About the product
CREP2 (Creatinine plus ver.2) is an in vitro diagnostic reagent from Roche Diagnostics for creatinine measurement. According to Roche’s product page, the test is for the quantitative determination of creatinine concentration in human serum, plasma and urine.
The reagent is based on an enzymatic principle, which distinguishes it from creatinine reagents using the Jaffé method. The product is part of the Roche Diagnostics test kit range supplied by Tilia Medical.
Measured parameter and clinical significance
Creatinine is a waste product formed during muscle use and is filtered by healthy kidneys. According to MedlinePlus, blood creatinine is used to assess kidney function and to calculate eGFR; high values may point to reduced kidney function, and low values to low muscle mass.
Urine creatinine is measured on a 24-hour urine collection. According to MedlinePlus, this value is used to calculate creatinine clearance and the urine albumin-to-creatinine ratio. The test alone is not regarded as the best way to assess kidney function.
Technical information
- Sample type (Roche): human serum, plasma and urine
- Sample type (FDA 510(k) K024098 summary, COBAS INTEGRA): serum, plasma (lithium heparin, K3 EDTA) and urine
- Method (according to the FDA 510(k) K024098 summary, COBAS INTEGRA application): enzymatic colorimetric; creatininase, creatinase and sarcosine oxidase form hydrogen peroxide, the peroxide yields a quinone imine dye, and the color intensity is directly proportional to the creatinine concentration
- Analyzers (Roche): cobas c 111; cobas c 303/503/703; cobas c 311/501/502; cobas c 701/702; COBAS INTEGRA 400 plus
- Pack size (Roche): 600 tests (cobas c 303/503/703); 600 tests (cobas c 701/702); 250 tests (COBAS INTEGRA 400 plus and cobas c 311/501/502); 2 x 100 tests (cobas c 111)
- Measuring range: not stated on the Roche product page
Use and compatibility
The Roche page lists four analyzer groups for CREP2 and gives separate intended-use statements for the COBAS INTEGRA and the cobas c 111. The method information in the FDA summary belongs to the COBAS INTEGRA version; for details of the cobas c packs, the Method Sheet should be taken as the reference.
For product, quotation and technical information requests, use the contact form or write to info@tiliamedical.com.
Frequently asked questions
According to the FDA 510(k) K024098 summary, it is an enzymatic colorimetric method. Creatininase, creatinase and sarcosine oxidase are used.
According to Roche, it is used with human serum, plasma and urine.
The Roche page lists the cobas c 111, cobas c 303/503/703, cobas c 311/501/502, cobas c 701/702 and COBAS INTEGRA 400 plus.
