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

!"#$%!"#$"%&!&'

Pipette into cuvettes

Enzymatic Colorimetric Test for Urea

&'()'*+%,-.+/
6
10505
!"#$%
10506
10507
10104
!&'(%

100 ml
1000 ml
1000 ml
9 x 3 ml

Sample/!0+(%
Enzyme reagent 1a

Complete Test Kit

Reagent 1, Enzyme, Standard
Reagent 2
Standard

0+1234%1, 2, 3
Urea is hydrolysed in the presence of water and urease to produce
ammonia and carbon dioxide. In a modified Berthelot reaction the
ammonium ions react with hypochlorite and salicylate to form a green
dye. The absorbance increase at 578 nm is proportional to the urea
concentration in the sample.
5361+61/
!"#$%))
!"*+,%
!"*+-%
!#./%
!0+(%
!"*+,%

!"*+-%

!#./%
!0+(%

7898:
1000 ml

7898;

1000 l
1000 l
Mix, incubate for 10 min. at 20...25C or for 5 min. at 37C. Measure
the absorbance of the sample (!A sample) and the !0+(% (!A !0+(%)
against the reagent blank within 60 min.
5'C(EC'1-36%3F%!@+'%'64%G!H%536(+61@'1-36
!Asample
C = """"" x factor
!A!0+(%
I'(13@

F3@%!@-6+M

"+'*+61%7
Phosphate buffer (pH 7.0)
Sodium salicylate
Sodium nitroprusside
EDTA

9 x 3 ml
120 mmol/l
60 mmol/l
5 mmol/l
1 mmol/l

"+'*+61%=
Phosphate buffer (pH < 13)
120 mmol/l
Hypochlorite
!"#$%"&'(")(
Irritates eyes and skin. Keep out of reach of children.
Upon contact with the eyes, rinse thoroughly with water
and consult a doctor.
#6.>?+
Urease
> 500 KU/l
,1'64'@4
Urea
equivalent to BUN
Sodium azide

80 mg/dl or 13.3 mmol/l

37.28 mg/dl or 6.2 mmol/l
0.095 %

"+'*+61%&@+A'@'1-36
!"*+-%%and !0+(% are ready for use.
The Enzyme reagent 1a is prepared by mixing the contents of bottle
!#./% with bottle !"*+,%:
!#./% + 100 ml !"*+,% or
e.g.
1 ml
10 ml !#./% + 1000 ml !"*+,%

10 l
1000 l

!"*+-%

7878<

1000 ml
10 ml
3 ml

!0+(%

Mix and incubate for 5 min. at 20...25C or for 3 min. at 37C.

F3@%,+@E?LAC'/?'
78989
100 ml
100 ml
1 ml
3 ml

Sample or

Reagent
blank
--1000 l

5%J!"#$K

5%JG!HK

[mg/dl]

[mmol/l]

[mg/dl]

80

13.3

37.28

[mmol/l]
6.2

[g/l]

[mmol/l]

[g/l]

[mmol/l]

80.8

1343

37.65

626.2

536N+@/-36%I'(13@%F3@%G!HO%!@+'
5%JG!HK%P%8Q<::%R%5%J!@+'K
5%J!@+'K%P%=Q7<%R%5%JG!HK
&+@F3@?'6(+%52'@'(1+@-/1-(/
Linearity
Serum/plasma:
up to 400 mg/dl or
Urine:
up to 400 g/l
or

66.6 mmol/l (Urea)

6600 mmol/l (Urea)

Samples with a higher urea concentration have to be diluted 1+1 with

distilled water. Repeat the assay and multiply the results by 2.
Typical performance date can be found in the Verification Report,
accessible via
www.human.de/data/gb/vr/su-urlqc.pdf or
www.human-de.com/data/gb/vr/su-urlqc.pdf
H3@?'C%S'CE+/%4, 5
Serum (Urea):
10 - 50 mg/dl
Urine (Urea):
20 - 35 g/24 h

or 1.7 - 8.3 mmol/l

or 333 - 583 mmol/24 h

TE'C-1>%5361@3C
All control sera with urea or BUN values determined by this method
may be employed.
We recommend to use our animal serum based HUMATROL quality
control sera or our human serum based SERODOS.
$E13?'1-36
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>
The reagents are stable up to the stated expiry date when sealed and
stored at 2...8C.
!"*+,%, !"*+-% and !#./% are stable after opening for 6 weeks at
2...8C or =%D++)/ at 15...25C.
!0+(% is stable up to the expiry date even after opening.
The Enzyme reagent 1a is stable for < D++)/ at 2...8C or = D++)/ at
15...25C.
Contamination after opening must be avoided.

H31+/
1. The test is not influenced by hemoglobin up to 200 mg/dl and by
bilirubin up to 10 mg/dl.
2. !0+(% contains sodium azide (0.095%) as preservative. Do not
swallow. Avoid contact with skin and mucous membranes.
3. !"*+-% contains sodium hypochlorite in alkaline solution. !"*+-% is
irritant to eyes, skin and mucous membranes. In case of contact
with eyes, skin and mucous membranes flush with copious
amounts of water and consult a doctor.

,A+(-?+6
Serum, plasma, except ammonium heparinate plasma, and urine.
Dilute urine 1 + 100 with distilled water.
Do not use lipemic sera.
Serum or plasma can be stored for up to 3 days at 4C, for longer
periods they should be kept frozen at -20C.

"+F+@+6(+/
1. Berthelot, M., Report Chem. Applique 7, 284 (1859)
2. Fawcett, J.K., Scott, J.E.; J. Clin. Path. 7U, 156 (1960)
3. Tobacco, A. !"#$%&, Clin. Chem. =9 (2), 336 (1979)
4. MacKay, E.M., MacKay, L.L., J. Clin. Invest. <, 295 (1927)
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:
Optical path:
Temperature:
Measurement:

Hg 578 nm, 570 - 600 nm

1 cm
20...25C or 37C
Against reagent blank. Only one reagent blank per
series is required.

SU-URLQC
INF 1050501 GB
12-2003-15

Human Gesellschaft fr Biochemica und Diagnostica mbH

Max-Planck-Ring 21 - D-65205 Wiesbaden - Germany
Telefon: +49 6122 9988 0 - Telefax: +49 6122 9988 100 - eMail: human@human.de