CHEMISTRY PREMIUM - LEVEL 2
(CHEM PREMIUM 2)
CAT. NO. HN 5067 LOT NO. 957UN
SIZE: 12 x 5 ml EXP: 2018-09
INTENDED USE
This product is intended for in vitro diagnostic use in the quality control of diagnostic assays. Chemistry Premium is for the control of
accuracy.
DEVICE DESCRIPTION
Chemistry Premium is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values
section.
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 serum is stable for 8 hours at +25°C or 7 days at +2°C to +8°C, and
28 days when frozen once at –20°C (See Limitations).
UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.
LIMITATIONS
For Total & 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 exactly 30 minutes after reconstitution. After stabilisation Total and Prostatic Acid Phosphatase is stable for 2
hours at +15°C to +25°C, 2 days at +2°C to +8°C, and 28 days when frozen once at –20°C.
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 +25°C 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, it is stable for
4 days at +2°C to +8°C. Do not store at +15°C to +25°C. Do not freeze.
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.
PREPARATION FOR USE
Chemistry Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 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.
PAGE 1 OF 6
LOT NO. 957UN
MATERIALS PROVIDED
Chemistry Premium - Level 2 12 x 5 ml
MATERIALS REQUIRED BUT NOT PROVIDED
Volumetric pipette
ASSIGNED VALUES
Each batch of Chemistry Premium is assigned at Randox Laboratories, with reference to an internal master calibrator which is
traceable to international Reference Standards.
NOTES
® All trademarks recognized.
(1) DGKC: German Society for Clinical Chemistry
(2) IFCC: International Federation of Clinical Chemistry
(3) SCE : Scandinavian Committee on Enzymes
29 May ’15 ne
PAGE 2 OF 6
A
CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2)
Cat. No. HN5067 Lot No. 957UN
Size: 12 x 5 ml Expiry: 2018-09 Range
Analyte unit Target low high 1SD 2SD methods
alpha-HBDH U/I 262 207 317 27.50 55.00 Oxobutyrate < 10 mmol/l 37°C
U/I 198 156 240 21.00 42.00 Oxobutyrate < 10 mmol/l 30°C
U/I 148 117 179 15.50 31.00 Oxobutyrate < 10 mmol/l 25°C
Acid Phosphatase (Prostatic) U/I 9.19 6.16 12.2 1.52 3.03 1-Naphthyl Phosphate substrate Kinetic 37°C
Acid Phosphatase (Total) U/I 16.2 10.9 21.5 2.65 5.30 1-Naphthyl Phosphate substrate Kinetic 37°C
Albumin g/l 39.0 33.2 44.8 2.90 5.80 Bromocresol Green
g/dl 3.90 3.32 4.48 0.29 0.58
Alkaline Phosphatase U/l 170 145 195 12.50 25.00 AMP optimised to IFCC 37°C
U/I 132 113 151 9.50 19.00 AMP optimised to IFCC 30°C
U/I 109 93 125 8.00 16.00 AMP optimised to IFCC 25°C
U/l 281 239 323 21.00 42.00 Diethanolamine buffer DEA 37°C
U/I 219 186 252 16.50 33.00 Diethanolamine buffer DEA 30°C
U/I 180 153 207 13.50 27.00 Diethanolamine buffer DEA 25°C
ALT (GPT) U/l 39 31 47 4.00 8.00 Tris buffer without P5P 37°C
U/I 29 23 35 3.00 6.00 Tris buffer without P5P 30°C
U/I 22 17 27 2.50 5.00 Tris buffer without P5P 25°C
Amylase Pancreatic U/I 81 69 93 6.00 12.00 Randox liquid stable pNPG7 37°C
Amylase Total U/I 100 85 115 7.50 15.00 Randox liquid stable pNPG7 37°C
AST (GOT) U/l 50 40 60 5.00 10.00 Tris buffer without P5P 37°C
U/I 34 27 41 3.50 7.00 Tris buffer without P5P 30°C
U/I 24 19 29 2.50 5.00 Tris buffer without P5P 25°C
Page 3 of 6 29/05/2015
___________________________________________________________________________________________________
RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2)
Cat. No. HN5067 Lot No. 957UN
Size: 12 x 5 ml Expiry: 2018-09 Range
Analyte unit Target low high 1SD 2SD methods
Bilirubin Direct µmol/l 20.4 16.1 24.7 2.15 4.30 Diazo with Sulphanilic Acid
mg/dl 1.19 0.942 1.44 0.12 0.25
Bilirubin Total µmol/l 31.5 24.9 38.1 3.30 6.60 Diazo with Sulphanilic Acid
mg/dl 1.84 1.46 2.22 0.19 0.38
Calcium mmol/l 2.22 2.00 2.44 0.11 0.22 Cresolphthalein complexone
mg/dl 8.90 8.02 9.78 0.44 0.88
Chloride mmol/l 98.3 90.4 106 3.95 7.90 ISE direct
mmol/l 96.4 88.7 104 3.85 7.70 ISE indirect
Cholesterol mmol/l 4.18 3.64 4.72 0.27 0.54 Cholesterol Oxidase
mg/dl 161 141 181 10.00 20.00
Cholinesterase U/l 5268 4214 6322 527.00 1054.00 Colorimetric Butyrylthiocholine 37°C
CK Total U/l 253 207 299 23.00 46.00 CK-NAC substrate start (DGKC) 37°C
U/I 158 130 186 14.00 28.00 CK-NAC substrate start (DGKC) 30°C
U/I 108 88 128 10.00 20.00 CK-NAC substrate start (DGKC) 25°C
Creatinine µmol/l 117 93.6 140 11.70 23.40 Alkaline picrate no deproteinization
mg/dl 1.32 1.06 1.58 0.13 0.26
gamma-GT U/I 56 48 64 4.00 8.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C
U/I 44 38 50 3.00 6.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C
U/I 35 30 40 2.50 5.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C
GLDH U/I 14 11 17 1.50 3.00 Triethanolamine buffer 50 mmol 37°C
U/I 11 8 14 1.50 3.00 Triethanolamine buffer 50 mmol 30°C
U/I 9 7 11 1.00 2.00 Triethanolamine buffer 50 mmol 25°C
Glucose mmol/l 6.28 5.34 7.22 0.47 0.94 Glucose oxidase
mg/dl 113 96.2 130 8.40 16.80
Immunoglobulin A g/l 1.53 1.15 1.91 0.19 0.38 Immunoturbidimetric
mg/dl 153 115 191 19.00 38.00
Page 4 of 6 29/05/2015
___________________________________________________________________________________________________
RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2)
Cat. No. HN5067 Lot No. 957UN
Size: 12 x 5 ml Expiry: 2018-09 Range
Analyte unit Target low high 1SD 2SD methods
Immunoglobulin G g/l 6.13 5.03 7.23 0.55 1.10 Immunoturbidimetric
mg/dl 613 503 723 55.00 110.00
Immunoglobulin M g/l 0.49 0.39 0.58 0.05 0.10 Immunoturbidimetric
mg/dl 48.5 38.8 58.2 4.85 9.70
Iron µmol/l 20.1 16.5 23.7 1.80 3.60 Colorimetric without ppt.
µg/dl 112 92.2 132 9.90 19.80
Lactate mmol/l 1.34 1.10 1.58 0.12 0.24 Colorimetric Lactate Oxidase
mg/dl 12.1 9.91 14.3 1.10 2.19
LAP U/l 16 14 18 1.00 2.00 NAGEL 37°C
LD (LDH) U/l 440 374 506 33.00 66.00 P->L German methods 37°C
U/I 318 270 366 24.00 48.00 P->L German methods 30°C
U/I 223 190 256 16.50 33.00 P->L German methods 25°C
Lipase U/I 42 34 50 4.00 8.00 Randox Colorimetric 37°C
Lithium mmol/l 1.09 0.96 1.22 0.07 0.13 Randox Colorimetric
mg/dl 0.757 0.666 0.848 0.05 0.09
Magnesium mmol/l 0.91 0.80 1.02 0.05 0.11 Xylidyl Blue
mg/dl 2.20 1.94 2.46 0.13 0.26
Phosphate Inorganic mmol/l 1.35 1.15 1.55 0.10 0.20 Phosphomolybdate UV
mg/dl 4.19 3.57 4.81 0.31 0.62
Potassium mmol/l 4.28 3.94 4.62 0.17 0.34 ISE direct
mmol/l 3.95 3.63 4.27 0.16 0.32 ISE indirect
Protein Total g/l 59.3 47.4 71.2 5.95 11.90 Biuret reaction end point
g/dl 5.93 4.74 7.12 0.60 1.19
Sodium mmol/l 155 147 163 4.00 8.00 ISE direct
Page 5 of 6 29/05/2015
___________________________________________________________________________________________________
RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2)
Cat. No. HN5067 Lot No. 957UN
Size: 12 x 5 ml Expiry: 2018-09 Range
Analyte unit Target low high 1SD 2SD methods
Sodium mmol/l 142 135 149 3.50 7.00 ISE indirect
TIBC µmol/l 47.9 37.8 58.0 5.05 10.10 Randox Direct
µg/dl 268 212 324 28.00 56.00
Transferrin g/l 1.85 1.48 2.22 0.19 0.37 Immunoturbidimetric
mg/dl 185 148 222 18.50 37.00
Triglycerides mmol/l 1.12 0.94 1.30 0.09 0.18 Lipase/GPO-PAP no correction
mg/dl 99.1 83.3 115 7.90 15.80
UIBC µmol/l 27.8 22.8 32.8 2.50 5.00 TIBC - FE
µg/dl 155 127 183 14.00 28.00
Urea mmol/l 7.23 6.15 8.31 0.54 1.08 Urease kinetic
mg/dl 43.5 37.0 50.0 3.25 6.50
Uric Acid (Urate) mmol/l 0.35 0.30 0.39 0.02 0.05 Uricase Peroxidase with ascorbate oxidase @ 546nm
mg/dl 5.83 5.07 6.59 0.38 0.76
Page 6 of 6 29/05/2015
___________________________________________________________________________________________________
RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
