PRODUCT INFORMATION

AU2353

1253UC

Please note that while Copper is present in 1253UC – Assayed Urine Control Level 3, targets and
ranges are not provided for this analyte.

INC1862

Page 1 of 1 FORM NO. 8373-GP

REVISION (2)
2 Aug 2019
ASSAYED URINE CONTROL - LEVEL 3
(URN ASY CONTROL 3)
CAT. NO. AU 2353 LOT NO. 1253UC
SIZE: 12 x 10 ml EXPIRY: 2026-11-28
GTIN: 05055273200546

INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of urine on clinical chemistry systems. The
Assayed Urine Controls are for the control of accuracy.

DEVICE DESCRIPTION
The Urine Controls are supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the following
analytes at both levels; amylase, calcium, chloride, copper, cortisol, creatinine, dopamine, epinephrine, glucose, 5 hydroxy
indole acetic acid, magnesium, metanephrine, microalbumin, norepinephrine (noradrenalin), normetanephrine, osmolality,
oxalate, phosphorous inorganic, potassium, total protein, sodium, urea, uric acid and vanillylmandelic acid (VMA).

SAFETY PRECAUTIONS AND WARNINGS

For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling
laboratory reagents.

Human source material, from which this product has been derived, has been tested at donor level for the Human
Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV)
antibody and found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all
patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY

OPENED: Store refrigerated (+2°C to +8°C). Reconstituted urine is stable for 8 hours at +15°C to +25°C and 5 days
at +2°C to +8°C if kept capped in original container and free from contamination, or 14 days at –20°C. No
stability claims are made for copper. Only the required amount of product should be removed. After use, any
residual product should NOT BE RETURNED to the original vial.

PREPARATION AND STABILITY OF SAMPLES FOR:

Catecholamines, Vanillylmandelic Acid (VMA) and Oxalate:

These analytes are unstable in urine samples. Fifteen minutes after complete reconstitution of the urine, remove an
aliquot and add 8 µl of HCl (6M) per ml urine. Sample is stable for 5 days at +2°C to +8°C. For Oxalate measurement,
it is recommended that EDTA be added to the urine sample at a concentration of 5 mg/10 ml material. This is to
prevent the precipitation of Calcium Oxalate.

5-Hydroxyindole Acetic Acid (5-HIAA):

These analytes are unstable in urine samples. Fifteen minutes after complete reconstitution of the urine, remove an
aliquot and add 10 µl of Glacial Acetic Acid (17.4M) per ml of urine. Sample is stable for 7 days at +2°C to +8°C.

Please note that if Nitroso-Naphthol method is used for 5-HIAA, 12 µl of HCI (6M) per ml of urine should be added to
an aliquot of reconstituted urine. Sample is stable for 7 days at +2°C to +8°C. The addition of HCI is also
recommended where 5-HIAA is assayed using HPLC methods with prior extraction.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

PAGE 1 OF 5
 LOT NO. 1253UC

PREPARATION FOR USE

The Assayed Urine Control is supplied lyophilised.

1. Carefully reconstitute each vial of lyophilised urine with exactly 10 ml of distilled water at +15°C to +25°C. Close
the bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently.
Avoid formation of foam. Do not shake.

2. Refer to the Control section of the individual analyser application.

3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Assayed Urine Control - Level 3 12 x 10 ml

MATERIALS REQUIRED BUT NOT PROVIDED

Volumetric pipette

ASSIGNED VALUES
Due to the variation caused by test equipment, test reagents and laboratory technique, the quoted ranges are provided
for guidance. It is recommended that these ranges are used until each laboratory has established its own ranges, based
on individual laboratory requirements.

Each batch of Assayed Urine Control is submitted to a number of external laboratories and values are assigned from a
consensus of results obtained by these laboratories. With each batch, a control range is provided for individual
parameters and each parameter method. The control range is equivalent to the assigned mean ± 2SD.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or
email [email protected].

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

31 Jan ’23 me

PAGE 2 OF 5
a
ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3)
Cat. No. AU2353 Lot. No. 1253UC Size 12 x 10ml Expiry 2026-11-28
Range
Analyte unit Target low high methods
5-HIAA µmol/l 287 230 344 HPLC
Amylase U/I 983 786 1180 Siemens - blocked pNPG7
U/I 931 745 1117 Randox Liquid Ethylidene pNPG7
U/I 777 622 932 Roche liquid pNPG7
U/I 880 704 1056 Beckman Coulter - blocked pNPG7
U/I 808 646 970 Roche Integra 2-chloro-pNPG7
U/I 1086 869 1303 Siemens 2-chloro-pNPG3
U/I 983 786 1180 Other 2-chloro-pNPG3
U/I 1015 812 1218 Abbott Architect IFCC Cal.
U/I 997 798 1196 Abbott Architect Non-IFCC Cal.
U/I 458 366 550 Vitros
Calcium mmol/l 4.51 4.06 4.96 NM-BAPTA
mg/dl 18.1 16.3 19.9
mmol/l 4.71 4.24 5.18 Cresolphthalein complexone
mg/dl 18.9 17.0 20.8
mmol/l 4.19 3.77 4.61 Arsenazo III
mg/dl 16.8 15.1 18.5
mmol/l 3.50 3.15 3.85 Vitros
mg/dl 14.0 12.6 15.4
Chloride mmol/l 245 208 282 Vitros
mmol/l 254 216 292 ISE indirect
mmol/l 251 213 289 ISE direct
Cortisol nmol/l 237 178 296 Chemiluminescence (direct)
µg/dl 8.53 6.41 10.7
nmol/l 236 177 295 Chemiluminescence (+ solvent extraction.)
µg/dl 8.50 6.37 10.6
Creatinine mmol/l 15.7 12.6 18.8 Other enzymatic methods
mg/dl 177 142 212
mmol/l 16.1 12.9 19.3 Roche Creatinine Plus
mg/dl 182 146 218
mmol/l 15.2 12.2 18.2 Vitros IDMS Traceable
mg/dl 172 138 206
mmol/l 15.7 12.6 18.8 Jaffe rate blanked compensated (-18 µmol/l)
mg/dl 177 142 212
mmol/l 15.4 12.3 18.5 Jaffe rate blanked
mg/dl 174 139 209
mmol/l 15.4 12.3 18.5 Jaffe rate blanked comp. (-26 µmol/l)
mg/dl 174 139 209
mmol/l 15.1 12.1 18.1 Alkaline picrate no deproteinization
mg/dl 171 137 205
mmol/l 15.8 12.6 19.0 Enzymatic UV method
mg/dl 179 142 216

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 5
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3)
Cat. No. AU2353 Lot. No. 1253UC Size 12 x 10ml Expiry 2026-11-28
Range
Analyte unit Target low high methods
Creatinine mmol/l 15.6 12.5 18.7 IDMS traceable
mg/dl 176 141 211
mmol/l 15.9 12.7 19.1 Creatinine PAP method
mg/dl 180 144 216
Dopamine nmol/l 1897 1518 2276 HPLC
Epinephrine nmol/l 366 293 439 HPLC
Glucose mmol/l 14.3 11.4 17.2 Hexokinase
mg/dl 258 205 311
mmol/l 13.9 11.1 16.7 Glucose oxidase
mg/dl 250 200 300
mmol/l 14.5 11.6 17.4 Vitros
mg/dl 261 209 313
Magnesium mmol/l 13.5 10.8 16.2 Chlorphosphonazo III
mg/dl 32.8 26.2 39.4
mmol/l 13.5 10.8 16.2 Vitros
mg/dl 32.8 26.2 39.4
mmol/l 13.5 10.8 16.2 Enzymatic
mg/dl 32.8 26.2 39.4
mmol/l 13.4 10.7 16.1 Methylthymol blue
mg/dl 32.6 26.0 39.2
mmol/l 13.2 10.6 15.8 Xylidyl Blue
mg/dl 32.1 25.8 38.4
mmol/l 13.5 10.8 16.2 Arsenazo III
mg/dl 32.8 26.2 39.4
Metanephrine µmol/l 2.56 2.05 3.07 HPLC
Microalbumin mg/l 183 146 220 Nephelometric
mg/l 173 138 208 Immunoturbidimetric
Norepinephrine nmol/l 1485 1188 1782 HPLC
Normetanephrine µmol/l 4.07 3.26 4.88 HPLC
Osmolality mOsm/kg 1076 861 1291 Calculated
mOsm/kg 1124 899 1349 Freezing point depression
Oxalate mmol/l 0.440 0.352 0.528 Oxalate oxidase
Phosphate Inorganic mmol/l 27.2 21.8 32.6 Beckman PHOSm (365nm)
mg/dl 84.3 67.6 101
mmol/l 28.1 22.5 33.7 Vitros
mg/dl 87.1 69.8 104
mmol/l 26.8 21.4 32.2 Phosphomolybdate enzymatic
mg/dl 83.1 66.3 100
mmol/l 26.7 21.4 32.0 Phosphomolybdate UV
mg/dl 82.8 66.3 99.3
Potassium mmol/l 134 114 154 Vitros
mmol/l 123 105 141 ISE direct
mmol/l 122 104 140 ISE indirect
Protein Total g/l 0.260 0.208 0.312 Biuret reaction - direct
mg/dl 26.0 20.8 31.2
mg/l 260 208 312

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 5
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3)
Cat. No. AU2353 Lot. No. 1253UC Size 12 x 10ml Expiry 2026-11-28
Range
Analyte unit Target low high methods
Protein Total g/l 0.230 0.184 0.276 Turbidimetry
mg/dl 23.0 18.4 27.6
mg/l 230 184 276
g/l 0.090 0.072 0.108 Vitros
mg/dl 9.00 7.20 10.8
mg/l 90.0 72.0 108
g/l 0.160 0.128 0.192 Siemens UCFP Reagent
mg/dl 16.0 12.8 19.2
mg/l 160 128 192
Sodium mmol/l 200 176 224 ISE direct
mmol/l 217 191 243 Vitros
mmol/l 202 178 226 ISE indirect
Urea mmol/l 418 334 502 Vitros
mg/dl 2512 2007 3017
mmol/l 430 344 516 Urease end point
mg/dl 2584 2067 3101
mmol/l 428 342 514 Urease kinetic
mg/dl 2572 2055 3089
Uric Acid (Urate) mmol/l 1.39 1.11 1.67 Ortho Vitros Microslide Systems
mg/dl 23.4 18.6 28.2
mmol/l 1.36 1.09 1.63 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 22.8 18.3 27.3
mmol/l 1.38 1.10 1.66 Uricase peroxidase with ascorbate oxidase
mg/dl 23.2 18.5 27.9
mmol/l 1.39 1.11 1.67 Uricase peroxidase no ascorbate oxidase
mg/dl 23.4 18.6 28.2
mmol/l 1.48 1.18 1.78 Spectrophotometric at 280-290
mg/dl 24.9 19.8 30.0
Vanillylmandelic Acid µmol/l 153 122 184 HPLC
(VMA)
µmol/l 141 113 169 Column test

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 5
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com