples indicates the effectiveness of treatment and the assessment of patient recovery. It is used in particular to differentiate bacterial infections from virus infections.
