&-A+11-6*%,(2+?

+
!"#$%!"#$"%&!&' Pipette into cuvettes Reagent Sample or
blank !0+(%
Enzymatic Colorimetric Test for Urea
Sample/!0+(% --- 10 l
&'()'*+%,-.+/ Enzyme reagent 1a 1000 l 1000 l
6
!"#$% 10505 100 ml Complete Test Kit Mix and incubate for 5 min. at 20...25C or for 3 min. at 37C.
10506 1000 ml Reagent 1, Enzyme, Standard !"*+-% 1000 l 1000 l
10507 1000 ml Reagent 2 Mix, incubate for 10 min. at 20...25C or for 5 min. at 37C. Measure
10104 9 x 3 ml Standard the absorbance of the sample (!A sample) and the !0+(% (!A !0+(%)
!&'(% against the reagent blank within 60 min.

0+1234%1, 2, 3 5'C(EC'1-36%3F%!@+'%'64%G!H%536(+61@'1-36
Urea is hydrolysed in the presence of water and urease to produce
!Asample
ammonia and carbon dioxide. In a modified Berthelot reaction the
C = """"" x factor
ammonium ions react with hypochlorite and salicylate to form a green
!A!0+(%
dye. The absorbance increase at 578 nm is proportional to the urea
concentration in the sample.
I'(13@ 5%J!"#$K 5%JG!HK
5361+61/ F3@%,+@E?LAC'/?' [mg/dl] [mmol/l] [mg/dl] [mmol/l]
!"#$%)) 78989 7898: 7898; 7878< 80 13.3 37.28 6.2
!"*+,% 100 ml 1000 ml F3@%!@-6+M [g/l] [mmol/l] [g/l] [mmol/l]
!"*+-% 100 ml 1000 ml 80.8 1343 37.65 626.2
!#./% 1 ml 10 ml
536N+@/-36%I'(13@%F3@%G!HO%!@+'
!0+(% 3 ml 3 ml 9 x 3 ml
5%JG!HK%P%8Q<::%R%5%J!@+'K
!"*+,% "+'*+61%7 5%J!@+'K%P%=Q7<%R%5%JG!HK
Phosphate buffer (pH 7.0) 120 mmol/l
Sodium salicylate 60 mmol/l &+@F3@?'6(+%52'@'(1+@-/1-(/
Sodium nitroprusside 5 mmol/l Linearity
EDTA 1 mmol/l Serum/plasma: up to 400 mg/dl or 66.6 mmol/l (Urea)
!"*+-% "+'*+61%= Urine: up to 400 g/l or 6600 mmol/l (Urea)
Phosphate buffer (pH < 13) 120 mmol/l Samples with a higher urea concentration have to be diluted 1+1 with
Hypochlorite !"#$%"&'(")( distilled water. Repeat the assay and multiply the results by 2.
Irritates eyes and skin. Keep out of reach of children.
Upon contact with the eyes, rinse thoroughly with water Typical performance date can be found in the Verification Report,
and consult a doctor. accessible via
!#./% #6.>?+ www.human.de/data/gb/vr/su-urlqc.pdf or
Urease > 500 KU/l www.human-de.com/data/gb/vr/su-urlqc.pdf
!0+(% ,1'64'@4 H3@?'C%S'CE+/%4, 5
Urea 80 mg/dl or 13.3 mmol/l Serum (Urea): 10 - 50 mg/dl or 1.7 - 8.3 mmol/l
equivalent to BUN 37.28 mg/dl or 6.2 mmol/l Urine (Urea): 20 - 35 g/24 h or 333 - 583 mmol/24 h
Sodium azide 0.095 %
TE'C-1>%5361@3C
"+'*+61%&@+A'@'1-36 All control sera with urea or BUN values determined by this method
!"*+-%%and !0+(% are ready for use. may be employed.
The Enzyme reagent 1a is prepared by mixing the contents of bottle We recommend to use our animal serum based HUMATROL quality
!#./% with bottle !"*+,%: control sera or our human serum based SERODOS.
e.g. 1 ml !#./% + 100 ml !"*+,% or $E13?'1-36
10 ml !#./% + 1000 ml !"*+,% Proposals to apply the reagents on analysers are available on request.
Each laboratory has to validate the application in its own responsibility.
"+'*+61%,1'B-C-1> H31+/
The reagents are stable up to the stated expiry date when sealed and 1. The test is not influenced by hemoglobin up to 200 mg/dl and by
stored at 2...8C. bilirubin up to 10 mg/dl.
!"*+,%, !"*+-% and !#./% are stable after opening for 6 weeks at 2. !0+(% contains sodium azide (0.095%) as preservative. Do not
2...8C or =%D++)/ at 15...25C. swallow. Avoid contact with skin and mucous membranes.
!0+(% is stable up to the expiry date even after opening. 3. !"*+-% contains sodium hypochlorite in alkaline solution. !"*+-% is
The Enzyme reagent 1a is stable for < D++)/ at 2...8C or = D++)/ at irritant to eyes, skin and mucous membranes. In case of contact
15...25C. with eyes, skin and mucous membranes flush with copious
Contamination after opening must be avoided. amounts of water and consult a doctor.

,A+(-?+6 "+F+@+6(+/
Serum, plasma, except ammonium heparinate plasma, and urine. 1. Berthelot, M., Report Chem. Applique 7, 284 (1859)
Dilute urine 1 + 100 with distilled water. 2. Fawcett, J.K., Scott, J.E.; J. Clin. Path. 7U, 156 (1960)
Do not use lipemic sera. 3. Tobacco, A. !"#$%&, Clin. Chem. =9 (2), 336 (1979)
Serum or plasma can be stored for up to 3 days at 4C, for longer 4. MacKay, E.M., MacKay, L.L., J. Clin. Invest. <, 295 (1927)
periods they should be kept frozen at -20C. 5. Sarre H., Nierenkrankheiten, Georg Thieme Verlag Stuttgart
(1959)
$//'> 6. ISO 15223 Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied
Wavelength: Hg 578 nm, 570 - 600 nm
Optical path: 1 cm
Temperature: 20...25C or 37C SU-URLQC
Measurement: Against reagent blank. Only one reagent blank per
series is required.
INF 1050501 GB
12-2003-15 !

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