2797

ASSAYED BOVINE MULTI-SERA - LEVEL 3

(BOV ASY CONTROL 3)
CAT. NO. AE1032 LOT NO. 355SE
SIZE: 20 x 5 ml EXPIRY: 2025-09-28
GTIN: 05055273200119
INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Assayed Bovine Multi-sera is for the control of
accuracy.
DEVICE DESCRIPTION
The Assayed Bovine Multi-sera is supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the value section
at 3 levels.
SAFETY PRECAUTIONS AND WARNINGS
For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.
Assayed Bovine Multi-sera is manufactured from bovine sera. Human source material, which has been added, 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 (+2ºC to +8ºC). Reconstituted serum is stable for 8 hours at +15ºC to +25ºC or 7 days at +2ºC to +8ºC, and 28
days when frozen once at –20ºC (see Limitations).
UNOPENED: Store refrigerated (+2ºC to +8ºC). Stable to expiration date printed on individual vials.
LIMITATIONS
For Total and Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25 - 30 µl) of 0.7M Acetic acid solution to 1 ml of the
serum. After stabilisation Total & Prostatic Acid Phosphatase is stable for 2 hours at +15ºC to +25ºC, 2 days at +2ºC to +8ºC, and 28 days when
frozen once at –20ºC.
Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that the reconstituted serum is allowed to
stand for 1 hour at +15ºC to +25ºC before measurement.
Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. Stored in the dark, Bilirubin is stable for 2 days at
+2ºC to +8ºC. Do not store at +15ºC to +25ºC. Do not freeze.
GLDH is stable for 1 day at 2 - 8ºC.
PSA is stable for 4 days at +2ºC to +8ºC, or 28 days in aliquots frozen at –20ºC.
Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components.
Different lot numbers of this control should not be interchanged as the values assigned to the controls vary from lot to lot.
The control should not be used as a calibration material.
Due to the zinc content in some batches of rubber stoppers, the QC and calibrator material should be aliquoted into polypropylene tubes and stored
at +2°C to +8°C to ensure stable zinc levels throughout the stability period.
PREPARATION FOR USE
The Assayed Bovine Multi-sera is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15ºC to +25ºC. 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 Bovine Multi-sera - Level 3 20 x 5 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 lot of serum is submitted to a number of external laboratories. Values are assigned from a consensus of results obtained by these laboratories and
internal testing conducted at Randox Laboratories Ltd. With each batch, a control range is provided for individual parameters and each parameter
method. The control range is equivalent to the assigned mean ±2 S.D.

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

18 Nov ‘21 me

PAGE 1 OF 6
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ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 355SE Size 20 x 5ml Expiry 2025-09-28
MEAN OF ALL INSTRUMENTS Range
Analyte unit Target low high methods
Alpha-HBDH U/I 422 333 511 Oxobutyrate < 10 mmol/l 37°C
U/I 319 251 386 Oxobutyrate < 10 mmol/l 30°C
U/I 239 188 289 Oxobutyrate < 10 mmol/l 25°C
Acid Phosphatase (Total) U/I 44.9 30.1 59.7 1-Naphthyl Phosphate substrate Kinetic 37°C
Albumin g/l 45.3 38.5 52.1 Bromocresol Green
g/dl 4.53 3.85 5.21
Alkaline Phosphatase U/l 587 499 675 Diethanolamine buffer DEA 37°C
U/I 457 389 525 Diethanolamine buffer DEA 30°C
U/I 375 319 431 Diethanolamine buffer DEA 25°C
U/l 343 292 394 AMP optimised to IFCC 37°C
U/I 267 227 307 AMP optimised to IFCC 30°C
U/I 219 187 252 AMP optimised to IFCC 25°C
ALT (GPT) U/l 153 122 184 Tris buffer without P5P 37°C
U/I 113 90 136 Tris buffer without P5P 30°C
U/I 86 69 103 Tris buffer without P5P 25°C
Amylase Total U/I 575 489 661 Randox Lyo. Ethylidene pNPG7 37°C
U/I 617 524 710 Randox Liquid Ethylidene pNPG7 37°C
AST (GOT) U/l 199 159 239 Tris buffer without P5P 37°C
U/I 135 107 163 Tris buffer without P5P 30°C
U/I 95 76 114 Tris buffer without P5P 25°C
Bicarbonate mmol/l 26.9 21.3 32.5 Enzymatic
Bile Acids µmol/l 98.6 78.9 118 5th Generation Colorimetric
µmol/l 117 93.6 140 4th Generation Colorimetric
Bilirubin Direct µmol/l 33.3 26.3 40.3 Diazo with Sulphanilic Acid
mg/dl 1.95 1.54 2.36
µmol/l 32.2 25.4 39.0 Oxidation to Biliverdin/Vanadate
mg/dl 1.88 1.49 2.27
µmol/l 28.3 22.4 34.2 Modified Jendrassik
mg/dl 1.66 1.31 2.01
Bilirubin Total µmol/l 78.4 61.9 94.9 Diazo with Sulphanilic Acid
mg/dl 4.59 3.62 5.56
µmol/l 82.8 65.4 100 Oxidation to Biliverdin/Vanadate
mg/dl 4.84 3.83 5.85
µmol/l 88.8 70.2 107 Modified Jendrassik
mg/dl 5.19 4.11 6.26
Calcium mmol/l 3.14 2.83 3.45 Arsenazo III
mg/dl 12.6 11.3 13.9
mmol/l 3.13 2.82 3.44 Cresolphthalein complexone
mg/dl 12.5 11.3 13.7
Chloride mmol/l 114 105 123 ISE indirect
mmol/l 109 100 118 ISE direct
Cholesterol mmol/l 6.60 5.74 7.46 Cholesterol Oxidase - Abell Kendall
mg/dl 255 222 288

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
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ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 355SE Size 20 x 5ml Expiry 2025-09-28
MEAN OF ALL INSTRUMENTS Range
Analyte unit Target low high methods
CK Total U/l 514 421 607 CK-NAC substrate start (DGKC) 37°C
U/I 322 264 380 CK-NAC substrate start (DGKC) 30°C
U/I 218 179 257 CK-NAC substrate start (DGKC) 25°C
U/l 532 436 628 CK-NAC (IFCC) 37°C
U/I 333 273 393 CK-NAC (IFCC) 30°C
U/I 226 185 267 CK-NAC (IFCC) 25°C
Copper µmol/l 24.8 19.8 29.8 Colorimetric
µg/dl 158 126 190
Cortisol nmol/l 392 294 490 Roche Cobas e801
µg/dl 14.1 10.6 17.6
Creatinine µmol/l 458 366 550 Alkaline picrate no deproteinization
mg/dl 5.18 4.14 6.22
µmol/l 492 394 590 Enzymatic UV method
mg/dl 5.56 4.45 6.67
D-3-Hydroxybutyrate mmol/l 2.44 2.07 2.81 Tris buffer 100mmol pH 8.5
Free T4 pmol/l >100 - - Roche Cobas e801
ng/dl >7.80 - -
pg/ml >78.0 - -
Gamma-GT U/I 143 122 164 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 113 96 130 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 88 75 101 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
GLDH U/I 22 17 27 Triethanolamine buffer 50 mmol 37°C
U/I 17 13 21 Triethanolamine buffer 50 mmol 30°C
U/I 14 11 17 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 15.2 12.9 17.5 Hexokinase
mg/dl 274 232 316
mmol/l 16.5 14.0 19.0 Glucose oxidase
mg/dl 297 252 342
Iron µmol/l 34.1 28.0 40.2 Colorimetric without ppt.
µg/dl 191 157 225
Lactate mmol/l 8.13 6.67 9.59 Colorimetric Lactate Oxidase
mg/dl 73.3 60.1 86.4
LD (LDH) U/l 798 678 918 P->L German methods 37°C
U/I 576 490 662 P->L German methods 30°C
U/I 405 344 466 P->L German methods 25°C
U/l 350 298 403 L->P IFCC 37°C
U/I 253 215 291 L->P IFCC 30°C
U/I 177 151 204 L->P IFCC 25°C
Lipase U/I 89 71 107 Randox Colorimetric 37°C
Lithium mmol/l 1.85 1.63 2.07 Spectrophotometric
mg/dl 1.28 1.13 1.44
Magnesium mmol/l 1.41 1.24 1.58 Xylidyl Blue
mg/dl 3.43 3.01 3.85
NEFA mmol/l 2.78 2.22 3.34 Colorimetric
Osmolality mOsm/kg 463 370 556 Freezing point depression

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
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ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 355SE Size 20 x 5ml Expiry 2025-09-28
MEAN OF ALL INSTRUMENTS Range
Analyte unit Target low high methods
Phosphate Inorganic mmol/l 2.31 1.96 2.66 Phosphomolybdate UV
mg/dl 7.16 6.08 8.24
Potassium mmol/l 6.39 5.88 6.90 ISE method - indirect
mmol/l 6.40 5.89 6.91 Enzymatic
mmol/l 6.33 5.82 6.84 ISE direct
Protein Total g/l 70.3 56.2 84.4 Biuret reaction end point
g/dl 7.03 5.62 8.44
PSA Total ng/ml = µg/l 45.6 34.2 57.0 Roche Cobas e801
Sodium mmol/l 149 142 156 Enzymatic
mmol/l 151 143 159 ISE direct
mmol/l 151 143 159 ISE indirect
TIBC µmol/l 43.4 34.3 52.5 Randox Direct
µg/dl 243 192 293
Total T3 nmol/l 3.51 2.63 4.39 Roche Cobas e801
ng/ml 2.29 1.71 2.86
ng/dl 229 171 286
Total T4 nmol/l 214 161 268 Roche Cobas e801
µg/dl 16.7 12.6 20.9
ng/ml 167 126 209
Triglycerides mmol/l 2.87 2.41 3.33 Lipase/GPO-PAP no correction
mg/dl 254 213 295
UIBC µmol/l 9.30 7.63 11.0 TIBC - FE
µg/dl 52.0 42.7 61.5
Urea mmol/l 23.4 19.9 26.9 Urease kinetic
mg/dl 141 120 162
mmol/l 23.0 19.6 26.5 Urease hypochlorite
mg/dl 138 118 158
mmol/l 23.4 19.9 26.9 BUN
mg/dl 65.7 55.8 75.6
Uric Acid (Urate) mmol/l 0.593 0.516 0.670 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 9.96 8.67 11.3
mmol/l 0.563 0.490 0.636 Uricase peroxidase no ascorbate oxidase
mg/dl 9.46 8.23 10.7
Vitamin B12 pmol/l 110 88.0 132 Roche Cobas e801
pg/ml 149 119 179
Zinc µmol/l 31.2 25.0 37.4 Colorimetric with deproteinisation
µg/dl 204 163 245

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
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ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 355SE Size 20 x 5ml Expiry 2025-09-28
RX SERIES® Range
Analyte unit Target low high methods
Albumin g/l 45.3 38.5 52.1 Bromocresol Green
g/dl 4.53 3.85 5.21
Alkaline Phosphatase U/l 587 499 675 Diethanolamine buffer DEA 37°C
U/l 343 292 394 AMP optimised to IFCC 37°C
ALT (GPT) U/l 153 122 184 Tris buffer without P5P 37°C
Amylase Total U/I 617 524 710 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 199 159 239 Tris buffer without P5P 37°C
Bicarbonate mmol/l 26.9 21.3 32.5 Enzymatic
Bile Acids µmol/l 98.6 78.9 118 5th Generation Colorimetric
Bilirubin Direct µmol/l 30.7 24.3 37.1 Diazo with Sulphanilic Acid
mg/dl 1.80 1.42 2.18
µmol/l 32.2 25.4 39.0 Oxidation to Biliverdin/Vanadate
mg/dl 1.88 1.49 2.27
Bilirubin Total µmol/l 78.7 62.2 95.2 Diazo with Sulphanilic Acid
mg/dl 4.60 3.64 5.56
µmol/l 82.8 65.4 100 Oxidation to Biliverdin/Vanadate
mg/dl 4.84 3.83 5.85
Calcium mmol/l 3.14 2.83 3.45 Arsenazo III
mg/dl 12.6 11.3 13.9
Chloride mmol/l 109 100 118 ISE direct
Cholesterol mmol/l 6.60 5.74 7.46 Cholesterol Oxidase - Abell Kendall
mg/dl 255 222 288
CK Total U/l 514 421 607 CK-NAC substrate start (DGKC) 37°C
U/l 532 436 628 CK-NAC (IFCC) 37°C
Creatinine µmol/l 458 366 550 Alkaline picrate no deproteinization
mg/dl 5.18 4.14 6.22
µmol/l 492 394 590 Enzymatic UV method
mg/dl 5.56 4.45 6.67
Gamma-GT U/I 143 122 164 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
Glucose mmol/l 15.2 12.9 17.5 Hexokinase
mg/dl 274 232 316
mmol/l 16.5 14.0 19.0 Glucose oxidase
mg/dl 297 252 342
Iron µmol/l 34.1 28.0 40.2 Colorimetric without ppt.
µg/dl 191 157 225
Lactate mmol/l 8.13 6.67 9.59 Colorimetric Lactate Oxidase
mg/dl 73.3 60.1 86.4
LD (LDH) U/l 798 678 918 P->L German methods 37°C
U/l 350 298 403 L->P IFCC 37°C
Lipase U/I 89 71 107 Randox Colorimetric
Magnesium mmol/l 1.41 1.24 1.58 Xylidyl Blue
mg/dl 3.43 3.01 3.85

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
R
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 355SE Size 20 x 5ml Expiry 2025-09-28
RX SERIES® Range
Analyte unit Target low high methods
Phosphate Inorganic mmol/l 2.31 1.96 2.66 Phosphomolybdate UV
mg/dl 7.16 6.08 8.24
Potassium mmol/l 6.33 5.82 6.84 ISE method - direct
mmol/l 6.40 5.89 6.91 Enzymatic
Protein Total g/l 70.3 56.2 84.4 Biuret reaction end point
g/dl 7.03 5.62 8.44
Sodium mmol/l 151 143 159 ISE method - direct
mmol/l 149 142 156 Enzymatic
TIBC µmol/l 43.4 34.3 52.5 Direct Colorimetric
µg/dl 243 192 294
Triglycerides mmol/l 2.87 2.41 3.33 Lipase/GPO-PAP no correction
mg/dl 254 213 295
Urea mmol/l 23.4 19.9 26.9 Urease kinetic
mg/dl 141 120 162
mmol/l 23.4 19.9 26.9 BUN
mg/dl 65.7 55.8 75.6
Uric Acid (Urate) mmol/l 0.593 0.520 0.670 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 10.0 8.74 11.3
mmol/l 0.563 0.490 0.640 Uricase peroxidase no ascorbate oxidase
mg/dl 9.46 8.23 10.8

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 6
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]