PRODUCT INFORMATION
AE1032
357SE
The reconstituted stability for Assayed Bovine Multi-Sera Level 3 lot 357SE for LD(LDH) is 4 days
when stored at +2°C to +8°C.
LD(LDH) is stable for 8 hours at +15°C to +25°C, and 28 days when frozen once at -18°C to -24°C
CCS INC409
Page 1 of 1 FORM NO. 8373-GP
REVISION (2)
2 Aug 2019
2797
ASSAYED BOVINE MULTI-SERA - LEVEL 3
(BOV ASY CONTROL 3)
CAT. NO. AE1032 LOT NO. 357SE
SIZE: 20 x 5 ml EXPIRY: 2027-08-28
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 +2ºC to +8ºC.
NEFA levels may be above the assay range for some manufacturer’s reagents and will therefore require dilution before testing.
PSA is stable for 4 days at +2ºC to +8ºC, or 28 days in aliquots frozen at –20ºC.
LD(LDH) is stable for 4 days at +2ºC to +8ºC, 8 hours at +15°C to +25°C, and 28 days when frozen once at -18°C to -24°C.
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 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
Rev. 08 Dec ’23 me
PAGE 1 OF 6
a
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 357SE Size 20 x 5ml Expiry 2027-08-28
METHOD Range
Analyte unit Target low high methods
Alpha-HBDH U/I 376 297 455 Oxobutyrate < 10 mmol/l 37°C
U/I 284 224 344 Oxobutyrate < 10 mmol/l 30°C
U/I 213 168 258 Oxobutyrate < 10 mmol/l 25°C
Acid Phosphatase (Total) U/I 33.7 22.6 44.8 1-Naphthyl Phosphate substrate Kinetic 37°C
Albumin g/l 45.8 38.9 52.7 Bromocresol Green
g/dl 4.58 3.89 5.27
Alkaline Phosphatase U/l 605 514 696 Diethanolamine buffer DEA 37°C
U/I 471 400 542 Diethanolamine buffer DEA 30°C
U/I 387 328 446 Diethanolamine buffer DEA 25°C
U/l 366 311 421 AMP optimised to IFCC 37°C
U/I 285 242 328 AMP optimised to IFCC 30°C
U/I 234 199 269 AMP optimised to IFCC 25°C
ALT (GPT) U/l 136 109 163 Tris buffer with P5P 37°C
U/I 101 81 121 Tris buffer with P5P 30°C
U/I 77 61 93 Tris buffer with P5P 25°C
U/l 139 111 167 Tris buffer without P5P 37°C
U/I 103 82 124 Tris buffer without P5P 30°C
U/I 78 62 94 Tris buffer without P5P 25°C
Amylase Total U/I 592 503 681 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 200 160 240 Tris buffer with P5P 37°C
U/I 135 108 162 Tris buffer with P5P 30°C
U/I 95 76 114 Tris buffer with P5P 25°C
U/l 207 166 248 Tris buffer without P5P 37°C
U/I 140 112 168 Tris buffer without P5P 30°C
U/I 99 79 119 Tris buffer without P5P 25°C
Bicarbonate mmol/l 29.2 23.2 35.2 Enzymatic
Bile Acids µmol/l 128 102 154 4th Generation Colorimetric
µmol/l 93.3 74.6 112 5th Generation Colorimetric
Bilirubin Direct µmol/l 33.6 26.5 40.7 Diazo with Sulphanilic Acid
mg/dl 1.97 1.55 2.39
µmol/l 26.7 21.1 32.3 Modified Jendrassik
mg/dl 1.56 1.23 1.89
µmol/l 29.6 23.4 35.8 Oxidation to Biliverdin/Vanadate
mg/dl 1.73 1.37 2.09
Bilirubin Total µmol/l 80.8 63.8 97.8 Diazo with Sulphanilic Acid
mg/dl 4.73 3.73 5.73
µmol/l 84.3 66.6 102 Modified Jendrassik
mg/dl 4.93 3.90 5.96
µmol/l 82.1 64.9 99.0 Oxidation to Biliverdin/Vanadate
mg/dl 4.80 3.80 5.80
Calcium mmol/l 3.02 2.72 3.32 Arsenazo III
mg/dl 12.1 10.9 13.3
___________________________________________________________________________________________________
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: [email protected] Website: www.randox.com
a
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 357SE Size 20 x 5ml Expiry 2027-08-28
METHOD Range
Analyte unit Target low high methods
Calcium mmol/l 2.98 2.68 3.28 Cresolphthalein complexone
mg/dl 11.9 10.7 13.1
Chloride mmol/l 114 108 120 ISE indirect
mmol/l 112 106 118 ISE direct
Cholesterol mmol/l 6.70 5.83 7.57 Cholesterol Oxidase - Abell Kendall
mg/dl 259 225 293
CK Total U/l 498 408 588 CK-NAC substrate start (DGKC) 37°C
U/I 312 255 369 CK-NAC substrate start (DGKC) 30°C
U/I 212 173 251 CK-NAC substrate start (DGKC) 25°C
U/l 516 423 609 CK-NAC (IFCC) 37°C
U/I 323 265 381 CK-NAC (IFCC) 30°C
U/I 219 180 258 CK-NAC (IFCC) 25°C
Copper µmol/l 26.8 21.4 32.2 Colorimetric
µg/dl 170 136 204
Cortisol nmol/l 428 321 535 Roche Cobas e402/e801
µg/dl 15.4 11.6 19.2
Creatinine µmol/l 430 344 516 Alkaline picrate no deproteinization
mg/dl 4.86 3.89 5.83
µmol/l 477 382 572 Enzymatic UV method
mg/dl 5.39 4.32 6.46
D-3-Hydroxybutyrate mmol/l 2.31 1.97 2.66 Tris buffer 100mmol pH 8.5
Free T4 pmol/l 98.5 73.9 123 Roche Cobas e402/e801
ng/dl 7.68 5.76 9.60
pg/ml 76.8 57.6 96.0
Gamma-GT U/I 138 117 159 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 109 92 126 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 85 72 98 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
GLDH U/I 21 17 25 Triethanolamine buffer 50 mmol 37°C
U/I 16 13 19 Triethanolamine buffer 50 mmol 30°C
U/I 13 11 15 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 15.1 12.8 17.4 Hexokinase
mg/dl 272 231 313
mmol/l 15.6 13.3 17.9 Glucose oxidase
mg/dl 281 240 322
Iron µmol/l 37.7 30.9 44.5 Colorimetric without ppt.
µg/dl 211 173 249
Lactate mmol/l 5.19 4.26 6.12 Colorimetric Lactate Oxidase
mg/dl 46.8 38.4 55.2
LD (LDH) U/l 667 567 767 P->L German methods 37°C
U/I 482 409 555 P->L German methods 30°C
U/I 338 287 389 P->L German methods 25°C
U/l 340 289 391 L->P IFCC 37°C
U/I 245 209 281 L->P IFCC 30°C
U/I 172 147 197 L->P IFCC 25°C
Lipase U/I 98 79 117 Randox Colorimetric 37°C
Lithium mmol/l 1.97 1.73 2.21 Colorimetric
mg/dl 1.37 1.20 1.54
___________________________________________________________________________________________________
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: [email protected] Website: www.randox.com
a
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 357SE Size 20 x 5ml Expiry 2027-08-28
METHOD Range
Analyte unit Target low high methods
Magnesium mmol/l 1.47 1.29 1.65 Xylidyl Blue
mg/dl 3.57 3.13 4.01
NEFA mmol/l 2.79 2.23 3.35 Colorimetric
Osmolality mOsm/kg 465 372 558 Freezing point depression
Phosphate Inorganic mmol/l 2.07 1.76 2.38 Phosphomolybdate UV
mg/dl 6.42 5.46 7.38
Potassium mmol/l 6.32 6.00 6.64 ISE method - indirect
mmol/l 6.36 6.04 6.68 Enzymatic
mmol/l 6.24 5.93 6.55 ISE direct
Protein Total g/l 75.6 60.5 90.7 Biuret reaction end point
g/dl 7.56 6.05 9.07
PSA Total ng/ml = µg/l 31.9 23.9 39.9 Roche Cobas e402/e801
Sodium mmol/l 156 148 164 Enzymatic
mmol/l 155 147 163 ISE direct
mmol/l 156 148 164 ISE method - indirect
TIBC µmol/l 42.0 33.2 50.8 Randox Direct
µg/dl 235 186 284
Total T3 nmol/l 4.12 3.09 5.15 Roche Cobas e402/e801
ng/ml 2.68 2.01 3.35
ng/dl 268 201 335
Total T4 nmol/l 220 165 275 Roche Cobas e402/e801
µg/dl 17.2 12.9 21.5
ng/ml 172 129 215
Triglycerides mmol/l 2.59 2.18 3.00 Lipase/GPO-PAP no correction
mg/dl 229 193 265
Urea mmol/l 22.4 19.0 25.8 Urease kinetic
mg/dl 135 114 156
mmol/l 22.4 19.0 25.8 BUN
mg/dl 62.9 53.5 72.3
Uric Acid (Urate) mmol/l 0.521 0.453 0.589 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 8.75 7.61 9.89
mmol/l 0.506 0.440 0.572 Uricase peroxidase no ascorbate oxidase
mg/dl 8.50 7.39 9.61
Vitamin B12 pmol/l 108 86.4 130 Roche Cobas e402/e801
pg/ml 146 117 175
Zinc µmol/l 39.9 31.9 47.9 Colorimetric with deproteinisation
µg/dl 261 208 314
___________________________________________________________________________________________________
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: [email protected] Website: www.randox.com
a
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 357SE Size 20 x 5ml Expiry 2027-08-28
RX SERIES® Range
Analyte unit Target low high methods
Albumin g/l 45.8 38.9 52.7 Bromocresol Green
g/dl 4.58 3.89 5.27
Alkaline Phosphatase U/l 605 514 696 Diethanolamine buffer DEA 37°C
U/l 366 311 421 AMP optimised to IFCC 37°C
ALT (GPT) U/l 139 111 167 Tris buffer without P5P 37°C
Amylase Total U/I 592 503 681 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 207 166 248 Tris buffer without P5P 37°C
Bicarbonate mmol/l 29.2 23.2 35.2 Enzymatic
Bile Acids µmol/l 93.3 74.6 112 5th Generation Colorimetric
Bilirubin Direct µmol/l 26.6 21.0 32.2 Diazo with Sulphanilic Acid
mg/dl 1.56 1.23 1.89
µmol/l 29.6 23.4 35.8 Oxidation to Biliverdin/Vanadate
mg/dl 1.73 1.37 2.09
Bilirubin Total µmol/l 78.8 62.3 95.3 Diazo with Sulphanilic Acid
mg/dl 4.61 3.64 5.58
µmol/l 82.1 64.9 99.0 Oxidation to Biliverdin/Vanadate
mg/dl 4.80 3.80 5.80
Calcium mmol/l 3.02 2.72 3.32 Arsenazo III
mg/dl 12.1 10.9 13.3
Chloride mmol/l 112 106 118 ISE direct
Cholesterol mmol/l 6.70 5.83 7.57 Cholesterol Oxidase - Abell Kendall
mg/dl 259 225 293
CK Total U/l 498 408 588 CK-NAC substrate start (DGKC) 37°C
U/l 516 423 609 CK-NAC (IFCC) 37°C
Creatinine µmol/l 430 344 516 Alkaline picrate no deproteinization
mg/dl 4.86 3.89 5.83
µmol/l 477 382 572 Enzymatic UV method
mg/dl 5.39 4.32 6.46
Gamma-GT U/I 138 117 159 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
Glucose mmol/l 15.1 12.8 17.4 Hexokinase
mg/dl 272 231 313
mmol/l 15.6 13.3 17.9 Glucose oxidase
mg/dl 281 240 322
Iron µmol/l 37.7 30.9 44.5 Colorimetric without ppt.
µg/dl 211 173 249
Lactate mmol/l 5.19 4.26 6.12 Colorimetric Lactate Oxidase
mg/dl 46.8 38.4 55.2
LD (LDH) U/l 667 567 767 P->L German methods 37°C
U/l 340 289 391 L->P 37°C
Lipase U/I 98 79 117 Randox Colorimetric
Magnesium mmol/l 1.47 1.29 1.65 Xylidyl Blue
mg/dl 3.57 3.13 4.01
___________________________________________________________________________________________________
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: [email protected] Website: www.randox.com
a
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Cat. No. AE1032 Lot. No. 357SE Size 20 x 5ml Expiry 2027-08-28
RX SERIES® Range
Analyte unit Target low high methods
Phosphate Inorganic mmol/l 2.07 1.76 2.38 Phosphomolybdate UV
mg/dl 6.42 5.46 7.38
Potassium mmol/l 6.24 5.93 6.55 ISE method - direct
mmol/l 6.36 6.04 6.68 Enzymatic
Protein Total g/l 75.6 60.5 90.7 Biuret reaction end point
g/dl 7.56 6.05 9.07
Sodium mmol/l 155 147 163 ISE method - direct
mmol/l 156 148 164 Enzymatic
TIBC µmol/l 42.0 33.2 50.8 Direct Colorimetric
µg/dl 235 186 284
Triglycerides mmol/l 2.59 2.18 3.00 Lipase/GPO-PAP no correction
mg/dl 229 193 265
Urea mmol/l 22.4 19.0 25.8 Urease kinetic
mg/dl 135 114 156
mmol/l 22.4 19.0 25.8 BUN
mg/dl 62.9 53.5 72.3
Uric Acid (Urate) mmol/l 0.506 0.440 0.572 Uricase peroxidase no ascorbate oxidase
mg/dl 8.50 7.39 9.61
mmol/l 0.521 0.453 0.589 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 8.75 7.61 9.89
___________________________________________________________________________________________________
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: [email protected] Website: www.randox.com
