About the product
CRP4 (Tina-quant C-Reactive Protein IV, Roche code CPS_000847) is an immunoturbidimetric in vitro diagnostic test used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma. The Roche product page defines the test for cobas c systems. The same page also lists the COBAS INTEGRA 400 Plus.
Measured parameter and clinical significance
According to MedlinePlus, CRP is a protein produced by the liver when inflammation is present in the body, and the CRP test measures the level of this protein in the blood. The same source states that the test may be requested when there are signs of a bacterial infection, when screening for a long-term inflammatory condition, for checking infection after surgery, and for monitoring the response of an infection or chronic condition to treatment.
A high CRP level can be associated with infections, inflammatory bowel diseases and autoimmune disorders. According to MedlinePlus, the result shows how much inflammation there is, not its cause or location. The result is therefore evaluated together with other tests, symptoms and medical history.
Technical information
- Product: CRP4, Tina-quant C-Reactive Protein IV (Roche, CPS_000847)
- Method: Roche describes the test as immunoturbidimetric. The FDA 510(k) review document states that on the cobas c 501, human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies, and the resulting precipitate is measured turbidimetrically
- Sample: human serum and plasma. The FDA document lists Li-heparin, K2-EDTA and K3-EDTA tubes for plasma
- Standardization and calibrator: the same document states that it is standardized against ERM-DA474/IFCC and that Calibrator f.a.s. Proteins is used (manufacturer's statement)
- Pack size: 500 tests (cobas c 701/702 and cobas c 303/503/703)
- Pack size: 2 × 100 tests (cobas c 111)
- Pack size: 250 tests (cobas c 311/501/502 and COBAS INTEGRA 400 Plus)
Use and compatibility
On the Roche product page, the systems on which the test can be used are:
- cobas c 701 and 702
- cobas c 303, 503 and 703
- cobas c 111
- cobas c 311, 501 and 502
- COBAS INTEGRA 400 Plus
System pages: cobas c 111 and cobas c 303. For the COBAS INTEGRA 400 Plus, the relevant page can be used. Other parameters are in the biochemistry test kits category.
Measuring range and calibration details are in the Roche method sheet.
Frequently asked questions
According to the Roche product page, the test is immunoturbidimetric. The FDA review document describes the latex-particle-enhanced method and turbidimetric measurement.
The Roche product page specifies human serum and plasma. The FDA document lists Li-heparin, K2-EDTA and K3-EDTA tubes for plasma.
According to MedlinePlus, the result shows the level of inflammation, not its cause or location, and is interpreted together with other tests and clinical information.
Contact
For product, quotation and technical information requests, use the contact form or write to info@tiliamedical.com.
