€=- MEASUREMENT PRINCIPLE, Urea+H,0 UB, 2NH,+CO, ‘The ammonia formed reacts with o-Ketoglutarate and NADH in the presence of GLDH to yield Glutamate and NAD". GLDH NH, + a-Ketoglutarate + NADH; L-Glutamate + NAD*+H,0 ‘The decrease in absorbance due to consumption of NADH is ‘measured kinetically. CONCENTRATION OF WORKING SOLUTION Buffer TRIS buffer pH8.1 20°C) $0.00mmol/ -Ketoglutarate 15.00mmol/. Urease > 1000 UA Glutamate dehydrogenase = S4KUA Starter NADH 0.18 mmol/| (Standard 50 mg/dl (8.35 mmol/)) STORAGE AND STABILITY ‘The sealed reagents are stable up to the indicated expiry date if stored at +2°- 48°C. INTENDED USE In vitro test for the quantitative determination of Urea in human serum, plasma and urine, PRECAUTIONS AND WARNINGS: For in vitro diagnostic use only. Attend to the normal precautions required for handling all laboratory reagents. The reagents contain sodium azide as preservative. Do not swallow. Avoid contact with skin and mucous membranes. EXPECTED VALUES Seru UreaN _ mydl_[ mmol [mg/dl [ mmol Newborn: <2 <70 [e196 | <33 <6mo__| <4 | <70 [<196 27mo. | <48 [| <80 |<224 | <37 Adults: [<65a_ | <30 | <83 | <233 [| <39 26a [ mmol Factor: 0.167 mmol/l => mg/dl Factor: 6.006 Urea = Urea-N (BUN) Factor: 0.467 ‘mg/dl BUN => mmol/l BUN Factor: 0.357 LINEARITY Up to 400mg/dl (66.7mmol) If the linearity of 400 mg/dl is exceeded sample is to be diluted with phsiological saline (0.9%) L+2. Multiply result by 3 Edition 06/2014, Tv-075-cE-o04 UREA UV FLUID (5+1) Kinetic UV assay for the determination of urea IVD C € rest srecwricarioss Reproducibility in Intraassay and Interassay on Hitachi 717; Within run (n= 30) _| Between run (n= 30) Men] 8D] goo] Mean] 3D gl | mgr | ®¥ | nit | mgr | CY | Teel] 714 ] 208 [292] 8 [oe [3958 tevez] 1383 [3.01 [28 [usa] air [ 200 Sample ‘TEST COMPARISION ‘Comparision with a test of the market leader on the Hitachi 717: n= 54; r= 0,978; y = 1.059x — 4.2302 ASSAY PROCEDURE Wavelength 340 nm ‘Temperature arc ‘Measuremer against water Reaction mixture: Mix reagent 1 (5 volumes) with reagent 2 (1 volume). Stability of reaction mixture: at+ 2°C-+ 8°C: 20days, at +18°C- 422°C: 8 days Sample Standard Reaction mixture 100041 100041 Standard Out | Sample Tou : Mix well, read off absorbance (A,) afer 60 seconds at 37°C. Read off the change in absorbance (A2) per minute 120 sec. after stat. Sample: BA) = Aisy- Aug Standard: 5Acrp)= At srm ~ Anct CALCULATION 5A BA sro c= 50x (mg/dl) APPLICATIONS Applications are available for many analyzers after request LITERATURE, Guder, W.; Hoffmann, G.: Oppitz, K.H.: Normalbereiche klinisch- cchemischer Befunde in den Krankenhiiusern Minchens Talke, H. und Schubert, G-E.: Klin, Wochenzeitschrift 43, S.174 (1965) ‘Thomas, L.: Labor und Diagnose, 1. Auflage, $. 346 PACKAGE SIZE: KITSIZE, ORDER NO. 2x 60m ‘manual UROT000060 1120 mi ‘manual UFOIROS060 4x 120m ‘manual {UFO1000120 for Hitachi 10x60m | sosggamiror, | UROI9I1060 5x 120m | forHitachi717011 | UFOI911120 6x84mi | for Olympus AU | UFOI9I7084. 8x30 mi for Selecta UPOISELO30. Centronic GmbH Am Kleinfeld 11, 85456 Wartenberg/Germany Phone: 0049-8762724300, Fax: 0049-8762724312 email: info@centronic-embh.de adhe wermniealegediaaern