C-reactive protein (CRP), a major reactant of the acute phase response, is an established and widely accepted sensitive indicator of the inflammation status for a variety of inflammatory conditions. In healthy adults the concentrations of CRP in serum have been reported to be at 1 mg/L. The concentrations may increase rapidly and extensively (up to the factor 1000) in response to a tissue damaging processes, such as inflammations or infections. As such CRP has been used to monitor antibacterial treatments and post-surgical progression.
Most widely used CRP assays are only sensitive enough to determine CRP values from around 5 mg/L onwards with acceptable precision. Since 5 mg/L is currently the accepted upper limit of the normal range, these assays are best suited to assess clearly pathological CRP levels.
Measurements around the level of 5 mg/L require a highly sensitive immunoassay. Current classical assays may therefore fail to detect a significant increase in CRP as an early indicator for an infection.
To overcome the weaknesses of classical CRP tests, there was a need to develop an assay which allows both, to be used as a rapid screen in better assessing an inflammatory condition in the daily routine and for a more specific use covering the important range below 5 mg/L and the monitoring of very small changes in CRP levels.
With the introduction of the Tina-quant® C-Reactive Protein Gen.3 using Dual-radius enhanced latex (DuREL) technology, Roche Diagnostics has set a new milestone for accuracy and sensitivity of CRP measurements.