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1676UN

The Human Assayed Multi-sera - Level 2 is an in vitro diagnostic product used for quality control of diagnostic assays, available in two sizes. It includes safety precautions regarding handling and storage, as well as specific stability information for various analytes. The product is lyophilized and requires careful reconstitution with distilled water before use.

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1676UN

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You are on page 1/ 81

2797

HUMAN ASSAYED MULTI-SERA - LEVEL 2

(HUM ASY CONTROL 2)
CAT. NO. HN1530 GTIN: 05055273203783 SIZE: 20 x 5ml
CAT. NO. HS2611 GTIN: 05055273203813 SIZE: 5 x 5ml
LOT NO. 1676UN EXPIRY: 2028-01-28

INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the
control of accuracy.

DEVICE DESCRIPTION
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the
values section at both 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). Reconstituted serum is stable for 8 hours at +15°C to +25°C or 7 days at +2°C to
+8°C, and 28 days when frozen once at –18°C to –24°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 (25µl - 30µl) of 0.7M Acetic acid solution to
1ml 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 –18°C to –24°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 +15°C to +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.
GLDH is stable for 2 days at +2°C to +8°C.
NEFA is stable for 1 day at +2°C to +8°C.
Total PSA is stable for 4 days at +2°C to +8°C, or 28 days in aliquots frozen 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 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 Human Assayed Multi-sera is supplied lyophilised.

1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml 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 2
HN1530 - Lot No. 1676UN 2797

MATERIALS PROVIDED
Human Assayed Multi-sera - Level 2 20 x 5ml / 5 x 5ml

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 batch of Assayed Human Serum Control is assigned at Randox Laboratories and a number of external laboratories. Values are
assigned from a consensus of results obtained by these laboratories.

With each batch, a control range is provided for individual parameters and each parameter method. The control range is equivalent to
the assigned mean ±2S.D.
If an instrument specific value is not available, refer to the Method section. If necessary, contact Randox Laboratories - Technical
Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email Technical.Services@randox.com.
NOTES
® All trademarks recognised.

(1) Applies only in Germany. Ranges established according to the Guidelines of the Federal Chamber of Physicians in Germany.
(2) Values established by reference laboratories officially recognised by the Federal Chamber of Physicians in Germany.
(3) DGKC: German Society for Clinical Chemistry.
(4) IFCC: International Federation of Clinical Chemistry.
(5) SCE: Scandinavian Committee on Enzymes.

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

04 Jun ’24 me

PAGE 2 OF 2
Table of Content
Abbott Alinity c 3
Abbott Alinity i 6
Abbott Architect c systems 7
Abbott Architect i Systems 10
Abbott Architect Systems(Archem Reagent) 11
Advanced Ins. Micro Osmometer 3300/3320 12
Advanced Instruments Osmometer 13
Arkray OM-6050/ OM-6060 14
Beckman Access Series 15
Beckman Coulter AU Series 16
Biomerieux Vidas/miniVidas/Vidas 3 19
Diestro 103 Series 20
Dirui CS-Series 21
ELITech Selectra Series 22
Hitachi Series 23
Medica Easylyte instruments 24
Method 25
Mindray BS Series 33
Osmometer - Freezing Point Dep. 35
Radiometer ABL 90 FLEX/ FLEX PLUS 36
Randox RX Series 37
Roche AVL 9100 series 39
Roche AVL OMNI S/b221 40
Roche Cobas c111 41
Roche Cobas c303/c503 43
Roche Cobas c311 46
Roche Cobas c501/c502 48
Roche Cobas c701/c702/c711 51
Roche Cobas e402/ e801 54
Roche Cobas e411 55
Roche Cobas e601/602 56
Roche Integra 57
Sensa Core ST series 60
Siemens ADVIA Chemistry Instruments 61

Page 1 of 77 05/06/2024

Page 2 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 39.5 33.6 45.4 2.95 5.90 Abbott Alinity Albumin BCG 2
g/dl 3.95 3.36 4.54 0.295 0.590
g/l 38.1 32.4 43.8 2.85 5.70 Abbott Alinity Albumin BCP 2
g/dl 3.81 3.24 4.38 0.285 0.570
g/l 39.4 33.5 45.3 2.95 5.90 Bromocresol Green
g/dl 3.94 3.35 4.53 0.295 0.590
Alkaline Phosphatase U/l 189 161 217 14.0 28.0 Abbott Alinity Alkaline Phosphatase 2
U/l 187 159 215 14.0 28.0 AMP non-optimised
U/l 188 160 216 14.0 28.0 AMP optimised to IFCC
ALT (GPT) U/l 36 29 43 3.50 7.00 Abbott Alinity ALT 2
U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Amylase, Pancreatic U/l 57 48 66 4.50 9.00 Amyloclastic Methods
U/l 57 48 66 4.50 9.00 Immunoinhibition, EPS substrate
Amylase, Total U/l 85 72 98 6.50 13.0 Abbott Alinity Amylase 2
U/l 86 73 99 6.50 13.0 Abbott Architect/Alinity cal factor 3431
AST (GOT) U/l 40 32 48 4.00 8.00 Abbott Alinity AST 2
U/l 40 32 48 4.00 8.00 Tris buffer without P5P
Bicarbonate mmol/l 12.2 9.67 14.7 1.25 2.50 Enzymatic
mmol/l 12.6 9.99 15.2 1.30 2.60 PEP Carboxylase
Bile Acids µmol/l 22.8 18.2 27.4 2.30 4.60 Enzymatic Colorimetric
Bilirubin, Direct mg/dl 1.12 0.885 1.36 0.120 0.240 Diazo with Dichloroanaline
µmol/l 19.2 15.2 23.2 2.00 4.00
mg/dl 1.13 0.893 1.37 0.120 0.240 Diazo with Sulphanilic Acid
µmol/l 19.3 15.2 23.4 2.05 4.10
Bilirubin, Total mg/dl 1.56 1.23 1.89 0.165 0.330 Abbott Alin/Arch cal batch no > 97447/8/9
µmol/l 26.7 21.1 32.3 2.80 5.60
mg/dl 1.70 1.34 2.06 0.180 0.360 Abbott Alinity Total Bilirubin 2
µmol/l 29.1 23.0 35.2 3.05 6.10
mg/dl 1.69 1.34 2.04 0.175 0.350 Diazo with Dichloroaniline
µmol/l 28.9 22.8 35.0 3.05 6.10
mg/dl 1.68 1.33 2.03 0.175 0.350 Diazo with Sulphanilic Acid
µmol/l 28.7 22.7 34.7 3.00 6.00
mg/dl 1.65 1.30 2.00 0.175 0.350 Diazonium ion
µmol/l 28.2 22.3 34.1 2.95 5.90
Calcium mmol/l 2.15 1.94 2.36 0.105 0.210 Arsenazo III
mg/dl 8.62 7.76 9.48 0.430 0.860
Chloride mmol/l 102 93.8 110 4.00 8.00 ISE, indirect
Cholesterol mmol/l 3.95 3.44 4.46 0.255 0.510 Abbott Alinity Cholesterol 2
mg/dl 152 132 172 10.0 20.0

Page 3 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Cholesterol mmol/l 3.92 3.41 4.43 0.255 0.510 Cholesterol Oxidase - Abell Kendall
mg/dl 151 131 171 10.0 20.0
Cholinesterase U/l 7108 5686 8530 711 1422 Colorimetric - Butyrylthiocholine
CK, Total U/l 208 171 245 18.5 37.0 Abbott CK-NAC (IFCC)
U/l 205 168 242 18.5 37.0 CK-NAC (IFCC)
Creatinine mg/dl 1.38 1.10 1.66 0.140 0.280 Abbott Alinity Creatinine 2
µmol/l 122 97.6 146 12.0 24.0
mg/dl 1.40 1.12 1.68 0.140 0.280 Alkaline picrate no deproteinisation
µmol/l 124 99.2 149 12.5 25.0
mg/dl 1.37 1.10 1.64 0.135 0.270 IDMS traceable
µmol/l 121 96.8 145 12.0 24.0
gamma-GT U/l 54 46 62 4.00 8.00 Abbott Alinity GGT 2
U/l 53 45 61 4.00 8.00 Gamma glut.-3-carb.-4-nitro.
U/l 52 44 60 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 5.96 5.07 6.85 0.445 0.890 Hexokinase
mg/dl 107 91.0 123 8.00 16.0
HDL-Cholesterol mmol/l 1.44 1.22 1.66 0.110 0.220 Direct HDL, Clearance method
mg/dl 55.6 47.3 63.9 4.15 8.30
mmol/l 1.39 1.18 1.60 0.105 0.210 Direct HDL, PPD
mg/dl 53.7 45.6 61.8 4.05 8.10
mmol/l 1.42 1.21 1.63 0.105 0.210 HDL Ultra/Accel Selective Detergent
mg/dl 54.8 46.6 63.0 4.10 8.20
Iron µmol/l 20.9 17.1 24.7 1.90 3.80 Abbott Alinity Iron 2
µg/dl 117 95.9 138 10.5 21.0
µmol/l 20.9 17.1 24.7 1.90 3.80 Colorimetric without ppt.
µg/dl 117 95.9 138 10.5 21.0
Lactate mmol/l 1.54 1.26 1.82 0.140 0.280 Colorimetric - Lactate oxidase
mg/dl 13.9 11.4 16.4 1.25 2.50
LD (LDH) U/l 199 169 229 15.0 30.0 Abbott Alinity LD 2
U/l 201 171 231 15.0 30.0 L to P IFCC
U/l 198 168 228 15.0 30.0 Lactate to Pyruvate methods
Lithium mmol/l 0.939 0.826 1.05 0.056 0.111 Spectrophotometric
mg/dl 0.652 0.574 0.730 0.039 0.078
Magnesium mmol/l 0.914 0.804 1.02 0.053 0.106 Arsenazo III
mg/dl 2.22 1.95 2.49 0.135 0.270
mmol/l 0.936 0.824 1.05 0.057 0.114 Enzymatic
mg/dl 2.27 2.00 2.54 0.135 0.270
Phosphate, Inorganic mmol/l 1.69 1.44 1.94 0.125 0.250 Phosphomolybdate enzymatic
mg/dl 5.24 4.45 6.03 0.395 0.790

Page 4 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Phosphate, Inorganic mmol/l 1.67 1.42 1.92 0.125 0.250 Phosphomolybdate UV
mg/dl 5.18 4.40 5.96 0.390 0.780
Potassium mmol/l 3.92 3.61 4.23 0.155 0.310 ISE method - indirect
Protein, Total g/l 57.4 45.9 68.9 5.75 11.5 Abbott Alinity Total Protein 2
g/dl 5.74 4.59 6.89 0.575 1.15
g/l 57.0 45.6 68.4 5.70 11.4 Biuret reaction, end point
g/dl 5.70 4.56 6.84 0.570 1.14
Sodium mmol/l 143 136 150 3.50 7.00 ISE method - indirect
TIBC µmol/l 41.4 32.7 50.1 4.35 8.70 FE+UIBC(saturation with iron)
µg/dl 231 182 280 24.5 49.0
Triglycerides mmol/l 1.01 0.848 1.17 0.080 0.160 Abbott Alinity i
mg/dl 89.4 75.1 104 7.30 14.6
mmol/l 1.02 0.857 1.18 0.080 0.160 Lipase/GPO-PAP no correction
mg/dl 90.3 75.9 105 7.35 14.7
Urea mmol/l 6.60 5.61 7.59 0.495 0.990 Abbott Architect Urea Nitrogen 2
mg/dl 39.7 33.7 45.7 3.00 6.00
mg/dl 18.5 15.7 21.3 1.40 2.80
(BUN)
mmol/l 7.08 6.02 8.14 0.530 1.06 Urease, kinetic
mg/dl 42.6 36.2 49.0 3.20 6.40
mg/dl 19.8 16.8 22.8 1.50 3.00
(BUN)
Uric Acid (Urate) mmol/l 0.338 0.294 0.382 0.022 0.044 Abbott Alinity Uric Acid 2
mg/dl 5.68 4.94 6.42 0.370 0.740
mmol/l 0.336 0.292 0.380 0.022 0.044 Uricase perox. no ascorb. ox.
mg/dl 5.64 4.91 6.37 0.365 0.730
mmol/l 0.336 0.292 0.380 0.022 0.044 Uricase Perox. with ascorb. ox
mg/dl 5.64 4.91 6.37 0.365 0.730
mmol/l 0.344 0.299 0.389 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.78 5.03 6.53 0.375 0.750

Page 5 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 16.6 12.5 20.7 2.05 4.10 Abbott Architect/Alinity
pg/ml 12.9 9.68 16.1 1.60 3.20
ng/dl 1.29 0.968 1.61 0.160 0.320
Thyroid Stimulating µU/ml 1.14 0.912 1.37 0.115 0.230 Abbott Architect/ Alinity
Hormone (TSH)
Total T3 nmol/l 1.94 1.46 2.42 0.240 0.480 Abbott Architect/ Alinity
ng/ml 1.26 0.945 1.58 0.160 0.320
ng/dl 126 94.5 158 16.0 32.0
Total T4 nmol/l 91.1 68.3 114 11.5 22.9 Abbott Architect/ Alinity
ng/ml 71.1 53.3 88.9 8.90 17.8
µg/dl 7.11 5.33 8.89 0.890 1.78

Page 6 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 38.4 32.6 44.2 2.90 5.80 Abbott Alinity Albumin BCP 2
g/dl 3.84 3.26 4.42 0.290 0.580
g/l 39.3 33.4 45.2 2.95 5.90 Abbott Architect Albumin BCG 2
g/dl 3.93 3.34 4.52 0.295 0.590
g/l 38.9 33.1 44.7 2.90 5.80 Abbott Architect Albumin BCP 2
g/dl 3.89 3.31 4.47 0.290 0.580
g/l 39.2 33.3 45.1 2.95 5.90 Bromocresol Green
g/dl 3.92 3.33 4.51 0.295 0.590
Alkaline Phosphatase U/l 190 162 218 14.0 28.0 Abbott Architect Alkaline Phosphatase 2
U/l 185 157 213 14.0 28.0 AMP non-optimised
U/l 185 157 213 14.0 28.0 AMP optimised to IFCC
ALT (GPT) U/l 35 28 42 3.50 7.00 Abbott Architect ALT 2
U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Amylase, Pancreatic U/l 58 49 67 4.50 9.00 Immunoinhibition, EPS substrate
Amylase, Total U/l 87 74 100 6.50 13.0 Abbott Architect Amylase 2
U/l 87 74 100 6.50 13.0 Abbott Architect/Alinity cal factor 3431
AST (GOT) U/l 39 31 47 4.00 8.00 Abbott Architect AST 2
U/l 37 30 44 3.50 7.00 Tris buffer without P5P
Bicarbonate mmol/l 11.6 9.20 14.0 1.20 2.40 Enzymatic
mmol/l 11.5 9.12 13.9 1.20 2.40 PEP Carboxylase
Bile Acids µmol/l 23.8 19.0 28.6 2.40 4.80 Enzymatic Colorimetric
Bilirubin, Direct mg/dl 1.13 0.893 1.37 0.120 0.240 Diazo with Dichloroanaline
µmol/l 19.3 15.2 23.4 2.05 4.10
mg/dl 1.09 0.861 1.32 0.115 0.230 Diazo with Sulphanilic Acid
µmol/l 18.7 14.8 22.6 1.95 3.90
Bilirubin, Total mg/dl 1.68 1.33 2.03 0.175 0.350 Abbott Alin/Arch cal batch no > 97447/8/9
µmol/l 28.7 22.7 34.7 3.00 6.00
mg/dl 1.75 1.38 2.12 0.185 0.370 Diazo with Dichloroaniline
µmol/l 29.9 23.6 36.2 3.15 6.30
mg/dl 1.73 1.37 2.09 0.180 0.360 Diazo with Sulphanilic Acid
µmol/l 29.5 23.3 35.7 3.10 6.20
mg/dl 1.74 1.37 2.11 0.185 0.370 Diazonium ion
µmol/l 29.7 23.5 35.9 3.10 6.20
Calcium mmol/l 2.13 1.92 2.34 0.105 0.210 Arsenazo III
mg/dl 8.54 7.69 9.39 0.425 0.850
Chloride mmol/l 101 92.9 109 4.00 8.00 ISE, indirect
Cholesterol mmol/l 3.97 3.45 4.49 0.260 0.520 Abbott Architect Cholesterol 2
mg/dl 153 133 173 10.0 20.0

Page 7 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Cholesterol mmol/l 3.99 3.47 4.51 0.260 0.520 Cholesterol Oxidase - Abell Kendall
mg/dl 154 134 174 10.0 20.0
Cholinesterase U/l 7044 5635 8453 705 1409 Colorimetric - Butyrylthiocholine
CK, Total U/l 204 167 241 18.5 37.0 Abbott CK-NAC (IFCC)
U/l 202 166 238 18.0 36.0 CK-NAC (IFCC)
Creatinine mg/dl 1.39 1.11 1.67 0.140 0.280 Abbott Architect Creatinine 2
µmol/l 123 98.4 148 12.5 25.0
mg/dl 1.33 1.06 1.60 0.135 0.270 Alkaline picrate no deproteinisation
µmol/l 118 94.4 142 12.0 24.0
gamma-GT U/l 53 45 61 4.00 8.00 Abbott Architect GGT 2
U/l 53 45 61 4.00 8.00 Gamma glut.-3-carb.-4-nitro.
U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.00 5.10 6.90 0.450 0.900 Hexokinase
mg/dl 108 91.8 124 8.00 16.0
HDL-Cholesterol mmol/l 1.45 1.23 1.67 0.110 0.220 Direct HDL, PPD
mg/dl 56.0 47.6 64.4 4.20 8.40
mmol/l 1.42 1.21 1.63 0.105 0.210 HDL Ultra/Accel Selective Detergent
mg/dl 54.8 46.6 63.0 4.10 8.20
Iron µmol/l 21.5 17.6 25.4 1.95 3.90 Abbott Architect Chemilum
µg/dl 120 98.4 142 11.0 22.0
µmol/l 21.2 17.4 25.0 1.90 3.80 Colorimetric without ppt.
µg/dl 119 97.6 140 10.5 21.0
Lactate mmol/l 1.57 1.29 1.85 0.140 0.280 Colorimetric - Lactate oxidase
mg/dl 14.1 11.6 16.6 1.25 2.50
LD (LDH) U/l 199 169 229 15.0 30.0 Abbott Architect LD 2
U/l 201 171 231 15.0 30.0 L to P IFCC
U/l 201 171 231 15.0 30.0 Lactate to Pyruvate methods
Lipase U/l 37 30 44 3.50 7.00 Other Colorimetric
Lithium mmol/l 0.972 0.855 1.09 0.059 0.118 Spectrophotometric
mg/dl 0.675 0.594 0.756 0.041 0.081
Magnesium mmol/l 0.921 0.810 1.03 0.055 0.109 Arsenazo III
mg/dl 2.24 1.97 2.51 0.135 0.270
mmol/l 0.936 0.824 1.05 0.057 0.114 Enzymatic
mg/dl 2.27 2.00 2.54 0.135 0.270
Osmolality mOsm/ 306 245 367 30.5 61.0 Calculated
kg
Phosphate, Inorganic mmol/l 1.70 1.45 1.95 0.125 0.250 Phosphomolybdate enzymatic
mg/dl 5.27 4.48 6.06 0.395 0.790

Page 8 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Phosphate, Inorganic mmol/l 1.68 1.43 1.93 0.125 0.250 Phosphomolybdate UV
mg/dl 5.21 4.43 5.99 0.390 0.780
Potassium mmol/l 3.92 3.61 4.23 0.155 0.310 ISE method - indirect
Protein, Total g/l 58.1 46.5 69.7 5.80 11.6 Abbott Architect total Protein 2
g/dl 5.81 4.65 6.97 0.580 1.16
g/l 58.0 46.4 69.6 5.80 11.6 Biuret reaction, end point
g/dl 5.80 4.64 6.96 0.580 1.16
Sodium mmol/l 143 136 150 3.50 7.00 ISE method - indirect
TIBC µmol/l 47.7 37.7 57.7 5.00 10.0 Calculated from Transferrin
µg/dl 267 211 323 28.0 56.0
µmol/l 43.0 34.0 52.0 4.50 9.00 FE+UIBC(saturation with iron)
µg/dl 240 190 290 25.0 50.0
Triglycerides mmol/l 1.03 0.865 1.20 0.085 0.170 Abbott Architect Triglyceride 2
mg/dl 91.2 76.6 106 7.40 14.8
mmol/l 0.999 0.839 1.16 0.081 0.161 Lipase/GK UV. no correction
mg/dl 88.4 74.3 103 7.30 14.6
mmol/l 1.04 0.874 1.21 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 92.0 77.3 107 7.50 15.0
Urea mmol/l 7.80 6.63 8.97 0.585 1.17 Abbott Architect Urea Nitrogen 2
mg/dl 46.9 39.9 53.9 3.50 7.00
mg/dl 21.8 18.5 25.1 1.65 3.30
(BUN)
mmol/l 7.54 6.41 8.67 0.565 1.13 Urease, kinetic
mg/dl 45.3 38.5 52.1 3.40 6.80
mg/dl 21.1 17.9 24.3 1.60 3.20
(BUN)
Uric Acid (Urate) mmol/l 0.341 0.297 0.385 0.022 0.044 Abbott Architect Uric Acid 2
mg/dl 5.73 4.99 6.47 0.370 0.740
mmol/l 0.343 0.298 0.388 0.023 0.045 Uricase perox. no ascorb. ox.
mg/dl 5.76 5.01 6.51 0.375 0.750
mmol/l 0.341 0.297 0.385 0.022 0.044 Uricase Perox. with ascorb. ox
mg/dl 5.73 4.99 6.47 0.370 0.740

Page 9 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 16.6 12.5 20.7 2.05 4.10 Abbott Architect/Alinity
pg/ml 12.9 9.68 16.1 1.60 3.20
ng/dl 1.29 0.968 1.61 0.160 0.320
PSA, Total ng/ml 9.43 7.07 11.8 1.19 2.37 Abbott Architect/ Alinity
Thyroid Stimulating µU/ml 1.20 0.960 1.44 0.120 0.240 Abbott Architect/ Alinity
Hormone (TSH)
Total T3 nmol/l 1.94 1.46 2.42 0.240 0.480 Abbott Architect/ Alinity
ng/ml 1.26 0.945 1.58 0.160 0.320
ng/dl 126 94.5 158 16.0 32.0
Total T4 nmol/l 89.7 67.3 112 11.2 22.3 Abbott Architect/ Alinity
ng/ml 70.0 52.5 87.5 8.75 17.5
µg/dl 7.00 5.25 8.75 0.875 1.75

Page 10 of 77 05/06/2024

Page 11 of 77 05/06/2024

Page 12 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Osmolality mOsm/ 314 251 377 31.5 63.0 Freezing point depression
kg

Page 13 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Osmolality mOsm/ 313 250 376 31.5 63.0 Freezing point depression
kg

Page 14 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 18.8 14.1 23.5 2.35 4.70 Beckman Access/LXi725
pg/ml 14.7 11.0 18.4 1.85 3.70
ng/dl 1.47 1.10 1.84 0.185 0.370
Thyroid Stimulating µU/ml 1.40 1.12 1.68 0.140 0.280 Beckman DXI600/800/ Access 2 (3rd IS)
Hormone (TSH)

Page 15 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 38.6 32.8 44.4 2.90 5.80 Bromocresol Green
g/dl 3.86 3.28 4.44 0.290 0.580
Alkaline Phosphatase U/l 203 173 233 15.0 30.0 AMP optimised to IFCC
U/l 198 168 228 15.0 30.0 Beckman AMP (Calibrator)
U/l 193 164 222 14.5 29.0 Beckman AMP (Extinction Coeff)
U/l 286 243 329 21.5 43.0 Diethanolamine buffer, DEA
ALT (GPT) U/l 36 29 43 3.50 7.00 Beckman (Extinction Coefficient)
U/l 39 31 47 4.00 8.00 Beckman Mod. IFCC Ref. without P5P
Amylase, Total U/l 73 62 84 5.50 11.0 Beckman CNPG3 (Extinction Coeff)
U/l 80 68 92 6.00 12.0 Beckman CNPG3 (Master Cal)
U/l 89 76 102 6.50 13.0 Beckman Coulter - blocked pNPG7
U/l 79 67 91 6.00 12.0 Beckman maltotetraose
AST (GOT) U/l 36 29 43 3.50 7.00 Beckman (Extinction Coefficient)
U/l 38 30 46 4.00 8.00 Beckman Mod. IFCC Ref. without P5P
Bicarbonate mmol/l 13.8 10.9 16.7 1.45 2.90 PEP Carboxylase
Bile Acids µmol/l 24.0 19.2 28.8 2.40 4.80 Enzymatic Colorimetric
µmol/l 24.0 19.2 28.8 2.40 4.80 Enzymatic Colorimetric - Sentinel
Bilirubin, Direct mg/dl 1.15 0.909 1.39 0.120 0.240 Dichlorophenyl Diazonium
µmol/l 19.7 15.6 23.8 2.05 4.10
Bilirubin, Total mg/dl 1.87 1.48 2.26 0.195 0.390 DPD (Beckman AU)
µmol/l 31.9 25.2 38.6 3.35 6.70
Calcium mmol/l 2.19 1.97 2.41 0.110 0.220 Arsenazo III
mg/dl 8.78 7.90 9.66 0.440 0.880
Chloride mmol/l 98.2 90.3 106 3.90 7.80 ISE, indirect
Cholesterol mmol/l 3.80 3.31 4.29 0.245 0.490 Cholesterol Dehydrogenase
mg/dl 147 128 166 9.50 19.0
mmol/l 3.92 3.41 4.43 0.255 0.510 Cholesterol Oxidase - Abell Kendall
mg/dl 151 131 171 10.0 20.0
mmol/l 4.08 3.55 4.61 0.265 0.530 Cholesterol Oxidase - IDMS
mg/dl 157 137 177 10.0 20.0
CK, Total U/l 204 167 241 18.5 37.0 Beckman CK-NAC (Extinction Coeff)
U/l 215 176 254 19.5 39.0 Beckman CK-NAC (IFCC)
U/l 215 176 254 19.5 39.0 CK-NAC (IFCC)
Creatinine mg/dl 1.34 1.07 1.61 0.135 0.270 Alkaline picrate no deproteinisation
µmol/l 119 95.2 143 12.0 24.0
mg/dl 1.33 1.06 1.60 0.135 0.270 IDMS traceable
µmol/l 118 94.4 142 12.0 24.0
mg/dl 1.42 1.14 1.70 0.140 0.280 Jaffe rate blanked
µmol/l 126 101 151 12.5 25.0

Page 16 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Creatinine mg/dl 1.34 1.07 1.61 0.135 0.270 Jaffe rate comp. (-18umol/l)
µmol/l 119 95.2 143 12.0 24.0
D-3-Hydroxybutyrate mmol/l 0.301 0.256 0.346 0.023 0.045 Tris buffer 100mmol pH 8.5
gamma-GT U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
GLDH U/l 16 13 19 1.50 3.00 Triethanolamine buffer
Glucose mmol/l 5.85 4.97 6.73 0.440 0.880 Glucose oxidase
mg/dl 105 89.3 121 8.00 16.0
mmol/l 5.99 5.09 6.89 0.450 0.900 Hexokinase
mg/dl 108 91.8 124 8.00 16.0
HDL-Cholesterol mmol/l 1.24 1.05 1.43 0.095 0.190 Direct HDL, Immunoseparation
mg/dl 47.9 40.7 55.1 3.60 7.20
mmol/l 1.22 1.04 1.40 0.090 0.180 Direct HDL, PPD
mg/dl 47.1 40.0 54.2 3.55 7.10
mmol/l 1.46 1.24 1.68 0.110 0.220 HDL Ultra/Accel Selective Detergent
mg/dl 56.4 47.9 64.9 4.25 8.50
Iron µmol/l 20.6 16.9 24.3 1.85 3.70 Colorimetric with ppt.
µg/dl 115 94.3 136 10.5 21.0
µmol/l 20.2 16.6 23.8 1.80 3.60 Colorimetric without ppt.
µg/dl 113 92.7 133 10.0 20.0
Lactate mmol/l 1.47 1.21 1.73 0.130 0.260 Colorimetric - Lactate oxidase
mg/dl 13.2 10.8 15.6 1.20 2.40
LD (LDH) U/l 186 158 214 14.0 28.0 L to P Beckman (Extinction Coeff)
U/l 204 173 235 15.5 31.0 L to P IFCC
U/l 445 378 512 33.5 67.0 P to L Scandinavian & Dutch
U/l 435 370 500 32.5 65.0 Pyruvate 1.4 mM - Beckman LD-P
Lipase U/l 46 37 55 4.50 9.00 Colorimetric Randox
U/l 38 30 46 4.00 8.00 Other Colorimetric
Lithium mmol/l 0.976 0.859 1.09 0.057 0.114 Spectrophotometric
mg/dl 0.678 0.597 0.759 0.041 0.081
Magnesium mmol/l 0.943 0.830 1.06 0.059 0.117 Xylidyl Blue
mg/dl 2.29 2.02 2.56 0.135 0.270
Osmolality mOsm/ 297 238 356 29.5 59.0 Calculated
kg
Phosphate, Inorganic mmol/l 1.70 1.45 1.95 0.125 0.250 Phosphomolybdate UV
mg/dl 5.27 4.48 6.06 0.395 0.790
Potassium mmol/l 3.91 3.60 4.22 0.155 0.310 ISE method - indirect
Protein, Total g/l 56.1 44.9 67.3 5.60 11.2 Biuret reaction, end point
g/dl 5.61 4.49 6.73 0.560 1.12
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - indirect

Page 17 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
TIBC µmol/l 46.6 36.8 56.4 4.90 9.80 Direct Colorimetric
µg/dl 260 205 315 27.5 55.0
µmol/l 47.2 37.3 57.1 4.95 9.90 FE+UIBC(saturation with iron)
µg/dl 264 209 319 27.5 55.0
Triglycerides mmol/l 1.06 0.890 1.23 0.085 0.170 Lipase/GK UV. no correction
mg/dl 93.8 78.8 109 7.60 15.2
mmol/l 1.05 0.882 1.22 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 92.9 78.0 108 7.55 15.1
Urea mmol/l 7.38 6.27 8.49 0.555 1.11 Urease, end point
mg/dl 44.4 37.7 51.1 3.35 6.70
mg/dl 20.7 17.6 23.8 1.55 3.10
(BUN)
mmol/l 7.45 6.33 8.57 0.560 1.12 Urease, kinetic
mg/dl 44.8 38.1 51.5 3.35 6.70
mg/dl 20.9 17.8 24.0 1.55 3.10
(BUN)
Uric Acid (Urate) mmol/l 0.352 0.306 0.398 0.023 0.046 Uricase perox. no ascorb. ox.
mg/dl 5.91 5.14 6.68 0.385 0.770
mmol/l 0.351 0.305 0.397 0.023 0.046 Uricase Perox. with ascorb. ox
mg/dl 5.90 5.13 6.67 0.385 0.770

Page 18 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 19.2 14.4 24.0 2.40 4.80 bioMerieux, VIDAS-FT4N Kit
pg/ml 15.0 11.3 18.7 1.85 3.70
ng/dl 1.50 1.13 1.87 0.185 0.370

Page 19 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Chloride mmol/l 99.4 91.4 107 3.80 7.60 ISE, direct
Potassium mmol/l 3.87 3.56 4.18 0.155 0.310 ISE method - direct
Sodium mmol/l 139 132 146 3.50 7.00 ISE method - direct

Page 20 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Calcium mmol/l 2.15 1.94 2.36 0.105 0.210 Arsenazo III
mg/dl 8.62 7.76 9.48 0.430 0.860
Glucose mmol/l 6.10 5.19 7.01 0.455 0.910 Glucose oxidase
mg/dl 110 93.5 127 8.50 17.0
Urea mmol/l 7.65 6.50 8.80 0.575 1.15 Urease, kinetic
mg/dl 46.0 39.1 52.9 3.45 6.90
mg/dl 21.4 18.2 24.6 1.60 3.20
(BUN)

Page 21 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 41.8 35.5 48.1 3.15 6.30 Bromocresol Green
g/dl 4.18 3.55 4.81 0.315 0.630
ALT (GPT) U/l 39 31 47 4.00 8.00 Tris buffer without P5P
AST (GOT) U/l 37 30 44 3.50 7.00 Tris buffer without P5P
Calcium mmol/l 2.21 1.99 2.43 0.110 0.220 Arsenazo III
mg/dl 8.86 7.97 9.75 0.445 0.890
Glucose mmol/l 6.22 5.29 7.15 0.465 0.930 Glucose oxidase
mg/dl 112 95.2 129 8.50 17.0
Protein, Total g/l 57.0 45.6 68.4 5.70 11.4 Biuret reaction, end point
g/dl 5.70 4.56 6.84 0.570 1.14
Urea mmol/l 7.48 6.36 8.60 0.560 1.12 Urease, kinetic
mg/dl 45.0 38.3 51.7 3.35 6.70
mg/dl 21.0 17.9 24.1 1.55 3.10
(BUN)

Page 22 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Chloride mmol/l 96.1 88.4 104 3.95 7.90 ISE, indirect
Cholesterol mmol/l 3.87 3.37 4.37 0.250 0.500 Cholesterol Oxidase - Abell Kendall
mg/dl 149 130 168 9.50 19.0
Potassium mmol/l 3.97 3.65 4.29 0.160 0.320 ISE method - indirect
Sodium mmol/l 143 136 150 3.50 7.00 ISE method - indirect

Page 23 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Chloride mmol/l 101 92.9 109 4.00 8.00 ISE, direct
Potassium mmol/l 3.81 3.51 4.11 0.150 0.300 ISE method - direct
Sodium mmol/l 140 133 147 3.50 7.00 ISE method - direct

Page 24 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Acid Phos., Total U/l 13 9 17 2.00 4.00 Naphthyl phos. sub., kinetic
Albumin g/l 40.0 34.0 46.0 3.00 6.00 Bromocresol Green
g/dl 4.00 3.40 4.60 0.300 0.600
g/l 40.3 34.3 46.3 3.00 6.00 Bromocresol Purple
g/dl 4.03 3.43 4.63 0.300 0.600
g/l 39.7 33.7 45.7 3.00 6.00 Ortho Vitros MicroSlide Systems
g/dl 3.97 3.37 4.57 0.300 0.600
g/l 38.9 33.1 44.7 2.90 5.80 Turbidimetric Assays
g/dl 3.89 3.31 4.47 0.290 0.580
Alkaline Phosphatase U/l 185 157 213 14.0 28.0 AMP non-optimised
U/l 187 159 215 14.0 28.0 AMP optimised to IFCC
U/l 177 150 204 13.5 27.0 Colorimetric
U/l 264 224 304 20.0 40.0 Diethanolamine buffer, DEA
alpha-HBDH U/l 205 162 248 21.5 43.0 Oxobutyrate < 10 mmol/l
ALT (GPT) U/l 35 28 42 3.50 7.00 Colorimetric
U/l 38 30 46 4.00 8.00 Tris buffer with P5P
U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Amylase, Pancreatic U/l 58 49 67 4.50 9.00 Immunoinhibition, EPS substrate
Amylase, Total U/l 85 72 98 6.50 13.0 Abbott Alinity Amylase 2
U/l 87 74 100 6.50 13.0 Abbott Architect Amylase 2
U/l 86 73 99 6.50 13.0 Abbott Architect/Alinity cal factor 3431
U/l 80 68 92 6.00 12.0 Beckman CNPG3 (Master Cal)
U/l 89 76 102 6.50 13.0 Beckman Coulter - blocked pNPG7
U/l 85 72 98 6.50 13.0 BM/Roche Colorimetric pNPG7
U/l 66 56 76 5.00 10.0 Ortho Vitros MicroSlide Systems
U/l 85 72 98 6.50 13.0 Roche Integra 2-chloro-pNPG7
U/l 85 72 98 6.50 13.0 Roche liquid stable pNPG7
U/l 92 78 106 7.00 14.0 Siemens - blocked pNPG7
U/l 88 75 101 6.50 13.0 Siemens 2-chloro-pNPG3
Apolipoprotein A1 g/l 1.07 0.877 1.26 0.095 0.190 Immunoturbidimetric
mg/dl 107 87.7 126 9.50 19.0
Apolipoprotein B g/l 0.691 0.567 0.815 0.062 0.124 Immunoturbidimetric
mg/dl 69.1 56.7 81.5 6.20 12.4
AST (GOT) U/l 51 41 61 5.00 10.0 Ortho Vitros MicroSlide visible
U/l 47 38 56 4.50 9.00 Tris buffer with P5P
U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Bicarbonate mmol/l 13.0 10.3 15.7 1.35 2.70 Enzymatic
Bile Acids µmol/l 27.8 22.2 33.4 2.80 5.60 4th Generation Colorimetric
µmol/l 24.6 19.7 29.5 2.45 4.90 5th Generation Colorimetric

Page 25 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Bilirubin, Direct mg/dl 1.13 0.893 1.37 0.120 0.240 Diazo with Dichloroanaline
µmol/l 19.3 15.2 23.4 2.05 4.10
mg/dl 1.13 0.893 1.37 0.120 0.240 Diazo with Sulphanilic Acid
µmol/l 19.4 15.3 23.5 2.05 4.10
mg/dl 0.825 0.652 0.998 0.087 0.173 Diazo/ Sulphanilic Siemens Dimension
µmol/l 14.1 11.1 17.1 1.50 3.00
mg/dl 1.18 0.932 1.43 0.125 0.250 Dichlorophenyl Diazonium
µmol/l 20.2 16.0 24.4 2.10 4.20
mg/dl 1.12 0.885 1.36 0.120 0.240 Modified Jendrassik
µmol/l 19.1 15.1 23.1 2.00 4.00
mg/dl 1.13 0.893 1.37 0.120 0.240 Oxidation to Biliverdin/Vanadate
µmol/l 19.3 15.2 23.4 2.05 4.10
Bilirubin, Total mg/dl 1.71 1.35 2.07 0.180 0.360 Diazo with Dichloroaniline
µmol/l 29.2 23.1 35.3 3.05 6.10
mg/dl 1.75 1.38 2.12 0.185 0.370 Diazo with Sulphanilic Acid
µmol/l 29.9 23.6 36.2 3.15 6.30
mg/dl 1.64 1.30 1.98 0.170 0.340 Diazonium ion
µmol/l 28.1 22.2 34.0 2.95 5.90
mg/dl 1.63 1.29 1.97 0.170 0.340 Dichlorophenyl Diazonium
µmol/l 27.8 22.0 33.6 2.90 5.80
mg/dl 2.23 1.76 2.70 0.235 0.470 Modified Jendrassik
µmol/l 38.1 30.1 46.1 4.00 8.00
mg/dl 1.83 1.45 2.21 0.190 0.380 Ortho Vitros MicroSlide Total Bil
µmol/l 31.3 24.7 37.9 3.30 6.60
mg/dl 1.96 1.55 2.37 0.205 0.410 Oxidation to Biliverdin/Vanadate
µmol/l 33.5 26.5 40.5 3.50 7.00
Calcium mmol/l 2.16 1.94 2.38 0.110 0.220 Arsenazo III
mg/dl 8.66 7.79 9.53 0.435 0.870
mmol/l 2.12 1.91 2.33 0.105 0.210 Cresolphthalein complexone
mg/dl 8.50 7.65 9.35 0.425 0.850
mmol/l 2.17 1.95 2.39 0.110 0.220 NM-BAPTA
mg/dl 8.70 7.83 9.57 0.435 0.870
mmol/l 2.16 1.94 2.38 0.110 0.220 Ortho Vitros MicroSlide Systems
mg/dl 8.66 7.79 9.53 0.435 0.870
Chloride mmol/l 100 92.0 108 4.00 8.00 ISE, direct
mmol/l 97.9 90.1 106 4.05 8.10 ISE, indirect
mmol/l 102 93.8 110 4.00 8.00 Ortho Vitros MicroSlide Systems
Cholesterol mmol/l 3.97 3.45 4.49 0.260 0.520 Abbott Architect Cholesterol 2
mg/dl 153 133 173 10.0 20.0

Page 26 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Cholesterol mmol/l 3.97 3.45 4.49 0.260 0.520 Cholesterol Oxidase - Abell Kendall
mg/dl 153 133 173 10.0 20.0
mmol/l 3.99 3.47 4.51 0.260 0.520 Cholesterol Oxidase - IDMS
mg/dl 154 134 174 10.0 20.0
mmol/l 4.00 3.48 4.52 0.260 0.520 Ortho Vitros MicroSlide Systems
mg/dl 154 134 174 10.0 20.0
CK, Total U/l 198 162 234 18.0 36.0 CK-NAC (IFCC)
U/l 196 161 231 17.5 35.0 CK-NAC substrate start (DGKC)
U/l 195 160 230 17.5 35.0 Creatine phosphate substrate start
U/l 190 156 224 17.0 34.0 Ortho Vitros MicroSlide Systems
Copper µmol/l 18.5 14.8 22.2 1.85 3.70 Colorimetric
µg/dl 118 94.4 142 12.0 24.0
Cortisol nmol/l 467 350 584 58.5 117 Roche Cobas e402/e801
µg/dl 16.8 12.6 21.0 2.10 4.20
Creatinine mg/dl 1.39 1.11 1.67 0.140 0.280 Alkaline picrate no deproteinisation
µmol/l 123 98.4 148 12.5 25.0
mg/dl 1.34 1.07 1.61 0.135 0.270 IDMS traceable
µmol/l 119 95.2 143 12.0 24.0
mg/dl 1.41 1.13 1.69 0.140 0.280 Jaffe rate blanked
µmol/l 125 100 150 12.5 25.0
mg/dl 1.37 1.10 1.64 0.135 0.270 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 121 96.8 145 12.0 24.0
mg/dl 1.36 1.09 1.63 0.135 0.270 Jaffe rate comp. (-18umol/l)
µmol/l 120 96.0 144 12.0 24.0
mg/dl 1.33 1.06 1.60 0.135 0.270 Vitros, IDMS traceable
µmol/l 118 94.4 142 12.0 24.0
mg/dl 1.42 1.14 1.70 0.140 0.280 Enzymatic
µmol/l 126 101 151 12.5 25.0
D-3-Hydroxybutyrate mmol/l 0.299 0.254 0.344 0.023 0.045 Tris buffer 100mmol pH 8.5
Digoxin nmol/l 1.98 1.58 2.38 0.200 0.400 Immunoturbidimetric
ng/ml 1.55 1.24 1.86 0.155 0.310
Folate nmol/l 18.9 14.4 23.4 2.25 4.50 Roche Cobas e402/e801
ng/ml 8.33 6.33 10.3 0.985 1.97
Free T4 pmol/l 16.6 12.5 20.7 2.05 4.10 Abbott Architect/Alinity
pg/ml 12.9 9.68 16.1 1.60 3.20
ng/dl 1.29 0.968 1.61 0.160 0.320
pmol/l 21.1 15.8 26.4 2.65 5.30 Roche Cobas 4000/e411
pg/ml 16.5 12.4 20.6 2.05 4.10
ng/dl 1.65 1.24 2.06 0.205 0.410

Page 27 of 77 10/03/2025

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 21.8 16.4 27.2 2.70 5.40 Roche Cobas e402/e801
pg/ml 17.0 12.8 21.2 2.10 4.20
ng/dl 1.70 1.28 2.12 0.210 0.420
pmol/l 21.5 16.1 26.9 2.70 5.40 Roche Cobas e601/ 602
pg/ml 16.8 12.6 21.0 2.10 4.20
ng/dl 1.68 1.26 2.10 0.210 0.420
gamma-GT U/l 54 46 62 4.00 8.00 Abbott Alinity GGT 2
U/l 54 46 62 4.00 8.00 Abbott Architect GGT 2
U/l 50 43 57 3.50 7.00 Gamma glut.-3-carb.-4-nitro.
U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
U/l 57 48 66 4.50 9.00 Ortho Vitros MicroSlide Systems
Gentamicin µmol/l 7.11 5.69 8.53 0.710 1.42 Gravimetric
µg/ml 3.40 2.72 4.08 0.340 0.680
GLDH U/l 16 13 19 1.50 3.00 Triethanolamine buffer
Glucose mmol/l 6.16 5.24 7.08 0.460 0.920 Glucose oxidase
mg/dl 111 94.4 128 8.50 17.0
mmol/l 6.05 5.14 6.96 0.455 0.910 Hexokinase
mg/dl 109 92.7 125 8.00 16.0
mmol/l 6.04 5.13 6.95 0.455 0.910 Ortho Vitros MicroSlide Systems
mg/dl 109 92.7 125 8.00 16.0
HDL-Cholesterol mmol/l 1.24 1.05 1.43 0.095 0.190 Direct HDL, Immunoseparation
mg/dl 47.9 40.7 55.1 3.60 7.20
mmol/l 1.38 1.17 1.59 0.105 0.210 Direct HDL, PEGME
mg/dl 53.3 45.3 61.3 4.00 8.00
mmol/l 1.38 1.17 1.59 0.105 0.210 Direct HDL, PPD
mg/dl 53.3 45.3 61.3 4.00 8.00
mmol/l 1.32 1.12 1.52 0.100 0.200 Direct HDL, Roche 4th gen.
mg/dl 51.0 43.4 58.6 3.80 7.60
mmol/l 1.43 1.22 1.64 0.105 0.210 HDL Ultra/Accel Selective Detergent
mg/dl 55.2 46.9 63.5 4.15 8.30
mmol/l 1.26 1.07 1.45 0.095 0.190 Vitros dHDL, PTA/MgCl2 direct precip.
mg/dl 48.6 41.3 55.9 3.65 7.30
IgA g/l 1.92 1.44 2.40 0.240 0.480 Turbidimetric (IFCC Cal.)
mg/dl 192 144 240 24.0 48.0
IgG g/l 6.95 5.70 8.20 0.625 1.25 Turbidimetric (IFCC Cal.)
mg/dl 695 570 820 62.5 125
IgM g/l 0.663 0.530 0.796 0.067 0.133 Turbidimetric (IFCC Cal.)
mg/dl 66.3 53.0 79.6 6.65 13.3

Page 28 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Iron µmol/l 20.1 16.5 23.7 1.80 3.60 Colorimetric with ppt.
µg/dl 112 91.8 132 10.0 20.0
µmol/l 20.1 16.5 23.7 1.80 3.60 Colorimetric without ppt.
µg/dl 112 91.8 132 10.0 20.0
µmol/l 21.6 17.7 25.5 1.95 3.90 Ortho Vitros MicroSlide Systems
µg/dl 121 99.2 143 11.0 22.0
Lactate mmol/l 1.52 1.25 1.79 0.135 0.270 Colorimetric - Lactate oxidase
mg/dl 13.7 11.2 16.2 1.25 2.50
LD (LDH) U/l 211 179 243 16.0 32.0 L to P IFCC
U/l 204 173 235 15.5 31.0 Lactate to Pyruvate methods
U/l 231 196 266 17.5 35.0 Ortho Vitros IFCC Traceable
U/l 413 351 475 31.0 62.0 P to L German methods
U/l 444 377 511 33.5 67.0 P to L Scandinavian & Dutch
U/l 423 360 486 31.5 63.0 P to L SFBC / SEQC
Lipase U/l 46 37 55 4.50 9.00 Colorimetric Randox
U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)731/ID 0-100
U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)789/ID 0-052
U/l 249 200 298 24.5 49.0 Ortho Vitros MicroSlide Systems
Lithium mmol/l 0.965 0.849 1.08 0.058 0.115 Spectrophotometric
mg/dl 0.670 0.590 0.750 0.040 0.080
Magnesium mmol/l 0.912 0.803 1.02 0.054 0.108 Arsenazo III
mg/dl 2.22 1.95 2.49 0.135 0.270
mmol/l 0.956 0.841 1.07 0.057 0.114 Chlorphosphonazo III
mg/dl 2.32 2.04 2.60 0.140 0.280
mmol/l 0.937 0.825 1.05 0.057 0.113 Enzymatic
mg/dl 2.28 2.01 2.55 0.135 0.270
mmol/l 0.922 0.811 1.03 0.054 0.108 Methylthymol blue
mg/dl 2.24 1.97 2.51 0.135 0.270
mmol/l 0.951 0.837 1.07 0.060 0.119 Ortho Vitros MicroSlide Systems
mg/dl 2.31 2.03 2.59 0.140 0.280
mmol/l 0.947 0.833 1.06 0.057 0.113 Xylidyl Blue
mg/dl 2.30 2.02 2.58 0.140 0.280
NEFA mmol/l 1.21 0.968 1.45 0.120 0.240 Colorimetric
Osmolality mOsm/ 299 239 359 30.0 60.0 Calculated
kg
mOsm/ 313 250 376 31.5 63.0 Freezing point depression
kg
Paracetamol (Acetamin.) mmol/l 0.090 0.072 0.108 0.009 0.018 Gravimetric
mg/l 13.6 10.9 16.3 1.35 2.70

Page 29 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Phosphate, Inorganic mmol/l 1.75 1.49 2.01 0.130 0.260 Ortho Vitros MicroSlide Systems
mg/dl 5.43 4.62 6.24 0.405 0.810
mmol/l 1.70 1.45 1.95 0.125 0.250 Phosphomolybdate enzymatic
mg/dl 5.27 4.48 6.06 0.395 0.790
mmol/l 1.70 1.45 1.95 0.125 0.250 Phosphomolybdate UV
mg/dl 5.27 4.48 6.06 0.395 0.790
Potassium mmol/l 4.00 3.68 4.32 0.160 0.320 Enzymatic
mmol/l 3.87 3.56 4.18 0.155 0.310 ISE method - direct
mmol/l 3.94 3.62 4.26 0.160 0.320 ISE method - indirect
mmol/l 3.95 3.63 4.27 0.160 0.320 Ortho Vitros MicroSlide Systems
Protein, Total g/l 56.3 45.0 67.6 5.65 11.3 Biuret reaction, end point
g/dl 5.63 4.50 6.76 0.565 1.13
g/l 55.9 44.7 67.1 5.60 11.2 Biuret reaction, kinetic
g/dl 5.59 4.47 6.71 0.560 1.12
g/l 57.9 46.3 69.5 5.80 11.6 Ortho Vitros MicroSlide Systems
g/dl 5.79 4.63 6.95 0.580 1.16
PSA, Total ng/ml 9.66 7.25 12.1 1.22 2.44 Abbott Architect/ Alinity
ng/ml 12.9 9.68 16.1 1.60 3.20 Roche Cobas 4000/e411
ng/ml 12.3 9.23 15.4 1.55 3.10 Roche Cobas e402/e801
ng/ml 12.7 9.53 15.9 1.60 3.20 Roche Cobas e601/602
Salicylate mmol/l 0.430 0.344 0.516 0.043 0.086 Gravimetric
mg/dl 5.93 4.74 7.12 0.595 1.19
Sodium mmol/l 140 133 147 3.50 7.00 Enzymatic
mmol/l 141 134 148 3.50 7.00 ISE method - direct
mmol/l 142 135 149 3.50 7.00 ISE method - indirect
mmol/l 141 134 148 3.50 7.00 Ortho Vitros MicroSlide Systems
Theophylline µmol/l 28.3 22.6 34.0 2.85 5.70 Gravimetric
µg/ml 5.10 4.08 6.12 0.510 1.02
Thyroid Stimulating µU/ml 1.17 0.936 1.40 0.115 0.230 Abbott Architect/ Alinity
Hormone (TSH)
µU/ml 1.70 1.36 2.04 0.170 0.340 Roche Cobas 4000/e411
µU/ml 1.59 1.27 1.91 0.160 0.320 Roche Cobas e402/e801
µU/ml 1.64 1.31 1.97 0.165 0.330 Roche Cobas e601/ 602
TIBC µmol/l 46.5 36.7 56.3 4.90 9.80 Calculated from Transferrin
µg/dl 260 205 315 27.5 55.0
µmol/l 49.1 38.8 59.4 5.15 10.3 Direct Colorimetric
µg/dl 274 216 332 29.0 58.0
µmol/l 43.6 34.4 52.8 4.60 9.20 FE+UIBC(saturation with iron)
µg/dl 244 193 295 25.5 51.0

Page 30 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Tobramycin µmol/l 6.30 5.04 7.56 0.630 1.26 Gravimetric
µg/ml 2.95 2.36 3.54 0.295 0.590
Total T3 nmol/l 1.94 1.46 2.42 0.240 0.480 Abbott Architect/ Alinity
ng/ml 1.26 0.945 1.58 0.160 0.320
ng/dl 126 94.5 158 16.0 32.0
Total T4 nmol/l 90.8 68.1 114 11.6 23.2 Abbott Architect/ Alinity
ng/ml 70.8 53.1 88.5 8.85 17.7
µg/dl 7.08 5.31 8.85 0.885 1.77
Transferrin g/l 1.98 1.58 2.38 0.200 0.400 Turbidimetric (IFCC Cal.)
mg/dl 198 158 238 20.0 40.0
Triglycerides mmol/l 1.06 0.890 1.23 0.085 0.170 Lipase/GK UV. no correction
mg/dl 93.8 78.8 109 7.60 15.2
mmol/l 1.06 0.890 1.23 0.085 0.170 Lipase/Glycerol Dehydrogenase
mg/dl 93.8 78.8 109 7.60 15.2
mmol/l 1.07 0.899 1.24 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 94.7 79.5 110 7.65 15.3
mmol/l 1.07 0.899 1.24 0.085 0.170 Lipase/GPO-PAP, 0.11mmol/l correction
mg/dl 94.7 79.5 110 7.65 15.3
mmol/l 1.23 1.03 1.43 0.100 0.200 Ortho Vitros MicroSlide Systems
mg/dl 109 91.6 126 8.50 17.0
Urea mmol/l 6.84 5.81 7.87 0.515 1.03 Ortho Vitros MicroSlide Systems
mg/dl 41.1 34.9 47.3 3.10 6.20
mg/dl 19.2 16.3 22.1 1.45 2.90
(BUN)
mmol/l 7.27 6.18 8.36 0.545 1.09 Urease, end point
mg/dl 43.7 37.1 50.3 3.30 6.60
mg/dl 20.4 17.3 23.5 1.55 3.10
(BUN)
mmol/l 7.34 6.24 8.44 0.550 1.10 Urease, kinetic
mg/dl 44.1 37.5 50.7 3.30 6.60
mg/dl 20.6 17.5 23.7 1.55 3.10
(BUN)
Uric Acid (Urate) mmol/l 0.339 0.295 0.383 0.022 0.044 Ortho Vitros MicroSlide Systems
mg/dl 5.70 4.96 6.44 0.370 0.740
mmol/l 0.349 0.304 0.394 0.023 0.045 Uricase @ 293 nm
mg/dl 5.86 5.10 6.62 0.380 0.760
mmol/l 0.347 0.302 0.392 0.023 0.045 Uricase perox. no ascorb. ox.
mg/dl 5.83 5.07 6.59 0.380 0.760

Page 31 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Uric Acid (Urate) mmol/l 0.344 0.299 0.389 0.023 0.045 Uricase Perox. with ascorb. ox
mg/dl 5.78 5.03 6.53 0.375 0.750
mmol/l 0.344 0.299 0.389 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.78 5.03 6.53 0.375 0.750
Vitamin B12 pmol/l 458 366 550 46.0 92.0 Roche Cobas e402/e801
pg/ml 621 497 745 62.0 124
Zinc µmol/l 28.5 22.8 34.2 2.85 5.70 Colorimetric with deprot.
µg/dl 186 149 223 18.5 37.0

Page 32 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 39.4 33.5 45.3 2.95 5.90 Bromocresol Green
g/dl 3.94 3.35 4.53 0.295 0.590
Alkaline Phosphatase U/l 190 162 218 14.0 28.0 AMP optimised to IFCC
ALT (GPT) U/l 39 31 47 4.00 8.00 Tris buffer without P5P
Amylase, Total U/l 86 73 99 6.50 13.0 pNP Maltotrioside substrates
AST (GOT) U/l 37 30 44 3.50 7.00 Tris buffer without P5P
Bilirubin, Direct mg/dl 1.13 0.893 1.37 0.120 0.240 Dichlorophenyl Diazonium
µmol/l 19.3 15.2 23.4 2.05 4.10
Bilirubin, Total mg/dl 1.85 1.46 2.24 0.195 0.390 Diazo with Sulphanilic Acid
µmol/l 31.7 25.0 38.4 3.35 6.70
mg/dl 1.73 1.37 2.09 0.180 0.360 Dichlorophenyl Diazonium
µmol/l 29.5 23.3 35.7 3.10 6.20
Calcium mmol/l 2.18 1.96 2.40 0.110 0.220 Arsenazo III
mg/dl 8.74 7.87 9.61 0.435 0.870
Cholesterol mmol/l 4.00 3.48 4.52 0.260 0.520 Cholesterol Oxidase - Abell Kendall
mg/dl 154 134 174 10.0 20.0
CK, Total U/l 212 174 250 19.0 38.0 CK-NAC (IFCC)
Creatinine mg/dl 1.39 1.11 1.67 0.140 0.280 Alkaline picrate no deproteinisation
µmol/l 123 98.4 148 12.5 25.0
gamma-GT U/l 54 46 62 4.00 8.00 Gamma glut.-3-carb.-4-nitro.
Glucose mmol/l 6.27 5.33 7.21 0.470 0.940 Glucose oxidase
mg/dl 113 96.1 130 8.50 17.0
HDL-Cholesterol mmol/l 1.23 1.05 1.41 0.090 0.180 Direct HDL, Clearance method
mg/dl 47.5 40.4 54.6 3.55 7.10
LD (LDH) U/l 208 177 239 15.5 31.0 L to P IFCC
U/l 427 363 491 32.0 64.0 P to L German methods
U/l 427 363 491 32.0 64.0 P to L SFBC / SEQC
Magnesium mmol/l 0.981 0.863 1.10 0.060 0.119 Xylidyl Blue
mg/dl 2.38 2.09 2.67 0.145 0.290
Phosphate, Inorganic mmol/l 1.61 1.37 1.85 0.120 0.240 Phosphomolybdate UV
mg/dl 4.99 4.24 5.74 0.375 0.750
Protein, Total g/l 56.6 45.3 67.9 5.65 11.3 Biuret reaction, end point
g/dl 5.66 4.53 6.79 0.565 1.13
Triglycerides mmol/l 1.04 0.874 1.21 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 92.0 77.3 107 7.50 15.0

Page 33 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Urea mmol/l 7.59 6.45 8.73 0.570 1.14 Urease, kinetic
mg/dl 45.6 38.8 52.4 3.40 6.80
mg/dl 21.3 18.1 24.5 1.60 3.20
(BUN)
Uric Acid (Urate) mmol/l 0.350 0.305 0.395 0.023 0.045 Uricase perox. no ascorb. ox.
mg/dl 5.88 5.12 6.64 0.380 0.760
mmol/l 0.344 0.299 0.389 0.023 0.045 Uricase Perox. with ascorb. ox
mg/dl 5.78 5.03 6.53 0.375 0.750
mmol/l 0.352 0.306 0.398 0.023 0.046 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.91 5.14 6.68 0.385 0.770

Page 34 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Osmolality mOsm/ 313 250 376 31.5 63.0 Freezing point depression
kg

Page 35 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Lactate mmol/l 1.43 1.17 1.69 0.130 0.260 Enzymatic Electrode
mg/dl 12.9 10.6 15.2 1.15 2.30

Page 36 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 38.9 33.1 44.7 2.90 5.80 Bromocresol Green
g/dl 3.89 3.31 4.47 0.290 0.580
Alkaline Phosphatase U/l 197 167 227 15.0 30.0 AMP optimised to IFCC
U/l 314 267 361 23.5 47.0 Diethanolamine buffer, DEA
ALT (GPT) U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Amylase, Pancreatic U/l 65 55 75 5.00 10.0 Randox liquid stable pNPG7
Amylase, Total U/l 99 84 114 7.50 15.0 Randox Liquid Ethylidene pNPG7
AST (GOT) U/l 36 29 43 3.50 7.00 Tris buffer without P5P
Bicarbonate mmol/l 11.8 9.36 14.2 1.20 2.40 Enzymatic
Bile Acids µmol/l 24.6 19.7 29.5 2.45 4.90 5th Generation Colorimetric
Bilirubin, Direct mg/dl 1.24 0.980 1.50 0.130 0.260 Diazo with Sulphanilic Acid
µmol/l 21.2 16.7 25.7 2.25 4.50
mg/dl 1.02 0.806 1.23 0.105 0.210 Oxidation to Biliverdin/Vanadate
µmol/l 17.5 13.8 21.2 1.85 3.70
Bilirubin, Total mg/dl 1.94 1.53 2.35 0.205 0.410 Diazo with Sulphanilic Acid
µmol/l 33.2 26.2 40.2 3.50 7.00
mg/dl 1.84 1.45 2.23 0.195 0.390 Oxidation to Biliverdin/Vanadate
µmol/l 31.4 24.8 38.0 3.30 6.60
Calcium mmol/l 2.23 2.01 2.45 0.110 0.220 Arsenazo III
mg/dl 8.94 8.05 9.83 0.445 0.890
Chloride mmol/l 95.9 88.2 104 4.05 8.10 ISE, direct
Cholesterol mmol/l 4.30 3.74 4.86 0.280 0.560 Cholesterol Oxidase - Abell Kendall
mg/dl 166 144 188 11.0 22.0
CK, Total U/l 213 175 251 19.0 38.0 CK-NAC (IFCC)
U/l 205 168 242 18.5 37.0 CK-NAC substrate start (DGKC)
Creatinine mg/dl 1.36 1.09 1.63 0.135 0.270 Alkaline picrate no deproteinisation
µmol/l 120 96.0 144 12.0 24.0
mg/dl 1.47 1.18 1.76 0.145 0.290 Enzymatic UV method
µmol/l 130 104 156 13.0 26.0
gamma-GT U/l 57 48 66 4.50 9.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.12 5.20 7.04 0.460 0.920 Glucose oxidase
mg/dl 110 93.5 127 8.50 17.0
mmol/l 6.34 5.39 7.29 0.475 0.950 Hexokinase
mg/dl 114 96.9 131 8.50 17.0
Iron µmol/l 21.6 17.7 25.5 1.95 3.90 Colorimetric without ppt.
µg/dl 121 99.2 143 11.0 22.0
Lactate mmol/l 1.55 1.27 1.83 0.140 0.280 Colorimetric - Lactate oxidase
mg/dl 14.0 11.5 16.5 1.25 2.50
LD (LDH) U/l 214 182 246 16.0 32.0 L to P IFCC

Page 37 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
LD (LDH) U/l 405 344 466 30.5 61.0 P to L German methods
Lipase U/l 47 38 56 4.50 9.00 Colorimetric Randox
Magnesium mmol/l 0.947 0.833 1.06 0.057 0.113 Xylidyl Blue
mg/dl 2.30 2.02 2.58 0.140 0.280
Phosphate, Inorganic mmol/l 1.66 1.41 1.91 0.125 0.250 Phosphomolybdate UV
mg/dl 5.15 4.38 5.92 0.385 0.770
Potassium mmol/l 4.00 3.68 4.32 0.160 0.320 Enzymatic
mmol/l 4.04 3.72 4.36 0.160 0.320 ISE method - direct
Protein, Total g/l 57.2 45.8 68.6 5.70 11.4 Biuret reaction, end point
g/dl 5.72 4.58 6.86 0.570 1.14
Sodium mmol/l 140 133 147 3.50 7.00 Enzymatic
mmol/l 141 134 148 3.50 7.00 ISE method - direct
Triglycerides mmol/l 1.09 0.916 1.26 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 96.5 81.1 112 7.75 15.5
Urea mmol/l 7.28 6.19 8.37 0.545 1.09 Urease, kinetic
mg/dl 43.8 37.2 50.4 3.30 6.60
mg/dl 20.4 17.3 23.5 1.55 3.10
(BUN)
Uric Acid (Urate) mmol/l 0.353 0.307 0.399 0.023 0.046 Uricase perox. no ascorb. ox.
mg/dl 5.93 5.16 6.70 0.385 0.770
mmol/l 0.345 0.300 0.390 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.80 5.05 6.55 0.375 0.750

Page 38 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Chloride mmol/l 99.9 91.9 108 4.05 8.10 ISE, direct
Potassium mmol/l 3.95 3.63 4.27 0.160 0.320 ISE method - direct
Sodium mmol/l 141 134 148 3.50 7.00 ISE method - direct

Page 39 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Chloride mmol/l 98.2 90.3 106 3.90 7.80 ISE, direct
Potassium mmol/l 3.82 3.51 4.13 0.155 0.310 ISE method - direct
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - direct

Page 40 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 41.0 34.9 47.1 3.05 6.10 Bromocresol Green
g/dl 4.10 3.49 4.71 0.305 0.610
Alkaline Phosphatase U/l 169 144 194 12.5 25.0 Roche AMP buffer IFCC
ALT (GPT) U/l 33 26 40 3.50 7.00 Tris buffer without P5P
Amylase, Total U/l 84 71 97 6.50 13.0 Roche liquid stable pNPG7
AST (GOT) U/l 33 26 40 3.50 7.00 Tris buffer without P5P
Bilirubin, Direct mg/dl 1.22 0.964 1.48 0.130 0.260 Dichlorophenyl Diazonium
µmol/l 20.8 16.4 25.2 2.20 4.40
mg/dl 1.16 0.916 1.40 0.120 0.240 Roche DPD JG standardised
µmol/l 19.9 15.7 24.1 2.10 4.20
Bilirubin, Total mg/dl 1.67 1.32 2.02 0.175 0.350 Dichlorophenyl Diazonium
µmol/l 28.6 22.6 34.6 3.00 6.00
Calcium mmol/l 2.13 1.92 2.34 0.105 0.210 NM-BAPTA
mg/dl 8.54 7.69 9.39 0.425 0.850
Cholesterol mmol/l 3.87 3.37 4.37 0.250 0.500 Cholesterol Oxidase - Abell Kendall
mg/dl 149 130 168 9.50 19.0
mmol/l 3.94 3.43 4.45 0.255 0.510 Cholesterol Oxidase - IDMS
mg/dl 152 132 172 10.0 20.0
CK, Total U/l 193 158 228 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.42 1.14 1.70 0.140 0.280 Roche Creatinine Plus
µmol/l 126 101 151 12.5 25.0
gamma-GT U/l 48 41 55 3.50 7.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.16 5.24 7.08 0.460 0.920 Hexokinase
mg/dl 111 94.4 128 8.50 17.0
HDL-Cholesterol mmol/l 1.32 1.12 1.52 0.100 0.200 Direct HDL, Roche 4th gen.
mg/dl 51.0 43.4 58.6 3.80 7.60
LD (LDH) U/l 218 185 251 16.5 33.0 L to P IFCC
Magnesium mmol/l 0.936 0.824 1.05 0.057 0.114 Xylidyl Blue
mg/dl 2.27 2.00 2.54 0.135 0.270
Triglycerides mmol/l 1.08 0.907 1.25 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 95.6 80.3 111 7.70 15.4
Urea mmol/l 7.11 6.04 8.18 0.535 1.07 Urease, kinetic
mg/dl 42.7 36.3 49.1 3.20 6.40
mg/dl 19.9 16.9 22.9 1.50 3.00
(BUN)
Uric Acid (Urate) mmol/l 0.350 0.305 0.395 0.023 0.045 Uricase perox. no ascorb. ox.
mg/dl 5.88 5.12 6.64 0.380 0.760

Page 41 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Uric Acid (Urate) mmol/l 0.349 0.304 0.394 0.023 0.045 Uricase Perox. with ascorb. ox
mg/dl 5.86 5.10 6.62 0.380 0.760
mmol/l 0.346 0.301 0.391 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.81 5.05 6.57 0.380 0.760

Page 42 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 40.5 34.4 46.6 3.05 6.10 Bromocresol Green
g/dl 4.05 3.44 4.66 0.305 0.610
Alkaline Phosphatase U/l 159 135 183 12.0 24.0 Roche AMP buffer IFCC
ALT (GPT) U/l 38 30 46 4.00 8.00 Tris buffer without P5P
Amylase, Pancreatic U/l 58 49 67 4.50 9.00 Immunoinhibition, EPS substrate
Amylase, Total U/l 84 71 97 6.50 13.0 Roche Integra 2-chloro-pNPG7
U/l 85 72 98 6.50 13.0 Roche liquid stable pNPG7
AST (GOT) U/l 47 38 56 4.50 9.00 Tris buffer without P5P
Bicarbonate mmol/l 13.3 10.5 16.1 1.40 2.80 Enzymatic
Bile Acids µmol/l 22.5 18.0 27.0 2.25 4.50 Enzymatic Colorimetric
Bilirubin, Direct mg/dl 1.16 0.916 1.40 0.120 0.240 Diazo with Sulphanilic Acid
µmol/l 19.9 15.7 24.1 2.10 4.20
mg/dl 1.16 0.916 1.40 0.120 0.240 Dichlorophenyl Diazonium
µmol/l 19.9 15.7 24.1 2.10 4.20
mg/dl 0.959 0.758 1.16 0.101 0.201 Roche DPD Doumas standardised
µmol/l 16.4 13.0 19.8 1.70 3.40
mg/dl 1.19 0.940 1.44 0.125 0.250 Roche DPD JG standardised
µmol/l 20.4 16.1 24.7 2.15 4.30
Bilirubin, Total mg/dl 1.58 1.25 1.91 0.165 0.330 Diazo with Sulphanilic Acid
µmol/l 27.0 21.3 32.7 2.85 5.70
mg/dl 1.57 1.24 1.90 0.165 0.330 Diazonium ion
µmol/l 26.8 21.2 32.4 2.80 5.60
mg/dl 1.57 1.24 1.90 0.165 0.330 Dichlorophenyl Diazonium
µmol/l 26.8 21.2 32.4 2.80 5.60
Calcium mmol/l 2.15 1.94 2.36 0.105 0.210 Cresolphthalein complexone
mg/dl 8.62 7.76 9.48 0.430 0.860
mmol/l 2.17 1.95 2.39 0.110 0.220 NM-BAPTA
mg/dl 8.70 7.83 9.57 0.435 0.870
Chloride mmol/l 95.4 87.8 103 3.80 7.60 ISE, indirect
Cholesterol mmol/l 3.98 3.46 4.50 0.260 0.520 Cholesterol Oxidase - Abell Kendall
mg/dl 154 134 174 10.0 20.0
mmol/l 3.98 3.46 4.50 0.260 0.520 Cholesterol Oxidase - IDMS
mg/dl 154 134 174 10.0 20.0
Cholinesterase U/l 5748 4598 6898 575 1150 Colorimetric - Butyrylthiocholine
CK, Total U/l 194 159 229 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.40 1.12 1.68 0.140 0.280 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 124 99.2 149 12.5 25.0

Page 43 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Creatinine mg/dl 1.40 1.12 1.68 0.140 0.280 Jaffe rate comp. (-18umol/l)
µmol/l 124 99.2 149 12.5 25.0
mg/dl 1.48 1.18 1.78 0.150 0.300 Roche Creatinine Plus
µmol/l 131 105 157 13.0 26.0
gamma-GT U/l 51 43 59 4.00 8.00 Gamma glut.-3-carb.-4-nitro.
U/l 55 47 63 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.05 5.14 6.96 0.455 0.910 Hexokinase
mg/dl 109 92.7 125 8.00 16.0
HDL-Cholesterol mmol/l 1.33 1.13 1.53 0.100 0.200 Direct HDL, Roche 4th gen.
mg/dl 51.3 43.6 59.0 3.85 7.70
Iron µmol/l 19.9 16.3 23.5 1.80 3.60 Colorimetric with ppt.
µg/dl 111 91.0 131 10.0 20.0
µmol/l 19.7 16.2 23.2 1.75 3.50 Colorimetric without ppt.
µg/dl 110 90.2 130 10.0 20.0
Lactate mmol/l 1.52 1.25 1.79 0.135 0.270 Colorimetric - Lactate oxidase
mg/dl 13.7 11.2 16.2 1.25 2.50
LD (LDH) U/l 213 181 245 16.0 32.0 L to P IFCC
Lipase U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)731/ID 0-100
U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)789/ID 0-052
Lithium mmol/l 1.04 0.915 1.17 0.065 0.130 Spectrophotometric
mg/dl 0.722 0.635 0.809 0.044 0.087
Magnesium mmol/l 0.957 0.842 1.07 0.057 0.113 Chlorphosphonazo III
mg/dl 2.33 2.05 2.61 0.140 0.280
mmol/l 0.959 0.844 1.07 0.056 0.111 Xylidyl Blue
mg/dl 2.33 2.05 2.61 0.140 0.280
Osmolality mOsm/ 302 242 362 30.0 60.0 Calculated
kg
Phosphate, Inorganic mmol/l 1.71 1.45 1.97 0.130 0.260 Phosphomolybdate UV
mg/dl 5.30 4.51 6.09 0.395 0.790
Potassium mmol/l 3.97 3.65 4.29 0.160 0.320 ISE method - indirect
Protein, Total g/l 56.1 44.9 67.3 5.60 11.2 Biuret reaction, end point
g/dl 5.61 4.49 6.73 0.560 1.12
g/l 56.1 44.9 67.3 5.60 11.2 Biuret reaction, kinetic
g/dl 5.61 4.49 6.73 0.560 1.12
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - indirect
TIBC µmol/l 46.7 36.9 56.5 4.90 9.80 Calculated from Transferrin
µg/dl 261 206 316 27.5 55.0
µmol/l 43.1 34.0 52.2 4.55 9.10 FE+UIBC(saturation with iron)
µg/dl 241 190 292 25.5 51.0

Page 44 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Triglycerides mmol/l 1.09 0.916 1.26 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 96.5 81.1 112 7.75 15.5
Urea mmol/l 7.26 6.17 8.35 0.545 1.09 Urease, kinetic
mg/dl 43.6 37.1 50.1 3.25 6.50
mg/dl 20.3 17.3 23.3 1.50 3.00
(BUN)
Uric Acid (Urate) mmol/l 0.340 0.296 0.384 0.022 0.044 Uricase perox. no ascorb. ox.
mg/dl 5.71 4.97 6.45 0.370 0.740
mmol/l 0.341 0.297 0.385 0.022 0.044 Uricase Perox. with ascorb. ox
mg/dl 5.73 4.99 6.47 0.370 0.740
mmol/l 0.344 0.299 0.389 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.78 5.03 6.53 0.375 0.750

Page 45 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 40.8 34.7 46.9 3.05 6.10 Bromocresol Green
g/dl 4.08 3.47 4.69 0.305 0.610
Alkaline Phosphatase U/l 170 145 195 12.5 25.0 Roche AMP buffer IFCC
ALT (GPT) U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Amylase, Total U/l 86 73 99 6.50 13.0 Roche liquid stable pNPG7
AST (GOT) U/l 34 27 41 3.50 7.00 Tris buffer without P5P
Bilirubin, Direct mg/dl 1.23 0.972 1.49 0.130 0.260 Dichlorophenyl Diazonium
µmol/l 21.0 16.6 25.4 2.20 4.40
mg/dl 1.04 0.822 1.26 0.110 0.220 Roche DPD Doumas standardised
µmol/l 17.7 14.0 21.4 1.85 3.70
mg/dl 1.25 0.988 1.51 0.130 0.260 Roche DPD JG standardised
µmol/l 21.4 16.9 25.9 2.25 4.50
Bilirubin, Total mg/dl 1.61 1.27 1.95 0.170 0.340 Diazonium ion
µmol/l 27.6 21.8 33.4 2.90 5.80
mg/dl 1.64 1.30 1.98 0.170 0.340 Dichlorophenyl Diazonium
µmol/l 28.1 22.2 34.0 2.95 5.90
Calcium mmol/l 2.18 1.96 2.40 0.110 0.220 NM-BAPTA
mg/dl 8.74 7.87 9.61 0.435 0.870
Chloride mmol/l 96.0 88.3 104 4.00 8.00 ISE, indirect
Cholesterol mmol/l 4.01 3.49 4.53 0.260 0.520 Cholesterol Oxidase - Abell Kendall
mg/dl 155 135 175 10.0 20.0
mmol/l 4.05 3.52 4.58 0.265 0.530 Cholesterol Oxidase - IDMS
mg/dl 156 136 176 10.0 20.0
CK, Total U/l 200 164 236 18.0 36.0 CK-NAC (IFCC)
Creatinine mg/dl 1.39 1.11 1.67 0.140 0.280 Alkaline picrate no deproteinisation
µmol/l 123 98.4 148 12.5 25.0
mg/dl 1.36 1.09 1.63 0.135 0.270 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 120 96.0 144 12.0 24.0
mg/dl 1.49 1.19 1.79 0.150 0.300 Roche Creatinine Plus
µmol/l 132 106 158 13.0 26.0
gamma-GT U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.13 5.21 7.05 0.460 0.920 Hexokinase
mg/dl 110 93.5 127 8.50 17.0
HDL-Cholesterol mmol/l 1.32 1.12 1.52 0.100 0.200 Direct HDL, Roche 4th gen.
mg/dl 51.0 43.4 58.6 3.80 7.60
Iron µmol/l 19.8 16.2 23.4 1.80 3.60 Colorimetric without ppt.
µg/dl 111 91.0 131 10.0 20.0

Page 46 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Lactate mmol/l 1.51 1.24 1.78 0.135 0.270 Colorimetric - Lactate oxidase
mg/dl 13.6 11.2 16.0 1.20 2.40
LD (LDH) U/l 213 181 245 16.0 32.0 L to P IFCC
Lipase U/l 37 30 44 3.50 7.00 Colorimetric Roche ACN(8)731/ID 0-100
U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)789/ID 0-052
Magnesium mmol/l 0.950 0.836 1.06 0.055 0.110 Xylidyl Blue
mg/dl 2.31 2.03 2.59 0.140 0.280
Phosphate, Inorganic mmol/l 1.73 1.47 1.99 0.130 0.260 Phosphomolybdate UV
mg/dl 5.36 4.56 6.16 0.400 0.800
Potassium mmol/l 4.00 3.68 4.32 0.160 0.320 ISE method - indirect
Protein, Total g/l 56.7 45.4 68.0 5.65 11.3 Biuret reaction, end point
g/dl 5.67 4.54 6.80 0.565 1.13
Sodium mmol/l 143 136 150 3.50 7.00 ISE method - indirect
TIBC µmol/l 44.5 35.2 53.8 4.65 9.30 FE+UIBC(saturation with iron)
µg/dl 249 197 301 26.0 52.0
Triglycerides mmol/l 1.09 0.916 1.26 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 96.5 81.1 112 7.75 15.5
Urea mmol/l 7.48 6.36 8.60 0.560 1.12 Urease, kinetic
mg/dl 45.0 38.3 51.7 3.35 6.70
mg/dl 21.0 17.9 24.1 1.55 3.10
(BUN)
Uric Acid (Urate) mmol/l 0.348 0.303 0.393 0.023 0.045 Uricase perox. no ascorb. ox.
mg/dl 5.85 5.09 6.61 0.380 0.760
mmol/l 0.348 0.303 0.393 0.023 0.045 Uricase Perox. with ascorb. ox
mg/dl 5.85 5.09 6.61 0.380 0.760
mmol/l 0.350 0.305 0.395 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.88 5.12 6.64 0.380 0.760

Page 47 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 40.7 34.6 46.8 3.05 6.10 Bromocresol Green
g/dl 4.07 3.46 4.68 0.305 0.610
g/l 40.7 34.6 46.8 3.05 6.10 Bromocresol Purple
g/dl 4.07 3.46 4.68 0.305 0.610
Alkaline Phosphatase U/l 172 146 198 13.0 26.0 Roche AMP buffer IFCC
ALT (GPT) U/l 34 27 41 3.50 7.00 Tris buffer without P5P
Amylase, Pancreatic U/l 59 50 68 4.50 9.00 Roche liquid stable pNPG7
Amylase, Total U/l 84 71 97 6.50 13.0 Roche Integra 2-chloro-pNPG7
U/l 84 71 97 6.50 13.0 Roche liquid stable pNPG7
AST (GOT) U/l 34 27 41 3.50 7.00 Tris buffer without P5P
Bicarbonate mmol/l 13.0 10.3 15.7 1.35 2.70 Enzymatic
mmol/l 13.1 10.4 15.8 1.35 2.70 PEP Carboxylase
Bile Acids µmol/l 23.6 18.9 28.3 2.35 4.70 Enzymatic Colorimetric
Bilirubin, Direct mg/dl 1.21 0.956 1.46 0.125 0.250 Diazo with Sulphanilic Acid
µmol/l 20.6 16.3 24.9 2.15 4.30
mg/dl 1.18 0.932 1.43 0.125 0.250 Dichlorophenyl Diazonium
µmol/l 20.2 16.0 24.4 2.10 4.20
mg/dl 0.936 0.739 1.13 0.097 0.194 Roche (US calibrator only)
µmol/l 16.0 12.6 19.4 1.70 3.40
mg/dl 1.19 0.940 1.44 0.125 0.250 Roche DPD JG standardised
µmol/l 20.3 16.0 24.6 2.15 4.30
Bilirubin, Total mg/dl 1.65 1.30 2.00 0.175 0.350 Diazo with Sulphanilic Acid
µmol/l 28.2 22.3 34.1 2.95 5.90
mg/dl 1.61 1.27 1.95 0.170 0.340 Diazonium ion
µmol/l 27.5 21.7 33.3 2.90 5.80
mg/dl 1.63 1.29 1.97 0.170 0.340 Dichlorophenyl Diazonium
µmol/l 27.8 22.0 33.6 2.90 5.80
Calcium mmol/l 2.16 1.94 2.38 0.110 0.220 Cresolphthalein complexone
mg/dl 8.66 7.79 9.53 0.435 0.870
mmol/l 2.17 1.95 2.39 0.110 0.220 NM-BAPTA
mg/dl 8.70 7.83 9.57 0.435 0.870
Chloride mmol/l 95.1 87.5 103 3.95 7.90 ISE, indirect
Cholesterol mmol/l 3.96 3.45 4.47 0.255 0.510 Cholesterol Oxidase - Abell Kendall
mg/dl 153 133 173 10.0 20.0
mmol/l 3.97 3.45 4.49 0.260 0.520 Cholesterol Oxidase - IDMS
mg/dl 153 133 173 10.0 20.0
Cholinesterase U/l 5676 4541 6811 568 1135 Colorimetric - Butyrylthiocholine
CK, Total U/l 197 162 232 17.5 35.0 CK-NAC (IFCC)

Page 48 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
CK, Total U/l 194 159 229 17.5 35.0 CK-NAC substrate start (DGKC)
U/l 199 163 235 18.0 36.0 Creatine phosphate substrate start
Creatinine mg/dl 1.42 1.14 1.70 0.140 0.280 Alkaline picrate no deproteinisation
µmol/l 126 101 151 12.5 25.0
mg/dl 1.37 1.10 1.64 0.135 0.270 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 121 96.8 145 12.0 24.0
mg/dl 1.38 1.10 1.66 0.140 0.280 Jaffe rate comp. (-18umol/l)
µmol/l 122 97.6 146 12.0 24.0
mg/dl 1.48 1.18 1.78 0.150 0.300 Roche Creatinine Plus
µmol/l 131 105 157 13.0 26.0
D-3-Hydroxybutyrate mmol/l 0.300 0.255 0.345 0.023 0.045 Tris buffer 100mmol pH 8.5
gamma-GT U/l 48 41 55 3.50 7.00 Gamma glut.-3-carb.-4-nitro.
U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
GLDH U/l 15 12 18 1.50 3.00 Triethanolamine buffer
Glucose mmol/l 6.06 5.15 6.97 0.455 0.910 Hexokinase
mg/dl 109 92.7 125 8.00 16.0
HDL-Cholesterol mmol/l 1.31 1.11 1.51 0.100 0.200 Direct HDL, Roche 4th gen.
mg/dl 50.6 43.0 58.2 3.80 7.60
Iron µmol/l 20.1 16.5 23.7 1.80 3.60 Colorimetric with ppt.
µg/dl 112 91.8 132 10.0 20.0
µmol/l 20.1 16.5 23.7 1.80 3.60 Colorimetric without ppt.
µg/dl 112 91.8 132 10.0 20.0
Lactate mmol/l 1.54 1.26 1.82 0.140 0.280 Colorimetric - Lactate oxidase
mg/dl 13.9 11.4 16.4 1.25 2.50
LD (LDH) U/l 213 181 245 16.0 32.0 L to P IFCC
Lipase U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)731/ID 0-100
U/l 38 30 46 4.00 8.00 Colorimetric Roche ACN(8)789/ID 0-052
Lithium mmol/l 0.977 0.860 1.09 0.057 0.113 Spectrophotometric
mg/dl 0.678 0.597 0.759 0.041 0.081
Magnesium mmol/l 0.953 0.839 1.07 0.059 0.117 Chlorphosphonazo III
mg/dl 2.32 2.04 2.60 0.140 0.280
mmol/l 0.949 0.835 1.06 0.056 0.111 Xylidyl Blue
mg/dl 2.31 2.03 2.59 0.140 0.280
Phosphate, Inorganic mmol/l 1.70 1.45 1.95 0.125 0.250 Phosphomolybdate enzymatic
mg/dl 5.27 4.48 6.06 0.395 0.790
mmol/l 1.70 1.45 1.95 0.125 0.250 Phosphomolybdate UV
mg/dl 5.27 4.48 6.06 0.395 0.790
Potassium mmol/l 3.97 3.65 4.29 0.160 0.320 ISE method - indirect

Page 49 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Protein, Total g/l 56.1 44.9 67.3 5.60 11.2 Biuret reaction, end point
g/dl 5.61 4.49 6.73 0.560 1.12
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - indirect
TIBC µmol/l 48.6 38.4 58.8 5.10 10.2 Calculated from Transferrin
µg/dl 272 215 329 28.5 57.0
µmol/l 42.2 33.3 51.1 4.45 8.90 FE+UIBC(saturation with iron)
µg/dl 236 186 286 25.0 50.0
Triglycerides mmol/l 1.08 0.907 1.25 0.085 0.170 Lipase/GK UV. no correction
mg/dl 95.6 80.3 111 7.70 15.4
mmol/l 1.08 0.907 1.25 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 95.6 80.3 111 7.70 15.4
Urea mmol/l 7.35 6.25 8.45 0.550 1.10 Urease, kinetic
mg/dl 44.2 37.6 50.8 3.30 6.60
mg/dl 20.6 17.5 23.7 1.55 3.10
(BUN)
Uric Acid (Urate) mmol/l 0.339 0.295 0.383 0.022 0.044 Uricase perox. no ascorb. ox.
mg/dl 5.70 4.96 6.44 0.370 0.740
mmol/l 0.338 0.294 0.382 0.022 0.044 Uricase Perox. with ascorb. ox
mg/dl 5.68 4.94 6.42 0.370 0.740
mmol/l 0.343 0.298 0.388 0.023 0.045 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.76 5.01 6.51 0.375 0.750

Page 50 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 40.6 34.5 46.7 3.05 6.10 Bromocresol Green
g/dl 4.06 3.45 4.67 0.305 0.610
g/l 40.9 34.8 47.0 3.05 6.10 Bromocresol Purple
g/dl 4.09 3.48 4.70 0.305 0.610
Alkaline Phosphatase U/l 174 148 200 13.0 26.0 Colorimetric
U/l 169 144 194 12.5 25.0 Roche AMP buffer IFCC
ALT (GPT) U/l 35 28 42 3.50 7.00 Colorimetric
U/l 35 28 42 3.50 7.00 Tris buffer without P5P
Amylase, Total U/l 84 71 97 6.50 13.0 Roche liquid stable pNPG7
AST (GOT) U/l 33 26 40 3.50 7.00 Tris buffer without P5P
Bicarbonate mmol/l 13.2 10.5 15.9 1.35 2.70 Enzymatic
Bile Acids µmol/l 24.9 19.9 29.9 2.50 5.00 Enzymatic Colorimetric
Bilirubin, Direct mg/dl 1.21 0.956 1.46 0.125 0.250 Dichlorophenyl Diazonium
µmol/l 20.6 16.3 24.9 2.15 4.30
mg/dl 1.02 0.806 1.23 0.105 0.210 Oxidation to Biliverdin/Vanadate
µmol/l 17.5 13.8 21.2 1.85 3.70
mg/dl 0.948 0.749 1.15 0.101 0.202 Roche DPD Doumas standardised
µmol/l 16.2 12.8 19.6 1.70 3.40
mg/dl 1.22 0.964 1.48 0.130 0.260 Roche DPD JG standardised
µmol/l 20.8 16.4 25.2 2.20 4.40
Bilirubin, Total mg/dl 1.62 1.28 1.96 0.170 0.340 Diazonium ion
µmol/l 27.7 21.9 33.5 2.90 5.80
mg/dl 1.63 1.29 1.97 0.170 0.340 Dichlorophenyl Diazonium
µmol/l 27.9 22.0 33.8 2.95 5.90
Calcium mmol/l 2.15 1.94 2.36 0.105 0.210 Cresolphthalein complexone
mg/dl 8.62 7.76 9.48 0.430 0.860
mmol/l 2.16 1.94 2.38 0.110 0.220 NM-BAPTA
mg/dl 8.66 7.79 9.53 0.435 0.870
Chloride mmol/l 95.4 87.8 103 3.80 7.60 ISE, indirect
Cholesterol mmol/l 3.90 3.39 4.41 0.255 0.510 Cholesterol Oxidase - Abell Kendall
mg/dl 151 131 171 10.0 20.0
mmol/l 3.97 3.45 4.49 0.260 0.520 Cholesterol Oxidase - IDMS
mg/dl 153 133 173 10.0 20.0
Cholinesterase U/l 5725 4580 6870 573 1145 Colorimetric - Butyrylthiocholine
CK, Total U/l 199 163 235 18.0 36.0 CK-NAC (IFCC)
Creatinine mg/dl 1.38 1.10 1.66 0.140 0.280 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 122 97.6 146 12.0 24.0
mg/dl 1.49 1.19 1.79 0.150 0.300 Roche Creatinine Plus
µmol/l 132 106 158 13.0 26.0

Page 51 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
gamma-GT U/l 48 41 55 3.50 7.00 Gamma glut.-3-carb.-4-nitro.
U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.01 5.11 6.91 0.450 0.900 Hexokinase
mg/dl 108 91.8 124 8.00 16.0
HDL-Cholesterol mmol/l 1.30 1.11 1.49 0.095 0.190 Direct HDL, Roche 4th gen.
mg/dl 50.2 42.7 57.7 3.75 7.50
Iron µmol/l 19.6 16.1 23.1 1.75 3.50 Colorimetric with ppt.
µg/dl 110 90.2 130 10.0 20.0
µmol/l 19.6 16.1 23.1 1.75 3.50 Colorimetric without ppt.
µg/dl 110 90.2 130 10.0 20.0
Lactate mmol/l 1.51 1.24 1.78 0.135 0.270 Colorimetric - Lactate oxidase
mg/dl 13.6 11.2 16.0 1.20 2.40
LD (LDH) U/l 211 179 243 16.0 32.0 L to P IFCC
Lipase U/l 39 31 47 4.00 8.00 Colorimetric Roche ACN(8)731/ID 0-100
U/l 39 31 47 4.00 8.00 Colorimetric Roche ACN(8)789/ID 0-052
Lithium mmol/l 0.978 0.861 1.10 0.061 0.122 Spectrophotometric
mg/dl 0.679 0.598 0.760 0.041 0.081
Magnesium mmol/l 0.958 0.843 1.07 0.056 0.112 Xylidyl Blue
mg/dl 2.33 2.05 2.61 0.140 0.280
Phosphate, Inorganic mmol/l 1.69 1.44 1.94 0.125 0.250 Phosphomolybdate UV
mg/dl 5.24 4.45 6.03 0.395 0.790
Potassium mmol/l 3.94 3.62 4.26 0.160 0.320 ISE method - indirect
Protein, Total g/l 56.1 44.9 67.3 5.60 11.2 Biuret reaction, end point
g/dl 5.61 4.49 6.73 0.560 1.12
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - indirect
TIBC µmol/l 42.6 33.7 51.5 4.45 8.90 Calculated from Transferrin
µg/dl 238 188 288 25.0 50.0
µmol/l 43.3 34.2 52.4 4.55 9.10 FE+UIBC(saturation with iron)
µg/dl 242 191 293 25.5 51.0
Triglycerides mmol/l 1.07 0.899 1.24 0.085 0.170 Lipase/GK UV. no correction
mg/dl 94.7 79.5 110 7.65 15.3
mmol/l 1.08 0.907 1.25 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 95.6 80.3 111 7.70 15.4
Urea mmol/l 7.26 6.17 8.35 0.545 1.09 Urease, kinetic
mg/dl 43.6 37.1 50.1 3.25 6.50
mg/dl 20.3 17.3 23.3 1.50 3.00
(BUN)
Uric Acid (Urate) mmol/l 0.339 0.295 0.383 0.022 0.044 Uricase perox. no ascorb. ox.
mg/dl 5.70 4.96 6.44 0.370 0.740

Page 52 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Uric Acid (Urate) mmol/l 0.335 0.291 0.379 0.022 0.044 Uricase Perox. with ascorb. ox
mg/dl 5.63 4.90 6.36 0.365 0.730
mmol/l 0.339 0.295 0.383 0.022 0.044 Uricase Perox. with ascorb. ox @ 546nm
mg/dl 5.70 4.96 6.44 0.370 0.740

Page 53 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 21.8 16.4 27.2 2.70 5.40 Roche Cobas e402/e801
pg/ml 17.0 12.8 21.2 2.10 4.20
ng/dl 1.70 1.28 2.12 0.210 0.420
PSA, Total ng/ml 12.3 9.23 15.4 1.55 3.10 Roche Cobas e402/e801
Thyroid Stimulating µU/ml 1.59 1.27 1.91 0.160 0.320 Roche Cobas e402/e801
Hormone (TSH)

Page 54 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 21.0 15.8 26.2 2.60 5.20 Roche Cobas 4000/e411
pg/ml 16.4 12.3 20.5 2.05 4.10
ng/dl 1.64 1.23 2.05 0.205 0.410
PSA, Total ng/ml 12.9 9.68 16.1 1.60 3.20 Roche Cobas 4000/e411
Thyroid Stimulating µU/ml 1.70 1.36 2.04 0.170 0.340 Roche Cobas 4000/e411
Hormone (TSH)
Total T3 nmol/l 2.62 1.97 3.27 0.325 0.650 Roche Cobas 4000/e411
ng/ml 1.71 1.28 2.14 0.215 0.430
ng/dl 171 128 214 21.5 43.0
Total T4 nmol/l 92.4 69.3 116 11.8 23.6 Roche Cobas 4000/e411
ng/ml 72.1 54.1 90.1 9.00 18.0
µg/dl 7.21 5.41 9.01 0.900 1.80

Page 55 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Free T4 pmol/l 21.3 16.0 26.6 2.65 5.30 Roche Cobas e601/ 602
pg/ml 16.6 12.5 20.7 2.05 4.10
ng/dl 1.66 1.25 2.07 0.205 0.410
PSA, Total ng/ml 12.6 9.45 15.8 1.60 3.20 Roche Cobas e601/602
Thyroid Stimulating µU/ml 1.65 1.32 1.98 0.165 0.330 Roche Cobas e601/ 602
Hormone (TSH)

Page 56 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 41.5 35.3 47.7 3.10 6.20 Bromocresol Green
g/dl 4.15 3.53 4.77 0.310 0.620
Alkaline Phosphatase U/l 173 147 199 13.0 26.0 Roche AMP buffer IFCC
ALT (GPT) U/l 32 26 38 3.00 6.00 Tris buffer without P5P
Amylase, Total U/l 84 71 97 6.50 13.0 BM/Roche Colorimetric pNPG7
U/l 86 73 99 6.50 13.0 Roche Integra 2-chloro-pNPG7
U/l 85 72 98 6.50 13.0 Roche liquid stable pNPG7
AST (GOT) U/l 32 26 38 3.00 6.00 Tris buffer without P5P
Bilirubin, Direct mg/dl 1.18 0.932 1.43 0.125 0.250 Diazo with Sulphanilic Acid
µmol/l 20.2 16.0 24.4 2.10 4.20
mg/dl 1.22 0.964 1.48 0.130 0.260 Dichlorophenyl Diazonium
µmol/l 20.9 16.5 25.3 2.20 4.40
mg/dl 1.21 0.956 1.46 0.125 0.250 Roche DPD JG standardised
µmol/l 20.6 16.3 24.9 2.15 4.30
Bilirubin, Total mg/dl 1.68 1.33 2.03 0.175 0.350 Diazo with Sulphanilic Acid
µmol/l 28.7 22.7 34.7 3.00 6.00
mg/dl 1.61 1.27 1.95 0.170 0.340 Diazonium ion
µmol/l 27.6 21.8 33.4 2.90 5.80
mg/dl 1.66 1.31 2.01 0.175 0.350 Dichlorophenyl Diazonium
µmol/l 28.3 22.4 34.2 2.95 5.90
Calcium mmol/l 2.15 1.94 2.36 0.105 0.210 Cresolphthalein complexone
mg/dl 8.62 7.76 9.48 0.430 0.860
mmol/l 2.15 1.94 2.36 0.105 0.210 NM-BAPTA
mg/dl 8.62 7.76 9.48 0.430 0.860
Chloride mmol/l 98.3 90.4 106 3.85 7.70 ISE, indirect
Cholesterol mmol/l 3.94 3.43 4.45 0.255 0.510 Cholesterol Oxidase - Abell Kendall
mg/dl 152 132 172 10.0 20.0
mmol/l 3.86 3.36 4.36 0.250 0.500 Cholesterol Oxidase - IDMS
mg/dl 149 130 168 9.50 19.0
CK, Total U/l 195 160 230 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.33 1.06 1.60 0.135 0.270 Alkaline picrate no deproteinisation
µmol/l 118 94.4 142 12.0 24.0
mg/dl 1.32 1.06 1.58 0.130 0.260 Alkaline picrate with deproteinisation
µmol/l 117 93.6 140 11.5 23.0
mg/dl 1.36 1.09 1.63 0.135 0.270 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 120 96.0 144 12.0 24.0
mg/dl 1.34 1.07 1.61 0.135 0.270 Jaffe rate comp. (-18umol/l)
µmol/l 119 95.2 143 12.0 24.0

Page 57 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Creatinine mg/dl 1.41 1.13 1.69 0.140 0.280 Roche Creatinine Plus
µmol/l 125 100 150 12.5 25.0
gamma-GT U/l 48 41 55 3.50 7.00 Gamma glut.-3-carb.-4-nitro.
U/l 54 46 62 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.16 5.24 7.08 0.460 0.920 Hexokinase
mg/dl 111 94.4 128 8.50 17.0
HDL-Cholesterol mmol/l 1.31 1.11 1.51 0.100 0.200 Direct HDL, Roche 4th gen.
mg/dl 50.6 43.0 58.2 3.80 7.60
Iron µmol/l 20.4 16.7 24.1 1.85 3.70 Colorimetric with ppt.
µg/dl 114 93.5 135 10.5 21.0
µmol/l 20.5 16.8 24.2 1.85 3.70 Colorimetric without ppt.
µg/dl 115 94.3 136 10.5 21.0
Lactate mmol/l 1.55 1.27 1.83 0.140 0.280 Colorimetric - Lactate oxidase
mg/dl 14.0 11.5 16.5 1.25 2.50
LD (LDH) U/l 217 184 250 16.5 33.0 L to P IFCC
Lipase U/l 39 31 47 4.00 8.00 Colorimetric Roche ACN(8)731/ID 0-100
U/l 39 31 47 4.00 8.00 Colorimetric Roche ACN(8)789/ID 0-052
Magnesium mmol/l 0.960 0.845 1.08 0.060 0.120 Chlorphosphonazo III
mg/dl 2.33 2.05 2.61 0.140 0.280
mmol/l 0.953 0.839 1.07 0.059 0.117 Xylidyl Blue
mg/dl 2.32 2.04 2.60 0.140 0.280
Phosphate, Inorganic mmol/l 1.77 1.50 2.04 0.135 0.270 Phosphomolybdate enzymatic
mg/dl 5.49 4.67 6.31 0.410 0.820
mmol/l 1.75 1.49 2.01 0.130 0.260 Phosphomolybdate UV
mg/dl 5.43 4.62 6.24 0.405 0.810
Potassium mmol/l 3.90 3.59 4.21 0.155 0.310 ISE method - indirect
Protein, Total g/l 54.2 43.4 65.0 5.40 10.8 Biuret reaction, end point
g/dl 5.42 4.34 6.50 0.540 1.08
g/l 54.1 43.3 64.9 5.40 10.8 Biuret reaction, kinetic
g/dl 5.41 4.33 6.49 0.540 1.08
Sodium mmol/l 141 134 148 3.50 7.00 ISE method - indirect
TIBC µmol/l 44.8 35.4 54.2 4.70 9.40 FE+UIBC(saturation with iron)
µg/dl 250 198 302 26.0 52.0
Triglycerides mmol/l 1.08 0.907 1.25 0.085 0.170 Lipase/GPO-PAP no correction
mg/dl 95.6 80.3 111 7.70 15.4
Urea mmol/l 7.09 6.03 8.15 0.530 1.06 Urease, kinetic
mg/dl 42.6 36.2 49.0 3.20 6.40
mg/dl 19.9 16.9 22.9 1.50 3.00
(BUN)

Page 58 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Uric Acid (Urate) mmol/l 0.355 0.309 0.401 0.023 0.046 Uricase perox. no ascorb. ox.
mg/dl 5.96 5.19 6.73 0.385 0.770
mmol/l 0.350 0.305 0.395 0.023 0.045 Uricase Perox. with ascorb. ox
mg/dl 5.88 5.12 6.64 0.380 0.760

Page 59 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Potassium mmol/l 3.71 3.41 4.01 0.150 0.300 ISE method - direct

Page 60 of 77 05/06/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
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 HUMAN ASSAYED MULTI-SERA - LEVEL 2 (HUM ASY CONTROL 2)
Instruments
Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28
Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 39.0 33.2 44.8 2.90 5.80 Bromocresol Green
g/dl 3.90 3.32 4.48 0.290 0.580
Alkaline Phosphatase U/l 160 136 184 12.0 24.0 AMP optimised to IFCC
ALT (GPT) U/l 43 34 52 4.50 9.00 Tris buffer without P5P
Amylase, Total U/l 85 72 98 6.50 13.0 Siemens - blocked pNPG7
AST (GOT) U/l 41 33 49 4.00 8.00 Tris buffer without P5P
Bicarbonate mmol/l 14.8 11.7 17.9 1.55 3.10 Enzymatic
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
Bilirubin, Total mg/dl 1.94 1.53 2.35 0.205 0.410 Oxidation to Biliverdin/Vanadate
µmol/l 33.2 26.2 40.2 3.50 7.00
Calcium mmol/l 2.08 1.87 2.29 0.105 0.210 Cresolphthalein complexone
mg/dl 8.34 7.51 9.17 0.415 0.830
Chloride mmol/l 100 92.0 108 4.00 8.00 ISE, indirect
Cholesterol mmol/l 3.96 3.45 4.47 0.255 0.510 Cholesterol Oxidase - Abell Kendall
mg/dl 153 133 173 10.0 20.0
CK, Total U/l 196 161 231 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.37 1.10 1.64 0.135 0.270 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 121 96.8 145 12.0 24.0
gamma-GT U/l 50 43 57 3.50 7.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 5.94 5.05 6.83 0.445 0.890 Glucose oxidase
mg/dl 107 91.0 123 8.00 16.0
mmol/l 5.89 5.01 6.77 0.440 0.880 Hexokinase
mg/dl 106 90.1 122 8.00 16.0
HDL-Cholesterol mmol/l 1.15 0.978 1.32 0.085 0.170 Direct HDL, Clearance method
mg/dl 44.4 37.7 51.1 3.35 6.70
Iron µmol/l 19.7 16.2 23.2 1.75 3.50 Colorimetric without ppt.
µg/dl 110 90.2 130 10.0 20.0
Lactate mmol/l 1.39 1.14 1.64 0.125 0.250 Colorimetric - Lactate oxidase
mg/dl 12.5 10.3 14.7 1.10 2.20
LD (LDH) U/l 216 184 248 16.0 32.0 L to P IFCC
Magnesium mmol/l 0.897 0.789 1.01 0.057 0.113 Xylidyl Blue
mg/dl 2.18 1.92 2.44 0.130 0.260
Phosphate, Inorganic mmol/l 1.73 1.47 1.99 0.130 0.260 Phosphomolybdate UV
mg/dl 5.36 4.56 6.16 0.400 0.800
Potassium mmol/l 3.97 3.65 4.29 0.160 0.320 ISE method - indirect
Protein, Total g/l 55.2 44.2 66.2 5.50 11.0 Biuret reaction, end point
g/dl 5.52 4.42 6.62 0.550 1.10

Page 61 of 77 05/06/2024

Page 62 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 38.8 33.0 44.6 2.90 5.80 Bromocresol Green
g/dl 3.88 3.30 4.46 0.290 0.580
g/l 39.6 33.7 45.5 2.95 5.90 Bromocresol Purple
g/dl 3.96 3.37 4.55 0.295 0.590
Alkaline Phosphatase U/l 166 141 191 12.5 25.0 AMP optimised to IFCC
ALT (GPT) U/l 40 32 48 4.00 8.00 Tris buffer without P5P
Amylase, Pancreatic U/l 67 57 77 5.00 10.0 Immunoinhibition, EPS substrate
Amylase, Total U/l 94 80 108 7.00 14.0 Siemens - blocked pNPG7
AST (GOT) U/l 37 30 44 3.50 7.00 Tris buffer without P5P
Bicarbonate mmol/l 13.8 10.9 16.7 1.45 2.90 Enzymatic
Bile Acids µmol/l 21.1 16.9 25.3 2.10 4.20 Enzymatic Colorimetric - Sentinel
Bilirubin, Direct mg/dl 1.19 0.940 1.44 0.125 0.250 Oxidation to Biliverdin/Vanadate
µmol/l 20.3 16.0 24.6 2.15 4.30
Bilirubin, Total mg/dl 1.97 1.56 2.38 0.205 0.410 Oxidation to Biliverdin/Vanadate
µmol/l 33.7 26.6 40.8 3.55 7.10
Calcium mmol/l 2.18 1.96 2.40 0.110 0.220 Arsenazo III
mg/dl 8.74 7.87 9.61 0.435 0.870
mmol/l 2.09 1.88 2.30 0.105 0.210 Cresolphthalein complexone
mg/dl 8.38 7.54 9.22 0.420 0.840
Chloride mmol/l 102 93.8 110 4.00 8.00 ISE, indirect
Cholesterol mmol/l 4.01 3.49 4.53 0.260 0.520 Cholesterol Oxidase - Abell Kendall
mg/dl 155 135 175 10.0 20.0
mmol/l 4.00 3.48 4.52 0.260 0.520 Cholesterol Oxidase - IDMS
mg/dl 154 134 174 10.0 20.0
Cholinesterase U/l 7832 6266 9398 783 1566 Colorimetric - Butyrylthiocholine
CK, Total U/l 197 162 232 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.37 1.10 1.64 0.135 0.270 Jaffe rate blanked
µmol/l 121 96.8 145 12.0 24.0
mg/dl 1.34 1.07 1.61 0.135 0.270 Jaffe rate blanked comp. (-26µmol/l)
µmol/l 119 95.2 143 12.0 24.0
Free T4 pmol/l 17.2 12.9 21.5 2.15 4.30 Siemens Atellica IM
pg/ml 13.4 10.1 16.7 1.65 3.30
ng/dl 1.34 1.01 1.67 0.165 0.330
gamma-GT U/l 55 47 63 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.10 5.19 7.01 0.455 0.910 Glucose oxidase
mg/dl 110 93.5 127 8.50 17.0
mmol/l 6.01 5.11 6.91 0.450 0.900 Hexokinase
mg/dl 108 91.8 124 8.00 16.0

Page 63 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
HDL-Cholesterol mmol/l 1.50 1.28 1.72 0.110 0.220 Direct HDL, Clearance method
mg/dl 57.9 49.2 66.6 4.35 8.70
mmol/l 1.51 1.28 1.74 0.115 0.230 HDL Ultra/Accel Selective Detergent
mg/dl 58.3 49.6 67.0 4.35 8.70
Iron µmol/l 19.8 16.2 23.4 1.80 3.60 Colorimetric without ppt.
µg/dl 111 91.0 131 10.0 20.0
Lactate mmol/l 1.48 1.21 1.75 0.135 0.270 Colorimetric - Lactate oxidase
mg/dl 13.3 10.9 15.7 1.20 2.40
LD (LDH) U/l 212 180 244 16.0 32.0 L to P IFCC
U/l 212 180 244 16.0 32.0 Siemens Dimension L-P Non IFCC
Lipase U/l 40 32 48 4.00 8.00 Other Colorimetric
Magnesium mmol/l 0.918 0.808 1.03 0.056 0.112 Xylidyl Blue
mg/dl 2.23 1.96 2.50 0.135 0.270
Phosphate, Inorganic mmol/l 1.76 1.50 2.02 0.130 0.260 Phosphomolybdate UV
mg/dl 5.46 4.64 6.28 0.410 0.820
Potassium mmol/l 3.88 3.57 4.19 0.155 0.310 ISE method - indirect
Protein, Total g/l 56.7 45.4 68.0 5.65 11.3 Biuret reaction, end point
g/dl 5.67 4.54 6.80 0.565 1.13
PSA, Total ng/ml 11.3 8.48 14.1 1.40 2.80 Siemens Atellica IM
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - indirect
Thyroid Stimulating µU/ml 1.41 1.13 1.69 0.140 0.280 Siemens Atellica IM
Hormone (TSH)
TIBC µmol/l 49.4 39.0 59.8 5.20 10.4 Direct Colorimetric
µg/dl 276 218 334 29.0 58.0
Triglycerides mmol/l 1.13 0.949 1.31 0.090 0.180 Lipase/GPO-PAP no correction
mg/dl 100 84.0 116 8.00 16.0
mmol/l 1.14 0.958 1.32 0.090 0.180 Siemens Atellica IM
mg/dl 101 84.8 117 8.00 16.0
Urea mmol/l 7.73 6.57 8.89 0.580 1.16 Urease, kinetic
mg/dl 46.5 39.5 53.5 3.50 7.00
mg/dl 21.7 18.4 25.0 1.65 3.30
(BUN)
Uric Acid (Urate) mmol/l 0.353 0.307 0.399 0.023 0.046 Uricase perox. no ascorb. ox.
mg/dl 5.93 5.16 6.70 0.385 0.770
mmol/l 0.347 0.302 0.392 0.023 0.045 Uricase Perox. with ascorb. ox
mg/dl 5.83 5.07 6.59 0.380 0.760

Page 64 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 40.2 34.2 46.2 3.00 6.00 Bromocresol Purple
g/dl 4.02 3.42 4.62 0.300 0.600
Alkaline Phosphatase U/l 173 147 199 13.0 26.0 Siemens Dimension AMP buffer
ALT (GPT) U/l 44 35 53 4.50 9.00 Tris buffer with P5P
Amylase, Total U/l 88 75 101 6.50 13.0 Siemens 2-chloro-pNPG3
AST (GOT) U/l 44 35 53 4.50 9.00 Siemens/Dade standard non IFCC corr.
U/l 44 35 53 4.50 9.00 Tris buffer with P5P
Bilirubin, Direct mg/dl 0.807 0.638 0.976 0.085 0.169 Diazo/ Sulphanilic Siemens Dimension
µmol/l 13.8 10.9 16.7 1.45 2.90
Bilirubin, Total mg/dl 1.87 1.48 2.26 0.195 0.390 Diazo with Sulphanilic Acid
µmol/l 31.9 25.2 38.6 3.35 6.70
Calcium mmol/l 2.07 1.86 2.28 0.105 0.210 Cresolphthalein complexone
mg/dl 8.30 7.47 9.13 0.415 0.830
Chloride mmol/l 95.2 87.6 103 3.90 7.80 ISE, indirect
Cholesterol mmol/l 3.59 3.12 4.06 0.235 0.470 Siemens Dimension
mg/dl 139 121 157 9.00 18.0
CK, Total U/l 192 157 227 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.45 1.16 1.74 0.145 0.290 Alkaline picrate no deproteinisation
µmol/l 128 102 154 13.0 26.0
mg/dl 1.45 1.16 1.74 0.145 0.290 Jaffe rate blanked
µmol/l 128 102 154 13.0 26.0
gamma-GT U/l 58 49 67 4.50 9.00 Gamma glut`3-carb`4-nitro(IFCC)
U/l 68 58 78 5.00 10.0 Siemens Dimension
Glucose mmol/l 6.28 5.34 7.22 0.470 0.940 Hexokinase
mg/dl 113 96.1 130 8.50 17.0
HDL-Cholesterol mmol/l 1.41 1.20 1.62 0.105 0.210 Direct HDL, PEGME
mg/dl 54.4 46.2 62.6 4.10 8.20
Iron µmol/l 18.6 15.3 21.9 1.65 3.30 Colorimetric without ppt.
µg/dl 104 85.3 123 9.50 19.0
LD (LDH) U/l 201 171 231 15.0 30.0 L to P IFCC
Lipase U/l 41 33 49 4.00 8.00 Colorimetric Dimension (LIP Kit)
Magnesium mmol/l 0.927 0.816 1.04 0.057 0.113 Methylthymol blue
mg/dl 2.25 1.98 2.52 0.135 0.270
Phosphate, Inorganic mmol/l 1.81 1.54 2.08 0.135 0.270 Phosphomolybdate enzymatic
mg/dl 5.61 4.77 6.45 0.420 0.840
mmol/l 1.78 1.51 2.05 0.135 0.270 Phosphomolybdate UV
mg/dl 5.52 4.69 6.35 0.415 0.830
Potassium mmol/l 3.86 3.55 4.17 0.155 0.310 ISE method - indirect

Page 65 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Protein, Total g/l 57.8 46.2 69.4 5.80 11.6 Biuret reaction, end point
g/dl 5.78 4.62 6.94 0.580 1.16
Sodium mmol/l 142 135 149 3.50 7.00 ISE method - indirect
Triglycerides mmol/l 1.02 0.857 1.18 0.080 0.160 Lipase/GPO-PAP no correction
mg/dl 90.3 75.9 105 7.35 14.7
mmol/l 0.972 0.816 1.13 0.079 0.158 Siemens Dimension
mg/dl 86.0 72.2 99.8 6.90 13.8
Urea mmol/l 7.47 6.35 8.59 0.560 1.12 Urease, kinetic
mg/dl 44.9 38.2 51.6 3.35 6.70
mg/dl 20.9 17.8 24.0 1.55 3.10
(BUN)
Uric Acid (Urate) mmol/l 0.349 0.304 0.394 0.023 0.045 Uricase @ 293 nm
mg/dl 5.86 5.10 6.62 0.380 0.760
mmol/l 0.349 0.304 0.394 0.023 0.045 Uricase perox. no ascorb. ox.
mg/dl 5.86 5.10 6.62 0.380 0.760

Page 66 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Glucose mmol/l 6.37 5.41 7.33 0.480 0.960 Hexokinase
mg/dl 115 97.8 132 8.50 17.0
Urea mmol/l 7.43 6.32 8.54 0.555 1.11 Urease, kinetic
mg/dl 44.7 38.0 51.4 3.35 6.70
mg/dl 20.8 17.7 23.9 1.55 3.10
(BUN)

Page 67 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Copper µmol/l 19.1 15.3 22.9 1.90 3.80 Atomic absorption
µg/dl 121 96.8 145 12.0 24.0

Page 68 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/l 37.6 32.0 43.2 2.80 5.60 Bromocresol Green
g/dl 3.76 3.20 4.32 0.280 0.560
ALT (GPT) U/l 39 31 47 4.00 8.00 Tris buffer without P5P
AST (GOT) U/l 38 30 46 4.00 8.00 Tris buffer without P5P
Calcium mmol/l 2.27 2.04 2.50 0.115 0.230 Arsenazo III
mg/dl 9.10 8.19 10.0 0.450 0.900
Cholesterol mmol/l 4.09 3.56 4.62 0.265 0.530 Cholesterol Oxidase - Abell Kendall
mg/dl 158 137 179 10.5 21.0
CK, Total U/l 210 172 248 19.0 38.0 CK-NAC (IFCC)

Creatinine mg/dl 1.47 1.18 1.76 0.145 0.290 Enzymatic

µmol/l 130 104 156 13.0 26.0
gamma-GT U/l 53 45 61 4.00 8.00 Gamma glut`3-carb`4-nitro(IFCC)
Glucose mmol/l 6.37 5.41 7.33 0.480 0.960 Glucose oxidase
mg/dl 115 97.8 132 8.50 17.0
Magnesium mmol/l 0.936 0.824 1.05 0.057 0.114 Xylidyl Blue
mg/dl 2.27 2.00 2.54 0.135 0.270
Phosphate, Inorganic mmol/l 1.75 1.49 2.01 0.130 0.260 Phosphomolybdate UV
mg/dl 5.43 4.62 6.24 0.405 0.810
Potassium mmol/l 3.85 3.54 4.16 0.155 0.310 ISE method - direct
Protein, Total g/l 56.1 44.9 67.3 5.60 11.2 Biuret reaction, end point
g/dl 5.61 4.49 6.73 0.560 1.12
Sodium mmol/l 139 132 146 3.50 7.00 ISE method - direct
Triglycerides mmol/l 1.12 0.941 1.30 0.090 0.180 Lipase/GPO-PAP no correction
mg/dl 99.1 83.2 115 7.95 15.9
Urea mmol/l 7.62 6.48 8.76 0.570 1.14 Urease, kinetic
mg/dl 45.8 38.9 52.7 3.45 6.90
mg/dl 21.3 18.1 24.5 1.60 3.20
(BUN)

Page 69 of 77 10/03/2025

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Osmolality mOsm/ 318 254 382 32.0 64.0 Freezing point depression
kg

Page 70 of 77 05/06/2024

Lot. No: 1676UN Cat. No: HN1530 / HS2611 Expiry: 2028-01-28

Size: 20 x 5ml / 5 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Alkaline Phosphatase U/l 261 222 300 19.5 39.0 Diethanolamine buffer, DEA
AST (GOT) U/l 36 29 43 3.50 7.00 Tris buffer without P5P
Creatinine mg/dl 1.51 1.21 1.81 0.150 0.300 Alkaline picrate no deproteinisation
µmol/l 134 107 161 13.5 27.0
LD (LDH) U/l 424 360 488 32.0 64.0 P to L SFBC / SEQC
Urea mmol/l 8.01 6.81 9.21 0.600 1.20 Urease, kinetic
mg/dl 48.1 40.9 55.3 3.60 7.20
mg/dl 22.4 19.0 25.8 1.70 3.40
(BUN)

Page 71 of 77 05/06/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Beacon B200 HUMAN ASSAYED MULTI-SERA - LEVEL 2 (HUM ASY CONTROL 2)
Lot. No: 1676UN Cat. No: HN1530 Expiry: 2028-01-28
Size: 20 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 3.91 3.32 4.50 0.295 0.590 Bromocresol Green
g/l 39.1 33.2 45.0 2.95 5.90
Alkaline Phosphatase U/l 202 172 232 15.0 30.0 AMP optimised to IFCC
ALT (GPT) U/l 34 27 41 3.50 7.00 IFCC Method
Amylase Total U/l 74 63 85 5.50 11.0 Direct Substrate Method
AST (GOT) U/l 31 25 37 3.00 6.00 IFCC Method
Bilirubin Direct mg/dl 0.837 0.661 1.01 0.087 0.173 DMSO Method
µmol/l 14.3 11.3 17.3 1.50 3.00
Bilirubin Total mg/dl 1.57 1.24 1.90 0.165 0.330 DMSO Method
µmol/l 26.9 21.3 32.5 2.80 5.60
Calcium mg/dl 9.06 7.88 10.2 0.570 1.14 Arsenazo III
mmol/l 2.26 1.97 2.55 0.145 0.290
Cholesterol mg/dl 157 137 177 10.0 20.0 CHOD/POD Method
mmol/l 4.06 3.53 4.59 0.265 0.530
CK Total U/l 172 141 203 15.5 31.0 Optimized IFCC Method
Creatinine mg/dl 1.42 1.14 1.70 0.140 0.280 Enzymatic
µmol/l 126 101 151 12.5 25.0
gamma-GT U/l 47 40 54 3.50 7.00 SASZ Method
Glucose mg/dl 109 92.7 125 8.00 16.0 GOD/POD Method
mmol/l 6.04 5.13 6.95 0.455 0.910
HDL - Cholesterol mg/dl 52.9 45.0 60.8 3.95 7.90 PEGME Method
mmol/l 1.37 1.16 1.58 0.105 0.210
LD (LDH) U/l 216 184 248 16.0 32.0 L to P Kinetic Method
Magnesium mg/dl 2.11 1.86 2.36 0.125 0.250 Xylidyl Blue
mmol/l 0.869 0.765 0.973 0.052 0.104
Phosphate Inorganic mg/dl 5.11 4.34 5.88 0.385 0.770 Molybdate UV Method
mmol/l 1.65 1.40 1.90 0.125 0.250
Protein Total g/dl 5.31 4.25 6.37 0.530 1.06 Biuret Method
g/l 53.1 42.5 63.7 5.30 10.6
Triglycerides mg/dl 88.5 74.3 103 7.25 14.5 GPO/POD Method
mmol/l 1.00 0.840 1.16 0.080 0.160
Urea mg/dl 41.3 35.1 47.5 3.10 6.20 U.V GLDH Method
mg/dl 19.3 16.4 22.2 1.45 2.90
(BUN)
mmol/l 6.88 5.85 7.91 0.515 1.03
Uric Acid (Urate) mg/dl 6.07 5.28 6.86 0.395 0.790 Uricase / POD Method
mmol/l 0.361 0.314 0.408 0.024 0.047

Page 72 of 77 2024/12/09

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
Beacon Unicorn 480 HUMAN ASSAYED MULTI-SERA - LEVEL 2 (HUM ASY CONTROL 2)
Lot. No: 1676UN Cat. No: HN1530 Expiry: 2028-01-28
Size: 20 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 3.88 3.30 4.46 0.290 0.580 Bromocresol Green
g/l 38.8 33.0 44.6 2.90 5.80
Alkaline Phosphatase U/l 208 177 239 15.5 31.0 AMP optimised to IFCC
ALT (GPT) U/l 35 28 42 3.50 7.00 IFCC Method
Amylase Total U/l 70 60 80 5.00 10.0 Direct Substrate Method
AST (GOT) U/l 30 24 36 3.00 6.00 IFCC Method
Bilirubin Direct mg/dl 0.837 0.661 1.01 0.087 0.173 DMSO Method
µmol/l 14.3 11.3 17.3 1.50 3.00
Bilirubin Total mg/dl 1.53 1.21 1.85 0.160 0.320 DMSO Method
µmol/l 26.1 20.6 31.6 2.75 5.50
Calcium mg/dl 9.90 8.61 11.2 0.650 1.30 Arsenazo III
mmol/l 2.47 2.15 2.79 0.160 0.320
Cholesterol mg/dl 159 138 180 10.5 21.0 CHOD/POD Method
mmol/l 4.12 3.58 4.66 0.270 0.540
CK Total U/l 215 176 254 19.5 39.0 Optimized IFCC Method
Creatinine mg/dl 1.44 1.15 1.73 0.145 0.290 Enzymatic
µmol/l 127 102 152 12.5 25.0
gamma-GT U/l 49 42 56 3.50 7.00 SASZ Method
Glucose mg/dl 114 96.9 131 8.50 17.0 GOD/POD Method
mmol/l 6.33 5.38 7.28 0.475 0.950
HDL - Cholesterol mg/dl 54.1 46.0 62.2 4.05 8.10 PEGME Method
mmol/l 1.40 1.19 1.61 0.105 0.210
LD (LDH) U/l 229 195 263 17.0 34.0 L to P Kinetic Method
Magnesium mg/dl 2.60 2.29 2.91 0.155 0.310 Xylidyl Blue
mmol/l 1.07 0.942 1.20 0.065 0.130
Phosphate Inorganic mg/dl 5.02 4.27 5.77 0.375 0.750 Molybdate UV Method
mmol/l 1.62 1.38 1.86 0.120 0.240
Protein Total g/dl 5.47 4.38 6.56 0.545 1.09 Biuret Method
g/l 54.7 43.8 65.6 5.45 10.9
Triglycerides mg/dl 87.0 73.1 101 7.00 14.0 GPO/POD Method
mmol/l 0.983 0.826 1.14 0.079 0.157
Urea mg/dl 43.5 37.0 50.0 3.25 6.50 U.V GLDH Method
mg/dl 20.3 17.3 23.3 1.50 3.00
(BUN)
mmol/l 7.24 6.15 8.33 0.545 1.09
Uric Acid (Urate) mg/dl 6.22 5.41 7.03 0.405 0.810 Uricase / POD Method
mmol/l 0.370 0.322 0.418 0.024 0.048

Page 73 of 77 2024/12/09

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
Beacon V Chem plus HUMAN ASSAYED MULTI-SERA - LEVEL 2 (HUM ASY CONTROL 2)
Lot. No: 1676UN Cat. No: HN1530 Expiry: 2028-01-28
Size: 20 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 3.78 3.21 4.35 0.285 0.570 Bromocresol Green
g/l 37.8 32.1 43.5 2.85 5.70
Alkaline Phosphatase U/l 158 134 182 12.0 24.0 AMP optimised to IFCC
ALT (GPT) U/l 30 24 36 3.00 6.00 IFCC Method
Amylase Total U/l 88 75 101 6.50 13.0 Direct Substrate Method
AST (GOT) U/l 30 24 36 3.00 6.00 IFCC Method
Bilirubin Direct mg/dl 1.33 1.05 1.61 0.140 0.280 DMSO Method
µmol/l 22.7 17.9 27.5 2.40 4.80
Bilirubin Total mg/dl 1.69 1.34 2.04 0.175 0.350 DMSO Method
µmol/l 28.9 22.8 35.0 3.05 6.10
Calcium mg/dl 8.46 7.36 9.56 0.550 1.10 Arsenazo III
mmol/l 2.11 1.84 2.38 0.135 0.270
Chloride mmol/l 99.6 91.6 108 4.20 8.40 Colorimetric
Cholesterol mg/dl 154 134 174 10.0 20.0 CHOD/POD Method
mmol/l 3.98 3.46 4.50 0.260 0.520
CK Total U/l 188 154 222 17.0 34.0 Optimized IFCC Method
Creatinine mg/dl 1.68 1.34 2.02 0.170 0.340 Enzymatic
µmol/l 149 119 179 15.0 30.0
gamma-GT U/l 47 40 54 3.50 7.00 SASZ Method
Glucose mg/dl 105 89.3 121 8.00 16.0 GOD/POD Method
mmol/l 5.81 4.94 6.68 0.435 0.870
HDL - Cholesterol mg/dl 48.3 41.1 55.5 3.60 7.20 PEGME Method
mmol/l 1.25 1.06 1.44 0.095 0.190
LD (LDH) U/l 199 169 229 15.0 30.0 L to P Kinetic Method
Lipase U/l 40 32 48 4.00 8.00 Methylresorufin Method
Magnesium mg/dl 2.60 2.29 2.91 0.155 0.310 Xylidyl Blue
mmol/l 1.07 0.942 1.20 0.065 0.130
Phosphate Inorganic mg/dl 5.33 4.53 6.13 0.400 0.800 Molybdate UV Method
mmol/l 1.72 1.46 1.98 0.130 0.260
Potassium mmol/l 2.99 2.75 3.23 0.120 0.240 Colorimetric
Protein Total g/dl 5.58 4.46 6.70 0.560 1.12 Biuret Method
g/l 55.8 44.6 67.0 5.60 11.2
Sodium mmol/l 132 125 139 3.50 7.00 Colorimetric
Triglycerides mg/dl 84.6 71.1 98.1 6.75 13.5 GPO/POD Method
mmol/l 0.956 0.803 1.11 0.077 0.154

Page 74 of 77 2024/12/09

Page 75 of 77 2024/12/09

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
MN Chip Chemistry Analyzer Human Assayed Multi-Sera - Level 2
Lot. No: 1676UN Cat. No: HN1530 Expiry: 2028-01-28
Size: 20 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 3.88 3.30 4.46 0.290 0.580 Bromocresol Purple
g/l 38.8 33.0 44.6 2.90 5.80
Alkaline Phosphatase U/l 188 160 216 14.0 28.0 AMP optimised to IFCC
alpha - HBDH U/l 162 130 194 16.0 32.0 Oxobutyrate < 10 mmol/l
ALT (GPT) U/l 39 31 47 4.00 8.00 Tris Buffer Without P5P
Amylase Total U/l 89 76 102 6.50 13.0 Immunoinhibition, EPS substrate
AST (GOT) U/l 39 31 47 4.00 8.00 Tris Buffer Without P5P
Bicarbonate mmol/l 15.3 12.1 18.5 1.60 3.20 Enzymatic
Bile Acids µmol/l 19.3 15.4 23.2 1.95 3.90 Enzymatic
Bilirubin Direct mg/dl 0.895 0.707 1.08 0.093 0.185 Bilirubin Oxidase
µmol/l 15.3 12.1 18.5 1.60 3.20
Bilirubin Total mg/dl 1.92 1.52 2.32 0.200 0.400 Bilirubin Oxidase
µmol/l 32.8 25.9 39.7 3.45 6.90
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
Chloride mmol/l 98.1 90.3 106 3.95 7.90 Enzymatic
Cholesterol mg/dl 147 128 166 9.50 19.0 Enzymatic
mmol/l 3.82 3.32 4.32 0.250 0.500
Cholinesterase U/l 6347 5078 7616 635 1269 Enzymatic
CK Total U/l 192 157 227 17.5 35.0 CK-NAC (IFCC)
Creatinine mg/dl 1.45 1.16 1.74 0.145 0.290 Sarcosine oxidase
µmol/l 128 102 154 13.0 26.0
gamma-GT U/l 55 47 63 4.00 8.00 Gamma Glutamyl-4-Nitroanilide
Glucose mg/dl 111 94.4 128 8.50 17.0 Hexokinase
mmol/l 6.15 5.23 7.07 0.460 0.920
HDL - Cholesterol mg/dl 49.0 40.2 57.8 4.40 8.80 Precipitation
mmol/l 1.27 1.04 1.50 0.115 0.230
Lactate mg/dl 14.1 11.6 16.6 1.25 2.50 Colorimetric - Lactate oxidase
mmol/l 1.57 1.29 1.85 0.140 0.280
LD (LDH) U/l 216 184 248 16.0 32.0 L to P, IFCC
Lipase U/l 45 36 54 4.50 9.00 Colorimetric
Magnesium mg/dl 2.28 2.01 2.55 0.135 0.270 Enzymatic
mmol/l 0.940 0.827 1.05 0.055 0.110
Phosphate Inorganic mg/dl 5.49 4.67 6.31 0.410 0.820 Enzymatic
mmol/l 1.77 1.50 2.04 0.135 0.270
Potassium mmol/l 4.27 3.93 4.61 0.170 0.340 Enzymatic
Protein Total g/dl 5.78 4.62 6.94 0.580 1.16 Biuret reaction
g/l 57.8 46.2 69.4 5.80 11.6

Page 76 of 77 2025/02/27

Page 77 of 77 2025/02/27

ADDITIONAL VALUES FOR

HUMAN ASSAYED MULTI-SERA – LEVEL 2
(HUM ASY CONTROL 2)
Cat No. HN1530 / HS2611
Lot No. 1676UN
GTIN: 05055273203783 / 05055273203813
Diatron Pictus 500/700

COMPONENT UNITS TARGET RANGE METHOD

Albumin g/l 39.3 31.4 – 47.2 Bromocresol Green

g/dl 3.93 3.14 – 4.72

Alkaline Phosphatase U/l 187 149 - 224 AMP optimised to IFCC 37°C

ALT (GPT) U/l 43.0 34.0 – 51.0 Tris buffer without P5P 37°C

Amylase Total U/l 81.0 65.0 – 97.0 Other 2-chloro-pNPG3 37°C

AST (GOT) U/l 37.0 30.0 – 45.0 Tris buffer without P5P 37°C

Bilirubin Direct µmol/l 17.8 14.2 – 21.4 Diazo with Sulphanilic Acid
mg/dl 1.04 0.830 – 1.25

Bilirubin Total µmol/l 29.1 23.3 – 34.9 Dichlorophenyl Diazonium (DPD)

mg/dl 1.70 1.36 – 2.04

Calcium mmol/l 2.10 1.67 – 2.52 Arsenazo III

mg/dl 8.40 6.70 – 10.1

Chloride mmol/l 98.0 89.0 - 106 ISE Direct

Cholesterol mmol/l 3.98 3.18 – 4.76 Cholesterol Oxidase

mg/dl 154 123 - 184

Cholinesterase U/l 6040 4832 - 7248 Colorimetric Butyrylthiocholine 37°C

CK Total U/l 203 163 - 244 CK-NAC (IFCC) 37°C

Creatinine µmol/l 111 89.3 - 133 Alkaline picrate no deproteinisation

mg/dl 1.26 1.01 – 1.51
µmol/l 128 103 - 154 Enzymatic UV method (340nm)
mg/dl 1.45 1.16 – 1.74

PAGE 1 OF 2
2797

COMPONENT UNITS TARGET RANGE METHOD

gamma-GT U/l 51.3 41.0 – 62.6 Gamma Glutamyl-3-Carboxy-4-

nitroanilide (IFCC) 37°C

Glucose mmol/l 6.11 4.88 – 7.33 Hexokinase

mg/dl 110 88.0 - 132
mmol/l 6.11 4.88 – 7.33 Glucose Oxidase
mg/dl 110 88.0 - 132

Iron µmol/l 20.4 16.3 – 24.5 Colorimetric without ppt.

µg/dl 114 91.0 - 137

LD (LDH) U/l 217 173 - 260 L->P IFCC 37°C

LD (LDH) U/l 422 338 - 507 P->L SFBC 37°C

Magnesium mmol/l 0.913 0.732 – 1.09 Xylidyl Blue

mg/dl 2.22 1.78 – 2.66

Phosphate Inorganic mmol/l 1.72 1.38 – 2.07 Phosphomolybdate UV

mg/dl 5.34 4.27 – 6.41

Potassium mmol/l 3.80 3.46 – 4.14 ISE Direct

Protein Total g/l 56.6 45.3 – 67.9 Biuret reaction end point
g/dl 5.66 4.53 – 6.79

Sodium mmol/l 144 135 - 153 ISE Direct

Triglycerides mmol/l 1.06 0.848 – 1.28 Lipase/GPO-PAP no correction (Dual

mg/dl 94.0 75.0 - 113 Reagent)
Triglycerides mmol/l 1.05 0.836 – 1.25 Lipase/GPO-PAP no correction
mg/dl 93.0 74.0 - 111 (Mono Reagent)

Urea mmol/l 7.49 5.99 – 8.99 Urease kinetic

mg/dl 45.0 36.0 – 54.0

Uric Acid (Urate) mmol/l 0.348 0.278 – 0.418 Uricase peroxidase no ascorbate oxidase
mg/dl 5.85 4.68 – 7.02

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

27 May ’24 me

PAGE 2 OF 2

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