2797
ASSAYED BOVINE MULTI-SERA - LEVEL 2
(BOV ASY CONTROL 2)
CAT. NO. AN1026 LOT NO. 510SN
SIZE: 20 x 5 ml EXPIRY: 2027-08-28
GTIN: 05055273200294
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.
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 2 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 Apr ’24 me
PAGE 1 OF 6
A
ASSAYED BOVINE MULTI SERA - LEVEL 2 (BOV ASY CONTROL 2)
Cat. No. AN1026 Lot. No. 510SN Size 20 x 5ml Expiry 2027-08-28
METHOD Range
Analyte unit Target low high methods
Alpha-HBDH U/I 156 123 189 Oxobutyrate < 10 mmol/l 37°C
U/I 118 93 143 Oxobutyrate < 10 mmol/l 30°C
U/I 88 70 107 Oxobutyrate < 10 mmol/l 25°C
Acid Phosphatase (Total) U/I 8.83 5.92 11.7 1-Naphthyl Phosphate substrate Kinetic 37°C
Albumin g/l 39.0 33.2 44.9 Bromocresol Green
g/dl 3.90 3.32 4.48
Alkaline Phosphatase U/l 241 205 277 Diethanolamine buffer DEA 37°C
U/I 188 160 216 Diethanolamine buffer DEA 30°C
U/I 154 131 177 Diethanolamine buffer DEA 25°C
U/l 132 112 152 AMP optimised to IFCC 37°C
U/I 103 87 119 AMP optimised to IFCC 30°C
U/I 84 72 96 AMP optimised to IFCC 25°C
ALT (GPT) U/l 50 40 60 Tris buffer with P5P 37°C
U/I 37 30 44 Tris buffer with P5P 30°C
U/I 28 23 33 Tris buffer with P5P 25°C
U/l 51 41 61 Tris buffer without P5P 37°C
U/I 38 30 46 Tris buffer without P5P 30°C
U/I 29 23 35 Tris buffer without P5P 25°C
Amylase Total U/I 124 105 143 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 41 33 49 Tris buffer with P5P 37°C
U/I 28 22 34 Tris buffer with P5P 30°C
U/I 20 16 24 Tris buffer with P5P 25°C
U/l 37 30 44 Tris buffer without P5P 37°C
U/I 25 20 30 Tris buffer without P5P 30°C
U/I 18 14 22 Tris buffer without P5P 25°C
Bicarbonate mmol/l 23.5 18.6 28.4 Enzymatic
Bile Acids µmol/l 31.5 25.2 37.8 4th Generation Colorimetric
µmol/l 24.8 19.8 29.8 5th Generation Colorimetric
Bilirubin Direct µmol/l 22.2 17.5 26.9 Diazo with Sulphanilic Acid
mg/dl 1.30 1.02 1.58
µmol/l 14.9 11.8 18.0 Modified Jendrassik
mg/dl 0.872 0.690 1.05
µmol/l 20.0 15.8 24.2 Oxidation to Biliverdin/Vanadate
mg/dl 1.17 0.924 1.42
Bilirubin Total µmol/l 30.0 23.7 36.3 Diazo with Sulphanilic Acid
mg/dl 1.76 1.39 2.13
µmol/l 33.1 26.1 40.1 Modified Jendrassik
mg/dl 1.94 1.53 2.35
µmol/l 28.8 22.8 34.8 Oxidation to Biliverdin/Vanadate
mg/dl 1.68 1.33 2.03
Calcium mmol/l 2.26 2.03 2.49 Arsenazo III
mg/dl 9.06 8.14 9.98
___________________________________________________________________________________________________
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 2 (BOV ASY CONTROL 2)
Cat. No. AN1026 Lot. No. 510SN Size 20 x 5ml Expiry 2027-08-28
METHOD Range
Analyte unit Target low high methods
Calcium mmol/l 2.29 2.06 2.52 Cresolphthalein complexone
mg/dl 9.18 8.26 10.1
Chloride mmol/l 96.0 91.2 101 ISE indirect
mmol/l 93.8 89.1 98.5 ISE direct
Cholesterol mmol/l 5.06 4.40 5.72 Cholesterol Oxidase - Abell Kendall
mg/dl 195 170 220
CK Total U/l 163 134 192 CK-NAC substrate start (DGKC) 37°C
U/I 102 84 120 CK-NAC substrate start (DGKC) 30°C
U/I 69 57 81 CK-NAC substrate start (DGKC) 25°C
U/l 172 141 203 CK-NAC (IFCC) 37°C
U/I 108 88 128 CK-NAC (IFCC) 30°C
U/I 73 60 86 CK-NAC (IFCC) 25°C
Copper µmol/l 20.9 16.7 25.1 Colorimetric
µg/dl 133 106 160
Cortisol nmol/l 233 175 291 Roche Cobas e402/e801
µg/dl 8.39 6.30 10.5
Creatinine µmol/l 140 112 168 Alkaline picrate no deproteinization
mg/dl 1.58 1.27 1.89
µmol/l 139 111 167 Enzymatic UV method
mg/dl 1.57 1.25 1.89
D-3-Hydroxybutyrate mmol/l 1.46 1.24 1.67 Tris buffer 100mmol pH 8.5
Free T4 pmol/l 48.6 36.5 60.8 Roche Cobas e402/e801
ng/dl 3.79 2.85 4.73
pg/ml 37.9 28.5 47.3
Gamma-GT U/I 60 51 69 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 47 40 54 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 37 31 43 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
GLDH U/I 15 12 18 Triethanolamine buffer 50 mmol 37°C
U/I 12 9 15 Triethanolamine buffer 50 mmol 30°C
U/I 9 7 11 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 6.18 5.25 7.11 Hexokinase
mg/dl 111 94.6 127
mmol/l 6.26 5.32 7.20 Glucose oxidase
mg/dl 113 95.9 130
Iron µmol/l 31.7 26.0 37.4 Colorimetric without ppt.
µg/dl 177 145 209
Lactate mmol/l 4.01 3.29 4.73 Colorimetric Lactate Oxidase
mg/dl 36.1 29.6 42.6
LD (LDH) U/l 303 258 348 P->L German methods 37°C
U/I 219 186 252 P->L German methods 30°C
U/I 154 131 177 P->L German methods 25°C
U/l 146 124 168 L->P IFCC 37°C
U/I 105 90 120 L->P IFCC 30°C
U/I 74 63 85 L->P IFCC 25°C
Lipase U/I 39 31 47 Randox Colorimetric 37°C
Lithium mmol/l 1.28 1.12 1.43 Colorimetric
mg/dl 0.887 0.778 0.996
___________________________________________________________________________________________________
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 2 (BOV ASY CONTROL 2)
Cat. No. AN1026 Lot. No. 510SN Size 20 x 5ml Expiry 2027-08-28
METHOD Range
Analyte unit Target low high methods
Magnesium mmol/l 0.831 0.731 0.931 Xylidyl Blue
mg/dl 2.02 1.78 2.26
NEFA mmol/l 2.63 2.10 3.16 Colorimetric
Osmolality mOsm/kg 343 274 412 Freezing point depression
Phosphate Inorganic mmol/l 1.24 1.05 1.43 Phosphomolybdate UV
mg/dl 3.84 3.26 4.42
Potassium mmol/l 4.29 4.08 4.50 ISE method - indirect
mmol/l 4.39 4.17 4.61 Enzymatic
mmol/l 4.40 4.18 4.62 ISE direct
Protein Total g/l 60.4 48.3 72.5 Biuret reaction end point
g/dl 6.04 4.83 7.25
PSA Total ng/ml = µg/l 3.27 2.45 4.09 Roche Cobas e402/e801
Sodium mmol/l 141 134 148 Enzymatic
mmol/l 137 130 144 ISE direct
mmol/l 140 133 147 ISE method - indirect
TIBC µmol/l 31.9 25.2 38.6 Randox Direct
µg/dl 178 141 215
Total T3 nmol/l 2.32 1.74 2.90 Roche Cobas e402/e801
ng/ml 1.51 1.13 1.89
ng/dl 151 113 189
Total T4 nmol/l 113 84.8 141 Roche Cobas e402/e801
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
Triglycerides mmol/l 1.08 0.907 1.25 Lipase/GPO-PAP no correction
mg/dl 95.6 80.3 111
Urea mmol/l 6.70 5.70 7.71 Urease kinetic
mg/dl 40.3 34.3 46.3
mmol/l 6.70 5.70 7.71 BUN
mg/dl 18.8 16.0 21.6
Uric Acid (Urate) mmol/l 0.298 0.259 0.337 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 5.01 4.35 5.67
mmol/l 0.276 0.240 0.312 Uricase peroxidase no ascorbate oxidase
mg/dl 4.64 4.03 5.25
Vitamin B12 pmol/l 121 96.8 145 Roche Cobas e402/e801
pg/ml 164 131 197
Zinc µmol/l 19.5 15.6 23.4 Colorimetric with deproteinisation
µg/dl 127 102 152
___________________________________________________________________________________________________
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 2 (BOV ASY CONTROL 2)
Cat. No. AN1026 Lot. No. 510SN Size 20 x 5ml Expiry 2027-08-28
RX SERIES® Range
Analyte unit Target low high methods
Albumin g/l 39.0 33.2 44.9 Bromocresol Green
g/dl 3.90 3.32 4.48
Alkaline Phosphatase U/l 241 205 277 Diethanolamine buffer DEA 37°C
U/l 132 112 152 AMP optimised to IFCC 37°C
ALT (GPT) U/l 51 41 61 Tris buffer without P5P 37°C
Amylase Total U/I 124 105 143 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 37 30 44 Tris buffer without P5P 37°C
Bicarbonate mmol/l 23.5 18.6 28.4 Enzymatic
Bile Acids µmol/l 24.8 19.8 29.8 5th Generation Colorimetric
Bilirubin Direct µmol/l 22.3 17.6 27.0 Diazo with Sulphanilic Acid
mg/dl 1.30 1.03 1.57
µmol/l 20.0 15.8 24.2 Oxidation to Biliverdin/Vanadate
mg/dl 1.17 0.924 1.42
Bilirubin Total µmol/l 30.0 23.7 36.3 Diazo with Sulphanilic Acid
mg/dl 1.76 1.39 2.13
µmol/l 28.8 22.8 34.8 Oxidation to Biliverdin/Vanadate
mg/dl 1.68 1.33 2.03
Calcium mmol/l 2.26 2.03 2.49 Arsenazo III
mg/dl 9.06 8.14 9.98
Chloride mmol/l 93.8 89.1 98.5 ISE direct
Cholesterol mmol/l 5.06 4.40 5.72 Cholesterol Oxidase - Abell Kendall
mg/dl 195 170 220
CK Total U/l 160 131 189 CK-NAC substrate start (DGKC) 37°C
U/l 167 137 197 CK-NAC (IFCC) 37°C
Creatinine µmol/l 140 112 168 Alkaline picrate no deproteinization
mg/dl 1.58 1.27 1.89
µmol/l 139 111 167 Enzymatic UV method
mg/dl 1.57 1.25 1.89
Gamma-GT U/I 60 51 69 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C
Glucose mmol/l 6.18 5.25 7.11 Hexokinase
mg/dl 111 94.6 127
mmol/l 6.26 5.32 7.20 Glucose oxidase
mg/dl 113 95.9 130
Iron µmol/l 31.7 26.0 37.4 Colorimetric without ppt.
µg/dl 177 145 209
Lactate mmol/l 4.01 3.29 4.73 Colorimetric Lactate Oxidase
mg/dl 36.1 29.6 42.6
LD (LDH) U/l 303 258 348 P->L German methods 37°C
U/l 146 124 168 L->P 37°C
Lipase U/I 39 31 47 Randox Colorimetric
Magnesium mmol/l 0.831 0.731 0.931 Xylidyl Blue
mg/dl 2.02 1.78 2.26
___________________________________________________________________________________________________
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 2 (BOV ASY CONTROL 2)
Cat. No. AN1026 Lot. No. 510SN Size 20 x 5ml Expiry 2027-08-28
RX SERIES® Range
Analyte unit Target low high methods
Phosphate Inorganic mmol/l 1.24 1.05 1.43 Phosphomolybdate UV
mg/dl 3.84 3.26 4.42
Potassium mmol/l 4.40 4.18 4.62 ISE method - direct
mmol/l 4.39 4.17 4.61 Enzymatic
Protein Total g/l 60.4 48.3 72.5 Biuret reaction end point
g/dl 6.04 4.83 7.25
Sodium mmol/l 137 130 144 ISE method - direct
mmol/l 141 134 148 Enzymatic
TIBC µmol/l 31.9 25.2 38.6 Direct Colorimetric
µg/dl 178 141 215
Triglycerides mmol/l 1.08 0.907 1.25 Lipase/GPO-PAP no correction
mg/dl 95.6 80.3 111
Urea mmol/l 6.70 5.70 7.71 Urease kinetic
mg/dl 40.3 34.3 46.3
mmol/l 6.70 5.70 7.71 BUN
mg/dl 18.8 16.0 21.6
Uric Acid (Urate) mmol/l 0.276 0.240 0.312 Uricase peroxidase no ascorbate oxidase
mg/dl 4.64 4.03 5.25
mmol/l 0.298 0.259 0.337 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 5.01 4.35 5.67
___________________________________________________________________________________________________
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
