Tina-quant® C-Reactive Protein Gen.3
CRP using DuREL technology offers outstanding performance
- 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.
|Assay time||10 min|
|Sample material||Serum, plasma|
|Sample volume||2 µL|
|Measuring range||0.3 - 350 mg/L|
|Intermediate precision (cobas c 501 module)||0.51 mg/L: CV: 3.59 %
1.44 mg/L: CV: 3.93 %
41.3 mg/L: CV: 1.74%
|Repeatability (cobas c 501 module)||0.57 mg/L CV: 3.59 %
1.56 mg/L CV: 1.63 %
43.2 mg/L: CV: 1.23 %
Dual-radius enhanced latex technology (DuREL) combines two different sized latex microparticles coated with monoclonal antibodies of different reactivity, to produce an assay with excellent low end analytical sensitivity and a high upper measuring limit, providing a wide dynamic range.
The high sensitivity is achieved by the larger diameter particles which define a steep calibration curve and therefore an accurate measurement of very low CRP concentrations.
The smaller particles exhibit a measuring range starting at the plateau phase of the larger particles and extending to high CRP concentrations.
The optimal mixing of these particles ensures the unrivalled precision and the wide dynamic range of the Tina-quant® C-Reactive Protein Gen.3 assay.
This patented DuREL technology is available on all platforms.
Turbidimetry setting new standards
- The Tina-quant® C-Reactive Protein assay and application is designed to achieve the very high sensitivity, offering a very accurate and precise measurements at very low levels of CRP.
- Measurement of CRP is of use for diagnosis and management of infection, assessment of inflammation.
- Whereas highly sensitive measurement of CRP is used as an aid in the assessment of the risk of future cardio- and peripheral vascular disease.
The assay was four to eight times more sensitive and precise than existing turbidimetric or nephelometric assays with comparable upper measuring limits.
Eda et al. Development of a New Microparticle-Enhanced Turbidimetric Assay for C-Reactive Protein With Superior Features in Analytical Sensitivity and Dynamic Range. Journal of Clinical Laboratory Analysis 12:137–144 (1998)