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Validation and evaluation of eight commercially available point of care CRP methods
Nannette Brouwer1, Johannes van Pelt1
1Department of Clinical Chemistry, Hematology and Immunology, Medical Centre Alkmaar, Postbus 501, 1800 AM Alkmaar, The Netherlands.
Background:
There are several situations compelling to measure CRP with a point of care (POC) method. Assay performance of various available POC CRP methods were evaluated as analytical quality is important and should be known before clinical use.
Methods:
We compared 2 semi-quantitative strips; Actim and Cleartest and 6 quantitative CRP tests; Afinion, QuikRead go, Smart, iChroma, Microsemi and AQT90 Flex to the Synchron CRP method, using the CLSI EP9 protocol. The coefficient of variance (CV) was determined. Various aspects of pre-analytical and analytical steps were evaluated.
Results:
CRP strips showed 50-60% concordance with the Synchron CRP. The linear regression lines (95% CI) of the quantitative POC CRP methods compared to the Synchron CRP method were: y=[0.96-1.04]x+[-4.7 to -2.04] (Smart); y=[1.00-1.06]x+[1.05-4.99] (AQT90 Flex), y=[0.84-0.91]x+[-1.13 to 3.95] (Afinion); y=[0.83-0.87]x+[0.25-1.5] (QuikRead go); y=[0.76-0.82]x+[-0.18 to 1.35] (iChroma) and y=[1.14-1.18]x+[-3.17 to -1.83] (Microsemi).
Conclusions:
At best, the semi-quantitative CRP strips could be used to discriminate between normal and increased levels of CRP. Of the quantitative methods, when combining analytical with practical evaluation, the Smart and Afinion would be the preferred analyzers for POCT.
