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1682UN

The document provides product information for the Liquid Assayed Chemistry Control Premium Plus - Level 2 (Lot No. 1682UN, Cat. No. LAN4214), including intended use, safety precautions, storage instructions, and assigned values for various analytes. It notes that Total Acid Phosphatase levels are low and undetectable in this lot, and some values are currently to be determined. For further inquiries, contact information for technical services is provided.

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chamsalonga15
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0% found this document useful (0 votes)
148 views26 pages

1682UN

The document provides product information for the Liquid Assayed Chemistry Control Premium Plus - Level 2 (Lot No. 1682UN, Cat. No. LAN4214), including intended use, safety precautions, storage instructions, and assigned values for various analytes. It notes that Total Acid Phosphatase levels are low and undetectable in this lot, and some values are currently to be determined. For further inquiries, contact information for technical services is provided.

Uploaded by

chamsalonga15
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 26

PRODUCT INFORMATION

LAN4214

1682UN

Please note the concentration of analyte Total Acid Phosphatase is low and undetectable in
Lot 1682UN when compared to previous controls. For this reason, values will not be provided for
Total Acid Phosphatase.
For any queries regarding this, please contact technical.services@randox.com

CCS INC743

Page 1 of 1 FORM NO. 8373-GP


REVISION (2)
2 Aug 2019
PRODUCT INFORMATION

LAN4214

1682UN

Please note, some values are currently TBD and will be updated in due course.

For any questions or queries please contact technical.services@randox.com

CCS INC868

Page 1 of 1 FORM NO. 8373-GP


REVISION (2)
2 Aug 2019
2797

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS -


LEVEL 2 (LIQ CHEM ASY PREMIUM PLUS 2)
CAT. NO. LAN4214 LOT NO. 1682UN
SIZE: 12 x 5 ml EXPIRY: 2026-02-28
GTIN: 05055273214536

INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control
Premium Plus is for the control of accuracy.

DEVICE DESCRIPTION
The Liquid Assayed Chemistry Control Premium Plus is supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the
analytes listed in the values section at all three 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.

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). Thawed serum is stable for 7 days at +2°C to +8°C, with the following exceptions: Troponin T
is stable for 3 days at +2°C to +8°C. Only the required amount of product should be removed. After use, any residual product should NOT
BE RETURNED to the original vial.

UNOPENED: Store frozen at –20ºC to –70ºC. Stable to expiration date printed on individual vials (see Limitations).

LIMITATIONS
Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. ALT, Alkaline Phosphatase, Total and
Direct Bilirubin and Lipase values may gradually decrease during the product’s shelf life. Bacterial contamination of the thawed serum will cause
reductions in the stability of many components. 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
1. Allow the frozen control to thaw at room temperature (+15°C to +25°C) until completely thawed. Swirl the contents to ensure
homogeneity.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Liquid Assayed Chemistry Control Premium Plus - Level 2 12 x 5 ml

MATERIALS REQUIRED BUT NOT PROVIDED


None.

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.

If an instrument specific value is not available, refer to the Method section. If necessary, contact Randox Laboratories - Customer Technical
Services, Northern Ireland, Tel: +44 (0) 28 9445 1070 or email Technical.Services@randox.com.

Randox Teoranta, Meenmore,


Dungloe, Donegal,
F94 TV06, Ireland

Rev. 01 Aug ’24 ld

PAGE 1 OF 1
Table of Content
Abbott Alinity / Architect c/ci Systems 2
Beckman Coulter AU Series 4
Method 6
Method (Elec.) 13
Ortho Clinical Diagnostics Vitros 14
Randox RX series 16
Roche Cobas Series 18
Siemens ADVIA Chemistry Instruments 20
Siemens Atellica Solution 21
Siemens Dimension Series 22

Page 1 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Abbott Alinity / Architect c/ci Systems Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.35 3.70 5.00 0.325 0.650 Bromocresol Green
g/l 43.5 37.0 50.0 3.25 6.50
Alkaline Phosphatase U/l 88 75 101 6.50 13.0 AMP optimised to IFCC
ALT (GPT) U/l 82 66 98 8.00 16.0 Tris Buffer Without P5P
Amylase Pancreatic U/l 63 54 72 4.50 9.00 Immunoinhibition, EPS substrate
Amylase Total U/l 139 118 160 10.5 21.0 Abbott Alinity Amylase 2
AST (GOT) U/l 105 84 126 10.5 21.0 Tris Buffer Without P5P
Bicarbonate mmol/l 18.0 14.3 21.7 1.85 3.70 Enzymatic
Bilirubin Direct mg/dl 1.13 0.893 1.37 0.120 0.240 Diazo With Dichloroaniline
µmol/l 19.3 15.2 23.4 2.05 4.10
Bilirubin Total mg/dl 3.06 2.42 3.70 0.320 0.640 Diazo With Dichloroaniline
µmol/l 52.4 41.4 63.4 5.50 11.0
C-Reactive Protein mg/l 19.6 15.7 23.5 1.95 3.90 Turbidimetric (IFCC Cal.)
Calcium mg/dl 8.18 7.36 9.00 0.410 0.820 Arsenazo III
mmol/l 2.04 1.84 2.24 0.100 0.200
Chloride mmol/l 99.6 91.6 108 4.20 8.40 ISE Indirect
Cholesterol mg/dl 177 154 200 11.5 23.0 Cholesterol Oxidase - Abell Kendall
mmol/l 4.58 3.98 5.18 0.300 0.600
CK Total U/l 258 212 304 23.0 46.0 CK-NAC (IFCC)
Creatinine mg/dl 0.965 0.772 1.16 0.098 0.195 Alkaline picrate no deproteinisation
µmol/l 85.4 68.3 103 8.80 17.6
mg/dl 1.66 1.33 1.99 0.165 0.330 Enzymatic UV method
µmol/l 147 118 176 14.5 29.0
gamma-GT U/l 73 62 84 5.50 11.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 128 109 147 9.50 19.0 Hexokinase
mmol/l 7.09 6.03 8.15 0.530 1.06
HDL - Cholesterol mg/dl 60.2 51.2 69.2 4.50 9.00 HDL Ultra/Accel Selective Detergent
mmol/l 1.56 1.33 1.79 0.115 0.230
Iron µg/dl 147 121 173 13.0 26.0 Colorimetric without ppt.
µmol/l 26.3 21.6 31.0 2.35 4.70
Lactate mg/dl 13.8 11.3 16.3 1.25 2.50 Colorimetric - Lactate oxidase
mmol/l 1.53 1.25 1.81 0.140 0.280
LD (LDH) U/l 134 114 154 10.0 20.0 L to P, IFCC
LDL Cholesterol mg/dl 110 93.5 127 8.50 17.0 Selective Detergent Methods
mmol/l 2.84 2.41 3.27 0.215 0.430
Lithium mg/dl 0.674 0.593 0.755 0.041 0.081 Spectrophotometric
mmol/l 0.970 0.854 1.09 0.060 0.120

Page 2 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Abbott Alinity / Architect c/ci Systems Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Magnesium mg/dl 2.43 2.14 2.72 0.145 0.290 Enzymatic
mmol/l 1.00 0.880 1.12 0.060 0.120
Phosphate Inorganic mg/dl 3.70 3.15 4.25 0.275 0.550 Phosphomolybdate UV
mmol/l 1.19 1.01 1.37 0.090 0.180
Potassium mmol/l 3.90 3.59 4.21 0.155 0.310 ISE Indirect
Protein Total g/dl 7.83 6.26 9.40 0.785 1.57 Biuret reaction, end point
g/l 78.3 62.6 94.0 7.85 15.7
Sodium mmol/l 133 126 140 3.50 7.00 ISE Indirect
Triglycerides mg/dl 265 223 307 21.0 42.0 Lipase/GPO-PAP No Correction
mmol/l 2.99 2.51 3.47 0.240 0.480
Urea mg/dl 61.8 52.5 71.1 4.65 9.30 Urease, kinetic
mg/dl 28.8 24.5 33.1 2.15 4.30
(BUN)
mmol/l 10.3 8.76 11.8 0.750 1.50
Uric Acid (Urate) mg/dl 4.00 3.48 4.52 0.260 0.520 Uricase Perox. with ascorb. ox
mmol/l 0.238 0.207 0.269 0.016 0.031

Page 3 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Beckman Coulter AU Series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.38 3.72 5.04 0.330 0.660 Bromocresol Green
g/l 43.8 37.2 50.4 3.30 6.60
Alkaline Phosphatase U/l 95 81 109 7.00 14.0 AMP optimised to IFCC
ALT (GPT) U/l 85 68 102 8.50 17.0 Tris Buffer Without P5P
Amylase Total U/l 129 110 148 9.50 19.0 Beckman blocked pNPG7
AST (GOT) U/l 109 87 131 11.0 22.0 Tris Buffer Without P5P
Bicarbonate mmol/l 20.0 15.9 24.1 2.05 4.10 Enzymatic
Bilirubin Direct mg/dl 0.907 0.717 1.10 0.097 0.193 Dichlorophenyl Diazonium
µmol/l 15.5 12.2 18.8 1.65 3.30
Bilirubin Total mg/dl 2.42 1.91 2.93 0.255 0.510 Dichlorophenyl Diazonium
µmol/l 41.4 32.7 50.1 4.35 8.70
C-Reactive Protein mg/l 17.7 14.2 21.2 1.75 3.50 Turbidimetric (IFCC Cal.)
Calcium mg/dl 8.70 7.83 9.57 0.435 0.870 Arsenazo III
mmol/l 2.17 1.95 2.39 0.110 0.220
mg/dl 8.42 7.58 9.26 0.420 0.840 Cresolphthalein Complexone
mmol/l 2.10 1.89 2.31 0.105 0.210
Chloride mmol/l 98.9 91.0 107 4.05 8.10 ISE Indirect
Cholesterol mg/dl 198 172 224 13.0 26.0 Cholesterol Oxidase - Abell Kendall
mmol/l 5.14 4.47 5.81 0.335 0.670
CK Total U/l 262 215 309 23.5 47.0 CK-NAC (IFCC)
Creatinine mg/dl 1.67 1.34 2.00 0.165 0.330 Jaffe Rate Blanked
µmol/l 147 118 176 14.5 29.0
gamma-GT U/l 68 58 78 5.00 10.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 126 107 145 9.50 19.0 Hexokinase
mmol/l 7.00 5.95 8.05 0.525 1.05
Iron µg/dl 149 122 176 13.5 27.0 Colorimetric without ppt.
µmol/l 26.7 21.9 31.5 2.40 4.80
LD (LDH) U/l 133 113 153 10.0 20.0 L to P, IFCC
U/l 263 224 302 19.5 39.0 P to L Scandinavian & Dutch
Magnesium mg/dl 2.50 2.20 2.80 0.150 0.300 Xylidyl Blue
mmol/l 1.03 0.906 1.15 0.060 0.120
Phosphate Inorganic mg/dl 3.75 3.19 4.31 0.280 0.560 Phosphomolybdate UV
mmol/l 1.21 1.03 1.39 0.090 0.180
Potassium mmol/l 3.90 3.71 4.09 0.095 0.190 ISE Indirect
Protein Total g/dl 7.36 5.89 8.83 0.735 1.47 Biuret reaction, end point
g/l 73.6 58.9 88.3 7.35 14.7
Sodium mmol/l 132 125 139 3.50 7.00 ISE Indirect

Page 4 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Beckman Coulter AU Series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Triglycerides mg/dl 217 182 252 17.5 35.0 Lipase/GPO-PAP No Correction
mmol/l 2.45 2.06 2.84 0.195 0.390
Urea mg/dl 62.3 53.0 71.6 4.65 9.30 Urease, kinetic
mg/dl 29.0 24.7 33.3 2.15 4.30
(BUN)
mmol/l 10.4 8.84 12.0 0.800 1.60
Uric Acid (Urate) mg/dl 4.14 3.60 4.68 0.270 0.540 Uricase perox. no ascorb. ox.
mmol/l 0.247 0.215 0.279 0.016 0.032

Page 5 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.43 3.77 5.09 0.330 0.660 Bromocresol Green
g/l 44.3 37.7 50.9 3.30 6.60
g/dl 4.74 4.03 5.45 0.355 0.710 Bromocresol Purple
g/l 47.4 40.3 54.5 3.55 7.10
Alkaline Phosphatase U/l 93 79 107 7.00 14.0 AMP optimised to IFCC
U/l 221 188 254 16.5 33.0 Diethanolamine buffer, DEA
alpha - HBDH U/l 115 91 139 12.0 24.0 Oxobutyrate < 10 mmol/l
Alpha-1-Acid g/l 0.763 0.610 0.916 0.077 0.153 Turbidimetric (IFCC Cal.)
Glycoprotein
Alpha-1-Antitrypsin g/l 1.35 1.08 1.62 0.135 0.270 Turbidimetric (IFCC Cal.)
mg/dl 135 108 162 13.5 27.0
Alpha-fetoprotein ng/ml 3.03 2.42 3.64 0.305 0.610 Roche Cobas e402/e801
KIU/l = 2.50 2.00 3.00 0.250 0.500
IU/ml
ALT (GPT) U/l 90 72 108 9.00 18.0 Tris Buffer With P5P
U/l 85 68 102 8.50 17.0 Tris Buffer Without P5P
Amikacin µg/ml 14.5 11.6 17.4 1.45 2.90 Gravimetric
µmol/l 24.8 19.8 29.8 2.50 5.00
Amylase Pancreatic U/l 118 100 136 9.00 18.0 Randox Liquid Ethylidene pNPG7
U/l 104 88 120 8.00 16.0 Roche Liquid Stable pNPG7
Amylase Total U/l 129 110 148 9.50 19.0 Beckman blocked pNPG7
U/l 139 118 160 10.5 21.0 Other 2-chloro-pNPG3
U/l 148 126 170 11.0 22.0 Randox Liquid Ethylidene pNPG7
U/l 137 116 158 10.5 21.0 Roche Liquid Stable pNPG7
U/l 152 129 175 11.5 23.0 Siemens - blocked pNPG7
U/l 144 122 166 11.0 22.0 Siemens/Dade Behring 2-chloro-pNPG3
Apolipoprotein A1 g/l 1.53 1.25 1.81 0.140 0.280 Immunoturbidimetric
mg/dl 153 125 181 14.0 28.0
Apolipoprotein B g/l 0.959 0.786 1.13 0.086 0.171 Immunoturbidimetric
mg/dl 95.9 78.6 113 8.55 17.1
AST (GOT) U/l 109 87 131 11.0 22.0 Tris Buffer With P5P
U/l 107 86 128 10.5 21.0 Tris Buffer Without P5P
Beta-2-Microglobulin µg/ml = 3.09 2.47 3.71 0.310 0.620 Turbidimetric (IFCC Cal.)
mg/l
Bicarbonate mmol/l 19.4 15.4 23.4 2.00 4.00 Enzymatic
Bile Acids µmol/l 35.1 28.1 42.1 3.50 7.00 5th Generation Colorimetric
Bilirubin Direct mg/dl 1.14 0.901 1.38 0.120 0.240 Modified Jendrassik
µmol/l 19.5 15.4 23.6 2.05 4.10

Page 6 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Bilirubin Direct mg/dl 1.15 0.909 1.39 0.120 0.240 Diazo With Sulphanilic Acid
µmol/l 19.7 15.6 23.8 2.05 4.10
mg/dl 1.12 0.885 1.36 0.120 0.240 Dichlorophenyl Diazonium
µmol/l 19.1 15.1 23.1 2.00 4.00
mg/dl 1.14 0.901 1.38 0.120 0.240 Oxidation to Biliverdin/Vanadate
µmol/l 19.5 15.4 23.6 2.05 4.10
Bilirubin Total mg/dl 3.35 2.65 4.05 0.350 0.700 Modified Jendrassik
µmol/l 57.3 45.3 69.3 6.00 12.0
mg/dl 3.07 2.43 3.71 0.320 0.640 Diazo With Dichloroaniline
µmol/l 52.4 41.4 63.4 5.50 11.0
mg/dl 3.26 2.58 3.94 0.340 0.680 Diazo With Sulphanilic Acid
µmol/l 55.8 44.1 67.5 5.85 11.7
mg/dl 2.58 2.04 3.12 0.270 0.540 Dichlorophenyl Diazonium
µmol/l 44.2 34.9 53.5 4.65 9.30
mg/dl 3.45 2.73 4.17 0.360 0.720 Oxidation to Biliverdin/Vanadate
µmol/l 59.0 46.6 71.4 6.20 12.4
C-Reactive Protein mg/l 18.2 14.6 21.8 1.80 3.60 Turbidimetric (IFCC Cal.)
Caeruloplasmin g/l 24.8 18.6 31.0 3.10 6.20 Turbidimetric (Non IFCC Cal.)
mg/dl 2480 1860 3100 310 620
Caffeine µg/ml 8.54 6.83 10.3 0.880 1.76 Gravimetric
µmol/l 44.0 35.2 52.8 4.40 8.80
Calcium mg/dl 8.62 7.76 9.48 0.430 0.860 Arsenazo III
mmol/l 2.15 1.94 2.36 0.105 0.210
mg/dl 8.11 7.30 8.92 0.405 0.810 Cresolphthalein Complexone
mmol/l 2.02 1.82 2.22 0.100 0.200
mg/dl 8.42 7.58 9.26 0.420 0.840 NM-BAPTA
mmol/l 2.10 1.89 2.31 0.105 0.210
Carbamazepine µg/ml 9.01 7.21 10.8 0.895 1.79 Gravimetric
µmol/l 38.1 30.5 45.7 3.80 7.60
µg/ml 7.89 6.31 9.47 0.790 1.58 Immunoturbidimetric
µmol/l 33.4 26.7 40.1 3.35 6.70
CEA ng/ml 1.72 1.38 2.06 0.170 0.340 Roche Cobas e402/e801
Chloride mmol/l 96.6 88.9 104 3.70 7.40 ISE Direct
mmol/l 99.7 91.7 108 4.15 8.30 ISE Indirect
Cholesterol mg/dl 192 167 217 12.5 25.0 Cholesterol Oxidase - Abell Kendall
mmol/l 4.96 4.32 5.60 0.320 0.640
Cholinesterase U/l 8563 6850 10276 857 1713 Colorimetric - Butyrylthiocholine
CK Total U/l 254 208 300 23.0 46.0 CK-NAC (IFCC)
U/l 240 197 283 21.5 43.0 CK-NAC substrate start (DGKC)

Page 7 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Complement C3 g/l 1.58 1.26 1.90 0.160 0.320 Turbidimetric (IFCC Cal.)
mg/dl 158 126 190 16.0 32.0
Complement C4 g/l 0.263 0.210 0.316 0.027 0.053 Turbidimetric (IFCC Cal.)
mg/dl 26.3 21.0 31.6 2.65 5.30
Copper µg/dl 136 109 163 13.5 27.0 Colorimetric
µmol/l 21.4 17.1 25.7 2.15 4.30
Cortisol nmol/l 585 439 731 73.0 146 Roche Cobas e402/e801
µg/dl 21.1 15.8 26.4 2.65 5.30
Creatinine mg/dl 1.68 1.34 2.02 0.170 0.340 Alkaline picrate no deproteinisation
µmol/l 149 119 179 15.0 30.0
mg/dl 1.57 1.26 1.88 0.155 0.310 Enzymatic UV method
µmol/l 139 111 167 14.0 28.0
mg/dl 1.66 1.33 1.99 0.165 0.330 Jaffe Rate Blanked
µmol/l 147 118 176 14.5 29.0
mg/dl 1.76 1.41 2.11 0.175 0.350 Jaffe rate blanked comp. (-26umol/l)
µmol/l 155 124 186 15.5 31.0
D-3-Hydroxybutyrate mmol/l 0.398 0.338 0.458 0.030 0.060 Tris buffer 100mmol pH 8.5
Digoxin ng/ml 1.50 1.20 1.80 0.150 0.300 Gravimetric
nmol/l 1.92 1.54 2.30 0.190 0.380
ng/ml 1.06 0.848 1.27 0.105 0.210 Immunoturbidimetric
nmol/l 1.36 1.09 1.63 0.135 0.270
Ferritin ng/ml = 68.2 54.6 81.8 6.80 13.6 Immunoturbidimetric
µg/l
Folate ng/ml 4.63 3.52 5.74 0.555 1.11 Roche Cobas e402/e801
nmol/l 10.5 7.98 13.0 1.25 2.50
Free T3 ng/dl 0.447 0.335 0.559 0.056 0.112 Roche Cobas e402/e801
pg/ml 4.47 3.35 5.59 0.560 1.12
pmol/l 6.87 5.15 8.59 0.860 1.72
Free T4 ng/dl 1.67 1.25 2.09 0.210 0.420 Roche Cobas e402/e801
pg/ml 16.7 12.5 20.9 2.10 4.20
pmol/l 21.4 16.1 26.7 2.65 5.30
FSH mU/ml 25.9 20.7 31.1 2.60 5.20 Roche Cobas e402/e801
gamma-GT U/l 72 61 83 5.50 11.0 Gamma glut'3-carb'4-nitro(IFCC)
Gentamicin µg/ml 5.74 4.59 6.89 0.575 1.15 Gravimetric
µmol/l 12.0 9.60 14.4 1.20 2.40
µg/ml 3.68 2.94 4.42 0.370 0.740 Immunoturbidimetric
µmol/l 7.71 6.17 9.25 0.770 1.54
GLDH U/l 23 18 28 2.50 5.00 Triethanolamine buffer

Page 8 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Glucose mg/dl 124 105 143 9.50 19.0 Glucose Oxidase
mmol/l 6.89 5.86 7.92 0.515 1.03
mg/dl 128 109 147 9.50 19.0 Hexokinase
mmol/l 7.11 6.04 8.18 0.535 1.07
Haptoglobin g/l 1.23 0.984 1.48 0.125 0.250 Turbidimetric (IFCC Cal.)
mg/dl 123 98.4 148 12.5 25.0
HDL - Cholesterol mg/dl 54.6 46.4 62.8 4.10 8.20 Direct HDL, Clearance method
mmol/l 1.42 1.21 1.63 0.105 0.210
mg/dl 54.7 46.5 62.9 4.10 8.20 Direct HDL, PEGME
mmol/l 1.42 1.21 1.63 0.105 0.210
mg/dl 54.1 46.0 62.2 4.05 8.10 Direct HDL, Roche 4th gen.
mmol/l 1.40 1.19 1.61 0.105 0.210
mg/dl 60.2 51.2 69.2 4.50 9.00 HDL Ultra/Accel Selective Detergent
mmol/l 1.56 1.33 1.79 0.115 0.230
Immunoglobulin A g/l 2.68 2.01 3.35 0.335 0.670 Turbidimetric (IFCC Cal.)
mg/dl 268 201 335 33.5 67.0
Immunoglobulin E KIU/l = 180 144 216 18.0 36.0 Turbidimetric (Non IFCC Cal.)
IU/ml
Immunoglobulin G g/l 11.4 9.35 13.5 1.05 2.10 Turbidimetric (IFCC Cal.)
mg/dl 1140 935 1345 103 205
Immunoglobulin M g/l 1.06 0.848 1.27 0.105 0.210 Turbidimetric (IFCC Cal.)
mg/dl 106 84.8 127 10.5 21.0
Iron µg/dl 148 121 175 13.5 27.0 Colorimetric without ppt.
µmol/l 26.4 21.6 31.2 2.40 4.80
Lactate mg/dl 12.8 10.5 15.1 1.15 2.30 UV-LDH
mmol/l 1.42 1.16 1.68 0.130 0.260
LD (LDH) U/l 134 114 154 10.0 20.0 L to P, IFCC
U/l 263 224 302 19.5 39.0 P to L Scandinavian & Dutch
U/l 245 208 282 18.5 37.0 P to L, German methods
LDL Cholesterol mg/dl 113 96.1 130 8.50 17.0 Direct Clearance Method
mmol/l 2.93 2.49 3.37 0.220 0.440
mg/dl 117 99.5 135 9.00 18.0 Selective Detergent Methods
mmol/l 3.04 2.58 3.50 0.230 0.460
Lipase U/l 53 43 63 5.00 10.0 Colorimetric Randox
U/l 50 40 60 5.00 10.0 Colorimetric Roche

Page 9 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Lipoprotein (a) mg/dl 25.9 20.7 31.1 2.60 5.20 Immunoturbidimetric
nmol/l 11.4 9.12 13.7 1.15 2.30
mg/dl 50.0 40.0 60.0 5.00 10.0
nmol/l 22.0 17.6 26.4 2.20 4.40
Lipoprotein (a) mg/dl mg/dl 25.9 20.7 31.1 2.60 5.20 Immunoturbidimetric
Lipoprotein (a) nmol/l nmol/l 50.0 40.0 60.0 5.00 10.0 Immunoturbidimetric
Lithium mg/dl 0.694 0.611 0.777 0.042 0.083 Gravimetric
mmol/l 1.00 0.880 1.12 0.060 0.120
mg/dl 0.716 0.630 0.802 0.043 0.086 Spectrophotometric
mmol/l 1.03 0.906 1.15 0.060 0.120
Magnesium mg/dl 2.43 2.14 2.72 0.145 0.290 Enzymatic
mmol/l 1.00 0.880 1.12 0.060 0.120
mg/dl 2.43 2.14 2.72 0.145 0.290 Methylthymol Blue
mmol/l 1.00 0.880 1.12 0.060 0.120
mg/dl 2.50 2.20 2.80 0.150 0.300 Xylidyl Blue
mmol/l 1.03 0.906 1.15 0.060 0.120
Myoglobin ng/ml 289 231 347 29.0 58.0 Roche Cobas e402/e801
ug/l 289 231 347 29.0 58.0
Osmolality mOsm/ 761 609 913 76.0 152 Freezing Point Depression
Kg
Paracetamol (Acetamin) mg/l 10576 8461 12691 1058 2115 Enzyme immunoassay (direct)
mmol/l 69.8 55.8 83.8 7.00 14.0
mg/l 80.3 64.2 96.4 8.05 16.1 Gravimetric
mmol/l 0.530 0.424 0.636 0.053 0.106
Phenobarbital µg/ml 27.8 22.2 33.4 2.80 5.60 Gravimetric
µmol/l 120 96.0 144 12.0 24.0
µg/ml 26.3 21.0 31.6 2.65 5.30 Immunoturbidimetric
µmol/l 114 91.2 137 11.5 23.0
Phenytoin µg/ml 12.0 9.60 14.4 1.20 2.40 Gravimetric
µmol/l 47.5 38.0 57.0 4.75 9.50
µg/ml 10.8 8.64 13.0 1.10 2.20 Immunoturbidimetric
µmol/l 42.9 34.3 51.5 4.30 8.60
Phosphate Inorganic mg/dl 3.76 3.20 4.32 0.280 0.560 Phosphomolybdate UV
mmol/l 1.21 1.03 1.39 0.090 0.180
Potassium mmol/l 4.08 3.75 4.41 0.165 0.330 Enzymatic
mmol/l 4.20 3.86 4.54 0.170 0.340 ISE Direct
mmol/l 3.97 3.65 4.29 0.160 0.320 ISE Indirect

Page 10 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Prealbumin g/l 0.239 0.191 0.287 0.024 0.048 Turbidimetric (IFCC Cal.)
mg/dl 23.9 19.1 28.7 2.40 4.80
Progesterone ng/ml 9.55 7.64 11.5 0.975 1.95 Roche Cobas e402/e801
nmol/l 30.5 24.4 36.6 3.05 6.10
Prolactin mU/l 303 242 364 30.5 61.0 Roche Cobas e402/e801
uU/ml 303 242 364 30.5 61.0
µU/ml 303 242 364 30.5 61.0
Protein Total g/dl 7.45 5.96 8.94 0.745 1.49 Biuret reaction, end point
g/l 74.5 59.6 89.4 7.45 14.9
PSA Total ng/ml = 9.62 7.22 12.0 1.19 2.38 Roche Cobas e402/e801
µg/l
Salicylate mg/dl 11.2 8.96 13.4 1.10 2.20 Colorimetric
mmol/l 0.808 0.646 0.970 0.081 0.162
mg/dl 13.8 11.0 16.6 1.40 2.80 Gravimetric
mmol/l 1.00 0.800 1.20 0.100 0.200
Sodium mmol/l 137 130 144 3.50 7.00 Enzymatic
mmol/l 138 131 145 3.50 7.00 ISE Direct
mmol/l 133 126 140 3.50 7.00 ISE Indirect
T Uptake %U 29.0 23.2 34.8 2.90 5.80 Siemens Immulite 2000
Testosterone ng/dl 481 385 577 48.0 96.0 Roche Cobas e402/e801
ng/ml 4.81 3.85 5.77 0.480 0.960
nmol/l 16.7 13.4 20.0 1.65 3.30
Theophylline µg/ml 14.4 11.5 17.3 1.45 2.90 Gravimetric
µmol/l 79.9 63.9 95.9 8.00 16.0
µg/ml 12.7 10.2 15.2 1.25 2.50 Immunoturbidimetric
µmol/l 70.4 56.3 84.5 7.05 14.1
Thyroid Stimulating µU/ml = 4.71 3.77 5.65 0.470 0.940 Roche Cobas e402/e801
Hormone mlU/l
TIBC µg/dl 344 272 416 36.0 72.0 Direct Colorimetric
µmol/l 61.5 48.6 74.4 6.45 12.9
µg/dl 371 293 449 39.0 78.0 Randox Colorimetric
µmol/l 66.4 52.5 80.3 6.95 13.9
Total Beta hCG mU/ml 50.8 40.6 61.0 5.10 10.2 Roche Cobas e402/e801
U/l 50.8 40.6 61.0 5.10 10.2
Total T3 ng/dl 159 119 199 20.0 40.0 Roche Cobas e402/e801
ng/ml 1.59 1.19 1.99 0.200 0.400
nmol/l 2.45 1.84 3.06 0.305 0.610

Page 11 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Total T4 ng/ml 82.7 62.0 103 10.2 20.3 Roche Cobas e402/e801
nmol/l 106 79.5 133 13.5 27.0
µg/dl 8.27 6.20 10.3 1.02 2.03
Transferrin g/l 2.69 2.15 3.23 0.270 0.540 Turbidimetric (IFCC Cal.)
mg/dl 269 215 323 27.0 54.0
Triglycerides mg/dl 225 189 261 18.0 36.0 Lipase/GPO-PAP No Correction
mmol/l 2.55 2.14 2.96 0.205 0.410
Troponin T ng/l 53.0 39.8 66.2 6.60 13.2 Roche Cobas e402/e801
ng/ml 0.053 0.040 0.066 0.007 0.013
Urea mg/dl 62.1 52.8 71.4 4.65 9.30 Urease, kinetic
mg/dl 28.9 24.6 33.2 2.15 4.30
(BUN)
mmol/l 10.3 8.76 11.8 0.750 1.50
Uric Acid (Urate) mg/dl 4.13 3.59 4.67 0.270 0.540 Uricase perox. no ascorb. ox.
mmol/l 0.246 0.214 0.278 0.016 0.032
mg/dl 4.00 3.48 4.52 0.260 0.520 Uricase Perox. with ascorb. ox
mmol/l 0.238 0.207 0.269 0.016 0.031
mg/dl 3.93 3.42 4.44 0.255 0.510 Uricase Perox. with ascorb. ox @ 546nm
mmol/l 0.234 0.204 0.264 0.015 0.030
Valproic Acid µg/ml 40.0 32.0 48.0 4.00 8.00 Gravimetric
µmol/l 277 222 332 27.5 55.0
Vancomycin µg/ml 14.7 11.8 17.6 1.45 2.90 Gravimetric
µmol/l 9.89 7.91 11.9 1.01 2.01
Vitamin B12 pg/ml 514 411 617 51.5 103 Roche Cobas e402/e801
pmol/l 379 303 455 38.0 76.0
Zinc µg/dl 238 190 286 24.0 48.0 Colorimetric with deprot.
µmol/l 36.4 29.1 43.7 3.65 7.30

Page 12 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method (Elec.) Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Alpha-2-Globulin % 7.80 5.85 9.75 0.975 1.95 % of total Protein (Beckman Capillary)
Beta-Globulin % 12.1 9.08 15.1 1.50 3.00 % of total Protein (Beckman Capillary)
Electrophoresis Albumin % 60.1 54.1 66.1 3.00 6.00 % of total Protein (Beckman Capillary)
(%)
Electrophoresis Gamma- % 14.5 10.9 18.1 1.80 3.60 % of total Protein (Beckman Capillary)
Globulin (conc)

Page 13 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Ortho Clinical Diagnostics Vitros Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.68 3.98 5.38 0.350 0.700 Ortho Vitros Microslide Systems
g/l 46.8 39.8 53.8 3.50 7.00
Alkaline Phosphatase U/l 99 84 114 7.50 15.0 Ortho Vitros Microslide Systems
ALT (GPT) U/l 91 73 109 9.00 18.0 Ortho Vitros MicroSlide visible
Amylase Total U/l 101 86 116 7.50 15.0 Ortho Vitros Microslide Systems
AST (GOT) U/l 126 101 151 12.5 25.0 Ortho Vitros MicroSlide visible
Bicarbonate mmol/l 16.6 13.2 20.0 1.70 3.40 Ortho Vitros Microslide Systems
Bilirubin Total mg/dl 3.22 2.54 3.90 0.340 0.680 Ortho Vitros MicroSlide Total Bil
µmol/l 55.1 43.5 66.7 5.80 11.6
C-Reactive Protein mg/l 21.4 17.1 25.7 2.15 4.30 Vitros (IFCC Cal.)
Calcium mg/dl 8.10 7.29 8.91 0.405 0.810 Ortho Vitros Microslide Systems
mmol/l 2.02 1.82 2.22 0.100 0.200
Chloride mmol/l 104 95.7 112 4.00 8.00 Ortho Vitros Microslide Systems
Cholesterol mg/dl 8092 7040 9144 526 1052 Ortho Vitros Microslide Systems
mmol/l 210 183 237 13.5 27.0
CK Total U/l 244 200 288 22.0 44.0 Ortho Vitros Microslide Systems
Creatinine mg/dl 1.80 1.44 2.16 0.180 0.360 Vitros, IDMS traceable
µmol/l 159 127 191 16.0 32.0
gamma-GT U/l 68 58 78 5.00 10.0 Ortho Vitros Microslide Systems
Glucose mg/dl 126 107 145 9.50 19.0 Ortho Vitros Microslide Systems
mmol/l 7.00 5.95 8.05 0.525 1.05
Iron µg/dl 170 139 201 15.5 31.0 Ortho Vitros Microslide Systems
µmol/l 30.4 24.9 35.9 2.75 5.50
LD (LDH) U/l 136 116 156 10.0 20.0 Ortho Vitros Microslide Systems
Lithium mg/dl 0.889 0.782 0.996 0.054 0.107 Ortho Vitros Microslide Systems
mmol/l 1.28 1.13 1.43 0.075 0.150
Magnesium mg/dl 2.34 2.06 2.62 0.140 0.280 Ortho Vitros Microslide Systems
mmol/l 0.963 0.847 1.08 0.059 0.117
Phosphate Inorganic mg/dl 4.06 3.45 4.67 0.305 0.610 Ortho Vitros Microslide Systems
mmol/l 1.31 1.11 1.51 0.100 0.200
Potassium mmol/l 4.35 4.13 4.57 0.110 0.220 Ortho Vitros Microslide Systems
Protein Total g/dl 7.68 6.14 9.22 0.770 1.54 Ortho Vitros Microslide Systems
g/l 76.8 61.4 92.2 7.70 15.4
Sodium mmol/l 143 136 150 3.50 7.00 Ortho Vitros Microslide Systems
Triglycerides mg/dl 204 171 237 16.5 33.0 Ortho Vitros Microslide Systems
mmol/l 2.30 1.93 2.67 0.185 0.370

Page 14 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Ortho Clinical Diagnostics Vitros Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Urea mg/dl 26.3 22.4 30.2 1.95 3.90 Ortho Vitros Microslide Systems
mg/dl 12.2 10.4 14.0 0.900 1.80
(BUN)
mmol/l 4.37 3.71 5.03 0.330 0.660
Uric Acid (Urate) mg/dl 4.04 3.51 4.57 0.265 0.530 Ortho Vitros Microslide Systems
mmol/l 0.240 0.209 0.271 0.016 0.031

Page 15 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Randox RX series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.40 3.74 5.06 0.330 0.660 Bromocresol Green
g/l 44.0 37.4 50.6 3.30 6.60
Alkaline Phosphatase U/l 94 80 108 7.00 14.0 AMP optimised to IFCC
U/l 221 188 254 16.5 33.0 Diethanolamine buffer, DEA
ALT (GPT) U/l 91 73 109 9.00 18.0 Tris Buffer Without P5P
Amylase Pancreatic U/l 118 100 136 9.00 18.0 Randox Liquid Ethylidene pNPG7
Amylase Total U/l 148 126 170 11.0 22.0 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 109 87 131 11.0 22.0 Tris Buffer Without P5P
Bicarbonate mmol/l 21.4 17.0 25.8 2.20 4.40 Enzymatic
Bilirubin Direct mg/dl 1.12 0.885 1.36 0.120 0.240 Diazo With Sulphanilic Acid
µmol/l 19.1 15.1 23.1 2.00 4.00
mg/dl 1.14 0.901 1.38 0.120 0.240 Oxidation to Biliverdin/Vanadate
µmol/l 19.5 15.4 23.6 2.05 4.10
Bilirubin Total mg/dl 3.26 2.58 3.94 0.340 0.680 Diazo With Sulphanilic Acid
µmol/l 55.8 44.1 67.5 5.85 11.7
mg/dl 3.45 2.73 4.17 0.360 0.720 Oxidation to Biliverdin/Vanadate
µmol/l 59.0 46.6 71.4 6.20 12.4
C-Reactive Protein mg/l 19.4 15.5 23.3 1.95 3.90 Turbidimetric (IFCC Cal.)
Calcium mg/dl 8.50 7.65 9.35 0.425 0.850 Arsenazo III
mmol/l 2.12 1.91 2.33 0.105 0.210
Chloride mmol/l 96.6 88.9 104 3.70 7.40 ISE Direct
Cholesterol mg/dl 204 177 231 13.5 27.0 Cholesterol Oxidase - Abell Kendall
mmol/l 5.29 4.60 5.98 0.345 0.690
CK Total U/l 242 198 286 22.0 44.0 CK-NAC (IFCC)
U/l 240 197 283 21.5 43.0 CK-NAC substrate start (DGKC)
Creatinine mg/dl 1.59 1.27 1.91 0.160 0.320 Alkaline picrate no deproteinisation
µmol/l 141 113 169 14.0 28.0
mg/dl 1.53 1.22 1.84 0.155 0.310 Enzymatic UV method
µmol/l 135 108 162 13.5 27.0
gamma-GT U/l 71 60 82 5.50 11.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 127 108 146 9.50 19.0 Glucose Oxidase
mmol/l 7.07 6.01 8.13 0.530 1.06
mg/dl 127 108 146 9.50 19.0 Hexokinase
mmol/l 7.07 6.01 8.13 0.530 1.06
Iron µg/dl 153 125 181 14.0 28.0 Colorimetric without ppt.
µmol/l 27.4 22.5 32.3 2.45 4.90
Lactate mg/dl 13.7 11.2 16.2 1.25 2.50 Colorimetric - Lactate oxidase
mmol/l 1.52 1.25 1.79 0.135 0.270
LD (LDH) U/l 132 112 152 10.0 20.0 L to P, IFCC

Page 16 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Randox RX series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
LD (LDH) U/l 245 208 282 18.5 37.0 P to L, German methods
Lipase U/l 53 43 63 5.00 10.0 Colorimetric Randox
Magnesium mg/dl 2.48 2.18 2.78 0.150 0.300 Xylidyl Blue
mmol/l 1.02 0.898 1.14 0.060 0.120
Phosphate Inorganic mg/dl 3.63 3.09 4.17 0.270 0.540 Phosphomolybdate UV
mmol/l 1.17 0.995 1.35 0.090 0.180
Potassium mmol/l 4.20 3.86 4.54 0.170 0.340 ISE Direct
Protein Total g/dl 7.34 5.87 8.81 0.735 1.47 Biuret reaction, end point
g/l 73.4 58.7 88.1 7.35 14.7
Sodium mmol/l 138 131 145 3.50 7.00 ISE Direct
TIBC µg/dl 371 293 449 39.0 78.0 Direct Colorimetric
µmol/l 66.4 52.5 80.3 6.95 13.9
Triglycerides mg/dl 218 183 253 17.5 35.0 Lipase/GPO-PAP No Correction
mmol/l 2.46 2.07 2.85 0.195 0.390
Urea mg/dl 60.7 51.6 69.8 4.55 9.10 Urease, kinetic
mg/dl 28.3 24.1 32.5 2.10 4.20
(BUN)
mmol/l 10.1 8.59 11.6 0.750 1.50
Uric Acid (Urate) mg/dl 4.03 3.51 4.55 0.260 0.520 Uricase perox. no ascorb. ox.
mmol/l 0.240 0.209 0.271 0.016 0.031
mg/dl 3.75 3.26 4.24 0.245 0.490 Uricase Perox. with ascorb. ox @ 546nm
mmol/l 0.223 0.194 0.252 0.015 0.029

Page 17 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Roche Cobas Series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.57 3.88 5.26 0.345 0.690 Bromocresol Green
g/l 45.7 38.8 52.6 3.45 6.90
g/dl 4.58 3.89 5.27 0.345 0.690 Bromocresol Purple
g/l 45.8 38.9 52.7 3.45 6.90
Alkaline Phosphatase U/l 101 86 116 7.50 15.0 Roche AMP buffer IFCC
ALT (GPT) U/l 81 65 97 8.00 16.0 Tris Buffer Without P5P
Amylase Pancreatic U/l 104 88 120 8.00 16.0 Roche Liquid Stable pNPG7
Amylase Total U/l 137 116 158 10.5 21.0 Roche Liquid Stable pNPG7
AST (GOT) U/l 104 83 125 10.5 21.0 Tris Buffer Without P5P
Bicarbonate mmol/l 17.1 13.6 20.6 1.75 3.50 Enzymatic
Bilirubin Direct mg/dl 1.32 1.04 1.60 0.140 0.280 Dichlorophenyl Diazonium
µmol/l 22.6 17.9 27.3 2.35 4.70
Bilirubin Total mg/dl 2.74 2.16 3.32 0.290 0.580 Dichlorophenyl Diazonium
µmol/l 46.9 37.1 56.7 4.90 9.80
C-Reactive Protein mg/l 17.5 14.0 21.0 1.75 3.50 Turbidimetric (IFCC Cal.)
Calcium mg/dl 8.42 7.58 9.26 0.420 0.840 NM-BAPTA
mmol/l 2.10 1.89 2.31 0.105 0.210
Chloride mmol/l 101 92.9 109 4.00 8.00 ISE Indirect
Cholesterol mg/dl 187 163 211 12.0 24.0 Cholesterol Oxidase - Abell Kendall
mmol/l 4.84 4.21 5.47 0.315 0.630
CK Total U/l 249 204 294 22.5 45.0 CK-NAC (IFCC)
Creatinine mg/dl 1.76 1.41 2.11 0.175 0.350 Jaffe rate blanked comp. (-26umol/l)
µmol/l 155 124 186 15.5 31.0
mg/dl 1.61 1.29 1.93 0.160 0.320 Roche Creatinine Plus
µmol/l 143 114 172 14.5 29.0
gamma-GT U/l 70 60 80 5.00 10.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 128 109 147 9.50 19.0 Hexokinase
mmol/l 7.09 6.03 8.15 0.530 1.06
HDL - Cholesterol mg/dl 54.1 46.0 62.2 4.05 8.10 Direct HDL, Roche 4th gen.
mmol/l 1.40 1.19 1.61 0.105 0.210
Iron µg/dl 154 126 182 14.0 28.0 Colorimetric without ppt.
µmol/l 27.5 22.6 32.4 2.45 4.90
Lactate mg/dl 14.9 12.2 17.6 1.35 2.70 Colorimetric - Lactate oxidase
mmol/l 1.65 1.35 1.95 0.150 0.300
LD (LDH) U/l 136 116 156 10.0 20.0 L to P, IFCC
LDL Cholesterol mg/dl 106 90.1 122 8.00 16.0 Selective Detergent Methods
mmol/l 2.75 2.34 3.16 0.205 0.410
Lipase U/l 50 40 60 5.00 10.0 Colorimetric Roche

Page 18 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Roche Cobas Series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Lithium mg/dl 0.703 0.619 0.787 0.042 0.084 Spectrophotometric
mmol/l 1.01 0.889 1.13 0.060 0.120
Magnesium mg/dl 2.50 2.20 2.80 0.150 0.300 Xylidyl Blue
mmol/l 1.03 0.906 1.15 0.060 0.120
Phosphate Inorganic mg/dl 3.72 3.16 4.28 0.280 0.560 Phosphomolybdate UV
mmol/l 1.20 1.02 1.38 0.090 0.180
Potassium mmol/l 4.12 3.91 4.33 0.105 0.210 ISE Indirect
Protein Total g/dl 7.25 5.80 8.70 0.725 1.45 Biuret reaction, end point
g/l 72.5 58.0 87.0 7.25 14.5
Sodium mmol/l 135 128 142 3.50 7.00 ISE Indirect
Triglycerides mg/dl 212 178 246 17.0 34.0 Lipase/GPO-PAP No Correction
mmol/l 2.40 2.02 2.78 0.190 0.380
Urea mg/dl 62.5 53.1 71.9 4.70 9.40 Urease, kinetic
mg/dl 29.1 24.7 33.5 2.20 4.40
(BUN)
mmol/l 10.4 8.84 12.0 0.800 1.60
Uric Acid (Urate) mg/dl 4.13 3.59 4.67 0.270 0.540 Uricase Perox. with ascorb. ox @ 546nm
mmol/l 0.246 0.214 0.278 0.016 0.032

Page 19 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens ADVIA Chemistry Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Instruments
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.46 3.79 5.13 0.335 0.670 Bromocresol Green
g/l 44.6 37.9 51.3 3.35 6.70
Amylase Pancreatic U/l 106 90 122 8.00 16.0 Immunoinhibition, EPS substrate
Amylase Total U/l 141 120 162 10.5 21.0 Siemens - blocked pNPG7
AST (GOT) U/l 111 89 133 11.0 22.0 Tris Buffer With P5P
Bilirubin Direct mg/dl 1.14 0.901 1.38 0.120 0.240 Oxidation to Biliverdin/Vanadate
µmol/l 19.5 15.4 23.6 2.05 4.10
Calcium mg/dl 8.38 7.54 9.22 0.420 0.840 Arsenazo III
mmol/l 2.09 1.88 2.30 0.105 0.210
Cholesterol mg/dl 190 165 215 12.5 25.0 Cholesterol Oxidase - Abell Kendall
mmol/l 4.91 4.27 5.55 0.320 0.640
Creatinine mg/dl 1.65 1.32 1.98 0.165 0.330 Jaffe rate blanked comp. (-26umol/l)
µmol/l 146 117 175 14.5 29.0
Glucose mg/dl 121 103 139 9.00 18.0 Hexokinase
mmol/l 6.74 5.73 7.75 0.505 1.01
HDL - Cholesterol mg/dl 55.6 47.3 63.9 4.15 8.30 Direct HDL, Clearance method
mmol/l 1.44 1.22 1.66 0.110 0.220
Iron µg/dl 143 117 169 13.0 26.0 Colorimetric without ppt.
µmol/l 25.5 20.9 30.1 2.30 4.60
LDL Cholesterol mg/dl 125 106 144 9.50 19.0 Selective Detergent Methods
mmol/l 3.24 2.75 3.73 0.245 0.490
Magnesium mg/dl 2.43 2.14 2.72 0.145 0.290 Xylidyl Blue
mmol/l 1.00 0.880 1.12 0.060 0.120
Phosphate Inorganic mg/dl 3.72 3.16 4.28 0.280 0.560 Phosphomolybdate UV
mmol/l 1.20 1.02 1.38 0.090 0.180
Protein Total g/dl 7.08 5.66 8.50 0.710 1.42 Biuret reaction, end point
g/l 70.8 56.6 85.0 7.10 14.2
Triglycerides mg/dl 217 182 252 17.5 35.0 Lipase/GPO-PAP No Correction
mmol/l 2.45 2.06 2.84 0.195 0.390
Urea mg/dl 61.9 52.6 71.2 4.65 9.30 Urease, kinetic
mg/dl 28.8 24.5 33.1 2.15 4.30
(BUN)
mmol/l 10.3 8.76 11.8 0.750 1.50
Uric Acid (Urate) mg/dl 4.12 3.58 4.66 0.270 0.540 Uricase perox. no ascorb. ox.
mmol/l 0.245 0.213 0.277 0.016 0.032

Page 20 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens Atellica Solution Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.43 3.77 5.09 0.330 0.660 Bromocresol Green
g/l 44.3 37.7 50.9 3.30 6.60
Alkaline Phosphatase U/l 92 78 106 7.00 14.0 AMP optimised to IFCC
Amylase Total U/l 152 129 175 11.5 23.0 Siemens - blocked pNPG7
AST (GOT) U/l 112 90 134 11.0 22.0 Tris Buffer With P5P
Calcium mg/dl 8.46 7.61 9.31 0.425 0.850 Arsenazo III
mmol/l 2.11 1.90 2.32 0.105 0.210
mg/dl 7.98 7.18 8.78 0.400 0.800 Cresolphthalein Complexone
mmol/l 1.99 1.79 2.19 0.100 0.200
Cholesterol mg/dl 186 162 210 12.0 24.0 Cholesterol Oxidase - Abell Kendall
mmol/l 4.81 4.18 5.44 0.315 0.630
CK Total U/l 257 211 303 23.0 46.0 CK-NAC (IFCC)
Creatinine mg/dl 1.65 1.32 1.98 0.165 0.330 Jaffe rate blanked comp. (-26umol/l)
µmol/l 146 117 175 14.5 29.0
gamma-GT U/l 70 60 80 5.00 10.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 121 103 139 9.00 18.0 Glucose Oxidase
mmol/l 6.70 5.70 7.70 0.500 1.00
mg/dl 119 101 137 9.00 18.0 Hexokinase
mmol/l 6.58 5.59 7.57 0.495 0.990
Iron µg/dl 143 117 169 13.0 26.0 Colorimetric without ppt.
µmol/l 25.6 21.0 30.2 2.30 4.60
Magnesium mg/dl 2.35 2.07 2.63 0.140 0.280 Xylidyl Blue
mmol/l 0.967 0.851 1.08 0.057 0.113
Protein Total g/dl 7.14 5.71 8.57 0.715 1.43 Biuret reaction, end point
g/l 71.4 57.1 85.7 7.15 14.3
TIBC µg/dl 348 275 421 36.5 73.0 Direct Colorimetric
µmol/l 62.2 49.1 75.3 6.55 13.1
Urea mg/dl 61.9 52.6 71.2 4.65 9.30 Urease, kinetic
mg/dl 28.8 24.5 33.1 2.15 4.30
(BUN)
mmol/l 10.3 8.76 11.8 0.750 1.50
Uric Acid (Urate) mg/dl 4.07 3.54 4.60 0.265 0.530 Uricase perox. no ascorb. ox.
mmol/l 0.242 0.211 0.273 0.016 0.031

Page 21 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens Dimension Series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 4.90 4.17 5.63 0.365 0.730 Bromocresol Purple
g/l 49.0 41.7 56.3 3.65 7.30
Alkaline Phosphatase U/l 96 82 110 7.00 14.0 Siemens/Dade Dimension AMP buffer
ALT (GPT) U/l 90 72 108 9.00 18.0 Tris Buffer With P5P
Amylase Total U/l 144 122 166 11.0 22.0 Siemens/Dade Behring 2-chloro-pNPG3
AST (GOT) U/l 109 87 131 11.0 22.0 Tris Buffer With P5P
Bicarbonate mmol/l 20.4 16.2 24.6 2.10 4.20 Enzymatic
Bilirubin Direct mg/dl 0.762 0.602 0.922 0.080 0.160 Diazo/ Sulphanilic Siemens Dimension
µmol/l 13.0 10.3 15.7 1.35 2.70
Bilirubin Total mg/dl 3.25 2.57 3.93 0.340 0.680 Diazo With Sulphanilic Acid
µmol/l 55.6 43.9 67.3 5.85 11.7
Calcium mg/dl 7.94 7.15 8.73 0.395 0.790 Cresolphthalein Complexone
mmol/l 1.98 1.78 2.18 0.100 0.200
Cholesterol mg/dl 182 158 206 12.0 24.0 Siemens Dimension
mmol/l 4.73 4.12 5.34 0.305 0.610
CK Total U/l 246 202 290 22.0 44.0 CK-NAC (IFCC)
Creatinine mg/dl 1.78 1.42 2.14 0.180 0.360 Alkaline picrate no deproteinisation
µmol/l 157 126 188 15.5 31.0
mg/dl 1.52 1.22 1.82 0.150 0.300 Enzymatic UV method
µmol/l 134 107 161 13.5 27.0
gamma-GT U/l 80 68 92 6.00 12.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 131 111 151 10.0 20.0 Hexokinase
mmol/l 7.26 6.17 8.35 0.545 1.09
HDL - Cholesterol mg/dl 54.8 46.6 63.0 4.10 8.20 Direct HDL, PEGME
mmol/l 1.42 1.21 1.63 0.105 0.210
Iron µg/dl 135 111 159 12.0 24.0 Colorimetric without ppt.
µmol/l 24.1 19.8 28.4 2.15 4.30
Lactate mg/dl 12.8 10.5 15.1 1.15 2.30 UV-LDH
mmol/l 1.42 1.16 1.68 0.130 0.260
LD (LDH) U/l 129 110 148 9.50 19.0 L to P Siemens/Dade, non-IFCC
LDL Cholesterol mg/dl 129 110 148 9.50 19.0 Selective Detergent Methods
mmol/l 3.35 2.85 3.85 0.250 0.500
Lipase U/l 130 104 156 13.0 26.0 Colorimetric Dimension (LIPL Kit)
Lithium mg/dl 0.726 0.639 0.813 0.044 0.087 Spectrophotometric
mmol/l 1.05 0.924 1.18 0.065 0.130
Magnesium mg/dl 2.51 2.21 2.81 0.150 0.300 Methylthymol Blue
mmol/l 1.03 0.906 1.15 0.060 0.120

Page 22 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens Dimension Series Liquid Assayed Chemistry Control Premium Plus - Level 2 (LIQ CHEM ASY
PREMIUM PLUS 2)
Lot. No: 1682UN Cat. No: LAN4214 Expiry: 2026-02-28
Size: 12 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Phosphate Inorganic mg/dl 4.00 3.40 4.60 0.300 0.600 Phosphomolybdate UV
mmol/l 1.29 1.10 1.48 0.095 0.190
Protein Total g/dl 7.79 6.23 9.35 0.780 1.56 Biuret reaction, end point
g/l 77.9 62.3 93.5 7.80 15.6
TIBC µg/dl 340 269 411 35.5 71.0 Direct Colorimetric
µmol/l 60.8 48.0 73.6 6.40 12.8
Triglycerides mg/dl 216 181 251 17.5 35.0 Lipase/GPO-PAP No Correction
mmol/l 2.44 2.05 2.83 0.195 0.390
Urea mg/dl 62.9 53.5 72.3 4.70 9.40 Urease, kinetic
mg/dl 29.3 24.9 33.7 2.20 4.40
(BUN)
mmol/l 10.5 8.93 12.1 0.800 1.60
Uric Acid (Urate) mg/dl 4.26 3.71 4.81 0.275 0.550 Uricase perox. no ascorb. ox.
mmol/l 0.253 0.220 0.286 0.017 0.033

Page 23 of 23 2025/04/25

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated

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