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IMMUNOASSAY PREMIUM - LEVEL 1


(IA PREMIUM 1)
CAT. NO. IA2638 GTIN: 05055273203844 SIZE: 12 x 5 ml
CAT. NO. IA2633 GTIN: 05055273203837 SIZE: 4 x 5 ml
LOT NO. 1720EC EXPIRY: 2020-04-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

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.

The Abbott Architect CA19-9 assay utilises an antibody/antigen system based on the 1116-NA-19-9 antibody. There are reports that
the formulation employed with this system may return elevated concentrations, when compared to other methods for samples
expressing high levels of 1116-NA-19-9 reactive determinants.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at
-20°C. ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial
contamination is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Immunoassay Premium - Level 1: 12 x 5 ml Tri-Level: 4 x 5 ml

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH)
is present in the control, but no claim is made for the expected value or stability of this analyte.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
Technical.Services@randox.com.
Rev. 31 Jan ’19 ne

PAGE 1 OF 14
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 2.95 2.21 3.69 DRG ELISA
ng/ml 0.976 0.732 1.22
nmol/l 4.24 3.18 5.30 DIAsource RIA
ng/ml 1.40 1.05 1.75
25-OH Vitamin D nmol/l 49.9 37.4 62.4 Diasorin Liaison
nmol/l 28.2 21.2 35.3 Siemens Centaur XP/XPT/Classic
nmol/l 20.4 15.3 25.5 Roche Vitamin D Total
nmol/l 22.8 17.1 28.5 Abbott Architect
nmol/l 79.0 59.3 98.8 Vitros ECi
nmol/l 33.2 24.9 41.5 BioMerieux Vidas
nmol/l 52.4 39.3 65.5 Beckman DxI 600/800
ACTH pmol/l 2.46 1.85 3.08 Siemens Immulite 2000/2500
pg/ml 11.2 8.41 14.0
pmol/l 3.86 2.90 4.83 Roche Cobas E411
pg/ml 17.5 13.2 21.8
pmol/l 4.77 3.50 6.04 Roche Cobas 6000/8000
pg/ml 21.7 15.9 27.5
pmol/l 3.01 2.26 3.76 Siemens Immulite 1000
pg/ml 13.7 10.3 17.1
Alphafoetoprotein KIU/l = lU/ml 9.88 7.90 11.9 BioMerieux Vidas
ng/ml 12.0 9.56 14.4
KIU/l = lU/ml 10.1 8.08 12.1 Roche Elecsys
ng/ml 12.2 9.78 14.6
KIU/l = lU/ml 10.2 8.16 12.2 Vitros ECi
ng/ml 12.3 9.87 14.7
KIU/l = lU/ml 10.6 8.37 12.8 Siemens Centaur XP/XPT/Classic
ng/ml 12.8 10.1 15.5
KIU/l = lU/ml 9.37 7.50 11.2 Siemens Immulite 2000/2500
ng/ml 11.3 9.08 13.5
KIU/l = lU/ml 9.08 7.26 10.9 Abbott Architect
ng/ml 11.0 8.78 13.2
KIU/l = lU/ml 10.5 8.93 12.1 Roche Modular E170
ng/ml 12.7 10.8 14.6
KIU/l = lU/ml 9.48 7.58 11.4 Beckman DxI800
ng/ml 11.5 9.17 13.8
KIU/l = lU/ml 10.4 8.32 12.5 Roche Cobas 6000/8000
ng/ml 12.6 10.1 15.1
KIU/l = lU/ml 10.3 8.24 12.4 Roche Cobas E411
ng/ml 12.5 9.97 15.0
Amikacin µmol/l 6.40 5.12 7.68 Gravimetric
µg/ml 3.75 3.00 4.50
Androstenedione nmol/l 4.00 3.00 5.00 Siemens Immulite 2000
ng/ml 1.15 0.860 1.44

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Beta-2-microglobulin µg/ml = mg/l 1.09 0.872 1.31 BioMerieux Vidas
µg/ml = mg/l 1.20 0.842 1.56 Siemens Immulite 2000/2500
µg/ml = mg/l 1.10 0.880 1.32 Abbott Architect
µg/ml = mg/l 1.19 0.952 1.43 Roche Cobas 6000/8000
C-Peptide nmol/l 0.624 0.468 0.780 Siemens Immulite 2000/2500
ng/ml 1.88 1.41 2.35
nmol/l 0.817 0.613 1.020 Roche Cobas 6000/8000
ng/ml 2.47 1.85 3.09
nmol/l 0.860 0.645 1.080 Diasorin Liaison
ng/ml 2.60 1.95 3.25
nmol/l 0.835 0.626 1.040 Roche Cobas E411
ng/ml 2.52 1.89 3.15
nmol/l 0.710 0.533 0.888 Abbott Architect
ng/ml 2.14 1.61 2.67
nmol/l 0.588 0.441 0.735 Siemens Centaur XP/XPT/Classic
ng/ml 1.78 1.33 2.23
Carbamazepine µmol/l 12.7 10.2 15.2 Vitros
µg/ml 3.00 2.41 3.59
µmol/l 16.5 11.9 21.1 Siemens Centaur XP/XPT/Classic
µg/ml 3.90 2.81 4.99
µmol/l 12.3 9.84 14.8 Siemens Immulite 1000
µg/ml 2.91 2.33 3.49
µmol/l 11.6 9.28 13.9 Siemens Immulite 2000/2500
µg/ml 2.74 2.19 3.29
µmol/l 15.4 12.3 18.5 Abbott Architect
µg/ml 3.64 2.91 4.37
µmol/l 15.4 12.3 18.5 Roche Cobas E411
µg/ml 3.64 2.91 4.37
µmol/l 14.0 11.2 16.8 Roche Cobas 6000/8000
µg/ml 3.31 2.65 3.97
µmol/l 15.4 12.3 18.5 Gravimetric
µg/ml 3.64 2.91 4.37
Carcinoembryonic ng/ml = µg/l 3.80 3.04 4.56 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 5.28 4.22 6.34 Siemens Immulite 1000
ng/ml = µg/l 4.27 3.42 5.12 Vitros ECi
ng/ml = µg/l 4.23 3.38 5.08 Beckman Access
ng/ml = µg/l 4.26 2.81 5.71 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 5.19 4.15 6.23 Siemens Immulite 2000/2500
ng/ml = µg/l 4.38 3.50 5.26 Abbott Architect
ng/ml = µg/l 3.88 3.10 4.66 Roche Modular E170
ng/ml = µg/l 4.08 3.26 4.90 Beckman DxI800
ng/ml = µg/l 3.94 3.15 4.73 Roche Cobas 6000/8000
ng/ml = µg/l 4.03 3.22 4.84 Roche Cobas E411
Cortisol nmol/l 142 107 178 BioMerieux Vidas
µg/dl 5.11 3.85 6.37

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 208 156 260 Siemens Immulite 1000
µg/dl 7.49 5.62 9.36
nmol/l 224 148 300 Siemens Centaur XP/XPT/Classic
µg/dl 8.06 5.32 10.8
nmol/l 214 161 268 Siemens Immulite 2000/2500
µg/dl 7.70 5.80 9.60
nmol/l 164 123 205 Vitros ECi
µg/dl 5.90 4.43 7.37
nmol/l 215 161 269 Abbott Architect
µg/dl 7.74 5.80 9.68
nmol/l 212 159 265 Beckman DxI800
µg/dl 7.63 5.72 9.54
nmol/l 191 143 239 Roche Cobas 6000/8000
µg/dl 6.88 5.15 8.61
nmol/l 199 149 249 Roche Cobas E411
µg/dl 7.16 5.36 8.96
nmol/l 202 152 253 Roche Cobas 4000/e411 Gen II
µg/dl 7.27 5.47 9.07
nmol/l 184 138 230 Roche Cobas 6000/8000 Gen II
µg/dl 6.62 4.97 8.27
DHEA-S µmol/l 2.39 1.91 2.87 Siemens Immulite 1000
µmol/l 2.34 1.87 2.81 Siemens Immulite 2000/2500
µmol/l 3.60 2.88 4.32 Roche Modular E170
µmol/l 3.05 2.44 3.66 Abbott Architect
µmol/l 2.97 2.38 3.56 Beckman DxI800
µmol/l 2.31 1.85 2.77 Siemens Centaur XP/XPT/Classic
µmol/l 3.69 2.95 4.43 Roche Cobas E411
µmol/l 3.60 2.88 4.32 Roche Cobas 6000/8000
Digoxin nmol/l 0.930 0.697 1.16 Siemens Centaur XP/XPT/Classic
ng/ml 0.730 0.545 0.907
nmol/l 0.540 0.432 0.648 Abbott Architect
ng/ml 0.422 0.337 0.507
nmol/l 0.750 0.600 0.900 Beckman DxI800
ng/ml 0.586 0.469 0.703
nmol/l 0.810 0.648 0.972 Roche Cobas 6000/8000
ng/ml 0.633 0.506 0.760
nmol/l 0.900 0.720 1.08 Gravimetric
ng/ml 0.703 0.562 0.844
Ethosuximide µmol/l 226 181 271 Gravimetric
µg/ml 32.0 25.7 38.4
Ferritin ng/ml = µg/l 10.9 8.18 13.6 BioMerieux Vidas
ng/ml = µg/l 9.93 7.94 11.9 Siemens Immulite 1000
ng/ml = µg/l 12.4 9.92 14.9 Roche Elecsys
ng/ml = µg/l 9.43 7.54 11.3 Vitros ECi
ng/ml = µg/l 10.8 8.10 13.5 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 10.6 8.48 12.7 Siemens Immulite 2000/2500

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 11.0 8.80 13.2 Abbott Architect
ng/ml = µg/l 11.8 9.44 14.2 Roche Modular E170
ng/ml = µg/l 11.7 9.36 14.0 Siemens Dimension
ng/ml = µg/l 8.28 6.20 10.4 Beckman DxI800
ng/ml = µg/l 11.4 9.12 13.7 Roche Cobas E411
Folate nmol/l 2.86 2.17 3.55 Siemens Immulite 2000
ng/ml 1.26 0.957 1.56
nmol/l 3.98 3.02 4.94 Vitros ECi
ng/ml 1.76 1.33 2.19
nmol/l 8.82 4.85 12.8 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 3.89 2.14 5.64
nmol/l 3.55 2.53 4.57 Beckman DxI800
ng/ml 1.57 1.12 2.02
nmol/l 3.06 2.30 3.82 Roche Cobas 6000/8000 Folate III
ng/ml 1.35 1.01 1.69
Free T3 pmol/l 4.44 3.33 5.55 BioMerieux Vidas
ng/dl 0.289 0.216 0.360
pg/ml 2.89 2.17 3.61
pmol/l 4.91 3.68 6.14 Roche Elecsys
ng/dl 0.319 0.239 0.399
pg/ml 3.20 2.40 4.00
pmol/l 4.65 3.49 5.81 Beckman Access
ng/dl 0.302 0.227 0.377
pg/ml 3.03 2.27 3.79
pmol/l 10.7 8.03 13.4 Vitros ECi
ng/dl 0.696 0.522 0.870
pg/ml 6.97 5.23 8.71
pmol/l 4.66 2.80 6.52 Siemens Centaur XP/XPT/Classic
ng/dl 0.300 0.182 0.424
pg/ml 3.03 1.82 4.24
pmol/l 4.07 3.05 5.09 Siemens Immulite 2000/2500
ng/dl 0.265 0.198 0.332
pg/ml 2.65 1.99 3.31
pmol/l 3.40 2.55 4.25 Abbott Architect
ng/dl 0.221 0.166 0.276
pg/ml 2.21 1.66 2.76
pmol/l 5.24 3.93 6.55 Roche Modular E170
ng/dl 0.341 0.255 0.427
pg/ml 3.41 2.56 4.26
pmol/l 4.70 3.53 5.88 Beckman DxI800
ng/dl 0.306 0.229 0.383
pg/ml 3.06 2.30 3.82
pmol/l 5.25 3.94 6.56 Roche Cobas E411
ng/dl 0.341 0.256 0.426
pg/ml 3.42 2.56 4.28
pmol/l 5.02 3.77 6.28 Roche Cobas 6000/8000
ng/dl 0.326 0.245 0.407
pg/ml 3.27 2.45 4.09

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 15.6 11.7 19.5 Siemens Immulite 1000
ng/dl 1.22 0.913 1.53
pg/ml 12.2 9.13 15.3
pmol/l 15.4 11.6 19.3 Roche Elecsys
ng/dl 1.20 0.905 1.50
pg/ml 12.0 9.05 15.0
pmol/l 12.3 9.23 15.4 Beckman Access
ng/dl 0.959 0.720 1.20
pg/ml 9.59 7.20 12.0
pmol/l 27.0 20.3 33.8 Vitros ECi
ng/dl 2.11 1.58 2.64
pg/ml 21.1 15.8 26.4
pmol/l 10.2 7.70 12.7 Siemens Centaur XP/XPT/Classic
ng/dl 0.800 0.597 0.995
pg/ml 7.96 5.97 9.95
pmol/l 15.9 11.9 19.9 Siemens Immulite 2000/2500
ng/dl 1.24 0.928 1.55
pg/ml 12.4 9.28 15.5
pmol/l 10.4 7.80 13.0 Abbott Architect
ng/dl 0.811 0.608 1.01
pg/ml 8.11 6.08 10.1
pmol/l 14.9 11.2 18.6 Diasorin Liaison
ng/dl 1.16 0.874 1.45
pg/ml 11.6 8.74 14.5
pmol/l 15.9 11.9 19.9 Roche Modular E170
ng/dl 1.24 0.928 1.55
pg/ml 12.4 9.28 15.5
pmol/l 12.1 9.08 15.1 Beckman DxI800
ng/dl 0.944 0.708 1.18
pg/ml 9.44 7.08 11.8
pmol/l 15.5 11.6 19.4 Roche Cobas 6000/8000
ng/dl 1.21 0.905 1.52
pg/ml 12.1 9.05 15.2
pmol/l 15.7 11.8 19.6 Roche Cobas E411
ng/dl 1.22 0.920 1.52
pg/ml 12.2 9.20 15.2
pmol/l 15.0 11.3 18.8 Biomerieux Vidas FT4N Kit
ng/dl 1.17 0.881 1.46
pg/ml 11.7 8.81 14.6
pmol/l 11.4 8.60 14.2 Siemens Centaur CP
ng/dl 0.890 0.667 1.11
pg/ml 8.89 6.67 11.1
FSH mU/ml 6.70 5.36 8.04 Siemens Immulite 1000
mU/ml 6.46 5.17 7.75 BioMerieux Vidas

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
FSH mU/ml 6.23 4.98 7.48 Beckman Access
mU/ml 6.70 5.36 8.04 Roche/BM Elecsys
mU/ml 4.71 3.77 5.65 Vitros ECi
mU/ml 8.37 5.86 10.9 Siemens Centaur XP/XPT/Classic
mU/ml 6.63 5.30 7.96 Siemens Immulite 2000/2500
mU/ml 5.05 4.04 6.06 Abbott Architect
mU/ml 5.95 4.76 7.14 Roche Modular E170
mU/ml 6.30 5.04 7.56 Beckman DxI800
mU/ml 6.24 4.99 7.49 Roche Cobas E411
mU/ml 6.10 4.88 7.32 Roche Cobas 6000/8000
Gentamicin µmol/l 3.65 2.58 4.72 Roche Cobas 6000/8000
µg/ml 1.74 1.23 2.25
µmol/l 4.85 3.88 5.82 Gravimetric
µg/ml 2.32 1.85 2.78
Growth Hormone (GH) µU/ml 5.88 4.70 7.06 Siemens Immulite 1000
ng/ml 1.96 1.57 2.35
µU/ml 6.57 5.26 7.88 Siemens Immulite 2000/2500
ng/ml 2.19 1.75 2.63
µU/ml 4.86 3.89 5.83 Beckman DxI800
ng/ml 1.62 1.30 1.94
µU/ml 4.38 3.50 5.26 Diasorin Liaison
ng/ml 1.46 1.17 1.75
µU/ml 5.56 4.45 6.67 Roche Cobas E411
ng/ml 1.85 1.48 2.22
µU/ml 5.75 4.60 6.90 Roche Cobas 6000/8000
ng/ml 1.91 1.53 2.29
Immunoglobulin E KIU/l = IU/ml 234 187 281 Siemens Immulite 1000
KIU/l = IU/ml 202 162 242 BioMerieux Vidas
KIU/l = IU/ml 219 131 307 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 246 197 295 Siemens Immulite 2000/2500
KIU/l = IU/ml 241 193 289 Roche Modular E170
KIU/l = IU/ml 215 172 258 Beckman DxI800
KIU/l = IU/ml 236 189 283 Abbott Architect
KIU/l = IU/ml 240 192 288 Roche Cobas E411
KIU/l = IU/ml 241 193 289 Roche Cobas 6000/8000
Insulin mU/l 1.72 1.29 2.15 Siemens Centaur XP/XPT/Classic
pmol/l 11.9 8.90 14.9
mU/l 1.42 1.07 1.78 Roche Modular E170
pmol/l 9.86 7.43 12.3
mU/l 1.00 0.750 1.25 Abbott Architect
pmol/l 6.95 5.21 8.69
mU/l 1.33 0.998 1.66 Roche Cobas E411
pmol/l 9.24 6.93 11.6
mU/l 1.38 1.04 1.73 Roche Cobas 6000/8000
pmol/l 9.58 7.22 11.9
mU/l 0.810 0.608 1.01 Beckman DxI 600/800
pmol/l 5.63 4.22 7.04

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Luteinising Hormone mU/ml 2.50 2.00 3.00 BioMerieux Vidas
(LH)
mU/ml 5.93 4.74 7.12 Siemens Immulite 1000
mU/ml 3.74 2.99 4.49 Roche Elecsys
mU/ml 6.72 4.71 8.73 Vitros ECi
mU/ml 2.74 2.06 3.42 Siemens Centaur XP/XPT/Classic
mU/ml 5.57 4.46 6.68 Siemens Immulite 2000
mU/ml 2.05 1.64 2.46 Abbott Architect
mU/ml 3.50 2.80 4.20 Roche Modular E170
mU/ml 1.58 1.26 1.90 Beckman DxI800
mU/ml 3.52 2.82 4.22 Roche Cobas E411
mU/ml 3.47 2.78 4.16 Roche Cobas 6000/8000
Oestradiol pmol/l 253 202 304 BioMerieux Vidas
pg/ml 68.8 54.9 82.7
pmol/l 171 137 205 Roche Elecsys (Estradiol II)
pg/ml 46.5 37.3 55.7
pmol/l 126 101 151 Vitros ECi
pg/ml 34.3 27.5 41.1
pmol/l 144 115 173 Siemens Immulite 2000/2500
pg/ml 39.2 31.3 47.1
pmol/l 219 175 263 Abbott Architect
pg/ml 59.6 47.6 71.6
pmol/l 190 152 228 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 51.7 41.3 62.1
pmol/l 179 143 215 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 48.7 38.9 58.5
pmol/l 207 124 290 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 56.3 33.8 78.8
pmol/l 188 150 226 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 51.1 40.8 61.4
pmol/l 181 145 217 Roche Elecsys (Estradiol III)
pg/ml 49.2 39.4 59.0
pmol/l 174 139 209 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 47.3 37.8 56.8
pmol/l 191 146 236 Roche Modular E170 (Estradiol III)
pg/ml 52.0 39.7 64.3
Paracetamol mmol/l 0.160 0.128 0.192 Abbott Architect
mg/l 24.2 19.4 29.0
mmol/l 0.132 0.106 0.158 Roche Cobas 6000/8000
mg/l 20.0 16.0 24.0
mmol/l 0.166 0.133 0.199 Gravimetric
mg/l 25.1 20.1 30.1
Phenobarbital µmol/l 34.6 27.7 41.5 Abbott Architect
µg/ml 8.03 6.43 9.63
µmol/l 33.6 26.9 40.3 Beckman AU400/600/640/2700/5400
µg/ml 7.80 6.24 9.36

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Phenobarbital µmol/l 34.5 27.6 41.4 Gravimetric
µg/ml 8.00 6.40 9.60
Phenytoin µmol/l 19.4 15.5 23.3 Abbott Architect
µg/ml 4.90 3.91 5.89
µmol/l 18.3 14.6 22.0 Beckman DxC
µg/ml 4.62 3.69 5.55
µmol/l 18.1 13.9 22.3 Roche Cobas 6000/8000
µg/ml 4.57 3.51 5.63
µmol/l 20.2 16.2 24.2 Gravimetric
µg/ml 5.10 4.09 6.11
Primidone µmol/l 12.3 9.84 14.8 Gravimetric
µg/ml 2.69 2.15 3.23
Progesterone nmol/l 3.48 2.78 4.18 Siemens Immulite 1000
ng/ml 1.09 0.870 1.31
nmol/l 4.71 3.34 6.08 BioMerieux Vidas
ng/ml 1.47 1.05 1.89
nmol/l 2.82 1.99 3.65 Roche Elecsys (Prog. II)
ng/ml 0.883 0.623 1.14
nmol/l 3.89 2.77 5.01 Vitros ECi
ng/ml 1.22 0.867 1.57
nmol/l 2.65 1.46 3.84 Siemens Centaur XP/XPT/Classic
ng/ml 0.830 0.456 1.20
nmol/l 3.67 2.94 4.40 Siemens Immulite 2000/2500
ng/ml 1.15 0.920 1.38
nmol/l 3.32 2.66 3.98 Abbott Architect
ng/ml 1.04 0.833 1.25
nmol/l 3.29 2.49 4.09 Beckman DxI Prog Cal 33555
ng/ml 1.03 0.779 1.28
nmol/l 3.06 2.45 3.67 Diasorin Liaison
ng/ml 0.958 0.767 1.15
nmol/l 2.97 2.29 3.65 Roche Cobas 4000/e411 (Prog. II)
ng/ml 0.930 0.717 1.14
nmol/l 2.83 2.20 3.46 Roche Cobas 6000/8000 (Prog. II)
ng/ml 0.886 0.689 1.08
ng/ml 0.820 0.698 0.940
nmol/l 2.16 1.59 2.73 Beckman DxI Prog DE Cal A80773
ng/ml 0.676 0.498 0.850
nmol/l 3.16 2.40 3.92 Roche Cobas 6000/8000 (Prog. III)
ng/ml 0.989 0.751 1.23
nmol/l 3.18 2.54 3.82 Roche Cobas 4000/e411 (Prog. III)
ng/ml 0.995 0.795 1.20
nmol/l 3.32 2.66 3.98 Roche Modular E170 (Prog. III)
ng/ml 1.04 0.833 1.25
Prolactin µU/ml 198 158 238 BioMerieux Vidas
µU/ml 192 154 230 Siemens Immulite 1000
µU/ml 214 171 257 Roche Elecsys

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Prolactin µU/ml 195 156 234 Vitros ECi
µU/ml 164 115 213 Siemens Centaur XP/XPT/Classic
µU/ml 177 142 212 Siemens Immulite 2000/2500
µU/ml 191 153 229 Abbott Architect
µU/ml 191 153 229 Roche Modular E170
µU/ml 172 138 206 Beckman DxI800
µU/ml 190 152 228 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 203 162 244 Roche Cobas E411
µU/ml 191 153 229 Roche Cobas 6000/8000
µU/ml 188 150 226 Abbott Architect restandardised
PSA Free ng/ml = µg/l 0.940 0.705 1.18 Siemens Immulite 2000/2500
ng/ml = µg/l 1.08 0.810 1.35 Abbott Architect
ng/ml = µg/l 1.18 0.890 1.47 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.06 0.795 1.33 Roche Modular E170
ng/ml = µg/l 1.52 1.14 1.90 Beckman DXI standardised to Hybritech
ng/ml = µg/l 1.11 0.833 1.39 Roche Cobas E411
ng/ml = µg/l 1.08 0.810 1.35 Roche Cobas 6000/8000
ng/ml = µg/l 0.950 0.713 1.19 Ortho Vitros 3600/5600/ECi PSA II
PSA Total ng/ml = µg/l 1.26 0.945 1.58 Siemens Immulite 1000 1st generation
ng/ml = µg/l 1.36 1.02 1.70 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.23 0.923 1.54 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.64 1.23 2.05 bioMerieux VIDAS TPSA
ng/ml = µg/l 1.40 1.05 1.75 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 1.22 0.915 1.53 Abbott Architect
ng/ml = µg/l 1.42 1.07 1.78 Siemens Immulite 2000/2500 3rd generation
ng/ml = µg/l 1.33 0.998 1.66 Vitros ECi
ng/ml = µg/l 1.45 1.09 1.81 Roche Modular E170
ng/ml = µg/l 1.31 0.983 1.64 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 1.09 0.818 1.36 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 1.50 1.13 1.88 Roche Cobas E411
ng/ml = µg/l 1.48 1.11 1.85 Roche Cobas 6000/8000
ng/ml = µg/l 1.31 0.983 1.64 Ortho Vitros 3600/5600/ECi PSA II
Salicylate mmol/l 0.286 0.229 0.343 Gravimetric
mg/dl 3.95 3.16 4.74
SHBG nmol/l 13.2 10.6 15.8 Siemens Immulite 1000
nmol/l 13.9 11.1 16.7 Siemens Immulite 2000/2500
nmol/l 12.9 10.3 15.5 Roche Modular E170
nmol/l 13.1 10.5 15.7 Abbott Architect
nmol/l 14.1 11.3 16.9 Roche Cobas E411
nmol/l 13.4 10.7 16.1 Roche Cobas 6000/8000
nmol/l 13.4 10.7 16.1 Beckman DxI800
T Uptake %U 39.4 32.3 46.5 Siemens Immulite 2000
Testosterone nmol/l 1.24 0.962 1.52 Vitros ECi
ng/ml 0.357 0.277 0.440
ng/dl 35.7 27.7 43.7
nmol/l 1.57 1.02 2.12 Siemens Centaur XP/XPT/Classic
ng/ml 0.450 0.294 0.610
ng/dl 45.2 29.4 61.0

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 1.38 1.04 1.72 Siemens Immulite 2000/2500
ng/ml 0.397 0.300 0.490
ng/dl 39.7 30.0 49.4
nmol/l 1.60 1.28 1.92 Abbott Architect
ng/ml 0.461 0.369 0.553
ng/dl 46.1 36.9 55.3
nmol/l 1.74 1.39 2.09 Beckman DxI800
ng/ml 0.501 0.400 0.602
ng/dl 50.1 40.0 60.2
nmol/l 1.81 1.45 2.17 Roche Elecsys Test II
ng/ml 0.521 0.418 0.624
ng/dl 52.1 41.8 62.4
nmol/l 1.84 1.47 2.21 Roche Modular E170 Test II
ng/ml 0.530 0.423 0.637
ng/dl 53.0 42.3 63.7
nmol/l 1.85 1.48 2.22 Roche Cobas 4000/e411 Test II
ng/ml 0.533 0.426 0.640
ng/dl 53.3 42.6 64.0
nmol/l 1.81 1.45 2.17 Roche Cobas 6000 Test 2
ng/ml 0.521 0.418 0.624
ng/dl 52.1 41.8 62.4
nmol/l 1.57 1.26 1.88 Abbott Architect 2nd Generation
ng/ml 0.452 0.363 0.541
ng/dl 45.2 36.3 54.1
nmol/l 1.14 0.912 1.37 BioMerieux Vidas Testosterone II
ng/ml 0.328 0.263 0.393
ng/dl 32.8 26.3 39.3
Theophylline µmol/l 27.2 20.4 34.0 Abbott Architect
µg/ml 4.90 3.68 6.12
µmol/l 28.3 22.6 34.0 Gravimetric
µg/ml 5.10 4.07 6.13
Thyroglobulin ng/ml 2.92 2.19 3.65 Roche Cobas E411
ng/ml 2.75 2.06 3.44 Roche Cobas 6000/8000
ng/ml 2.82 2.12 3.53 Roche Cobas 6000 TGII
ng/ml 3.02 2.27 3.78 Roche Cobas 4000/E411 TGII
Thyroid Stimulating µU/ml = mlU/l 0.073 0.058 0.088 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 0.125 0.100 0.150 Siemens Immulite 1000
µU/ml = mlU/l 0.132 0.106 0.158 Roche Elecsys
µU/ml = mlU/l 0.098 0.078 0.118 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 0.193 0.154 0.232 Vitros ECi
µU/ml = mlU/l 0.109 0.074 0.144 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 0.103 0.082 0.124 Siemens Immulite 2000/2500
µU/ml = mlU/l 0.101 0.081 0.121 Abbott Architect
µU/ml = mlU/l 0.135 0.108 0.162 Roche Modular E170

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 0.067 0.054 0.080 bioMerieux VIDAS TSH3 Ultrasensitive
Hormone
µU/ml = mlU/l 0.103 0.082 0.124 Beckman Access Fast TSH
µU/ml = mlU/l 0.132 0.106 0.158 Roche Cobas E411
µU/ml = mlU/l 0.135 0.108 0.162 Roche Cobas 6000/8000
µU/ml = mlU/l 0.096 0.077 0.115 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 0.112 0.076 0.148 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 0.091 0.073 0.109 Beckman DxI 600/800 Access (3rd IS)
Tobramycin µmol/l 4.17 3.34 5.00 Gravimetric
µg/ml 1.95 1.56 2.34
Total Beta hCG mU/ml=IU/l 13.5 10.8 16.2 BioMerieux Vidas
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 22.6 17.0 28.2 Siemens Immulite 1000
IU/ml 0.023 0.017 0.030
mU/ml=IU/l 13.2 10.6 15.8 Roche Cobas Core EIA
IU/ml 0.013 0.011 0.015
mU/ml=IU/l 16.9 13.5 20.3 Beckman Access
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 15.8 12.6 19.0 Vitros ECi
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 17.3 10.4 24.2 Siemens Centaur XP/XPT/Classic
IU/ml 0.017 0.010 0.024
mU/ml=IU/l 24.8 19.8 29.8 Siemens Immulite 2000
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 12.7 10.2 15.2 Abbott Architect
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 14.5 11.6 17.4 Siemens Dimension
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 17.0 13.6 20.4 Beckman DxI800
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 10.5 8.40 12.6 Roche STAT (Intact)
IU/ml 0.011 0.008 0.014
mU/ml=IU/l 13.5 10.8 16.2 Roche hCG+Beta
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 16.7 13.4 20.0 Beckman Access Total BhCG (5th IS)
IU/ml 0.017 0.013 0.021
mU/ml=IU/l 17.5 14.0 21.0 Beckman DxI Total BhCG (5th IS)
IU/ml 0.018 0.014 0.022
Total T3 nmol/l 0.735 0.551 0.919 BioMerieux Vidas
ng/ml 0.478 0.359 0.597
ng/dl 47.8 35.9 59.7
nmol/l 0.618 0.464 0.773 Siemens Immulite 1000
ng/ml 0.402 0.302 0.502
ng/dl 40.2 30.2 50.2
nmol/l 0.872 0.654 1.09 Siemens Centaur XP/XPT/Classic
ng/ml 0.568 0.426 0.710
ng/dl 56.8 42.6 71.0

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 0.669 0.502 0.836 Siemens Immulite 2000/2500
ng/ml 0.436 0.327 0.545
ng/dl 43.6 32.7 54.5
nmol/l 0.912 0.684 1.14 Abbott Architect
ng/ml 0.594 0.445 0.743
ng/dl 59.4 44.5 74.3
nmol/l 1.30 0.975 1.63 Vitros ECi
ng/ml 0.846 0.635 1.06
ng/dl 84.6 63.5 106
nmol/l 1.64 1.23 2.05 Roche Cobas E411
ng/ml 1.07 0.801 1.34
ng/dl 107 80.1 134
nmol/l 1.59 1.19 1.99 Roche Cobas 6000/8000
ng/ml 1.04 0.775 1.31
ng/dl 104 77.5 131
Total T4 nmol/l 27.4 20.6 34.3 Vitros ECi
µg/dl 2.14 1.61 2.67
ng/ml 21.4 16.1 26.7
nmol/l 35.4 26.6 44.3 BioMerieux Vidas
µg/dl 2.76 2.07 3.45
ng/ml 27.6 20.7 34.5
nmol/l 25.6 17.9 33.3 Siemens Centaur XP/XPT/Classic
µg/dl 2.00 1.40 2.60
ng/ml 20.0 14.0 26.0
nmol/l 25.3 19.0 31.6 Siemens Immulite 2000/2500
µg/dl 1.97 1.48 2.46
ng/ml 19.7 14.8 24.6
nmol/l 36.7 27.5 45.9 Abbott Architect
µg/dl 2.86 2.15 3.57
ng/ml 28.6 21.5 35.7
nmol/l 40.1 30.1 50.1 Roche Cobas E411
µg/dl 3.13 2.35 3.91
ng/ml 31.3 23.5 39.1
nmol/l 35.7 26.8 44.6 Roche Cobas 6000/8000
µg/dl 2.78 2.09 3.47
ng/ml 27.8 20.9 34.7
Valproic Acid µmol/l 200 160 240 Siemens Immulite 1000
µg/ml 28.9 23.1 34.7
µmol/l 195 156 234 Siemens Immulite 2000/2500
µg/ml 28.1 22.5 33.7
µmol/l 223 156 290 Siemens Centaur XP/XPT/Classic
µg/ml 32.2 22.5 41.9
µmol/l 174 139 209 Vitros
µg/ml 25.1 20.1 30.1
µmol/l 203 162 244 Siemens Dimension
µg/ml 29.3 23.4 35.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 1 (IA PREMIUM 1)
Cat. No. IA2638 / IA2633 Lot No. 1720EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 217 174 260 Abbott Architect
µg/ml 31.3 25.1 37.5
µmol/l 187 150 224 Beckman DxC
µg/ml 27.0 21.6 32.4
µmol/l 202 162 242 Roche Cobas 6000/8000
µg/ml 29.1 23.4 34.8
µmol/l 243 194 292 Gravimetric
µg/ml 35.1 28.0 42.1
Vancomycin µmol/l 3.22 2.58 3.86 Abbott Architect
µg/ml 4.78 3.83 5.73
µmol/l 2.74 2.19 3.29 Siemens Dimension
µg/ml 4.07 3.25 4.89
µmol/l 3.35 2.60 4.10 Roche Cobas 6000/8000
µg/ml 4.98 3.86 6.10
µmol/l 3.43 2.74 4.12 Gravimetric
µg/ml 5.10 4.07 6.12
Vitamin B12 pmol/l 106 74.2 138 Siemens Centaur XP/XPT/Classic
pg/ml 144 101 187
pmol/l 111 88.8 133 Siemens Immulite 2000
pg/ml 150 120 180
pmol/l 138 104 172 Abbott Architect
pg/ml 187 141 233
pmol/l 130 104 156 Vitros ECi
pg/ml 176 141 211
pmol/l 113 90.4 136 Roche Modular E170
pg/ml 153 122 184
pmol/l 80.3 62.7 97.9 Beckman DxI800
pg/ml 109 85.0 133
pmol/l 114 87.6 140 Roche Cobas 6000/8000
pg/ml 154 119 189
pmol/l 106 84.8 127 Siemens Dimension
pg/ml 144 115 173

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 14
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
0086

IMMUNOASSAY PREMIUM - LEVEL 2


(IA PREMIUM 2)
CAT. NO. IA2639 GTIN: 05055273203851 SIZE: 12 x 5 ml
CAT. NO. IA2633 GTIN: 05055273203837 SIZE: 4 x 5 ml
LOT NO. 1721EC EXPIRY: 2020-04-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

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.

The Abbott Architect CA19-9 assay utilises an antibody/antigen system based on the 1116-NA-19-9 antibody. There are reports that
the formulation employed with this system may return elevated concentrations, when compared to other methods for samples
expressing high levels of 1116-NA-19-9 reactive determinants.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at
–20°C. ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial
contamination is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Immunoassay Premium - Level 2: 12 x 5 ml Tri-Level: 4 x 5 ml

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH)
is present in the control, but no claim is made for the expected value or stability of this analyte.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
Technical.Services@randox.com.
03 Jan ’18 ne

PAGE 1 OF 24
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 10.6 7.95 13.3 Immunotech RIA
ng/ml 3.51 2.63 4.39
nmol/l 13.9 10.4 17.4 DRG ELISA
ng/ml 4.60 3.44 5.76
nmol/l 12.5 9.38 15.6 DIAsource RIA
ng/ml 4.14 3.10 5.18
nmol/l 13.0 9.75 16.3 DiaMetra ELISA
ng/ml 4.30 3.23 5.37
nmol/l 17.9 13.4 22.4 IBL ELISA
ng/ml 5.92 4.44 7.40
25-OH Vitamin D nmol/l 69.3 52.0 86.6 Diasorin Liaison
nmol/l 90.4 67.8 113 Siemens Centaur XP/XPT/Classic
nmol/l 50.4 37.8 63.0 Roche Vitamin D Total
nmol/l 72.6 54.5 90.8 HPLC
nmol/l 58.3 43.7 72.9 Abbott Architect
nmol/l 61.3 46.0 76.6 IDS iSYS
nmol/l 83.7 62.8 105 Vitros ECi
nmol/l 59.0 44.3 73.8 Tosoh Series
nmol/l 69.6 52.2 87.0 BioMerieux Vidas
nmol/l 55.8 41.9 69.8 Beckman DxI 600/800
nmol/l 58.9 44.2 73.6 Fujirebio Lumipulse G Series
nmol/l 60.4 45.3 75.5 Beckman Access 25 OH Vitamin D Total
ACTH pmol/l 10.1 7.58 12.6 Siemens Immulite 2000/2500
pg/ml 45.9 34.5 57.3
pmol/l 11.6 8.70 14.5 Roche Cobas E411
pg/ml 52.7 39.5 65.9
pmol/l 12.8 9.60 16.0 Roche Cobas 6000/8000
pg/ml 58.2 43.6 72.8
pmol/l 11.4 8.55 14.3 Siemens Immulite 1000
pg/ml 51.8 38.9 64.7
Aldosterone pmol/l 376 282 470 CIS RIA
pg/ml 136 102 170
pmol/l 781 586 976 ELISA
pg/ml 282 211 353
pmol/l 1045 784 1306 IDS iSYS
pg/ml 377 283 471
pmol/l 840 630 1050 Diasorin Liaison
pg/ml 303 227 379
Alphafoetoprotein KIU/l = lU/ml 48.0 38.4 57.6 Abbott Architect
ng/ml 58.1 46.5 69.7
KIU/l = lU/ml 47.6 38.1 57.1 BioMerieux Vidas
ng/ml 57.6 46.1 69.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Alphafoetoprotein KIU/l = lU/ml 55.4 43.8 67.0 Siemens Centaur XP/XPT/Classic
ng/ml 67.0 52.9 81.1
KIU/l = lU/ml 47.3 37.8 56.8 Siemens Immulite 2000/2500
ng/ml 57.2 45.7 68.7
KIU/l = lU/ml 45.1 36.1 54.1 Siemens Immulite 1000
ng/ml 54.6 43.7 65.5
KIU/l = lU/ml 47.6 38.1 57.1 Beckman DxI800
ng/ml 57.6 46.1 69.1
KIU/l = lU/ml 53.9 43.1 64.7 Roche Elecsys
ng/ml 65.2 52.2 78.2
KIU/l = lU/ml 52.4 41.9 62.9 Diasorin Liaison
ng/ml 63.4 50.7 76.1
KIU/l = lU/ml 54.0 43.2 64.8 Roche Modular E170
ng/ml 65.3 52.3 78.3
KIU/l = lU/ml 50.7 40.6 60.8 Beckman Access
ng/ml 61.3 49.1 73.5
KIU/l = lU/ml 45.7 36.6 54.8 Tosoh Series
ng/ml 55.3 44.3 66.3
KIU/l = lU/ml 50.7 40.6 60.8 Vitros ECi
ng/ml 61.3 49.1 73.5
KIU/l = lU/ml 53.8 43.0 64.6 Roche Cobas 6000/8000
ng/ml 65.1 52.0 78.2
KIU/l = lU/ml 74.1 59.3 88.9 CIS IRMA
ng/ml 89.7 71.8 108
KIU/l = lU/ml 54.4 43.5 65.3 Roche Cobas E411
ng/ml 65.8 52.6 79.0
KIU/l = lU/ml 50.3 40.2 60.4 Fujirebio Lumipulse G Series
ng/ml 60.9 48.6 73.2
KIU/l = lU/ml 53.6 42.9 64.3 Siemens Dimension
ng/ml 64.9 51.9 77.9
KIU/l = lU/ml 54.9 43.0 67.0 Siemens Centaur CP
ng/ml 66.4 52.0 81.0
Amikacin µmol/l 15.5 12.4 18.6 Roche Integra
µg/ml 9.08 7.26 10.9
µmol/l 14.6 11.7 17.5 Roche Cobas 6000/8000
µg/ml 8.55 6.85 10.3
µmol/l 15.2 12.2 18.2 Gravimetric
µg/ml 8.90 7.14 10.7
Androstenedione nmol/l 16.0 12.0 20.0 Siemens Immulite 2000
ng/ml 4.59 3.44 5.74
Beta-2-microglobulin µg/ml = mg/l 3.98 3.18 4.78 Abbott Architect
µg/ml = mg/l 3.68 2.94 4.42 BioMerieux Vidas
µg/ml = mg/l 3.96 3.17 4.75 Behring Nephelometer
µg/ml = mg/l 3.92 3.14 4.70 Roche Tinaquant
µg/ml = mg/l 3.45 2.76 4.14 Siemens Immulite 2000/2500
µg/ml = mg/l 3.68 2.76 4.60 Siemens Immulite 1000

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Beta-2-microglobulin µg/ml = mg/l 3.23 2.58 3.88 Diasorin Liaison
µg/ml = mg/l 4.09 3.27 4.91 Roche Cobas E411
µg/ml = mg/l 3.92 3.14 4.70 Roche Cobas 6000/8000
µg/ml = mg/l 3.86 3.09 4.63 Roche Modular E170
µg/ml = mg/l 3.85 3.08 4.62 Siemens ADVIA 1200/1650/1800/2400
C-Peptide nmol/l 1.860 1.400 2.330 Siemens Immulite 2000/2500
ng/ml 5.62 4.23 7.01
nmol/l 2.020 1.520 2.530 Roche Elecsys
ng/ml 6.10 4.59 7.61
nmol/l 2.010 1.510 2.510 Roche Cobas 6000/8000
ng/ml 6.07 4.56 7.58
nmol/l 1.830 1.370 2.290 Siemens Immulite 1000
ng/ml 5.52 4.14 6.90
nmol/l 2.320 1.740 2.900 Diasorin Liaison
ng/ml 7.00 5.25 8.75
nmol/l 2.030 1.520 2.540 Roche Cobas E411
ng/ml 6.13 4.59 7.67
nmol/l 1.960 1.470 2.450 Roche Modular E170
ng/ml 5.92 4.44 7.40
nmol/l 1.790 1.340 2.240 Abbott Architect
ng/ml 5.40 4.05 6.75
nmol/l 1.600 1.200 2.000 Siemens Centaur XP/XPT/Classic
ng/ml 4.83 3.62 6.04
nmol/l 1.910 1.430 2.390 Tosoh Series
ng/ml 5.77 4.32 7.22
Carbamazepine µmol/l 38.8 31.0 46.6 Abbott Architect
µg/ml 9.17 7.33 11.0
µmol/l 42.3 33.8 50.8 Behring Emit
µg/ml 10.0 7.99 12.0
µmol/l 41.9 29.3 54.5 Siemens Centaur XP/XPT/Classic
µg/ml 9.91 6.94 12.9
µmol/l 38.3 30.6 46.0 Siemens Dimension
µg/ml 9.05 7.23 10.9
µmol/l 34.7 27.8 41.6 Siemens Immulite 2000/2500
µg/ml 8.20 6.57 9.83
µmol/l 36.2 29.0 43.4 Siemens Immulite 1000
µg/ml 8.56 6.86 10.3
µmol/l 38.3 30.6 46.0 Roche Integra
µg/ml 9.05 7.23 10.9
µmol/l 37.4 29.9 44.9 Vitros
µg/ml 8.84 7.07 10.6
µmol/l 36.3 29.0 43.6 Roche Cobas E411
µg/ml 8.58 6.86 10.3
µmol/l 37.1 29.7 44.5 Roche Cobas 6000/8000
µg/ml 8.77 7.02 10.5
µmol/l 34.1 27.1 41.1 Beckman DxC
µg/ml 8.06 6.41 9.71

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 41.8 33.4 50.2 Beckman AU400/600/640/2700/5400
µg/ml 9.88 7.90 11.9
µmol/l 42.3 33.8 50.8 Siemens ADVIA 1200/1650/1800/2400
µg/ml 10.0 7.99 12.0
µmol/l 38.5 30.8 46.2 Gravimetric
µg/ml 9.10 7.28 10.9
Carcinoembryonic ng/ml = µg/l 29.4 23.5 35.3 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 24.7 19.8 29.6 BioMerieux Vidas
ng/ml = µg/l 28.8 19.6 38.0 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 18.7 15.0 22.4 CIS RIA Coated tube
ng/ml = µg/l 37.7 30.2 45.2 Siemens Immulite 2000/2500
ng/ml = µg/l 37.2 29.8 44.6 Siemens Immulite 1000
ng/ml = µg/l 23.3 18.6 28.0 Beckman DxI800
ng/ml = µg/l 23.3 18.6 28.0 Roche Elecsys
ng/ml = µg/l 22.5 18.0 27.0 Diasorin Liaison
ng/ml = µg/l 22.6 18.1 27.1 Roche Modular E170
ng/ml = µg/l 25.0 20.0 30.0 Beckman Access
ng/ml = µg/l 40.2 32.2 48.2 Tosoh Series
ng/ml = µg/l 28.2 22.6 33.8 Vitros ECi
ng/ml = µg/l 23.0 18.4 27.6 Roche Cobas 6000/8000
ng/ml = µg/l 23.2 18.6 27.8 Roche Cobas E411
ng/ml = µg/l 39.4 31.5 47.3 Fujirebio Lumipulse G Series
ng/ml = µg/l 28.9 19.7 38.1 Siemens Centaur CP
Cortisol nmol/l 524 393 655 Abbott Architect
µg/dl 18.9 14.1 23.7
nmol/l 539 403 675 BioMerieux Vidas
µg/dl 19.4 14.5 24.3
nmol/l 687 474 900 Siemens Centaur XP/XPT/Classic
µg/dl 24.7 17.0 32.4
nmol/l 498 374 623 CIS RIA
µg/dl 17.9 13.5 22.3
nmol/l 589 442 736 Siemens Immulite 2000/2500
µg/dl 21.2 15.9 26.5
nmol/l 623 467 779 Siemens Immulite 1000
µg/dl 22.4 16.8 28.0
nmol/l 556 417 695 Beckman DxI800
µg/dl 20.0 15.0 25.0
nmol/l 627 470 784 Roche Elecsys
µg/dl 22.6 16.9 28.3
nmol/l 602 452 753 Diasorin Liaison
µg/dl 21.7 16.3 27.1
nmol/l 593 445 741 Roche Modular E170
µg/dl 21.3 16.0 26.6
nmol/l 600 450 750 Beckman Access
µg/dl 21.6 16.2 27.0

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 639 479 799 Tosoh Series
µg/dl 23.0 17.2 28.8
nmol/l 533 400 666 Vitros ECi
µg/dl 19.2 14.4 24.0
nmol/l 594 446 743 Roche Cobas 6000/8000
µg/dl 21.4 16.1 26.7
nmol/l 619 464 774 Roche Cobas E411
µg/dl 22.3 16.7 27.9
nmol/l 709 489 929 Siemens Centaur CP
µg/dl 25.5 17.6 33.4
nmol/l 576 432 720 Roche Modular E170 Gen II
µg/dl 20.7 15.6 25.8
nmol/l 613 460 766 Roche Cobas 4000/e411 Gen II
µg/dl 22.1 16.6 27.6
nmol/l 573 430 716 Roche Cobas 6000/8000 Gen II
µg/dl 20.6 15.5 25.7
DHEA-S µmol/l 13.6 10.9 16.3 Abbott Architect
µmol/l 11.1 8.88 13.3 Siemens Immulite 2000/2500
µmol/l 10.9 8.72 13.1 Siemens Immulite 1000
µmol/l 11.2 8.96 13.4 Beckman DxI800
µmol/l 15.2 11.5 18.9 Roche Elecsys
µmol/l 14.9 11.9 17.9 Roche Modular E170
µmol/l 12.1 9.68 14.5 Beckman Access
µmol/l 11.1 8.68 13.5 Diasorin Liaison
µmol/l 11.0 7.15 14.9 Siemens Centaur XP/XPT/Classic
µmol/l 15.2 12.2 18.2 Roche Cobas E411
µmol/l 15.2 12.2 18.2 Roche Cobas 6000/8000
Digoxin nmol/l 2.41 1.93 2.89 Siemens ADVIA 1200/1650/1800/2400
ng/ml 1.88 1.51 2.25
nmol/l 2.68 2.14 3.22 Roche Cobas 4000/E411
ng/ml 2.09 1.67 2.51
nmol/l 2.82 2.17 3.47 Siemens Centaur CP
ng/ml 2.20 1.69 2.71
nmol/l 2.19 1.75 2.63 Abbott Architect
ng/ml 1.71 1.37 2.05
nmol/l 2.40 1.92 2.88 BioMerieux Vidas
ng/ml 1.87 1.50 2.25
nmol/l 2.95 2.27 3.63 Siemens Centaur XP/XPT/Classic
ng/ml 2.30 1.77 2.83
nmol/l 2.59 2.07 3.11 Siemens Dimension
ng/ml 2.02 1.62 2.43
nmol/l 2.93 2.34 3.52 Siemens Immulite 2000/2500
ng/ml 2.29 1.83 2.75
nmol/l 3.35 2.68 4.02 Siemens Immulite 1000
ng/ml 2.62 2.09 3.14
nmol/l 2.69 2.15 3.23 Beckman DxI800
ng/ml 2.10 1.68 2.52

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 2.68 2.14 3.22 Roche Elecsys
ng/ml 2.09 1.67 2.51
nmol/l 2.56 2.05 3.07 Roche Integra
ng/ml 2.00 1.60 2.40
nmol/l 2.61 2.09 3.13 Roche Modular E170
ng/ml 2.04 1.63 2.44
nmol/l 2.43 1.94 2.92 Vitros
ng/ml 1.90 1.52 2.28
nmol/l 2.60 2.08 3.12 Roche Cobas E411
ng/ml 2.03 1.62 2.44
nmol/l 2.63 2.10 3.16 Roche Cobas 6000/8000
ng/ml 2.05 1.64 2.47
nmol/l 2.43 1.94 2.92 Beckman DxC
ng/ml 1.90 1.52 2.28
nmol/l 2.73 2.18 3.28 Beckman AU400/600/640/2700/5400
ng/ml 2.13 1.70 2.56
nmol/l 3.07 2.46 3.68 Gravimetric
ng/ml 2.40 1.92 2.87
Ethosuximide µmol/l 360 288 432 Gravimetric
µg/ml 51.0 40.8 61.3
Ferritin ng/ml = µg/l 125 100 150 Abbott Architect
ng/ml = µg/l 94.0 75.2 113 BioMerieux Vidas
ng/ml = µg/l 103 82.4 124 Roche Tinaquant
ng/ml = µg/l 105 79.0 131 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 106 84.8 127 Siemens Dimension
ng/ml = µg/l 105 84.0 126 Siemens Immulite 2000/2500
ng/ml = µg/l 97.2 77.8 117 Siemens Immulite 1000
ng/ml = µg/l 79.4 63.5 95.3 Beckman DxI800
ng/ml = µg/l 121 96.8 145 Roche Elecsys
ng/ml = µg/l 110 88.0 132 Diasorin Liaison
ng/ml = µg/l 120 96.0 144 Roche Modular E170
ng/ml = µg/l 79.9 63.9 95.9 Beckman Access
ng/ml = µg/l 77.7 62.2 93.2 Tosoh Series
ng/ml = µg/l 76.6 61.3 91.9 Vitros ECi
ng/ml = µg/l 119 95.2 143 Roche Cobas E411
ng/ml = µg/l 101 80.8 121 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 65.8 52.6 79.0 Fujirebio Lumipulse G Series
ng/ml = µg/l 99.0 74.3 124 Siemens Centaur CP
Folate nmol/l 15.4 11.7 19.1 Abbott Architect
ng/ml 6.79 5.16 8.42
nmol/l 32.8 21.3 44.3 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 14.5 9.43 19.6
nmol/l 12.5 9.50 15.5 Siemens Immulite 2000
ng/ml 5.51 4.19 6.83
nmol/l 17.9 13.6 22.2 Beckman DxI800
ng/ml 7.89 6.00 9.78

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Folate nmol/l 17.8 13.4 22.2 Roche Elecsys
ng/ml 7.85 5.91 9.79
nmol/l 17.0 12.9 21.1 Roche Modular E170
ng/ml 7.50 5.69 9.31
nmol/l 18.4 14.0 22.8 Beckman Access
ng/ml 8.11 6.17 10.1
nmol/l 26.5 20.1 32.9 Tosoh Series
ng/ml 11.7 8.86 14.5
nmol/l 11.0 8.36 13.6 Vitros ECi
ng/ml 4.85 3.69 6.01
nmol/l 17.5 13.1 21.9 Roche Cobas E411
ng/ml 7.72 5.78 9.66
nmol/l 17.6 13.4 21.8 Roche Cobas 6000/8000
ng/ml 7.76 5.91 9.61
nmol/l 10.2 7.75 12.6 Siemens Dimension
ng/ml 4.50 3.42 5.58
nmol/l 37.8 24.6 51.0 Siemens Centaur CP (enhanced kit)
ng/ml 16.7 10.9 22.5
nmol/l 17.5 13.3 21.7 Roche Cobas 6000/8000 Folate III
ng/ml 7.72 5.87 9.57
nmol/l 17.7 13.5 21.9 Roche Cobas 4000/e411 Folate III
ng/ml 7.81 5.95 9.67
nmol/l 16.4 12.5 20.3 Roche Modular E170 Folate III
ng/ml 7.23 5.51 8.95
Free T3 pmol/l 13.9 10.4 17.4 Abbott Architect
ng/dl 0.904 0.676 1.13
pg/ml 9.05 6.77 11.3
pmol/l 15.4 11.6 19.3 BioMerieux Vidas
ng/dl 1.00 0.754 1.25
pg/ml 10.0 7.55 12.5
pmol/l 14.7 8.82 20.6 Siemens Centaur XP/XPT/Classic
ng/dl 0.956 0.570 1.34
pg/ml 9.57 5.74 13.4
pmol/l 12.2 9.15 15.3 Siemens Immulite 2000/2500
ng/dl 0.793 0.595 0.991
pg/ml 7.94 5.96 9.92
pmol/l 12.0 9.00 15.0 Siemens Immulite 1000
ng/dl 0.780 0.585 0.975
pg/ml 7.81 5.86 9.76
pmol/l 11.7 8.78 14.6 Beckman DxI800
ng/dl 0.761 0.571 0.951
pg/ml 7.62 5.72 9.52
pmol/l 18.4 13.8 23.0 Roche Elecsys
ng/dl 1.20 0.897 1.50
pg/ml 12.0 8.98 15.0

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 21.1 15.8 26.4 Diasorin Liaison
ng/dl 1.37 1.03 1.71
pg/ml 13.7 10.3 17.1
pmol/l 17.9 13.4 22.4 Roche Modular E170
ng/dl 1.16 0.871 1.45
pg/ml 11.7 8.72 14.7
pmol/l 12.8 9.60 16.0 Beckman Access
ng/dl 0.832 0.624 1.04
pg/ml 8.33 6.25 10.4
pmol/l 20.6 15.5 25.8 Tosoh Series
ng/dl 1.34 1.01 1.67
pg/ml 13.4 10.1 16.7
pmol/l 34.5 25.9 43.1 Vitros ECi
ng/dl 2.24 1.68 2.80
pg/ml 22.5 16.9 28.1
pmol/l 18.1 13.6 22.6 Roche Cobas E411
ng/dl 1.18 0.884 1.48
pg/ml 11.8 8.85 14.8
pmol/l 18.2 13.7 22.8 Roche Cobas 6000/8000
ng/dl 1.18 0.891 1.47
pg/ml 11.8 8.92 14.7
pmol/l 19.6 14.7 24.5 Siemens Dimension
ng/dl 1.27 0.956 1.58
pg/ml 12.8 9.57 16.0
pmol/l 18.6 14.0 23.3 Siemens Dimension Vista LOCI
ng/dl 1.21 0.910 1.51
pg/ml 12.1 9.11 15.1
pmol/l 14.0 8.40 19.6 Siemens Centaur CP
ng/dl 0.910 0.546 1.27
pg/ml 9.11 5.47 12.8
Free T4 pmol/l 29.4 22.1 36.8 Abbott Architect
ng/dl 2.29 1.72 2.86
pg/ml 22.9 17.2 28.6
pmol/l 30.0 22.5 37.5 Siemens Centaur XP/XPT/Classic
ng/dl 2.34 1.76 2.92
pg/ml 23.4 17.6 29.2
pmol/l 40.4 30.3 50.5 CIS RIA Coated tube
ng/dl 3.15 2.36 3.94
pg/ml 31.5 23.6 39.4
pmol/l 39.5 29.6 49.4 Siemens Dimension
ng/dl 3.08 2.31 3.85
pg/ml 30.8 23.1 38.5
pmol/l 44.3 33.2 55.4 Siemens Immulite 2000/2500
ng/dl 3.46 2.59 4.33
pg/ml 34.6 25.9 43.3
pmol/l 45.2 33.9 56.5 Siemens Immulite 1000
ng/dl 3.53 2.64 4.42
pg/ml 35.3 26.4 44.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 35.7 26.8 44.6 Beckman DxI800
ng/dl 2.78 2.09 3.47
pg/ml 27.8 20.9 34.7
pmol/l 43.0 32.3 53.8 Roche Elecsys
ng/dl 3.35 2.52 4.18
pg/ml 33.5 25.2 41.8
pmol/l 50.4 37.8 63.0 Diasorin Liaison
ng/dl 3.93 2.95 4.91
pg/ml 39.3 29.5 49.1
pmol/l 43.5 32.6 54.4 Roche Modular E170
ng/dl 3.39 2.54 4.24
pg/ml 33.9 25.4 42.4
pmol/l 34.4 25.8 43.0 Beckman Access
ng/dl 2.68 2.01 3.35
pg/ml 26.8 20.1 33.5
pmol/l 41.2 30.9 51.5 Tosoh Series
ng/dl 3.21 2.41 4.01
pg/ml 32.1 24.1 40.1
pmol/l 79.2 59.4 99.0 Vitros ECi
ng/dl 6.18 4.63 7.73
pg/ml 61.8 46.3 77.3
pmol/l 42.8 32.1 53.5 Roche Cobas 6000/8000
ng/dl 3.34 2.50 4.18
pg/ml 33.4 25.0 41.8
pmol/l 36.3 27.2 45.4 Immunotech IRMA
ng/dl 2.83 2.12 3.54
pg/ml 28.3 21.2 35.4
pmol/l 42.7 32.0 53.4 Roche Cobas E411
ng/dl 3.33 2.50 4.16
pg/ml 33.3 25.0 41.6
pmol/l 36.8 27.6 46.0 Monobind Inc. ELISA / CLIA
ng/dl 2.87 2.15 3.59
pg/ml 28.7 21.5 35.9
pmol/l 36.1 27.1 45.1 Siemens Dimension Vista LOCI
ng/dl 2.82 2.11 3.53
pg/ml 28.2 21.1 35.3
pmol/l 47.4 35.6 59.3 Biomerieux Vidas FT4N Kit
ng/dl 3.70 2.78 4.62
pg/ml 37.0 27.8 46.2
pmol/l 33.3 25.0 41.6 Siemens Centaur CP
ng/dl 2.60 1.95 3.25
pg/ml 26.0 19.5 32.5
FSH mU/ml 23.0 18.4 27.6 Abbott Architect
mU/ml 29.6 23.7 35.5 BioMerieux Vidas

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
FSH mU/ml 31.0 23.3 38.7 Siemens Centaur XP/XPT/Classic
mU/ml 26.4 21.1 31.7 Siemens Immulite 2000/2500
mU/ml 26.1 20.9 31.3 Siemens Immulite 1000
mU/ml 28.3 22.6 34.0 Beckman DxI800
mU/ml 25.8 20.6 31.0 Roche/BM Elecsys
mU/ml 35.1 24.9 45.3 Diasorin Liaison
mU/ml 24.5 19.6 29.4 Roche Modular E170
mU/ml 28.3 22.6 34.0 Beckman Access
mU/ml 28.7 23.0 34.4 Tosoh Series
mU/ml 20.5 16.4 24.6 Vitros ECi
mU/ml 26.0 20.8 31.2 Roche Cobas E411
mU/ml 25.2 20.2 30.2 Roche Cobas 6000/8000
mU/ml 22.8 18.2 27.4 Fujirebio Lumipulse G Series
mU/ml 26.5 19.9 33.1 Siemens Centaur CP
Gentamicin µmol/l 7.70 6.16 9.24 Roche Integra
µg/ml 3.68 2.94 4.42
µmol/l 8.37 5.94 10.8 Siemens Centaur XP/XPT/Classic
µg/ml 4.00 2.84 5.16
µmol/l 7.89 6.31 9.47 Siemens Dimension Vista
µg/ml 3.77 3.02 4.52
µmol/l 5.82 4.66 6.98 Roche Cobas 6000/8000
µg/ml 2.78 2.23 3.33
µmol/l 9.10 7.28 10.9 Beckman DxC
µg/ml 4.35 3.48 5.22
µmol/l 8.16 6.53 9.79 Gravimetric
µg/ml 3.90 3.12 4.68
Growth Hormone (GH) µU/ml 17.6 14.1 21.1 Siemens Immulite 2000/2500
ng/ml 5.86 4.70 7.02
µU/ml 16.7 13.4 20.0 Siemens Immulite 1000
ng/ml 5.56 4.46 6.66
µU/ml 13.1 10.5 15.7 Beckman DxI800
ng/ml 4.36 3.50 5.22
µU/ml 14.0 11.2 16.8 Beckman Access
ng/ml 4.66 3.73 5.59
µU/ml 14.6 11.7 17.5 Diasorin Liaison
ng/ml 4.86 3.90 5.82
µU/ml 14.9 11.9 17.9 Roche Cobas E411
ng/ml 4.96 3.96 5.96
µU/ml 15.7 12.6 18.8 Roche Cobas 6000/8000
ng/ml 5.23 4.20 6.26
µU/ml 15.9 12.7 19.1 IDS iSYS
ng/ml 5.29 4.23 6.35
Immunoglobulin E KIU/l = IU/ml 102 81.6 122 Abbott Architect
KIU/l = IU/ml 96.6 77.3 116 BioMerieux Vidas
KIU/l = IU/ml 115 69.0 161 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 120 96.0 144 Siemens Immulite 2000/2500

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 120 96.0 144 Siemens Immulite 1000
KIU/l = IU/ml 105 84.0 126 Beckman DxI800
KIU/l = IU/ml 126 101 151 Roche Elecsys
KIU/l = IU/ml 117 93.6 140 Pharmacia Unicap
KIU/l = IU/ml 125 100 150 Roche Modular E170
KIU/l = IU/ml 117 93.6 140 Tosoh Series
KIU/l = IU/ml 126 101 151 Roche Cobas E411
KIU/l = IU/ml 128 102 154 Roche Cobas 6000/8000
KIU/l = IU/ml 109 87.2 131 Fujirebio Lumipulse G Series
KIU/l = IU/ml 115 69.0 161 Siemens Centaur CP
Insulin mU/l 23.4 17.6 29.3 Siemens Centaur XP/XPT/Classic
pmol/l 163 122 204
mU/l 7.05 5.29 8.81 Siemens Immulite 1000
pmol/l 49.0 36.7 61.3
mU/l 18.9 14.2 23.6 Roche Modular E170
pmol/l 131 98.6 163
mU/l 18.3 13.7 22.9 Roche Elecsys
pmol/l 127 95.1 159
mU/l 16.5 12.4 20.6 Beckman Access
pmol/l 115 86.1 144
mU/l 17.7 13.3 22.1 Abbott Architect
pmol/l 123 92.4 154
mU/l 20.8 15.6 26.0 Tosoh Series
pmol/l 144 108 180
mU/l 18.8 14.1 23.5 Roche Cobas E411
pmol/l 131 97.9 164
mU/l 15.8 11.9 19.8 Beckman DxI 600/800
pmol/l 110 82.6 137
mU/l 26.6 20.0 33.3 Diasorin Liaison
pmol/l 185 139 231
mU/l 18.8 14.1 23.5 Roche Cobas 6000/8000
pmol/l 131 97.9 164
mU/l 18.8 14.1 23.5 Fujirebio Lumipulse G Series
pmol/l 131 97.9 164
mU/l 25.2 18.9 31.5 Siemens Centaur CP
pmol/l 175 131 219
mU/l 18.0 11.4 24.6 Ortho Vitros ECi
pmol/l 125 79.3 171
Luteinising Hormone (LH) mU/ml 22.1 17.7 26.5 Abbott Architect
mU/ml 24.6 19.7 29.5 BioMerieux Vidas
mU/ml 27.9 21.5 34.3 Siemens Centaur XP/XPT/Classic
mU/ml 40.5 32.4 48.6 Siemens Immulite 2000
mU/ml 40.9 32.7 49.1 Siemens Immulite 1000
mU/ml 18.1 14.5 21.7 Beckman DxI800
mU/ml 29.2 23.4 35.0 Roche Elecsys
mU/ml 34.3 27.4 41.2 Diasorin Liaison

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Luteinising Hormone (LH) mU/ml 29.3 23.4 35.2 Roche Modular E170
mU/ml 18.6 14.9 22.3 Beckman Access
mU/ml 25.3 20.2 30.4 Tosoh Series
mU/ml 39.5 31.6 47.4 Vitros ECi
mU/ml 29.9 23.9 35.9 Roche Cobas E411
mU/ml 29.9 23.9 35.9 Roche Cobas 6000/8000
mU/ml 25.8 20.6 31.0 Fujirebio Lumipulse G Series
mU/ml 29.2 22.5 35.9 Siemens Centaur CP
Oestradiol pmol/l 685 548 822 Abbott Architect
pg/ml 186 149 223
pmol/l 1176 941 1411 BioMerieux Vidas
pg/ml 320 256 384
pmol/l 964 578 1350 Siemens Centaur XP/XPT/Classic
pg/ml 262 157 367
pmol/l 983 786 1180 Siemens Immulite 2000/2500
pg/ml 267 214 320
pmol/l 1024 819 1229 Siemens Immulite 1000
pg/ml 279 223 335
pmol/l 972 778 1166 Beckman DxI800
pg/ml 264 212 316
pmol/l 722 578 866 Roche Elecsys (Estradiol II)
pg/ml 196 157 235
pmol/l 725 580 870 Roche Modular E170 (Estradiol II)
pg/ml 197 158 236
pmol/l 1006 805 1207 Beckman Access
pg/ml 274 219 329
pmol/l 765 612 918 Tosoh (E2)
pg/ml 208 166 250
pmol/l 917 734 1100 Vitros ECi
pg/ml 249 200 298
pmol/l 726 581 871 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 197 158 236
pmol/l 711 569 853 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 193 155 231
pmol/l 953 572 1334 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 259 155 363
pmol/l 977 586 1368 Siemens Centaur XP/XPT/Classic E26 III
pg/ml 266 160 372
pmol/l 752 602 902 Tosoh (iE2-hsE2)
pg/ml 205 164 246
pmol/l 978 587 1369 Siemens Centaur CP
pg/ml 266 160 372
pmol/l 960 576 1344 Siemens Centaur CP Enhanced (eE2)
pg/ml 261 157 365
pmol/l 933 746 1120 Fujirebio Lumipulse G Series
pg/ml 254 203 305

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 722 578 866 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 196 157 235
pmol/l 709 567 851 Roche Elecsys (Estradiol III)
pg/ml 193 154 232
pmol/l 721 577 865 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 196 157 235
pmol/l 713 570 856 Roche Modular E170 (Estradiol III)
pg/ml 194 155 233
Paracetamol mmol/l 0.320 0.256 0.384 Roche Integra
mg/l 48.4 38.7 58.1
mmol/l 0.380 0.304 0.456 Vitros
mg/l 57.5 46.0 69.0
mmol/l 0.330 0.264 0.396 Abbott Architect
mg/l 49.9 39.9 59.9
mmol/l 0.310 0.248 0.372 Roche Cobas 6000/8000
mg/l 46.9 37.5 56.3
mmol/l 0.348 0.280 0.420 Gravimetric
mg/l 52.7 42.4 63.5
Phenobarbital µmol/l 83.4 66.7 100 Abbott Architect
µg/ml 19.3 15.5 23.1
µmol/l 77.4 61.9 92.9 Siemens ADVIA 1200/1650/1800/2400
µg/ml 18.0 14.4 21.6
µmol/l 77.2 61.8 92.6 Siemens Immulite 2000/2500
µg/ml 17.9 14.3 21.5
µmol/l 83.6 66.9 100 Beckman AU400/600/640/2700/5400
µg/ml 19.4 15.5 23.3
µmol/l 90.6 65.2 116 Siemens Centaur XP/XPT/Classic
µg/ml 21.0 15.1 26.9
µmol/l 79.9 63.9 95.9 Roche Integra
µg/ml 18.5 14.8 22.2
µmol/l 76.0 60.8 91.2 Siemens Immulite 1000
µg/ml 17.6 14.1 21.1
µmol/l 77.6 62.1 93.1 Gravimetric
µg/ml 18.0 14.4 21.6
Phenytoin µmol/l 67.8 54.2 81.4 Abbott Architect
µg/ml 17.1 13.7 20.5
µmol/l 80.8 63.0 98.6 Siemens Centaur XP/XPT/Classic
µg/ml 20.4 15.9 24.9
µmol/l 68.6 54.9 82.3 Siemens Dimension
µg/ml 17.3 13.9 20.7
µmol/l 65.2 52.2 78.2 Siemens Immulite 2000/2500
µg/ml 16.5 13.2 19.8
µmol/l 67.3 53.8 80.8 Siemens Immulite 1000
µg/ml 17.0 13.6 20.4
µmol/l 65.6 52.5 78.7 Roche Integra
µg/ml 16.6 13.3 19.9

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Phenytoin µmol/l 72.8 56.0 89.6 Vitros
µg/ml 18.4 14.1 22.7
µmol/l 66.7 53.4 80.0 Roche Cobas E411
µg/ml 16.8 13.5 20.1
µmol/l 66.2 53.0 79.4 Roche Cobas 6000/8000
µg/ml 16.7 13.4 20.0
µmol/l 65.1 52.1 78.1 Beckman DxC
µg/ml 16.4 13.2 19.6
µmol/l 71.3 57.0 85.6 Gravimetric
µg/ml 18.0 14.4 21.6
Primidone µmol/l 22.5 18.0 27.0 Gravimetric
µg/ml 4.91 3.93 5.89
Progesterone nmol/l 30.3 24.2 36.4 Abbott Architect
ng/ml 9.48 7.57 11.4
nmol/l 47.2 37.8 56.6 BioMerieux Vidas
ng/ml 14.8 11.8 17.8
nmol/l 26.9 18.8 35.0 Siemens Centaur XP/XPT/Classic
ng/ml 8.42 5.89 11.0
nmol/l 29.0 23.2 34.8 Siemens Immulite 2000/2500
ng/ml 9.08 7.26 10.9
nmol/l 33.7 27.0 40.4 Siemens Immulite 1000
ng/ml 10.5 8.45 12.6
nmol/l 37.2 29.8 44.6 Beckman DxI Prog Cal 33555
ng/ml 11.6 9.33 13.9
nmol/l 36.0 28.8 43.2 Roche Elecsys (Prog. II)
ng/ml 11.3 9.01 13.6
nmol/l 36.7 29.4 44.0 Roche Modular E170 (Prog. II)
ng/ml 11.5 9.20 13.8
nmol/l 37.1 29.7 44.5 Beckman Access Prog Cal 33555
ng/ml 11.6 9.30 13.9
nmol/l 41.4 31.0 51.8 Tosoh Series
ng/ml 13.0 9.70 16.3
nmol/l 39.8 31.8 47.8 Vitros ECi
ng/ml 12.5 9.95 15.1
nmol/l 36.1 28.9 43.3 Roche Cobas 4000/e411 (Prog. II)
ng/ml 11.3 9.05 13.6
nmol/l 36.2 29.0 43.4 Roche Cobas 6000/8000 (Prog. II)
ng/ml 11.3 9.08 13.5
nmol/l 31.0 24.8 37.2 Diasorin Liaison
ng/ml 9.70 7.76 11.6
nmol/l 33.7 24.4 43.0 Beckman DxI Prog DE Cal A80773
ng/ml 10.5 7.64 13.4
nmol/l 32.3 24.2 40.4 Beckman Access Prog DE Cal A80773
ng/ml 10.1 7.57 12.6
nmol/l 28.1 19.7 36.5 Siemens Centaur CP
ng/ml 8.80 6.16 11.4

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 36.1 28.9 43.3 Roche Cobas 6000/8000 (Prog. III)
ng/ml 11.3 9.05 13.6
nmol/l 34.3 27.4 41.2 Roche Elecsys (Prog. III)
ng/ml 10.7 8.58 12.8
nmol/l 36.0 28.8 43.2 Roche Cobas 4000/e411 (Prog. III)
ng/ml 11.3 9.01 13.6
nmol/l 35.6 28.5 42.7 Roche Modular E170 (Prog. III)
ng/ml 11.1 8.92 13.3
Prolactin µU/ml 735 588 882 Abbott Architect
µU/ml 854 683 1025 BioMerieux Vidas
µU/ml 607 473 741 Siemens Centaur XP/XPT/Classic
µU/ml 658 526 790 Siemens Immulite 2000/2500
µU/ml 666 533 799 Siemens Immulite 1000
µU/ml 608 486 730 Beckman DxI800
µU/ml 719 575 863 Roche Elecsys
µU/ml 803 642 964 Diasorin Liaison
µU/ml 706 565 847 Roche Modular E170
µU/ml 636 509 763 Beckman Access
µU/ml 774 548 1000 Tosoh Series
µU/ml 636 509 763 Vitros ECi
µU/ml 710 568 852 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 777 622 932 Immunotech IRMA
µU/ml 740 592 888 Roche Cobas E411
µU/ml 714 571 857 Roche Cobas 6000/8000
µU/ml 913 730 1096 Fujirebio Lumipulse G Series
µU/ml 736 589 883 Abbott Architect restandardised
µU/ml 615 480 750 Siemens Centaur CP
PSA Free ng/ml = µg/l 8.69 6.52 10.9 Abbott Architect
ng/ml = µg/l 10.8 8.10 13.5 BioMerieux Vidas
ng/ml = µg/l 8.87 6.65 11.1 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 8.48 6.36 10.6 Siemens Dimension
ng/ml = µg/l 6.75 5.06 8.44 Siemens Immulite 2000/2500
ng/ml = µg/l 6.49 4.87 8.11 Siemens Immulite 1000
ng/ml = µg/l 10.5 7.88 13.1 Beckman DXI standardised to Hybritech
ng/ml = µg/l 8.20 6.15 10.3 Roche Elecsys
ng/ml = µg/l 3.09 2.32 3.86 Diasorin Liaison
ng/ml = µg/l 7.86 5.90 9.83 Roche Modular E170
ng/ml = µg/l 10.8 8.10 13.5 Beckman Access standardised to Hybritech
ng/ml = µg/l 7.13 5.35 8.91 Tosoh Series
ng/ml = µg/l 8.28 6.21 10.4 Roche Cobas E411
ng/ml = µg/l 8.15 6.11 10.2 Roche Cobas 6000/8000
ng/ml = µg/l 8.23 6.17 10.3 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 10.7 8.03 13.4 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 7.51 5.63 9.39 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 6.93 5.20 8.66 Fujirebio Lumipulse G Series
PSA Total ng/ml = µg/l 9.72 7.29 12.2 Abbott Architect

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
PSA Total ng/ml = µg/l 11.1 8.33 13.9 BioMerieux Vidas
ng/ml = µg/l 11.3 8.48 14.1 bioMerieux VIDAS TPSA
ng/ml = µg/l 9.31 6.98 11.6 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 10.1 7.58 12.6 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 8.01 6.01 10.0 Siemens Immulite 1000 3rd generation
ng/ml = µg/l 9.55 7.16 11.9 Siemens Immulite 2000/2500 3rd generation
ng/ml = µg/l 8.62 6.47 10.8 Siemens Immulite 1000 1st generation
ng/ml = µg/l 10.2 7.65 12.8 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 8.10 6.08 10.1 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 11.9 8.93 14.9 Roche Elecsys
ng/ml = µg/l 3.68 2.76 4.60 Diasorin Liaison
ng/ml = µg/l 11.1 8.33 13.9 Roche Modular E170
ng/ml = µg/l 10.5 7.88 13.1 Beckman Access standardised to Hybritech
ng/ml = µg/l 10.3 7.73 12.9 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 7.51 5.63 9.39 Tosoh Series
ng/ml = µg/l 11.0 8.25 13.8 Vitros ECi
ng/ml = µg/l 10.1 7.58 12.6 CIS RIA Coated tube
ng/ml = µg/l 11.9 8.93 14.9 Roche Cobas E411
ng/ml = µg/l 11.5 8.63 14.4 Roche Cobas 6000/8000
ng/ml = µg/l 9.29 6.97 11.6 Fujirebio Lumipulse G Series
ng/ml = µg/l 11.1 8.33 13.9 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 8.91 6.68 11.1 Siemens Centaur CP
Salicylic Acid mmol/l 1.18 0.944 1.42 Abbott Architect
mg/dl 16.3 13.0 19.6
mmol/l 1.29 1.03 1.55 Beckman DxC
mg/dl 17.8 14.2 21.4
mmol/l 1.22 0.980 1.46 Gravimetric
mg/dl 16.9 13.5 20.2
SHBG nmol/l 49.5 37.1 61.9 Siemens Centaur XP/XPT/Classic
nmol/l 34.2 27.4 41.0 Siemens Immulite 1000
nmol/l 37.5 30.0 45.0 Siemens Immulite 2000/2500
nmol/l 39.2 29.5 48.9 Roche Elecsys
nmol/l 39.2 31.4 47.0 Roche Modular E170
nmol/l 39.7 31.8 47.6 Abbott Architect
nmol/l 39.9 31.9 47.9 Roche Cobas E411
nmol/l 39.7 31.8 47.6 Roche Cobas 6000/8000
nmol/l 37.8 30.2 45.4 Beckman DxI800
T Uptake %U 36.8 30.2 43.4 Siemens Immulite 2000
Testosterone nmol/l 14.7 11.8 17.6 Abbott Architect
ng/ml 4.23 3.40 5.06
ng/dl 423 340 506
nmol/l 11.4 9.12 13.7 BioMerieux Vidas
ng/ml 3.28 2.63 3.93
ng/dl 328 263 393
nmol/l 11.8 8.26 15.3 Siemens Centaur XP/XPT/Classic
ng/ml 3.40 2.38 4.42
ng/dl 340 238 442

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 13.4 9.62 17.2 CIS RIA Coated tube
ng/ml 3.86 2.77 4.95
ng/dl 386 277 495
nmol/l 17.2 13.8 20.6 Siemens Immulite 2000/2500
ng/ml 4.95 3.97 5.93
ng/dl 495 397 593
nmol/l 21.9 16.4 27.4 Siemens Immulite 1000
ng/ml 6.31 4.72 7.90
ng/dl 631 472 790
nmol/l 12.9 10.3 15.5 Beckman DxI800
ng/ml 3.72 2.97 4.47
ng/dl 372 297 447
nmol/l 13.7 11.0 16.4 Beckman Access
ng/ml 3.95 3.17 4.73
ng/dl 395 317 473
nmol/l 19.5 15.6 23.4 Tosoh Series
ng/ml 5.62 4.49 6.75
ng/dl 562 449 675
nmol/l 18.5 14.8 22.2 Vitros ECi
ng/ml 5.33 4.26 6.40
ng/dl 533 426 640
nmol/l 15.2 12.2 18.2 Roche Cobas 6000 Test 2
ng/ml 4.38 3.51 5.25
ng/dl 438 351 525
nmol/l 14.9 11.9 17.9 Roche Elecsys Test II
ng/ml 4.29 3.43 5.15
ng/dl 429 343 515
nmol/l 15.0 12.0 18.0 Roche Modular E170 Test II
ng/ml 4.32 3.46 5.18
ng/dl 432 346 518
nmol/l 15.0 12.0 18.0 Roche Cobas 4000/e411 Test II
ng/ml 4.32 3.46 5.18
ng/dl 432 346 518
nmol/l 14.7 11.8 17.6 Abbott Architect 2nd Generation
ng/ml 4.23 3.40 5.06
ng/dl 423 340 506
nmol/l 12.4 8.68 16.1 Siemens Centaur CP
ng/ml 3.57 2.50 4.64
ng/dl 357 250 464
nmol/l 11.1 8.88 13.3 BioMerieux Vidas Testosterone II
ng/ml 3.20 2.56 3.84
ng/dl 320 256 384
Theophylline µmol/l 80.6 64.5 96.7 Siemens Centaur XP/XPT/Classic
µg/ml 14.5 11.6 17.4
µmol/l 84.3 67.4 101 Siemens Dimension
µg/ml 15.2 12.1 18.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Theophylline µmol/l 85.7 68.6 103 Roche Integra
µg/ml 15.4 12.4 18.4
µmol/l 97.6 78.1 117 Vitros
µg/ml 17.6 14.1 21.1
µmol/l 79.3 63.4 95.2 Abbott Architect
µg/ml 14.3 11.4 17.2
µmol/l 79.7 63.8 95.6 Roche Cobas 6000/8000
µg/ml 14.4 11.5 17.3
µmol/l 75.9 60.7 91.1 Beckman DxC
µg/ml 13.7 10.9 16.5
µmol/l 75.0 60.0 90.0 Beckman AU400/600/640/2700/5400
µg/ml 13.5 10.8 16.2
µmol/l 83.8 67.0 101 Gravimetric
µg/ml 15.1 12.1 18.2
Thyroglobulin ng/ml 21.5 16.1 26.9 Siemens Immulite 1000
ng/ml 18.4 13.8 23.0 Siemens Immulite 2000
ng/ml 28.2 21.2 35.3 Roche Elecsys
ng/ml 27.2 20.4 34.0 Roche Modular E170
ng/ml 29.5 22.1 36.9 Beckman DxI800
ng/ml 28.6 21.5 35.8 Roche Cobas E411
ng/ml 28.4 21.3 35.5 Roche Cobas 6000/8000
ng/ml 31.2 23.4 39.0 Beckman Access
ng/ml 29.8 22.4 37.3 Tosoh Series
ng/ml 28.1 21.1 35.1 Roche Cobas 6000 TGII
ng/ml 29.4 22.1 36.8 Roche Elecsys TGII
ng/ml 29.1 21.8 36.4 Roche Cobas 4000/E411 TGII
ng/ml 27.6 20.7 34.5 Roche Modular E170 TGII
Thyroid Stimulating µU/ml = mlU/l 2.13 1.70 2.56 Abbott Architect
Hormone
µU/ml = mlU/l 2.50 2.00 3.00 bioMerieux VIDAS TSH
µU/ml = mlU/l 2.26 1.81 2.71 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 2.43 1.65 3.21 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 2.83 2.26 3.40 CIS IRMA
µU/ml = mlU/l 2.44 1.65 3.23 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 2.25 1.80 2.70 Siemens Dimension
µU/ml = mlU/l 2.46 1.97 2.95 Siemens Immulite 2000/2500
µU/ml = mlU/l 2.29 1.83 2.75 Siemens Immulite 1000
µU/ml = mlU/l 2.20 1.76 2.64 Beckman DxI800 Fast TSH
µU/ml = mlU/l 2.19 1.75 2.63 Beckman DxI800
µU/ml = mlU/l 2.60 2.08 3.12 Roche Elecsys
µU/ml = mlU/l 2.95 2.36 3.54 Diasorin Liaison
µU/ml = mlU/l 2.56 2.05 3.07 Roche Modular E170
µU/ml = mlU/l 2.14 1.71 2.57 Beckman Access Fast TSH
µU/ml = mlU/l 2.23 1.78 2.68 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 2.50 2.00 3.00 Tosoh Series
µU/ml = mlU/l 2.76 2.21 3.31 Vitros ECi

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 2.59 2.07 3.11 Roche Cobas E411
Hormone
µU/ml = mlU/l 2.55 2.04 3.06 Roche Cobas 6000/8000
µU/ml = mlU/l 2.20 1.76 2.64 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 2.14 1.71 2.57 Siemens Dimension Vista LOCI
µU/ml = mlU/l 2.42 1.65 3.19 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 2.45 1.67 3.23 Siemens Centaur CP
µU/ml = mlU/l 2.41 1.64 3.18 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 2.19 1.75 2.63 Beckman DxI 600/800 Access (3rd IS)
Tobramycin µmol/l 7.16 5.73 8.59 Gravimetric
µg/ml 3.35 2.68 4.02
Total Beta hCG mU/ml=IU/l 14.9 11.9 17.9 Abbott Architect
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 24.3 19.4 29.2 BioMerieux Vidas
IU/ml 0.024 0.019 0.029
mU/ml=IU/l 17.7 10.6 24.8 Siemens Centaur XP/XPT/Classic
IU/ml 0.018 0.011 0.025
mU/ml=IU/l 24.4 19.5 29.3 Siemens Dimension
IU/ml 0.024 0.020 0.028
mU/ml=IU/l 30.8 24.6 37.0 Siemens Immulite 2000
IU/ml 0.031 0.025 0.037
mU/ml=IU/l 29.5 23.6 35.4 Siemens Immulite 1000
IU/ml 0.030 0.024 0.036
mU/ml=IU/l 16.9 13.5 20.3 Beckman DxI800
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 15.2 12.2 18.2 Diasorin Liaison
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 17.6 14.1 21.1 Roche Cobas Core EIA
IU/ml 0.018 0.014 0.022
mU/ml=IU/l 16.7 13.4 20.0 Beckman Access
IU/ml 0.017 0.013 0.021
mU/ml=IU/l 24.5 19.6 29.4 Tosoh Series
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 26.6 21.3 31.9 Vitros ECi
IU/ml 0.027 0.021 0.033
mU/ml=IU/l 17.3 13.8 20.8 Roche STAT (Intact)
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 16.8 13.4 20.2 Roche hCG+Beta
IU/ml 0.017 0.013 0.021
mU/ml=IU/l 13.9 11.1 16.7 Fujirebio Lumipulse G Series
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 16.1 12.9 19.3 Radiometer AQT90 Flex
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 16.9 13.5 20.3 Beckman Access Total BhCG (5th IS)
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 17.6 14.1 21.1 Beckman DxI Total BhCG (5th IS)
IU/ml 0.018 0.014 0.022

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 18.1 10.9 25.3 Siemens Centaur CP
IU/ml 0.018 0.011 0.025
Total T3 nmol/l 3.93 2.95 4.91 Abbott Architect
ng/ml 2.56 1.92 3.20
ng/dl 256 192 320
nmol/l 4.55 3.41 5.69 BioMerieux Vidas
ng/ml 2.96 2.22 3.70
ng/dl 296 222 370
nmol/l 4.85 3.64 6.06 Siemens Centaur XP/XPT/Classic
ng/ml 3.16 2.37 3.95
ng/dl 316 237 395
nmol/l 4.04 3.03 5.05 Siemens Immulite 2000/2500
ng/ml 2.63 1.97 3.29
ng/dl 263 197 329
nmol/l 4.39 3.27 5.51 Siemens Immulite 1000
ng/ml 2.86 2.13 3.59
ng/dl 286 213 359
nmol/l 3.80 2.85 4.75 Beckman DxI800
ng/ml 2.47 1.86 3.08
ng/dl 247 186 308
nmol/l 4.68 3.51 5.85 Roche Elecsys
ng/ml 3.05 2.29 3.81
ng/dl 305 229 381
nmol/l 3.62 2.59 4.65 Diasorin Liaison
ng/ml 2.36 1.69 3.03
ng/dl 236 169 303
nmol/l 4.54 3.41 5.68 Roche Modular E170
ng/ml 2.96 2.22 3.70
ng/dl 296 222 370
nmol/l 3.82 2.87 4.78 Beckman Access
ng/ml 2.49 1.87 3.11
ng/dl 249 187 311
nmol/l 4.42 3.32 5.53 Tosoh Series
ng/ml 2.88 2.16 3.60
ng/dl 288 216 360
nmol/l 5.09 3.82 6.36 Vitros ECi
ng/ml 3.31 2.49 4.13
ng/dl 331 249 413
nmol/l 3.22 2.42 4.03 CIS RIA Coated tube
ng/ml 2.10 1.58 2.62
ng/dl 210 158 262
nmol/l 4.58 3.44 5.73 Roche Cobas E411
ng/ml 2.98 2.24 3.72
ng/dl 298 224 372
nmol/l 4.53 3.40 5.66 Roche Cobas 6000/8000
ng/ml 2.95 2.21 3.69
ng/dl 295 221 369

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 4.01 3.01 5.01 Monobind Inc. ELISA / CLIA
ng/ml 2.61 1.96 3.26
ng/dl 261 196 326
nmol/l 5.15 3.86 6.44 Siemens Centaur CP
ng/ml 3.35 2.51 4.19
ng/dl 335 251 419
Total T4 nmol/l 138 104 173 Abbott Architect
µg/dl 10.8 8.11 13.5
ng/ml 108 81.1 135
nmol/l 155 116 194 BioMerieux Vidas
µg/dl 12.1 9.05 15.2
ng/ml 121 90.5 152
nmol/l 154 100 208 Siemens Centaur XP/XPT/Classic
µg/dl 12.0 7.80 16.2
ng/ml 120 78.0 162
nmol/l 152 114 190 Siemens Immulite 2000/2500
µg/dl 11.9 8.89 14.9
ng/ml 119 88.9 149
nmol/l 141 106 176 Siemens Immulite 1000
µg/dl 11.0 8.27 13.7
ng/ml 110 82.7 137
nmol/l 142 107 178 Beckman DxI800
µg/dl 11.1 8.35 13.9
ng/ml 111 83.5 139
nmol/l 142 107 178 Roche Elecsys
µg/dl 11.1 8.35 13.9
ng/ml 111 83.5 139
nmol/l 126 94.5 158 Diasorin Liaison
µg/dl 9.83 7.37 12.3
ng/ml 98.3 73.7 123
nmol/l 140 105 175 Roche Modular E170
µg/dl 10.9 8.19 13.6
ng/ml 109 81.9 136
nmol/l 143 107 179 Beckman Access
µg/dl 11.2 8.35 14.1
ng/ml 112 83.5 141
nmol/l 138 104 173 Tosoh Series
µg/dl 10.8 8.11 13.5
ng/ml 108 81.1 135
nmol/l 146 110 183 Vitros ECi
µg/dl 11.4 8.58 14.2
ng/ml 114 85.8 142
nmol/l 132 99.0 165 CIS RIA Coated tube
µg/dl 10.3 7.72 12.9
ng/ml 103 77.2 129

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 144 108 180 Roche Cobas E411
µg/dl 11.2 8.42 14.0
ng/ml 112 84.2 140
nmol/l 135 101 169 Roche Cobas 6000/8000
µg/dl 10.5 7.88 13.1
ng/ml 105 78.8 131
nmol/l 120 90.0 150 Immunotech IRMA
µg/dl 9.36 7.02 11.7
ng/ml 93.6 70.2 117
nmol/l 161 105 217 Siemens Centaur CP
µg/dl 12.6 8.20 17.0
ng/ml 126 82.0 170
Valproic Acid µmol/l 532 426 638 Abbott Architect
µg/ml 76.8 61.5 92.1
µmol/l 534 427 641 Siemens Centaur XP/XPT/Classic
µg/ml 77.1 61.6 92.6
µmol/l 558 446 670 Siemens Dimension
µg/ml 80.5 64.4 96.6
µmol/l 528 422 634 Siemens Immulite 2000/2500
µg/ml 76.2 60.9 91.5
µmol/l 548 438 658 Siemens Immulite 1000
µg/ml 79.1 63.2 95.0
µmol/l 537 430 644 Roche Integra
µg/ml 77.5 62.0 93.0
µmol/l 542 434 650 Vitros
µg/ml 78.2 62.6 93.8
µmol/l 546 437 655 Roche Cobas E411
µg/ml 78.8 63.1 94.5
µmol/l 545 436 654 Roche Cobas 6000/8000
µg/ml 78.6 62.9 94.3
µmol/l 547 438 656 Beckman DxC
µg/ml 78.9 63.2 94.6
µmol/l 585 468 702 Beckman AU400/600/640/2700/5400
µg/ml 84.4 67.5 101
µmol/l 584 467 701 Siemens ADVIA 1200/1650/1800/2400
µg/ml 84.3 67.4 101
µmol/l 561 449 673 Siemens Centaur CP
µg/ml 81.0 64.8 97.2
µmol/l 638 510 766 Gravimetric
µg/ml 92.1 73.6 111
Vancomycin µmol/l 8.27 6.62 9.92 Roche Integra
µg/ml 12.3 9.84 14.8
µmol/l 7.09 5.67 8.51 Ortho Vitros Microslide Systems
µg/ml 10.5 8.42 12.6
µmol/l 8.06 6.45 9.67 Abbott Architect
µg/ml 12.0 9.58 14.4

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM LEVEL 2 (IA PREMIUM 2)
Cat. No. IA2639 / IA2633 Lot No. 1721EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Vancomycin µmol/l 6.01 4.69 7.33 Siemens Centaur XP/XPT/Classic
µg/ml 8.93 6.97 10.9
µmol/l 7.41 5.93 8.89 Siemens Dimension
µg/ml 11.0 8.81 13.2
µmol/l 7.00 5.60 8.40 Roche Cobas 6000/8000
µg/ml 10.4 8.32 12.5
µmol/l 7.51 6.01 9.01 Beckman DxC
µg/ml 11.2 8.93 13.5
µmol/l 7.10 5.68 8.52 Gravimetric
µg/ml 10.5 8.44 12.7
Vitamin B12 pmol/l 397 318 476 Abbott Architect
pg/ml 538 431 645
pmol/l 395 296 494 Siemens Centaur XP/XPT/Classic
pg/ml 535 401 669
pmol/l 390 293 487 Siemens Immulite 2000
pg/ml 528 397 659
pmol/l 325 260 390 Beckman DxI800
pg/ml 440 352 528
pmol/l 413 330 496 Roche Elecsys
pg/ml 560 447 673
pmol/l 427 342 512 Roche Modular E170
pg/ml 579 463 695
pmol/l 345 276 414 Beckman Access
pg/ml 467 374 560
pmol/l 527 422 632 Tosoh Series
pg/ml 714 572 856
pmol/l 437 350 524 Vitros ECi
pg/ml 592 474 710
pmol/l 411 329 493 Roche Cobas E411
pg/ml 557 446 668
pmol/l 428 342 514 Roche Cobas 6000/8000
pg/ml 580 463 697
pmol/l 404 323 485 Siemens Dimension
pg/ml 547 438 656
pmol/l 426 320 532 Siemens Centaur CP
pg/ml 577 433 721

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 24
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
0086

IMMUNOASSAY PREMIUM - LEVEL 3


(IA PREMIUM 3)
CAT. NO. IA2640 GTIN: 05055273203868 SIZE: 12 x 5 ml
CAT. NO. IA2633 GTIN: 05055273203837 SIZE: 4 x 5 ml
LOT NO. 1722EC EXPIRY: 2020-04-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

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.

The Abbott Architect CA19-9 assay utilises an antibody/antigen system based on the 1116-NA-19-9 antibody. There are reports that
the formulation employed with this system may return elevated concentrations, when compared to other methods for samples
expressing high levels of 1116-NA-19-9 reactive determinants.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at
–20°C. ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial contamination
is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium is supplied lyophilised.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Immunoassay Premium - Level 3: 12 x 5 ml Tri-Level: 4 x 5 ml

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH)
is present in the control, but no claim is made for the expected value or stability of this analyte.

If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
Technical.Services@randox.com.
04 Aug ’17 ne

PAGE 1 OF 15
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
1-25 (OH)2 Vitamin D pmol/l 285 203 367 Diasorin Liaison
17-OH-Progesterone nmol/l 26.1 18.3 33.9 Immunotech RIA
ng/ml 8.64 6.06 11.2
nmol/l 30.5 22.9 38.1 DIAsource RIA
ng/ml 10.1 7.58 12.6
25-OH Vitamin D nmol/l 84.8 63.6 106 Diasorin Liaison
nmol/l 108 81.0 135 Siemens Centaur XP/XPT/Classic
nmol/l 62.4 46.8 78.0 Roche Vitamin D Total
nmol/l 74.1 55.6 92.6 Abbott Architect
nmol/l 97.2 72.9 122 Vitros ECi
nmol/l 74.7 56.0 93.4 BioMerieux Vidas
nmol/l 70.6 51.0 90.2 Beckman DxI 600/800
ACTH pmol/l 25.4 19.1 31.8 Siemens Immulite 2000/2500
pg/ml 115 86.8 143
pmol/l 17.3 13.0 21.6 Roche Cobas E411
pg/ml 78.6 59.1 98.1
pmol/l 25.6 19.2 32.0 Roche Cobas 6000/8000
pg/ml 116 87.3 145
pmol/l 38.3 28.7 47.9 Diasorin Liaison
pg/ml 174 130 218
Aldosterone pmol/l 642 517 767 Diasorin Liaison
pg/ml 232 187 277
Alphafoetoprotein KIU/l = lU/ml 188 150 226 BioMerieux Vidas
ng/ml 227 182 272
KIU/l = lU/ml 197 158 236 Roche Elecsys
ng/ml 238 191 285
KIU/l = lU/ml 194 155 233 Vitros ECi
ng/ml 235 188 282
KIU/l = lU/ml 204 161 247 Siemens Centaur XP/XPT/Classic
ng/ml 247 195 299
KIU/l = lU/ml 180 144 216 Siemens Immulite 2000/2500
ng/ml 218 174 262
KIU/l = lU/ml 173 138 208 Abbott Architect
ng/ml 209 167 251
KIU/l = lU/ml 194 155 233 Roche Modular E170
ng/ml 235 188 282
KIU/l = lU/ml 175 140 210 Beckman DxI800
ng/ml 212 169 255
KIU/l = lU/ml 195 156 234 Roche Cobas 6000/8000
ng/ml 236 189 283
KIU/l = lU/ml 201 161 241 Roche Cobas E411
ng/ml 243 195 291

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Amikacin µmol/l 23.2 18.6 27.8 Roche Cobas 6000/8000
µg/ml 13.6 10.9 16.3
µmol/l 24.1 19.3 28.9 Gravimetric
µg/ml 14.1 11.3 16.9
Androstenedione nmol/l 32.2 24.2 40.3 Siemens Immulite 2000
ng/ml 9.24 6.95 11.5
Beta-2-microglobulin µg/ml = mg/l 6.68 5.34 8.02 BioMerieux Vidas
µg/ml = mg/l 6.04 4.83 7.25 Siemens Immulite 2000/2500
µg/ml = mg/l 7.05 5.64 8.46 Abbott Architect
µg/ml = mg/l 6.86 5.49 8.23 Roche Cobas 6000/8000
C-Peptide nmol/l 3.440 2.580 4.300 Siemens Immulite 2000/2500
ng/ml 10.4 7.79 13.0
nmol/l 3.480 2.610 4.350 Roche Cobas 6000/8000
ng/ml 10.5 7.88 13.1
nmol/l 3.420 2.570 4.280 Roche Cobas E411
ng/ml 10.3 7.76 12.8
nmol/l 3.120 2.340 3.900 Abbott Architect
ng/ml 9.42 7.06 11.8
nmol/l 2.270 1.700 2.840 Siemens Centaur XP/XPT/Classic
ng/ml 6.85 5.13 8.57
Carbamazepine µmol/l 65.3 52.2 78.4 Vitros
µg/ml 15.4 12.3 18.5
µmol/l 72.0 44.6 99.4 Siemens Centaur XP/XPT/Classic
µg/ml 17.0 10.5 23.5
µmol/l 60.9 48.7 73.1 Siemens Immulite 2000/2500
µg/ml 14.4 11.5 17.3
µmol/l 68.7 55.0 82.4 Abbott Architect
µg/ml 16.2 13.0 19.4
µmol/l 65.8 52.6 79.0 Beckman DxC
µg/ml 15.6 12.4 18.8
µmol/l 68.6 54.9 82.3 Roche Cobas 6000/8000
µg/ml 16.2 13.0 19.4
µmol/l 72.2 57.8 86.6 Gravimetric
µg/ml 17.1 13.7 20.5
Carcinoembryonic ng/ml = µg/l 56.2 45.0 67.4 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 82.8 66.2 99.0 Siemens Immulite 1000
ng/ml = µg/l 47.3 37.8 56.8 Roche Elecsys
ng/ml = µg/l 60.4 48.3 72.5 Vitros ECi
ng/ml = µg/l 59.9 41.3 78.5 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 82.4 65.9 98.9 Siemens Immulite 2000/2500
ng/ml = µg/l 64.8 51.8 77.8 Abbott Architect
ng/ml = µg/l 46.0 36.8 55.2 Diasorin Liaison
ng/ml = µg/l 46.6 37.3 55.9 Roche Modular E170
ng/ml = µg/l 49.2 39.4 59.0 Beckman DxI800
ng/ml = µg/l 47.4 37.9 56.9 Roche Cobas 6000/8000
ng/ml = µg/l 48.1 38.5 57.7 Roche Cobas E411

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 908 681 1135 Siemens Immulite 1000
µg/dl 32.7 24.5 40.9
nmol/l 965 724 1206 Roche Elecsys
µg/dl 34.7 26.1 43.3
nmol/l 937 703 1171 Beckman Access
µg/dl 33.7 25.3 42.1
nmol/l 1074 741 1407 Siemens Centaur XP/XPT/Classic
µg/dl 38.7 27.0 50.0
nmol/l 829 622 1036 Siemens Immulite 2000/2500
µg/dl 29.8 22.4 37.2
nmol/l 843 632 1054 Vitros ECi
µg/dl 30.3 22.8 37.8
nmol/l 789 592 986 Abbott Architect
µg/dl 28.4 21.3 35.5
nmol/l 845 634 1056 Beckman DxI800
µg/dl 30.4 22.8 38.0
nmol/l 951 713 1189 Roche Cobas 6000/8000
µg/dl 34.2 25.7 42.7
nmol/l 947 710 1184 Roche Cobas E411
µg/dl 34.1 25.6 42.6
nmol/l 925 694 1156 Roche Cobas 4000/e411 Gen II
µg/dl 33.3 25.0 41.6
nmol/l 868 651 1085 Roche Cobas 6000/8000 Gen II
µg/dl 31.2 23.4 39.0
DHEA-S µmol/l 16.5 13.2 19.8 Siemens Immulite 1000
µmol/l 16.3 13.0 19.6 Siemens Immulite 2000/2500
µmol/l 21.3 17.0 25.6 Abbott Architect
µmol/l 15.1 12.1 18.1 Beckman DxI800
µmol/l 17.0 10.2 23.8 Siemens Centaur XP/XPT/Classic
µmol/l 24.1 19.3 28.9 Roche Cobas E411
µmol/l 24.5 19.6 29.4 Roche Cobas 6000/8000
Digoxin nmol/l 4.75 3.80 5.70 Vitros
ng/ml 3.71 2.97 4.45
nmol/l 5.34 4.17 6.51 Siemens Centaur XP/XPT/Classic
ng/ml 4.17 3.25 5.09
nmol/l 4.06 3.25 4.87 Abbott Architect
ng/ml 3.17 2.54 3.80
nmol/l 4.79 3.83 5.75 Beckman DxI800
ng/ml 3.74 2.99 4.49
nmol/l 4.90 3.92 5.88 Roche Cobas 6000/8000
ng/ml 3.83 3.06 4.60
nmol/l 5.12 4.10 6.14 Gravimetric
ng/ml 4.00 3.20 4.80
Ethosuximide µmol/l 493 394 592 Gravimetric
µg/ml 69.9 55.9 83.9
Ferritin ng/ml = µg/l 298 238 358 BioMerieux Vidas

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 273 218 328 Siemens Immulite 1000
ng/ml = µg/l 352 282 422 Roche Elecsys
ng/ml = µg/l 249 199 299 Beckman Access
ng/ml = µg/l 228 182 274 Vitros ECi
ng/ml = µg/l 339 264 414 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 303 242 364 Siemens Immulite 2000/2500
ng/ml = µg/l 422 338 506 Abbott Architect
ng/ml = µg/l 340 272 408 Roche Modular E170
ng/ml = µg/l 320 256 384 Siemens Dimension
ng/ml = µg/l 245 196 294 Beckman DxI800
ng/ml = µg/l 349 279 419 Roche Cobas E411
ng/ml = µg/l 315 252 378 Siemens Centaur CP
Folate nmol/l 24.5 18.6 30.4 Beckman Access
ng/ml 10.8 8.20 13.4
nmol/l 16.9 12.8 21.0 Siemens Immulite 2000
ng/ml 7.45 5.64 9.26
nmol/l 20.6 15.7 25.5 Abbott Architect
ng/ml 9.08 6.92 11.2
nmol/l 41.1 24.7 57.5 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 18.1 10.9 25.3
nmol/l 24.8 18.8 30.8 Beckman DxI800
ng/ml 10.9 8.29 13.5
nmol/l 26.2 19.9 32.5 Roche Cobas 6000/8000
ng/ml 11.6 8.78 14.4
nmol/l 25.9 19.7 32.1 Roche Cobas 6000/8000 Folate III
ng/ml 11.4 8.69 14.1
nmol/l 23.9 18.2 29.6 Roche Cobas 4000/e411 Folate III
ng/ml 10.5 8.03 13.0
Free T3 pmol/l 24.7 18.5 30.9 BioMerieux Vidas
ng/dl 1.61 1.20 2.02
pg/ml 16.1 12.0 20.2
pmol/l 29.4 22.1 36.8 Roche Elecsys
ng/dl 1.91 1.44 2.38
pg/ml 19.1 14.4 23.8
pmol/l 19.6 14.7 24.5 Beckman Access
ng/dl 1.27 0.956 1.58
pg/ml 12.8 9.57 16.0
pmol/l 35.0 26.3 43.8 Vitros ECi
ng/dl 2.28 1.71 2.85
pg/ml 22.8 17.1 28.5
pmol/l 22.9 13.7 32.1 Siemens Centaur XP/XPT/Classic
ng/dl 1.49 0.890 2.09
pg/ml 14.9 8.90 20.9
pmol/l 17.1 12.8 21.4 Siemens Immulite 2000/2500
ng/dl 1.11 0.832 1.39
pg/ml 11.1 8.33 13.9

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 22.7 17.0 28.4 Abbott Architect
ng/dl 1.48 1.11 1.85
pg/ml 14.8 11.1 18.5
pmol/l 30.1 22.6 37.6 Roche Modular E170
ng/dl 1.96 1.47 2.45
pg/ml 19.6 14.7 24.5
pmol/l 19.4 14.6 24.3 Beckman DxI800
ng/dl 1.26 0.949 1.57
pg/ml 12.6 9.50 15.7
pmol/l 29.9 22.4 37.4 Roche Cobas E411
ng/dl 1.94 1.46 2.42
pg/ml 19.5 14.6 24.4
pmol/l 30.0 22.5 37.5 Roche Cobas 6000/8000
ng/dl 1.95 1.46 2.44
pg/ml 19.5 14.6 24.4
Free T4 pmol/l 77.3 58.0 96.6 Siemens Immulite 1000
ng/dl 6.03 4.52 7.54
pg/ml 60.3 45.2 75.4
pmol/l 78.3 58.7 97.9 Roche Elecsys
ng/dl 6.11 4.58 7.64
pg/ml 61.1 45.8 76.4
pmol/l 51.9 38.9 64.9 Beckman Access
ng/dl 4.05 3.03 5.07
pg/ml 40.5 30.3 50.7
pmol/l 89.7 67.3 112 Vitros ECi
ng/dl 7.00 5.25 8.75
pg/ml 70.0 52.5 87.5
pmol/l 49.4 37.1 61.7 Siemens Centaur XP/XPT/Classic
ng/dl 3.85 2.89 4.81
pg/ml 38.5 28.9 48.1
pmol/l 76.7 57.5 95.9 Siemens Immulite 2000/2500
ng/dl 5.98 4.49 7.47
pg/ml 59.8 44.9 74.7
pmol/l 46.4 34.8 58.0 Abbott Architect
ng/dl 3.62 2.71 4.53
pg/ml 36.2 27.1 45.3
pmol/l 109 81.8 136 Diasorin Liaison
ng/dl 8.50 6.38 10.6
pg/ml 85.0 63.8 106
pmol/l 80.1 60.1 100 Roche Modular E170
ng/dl 6.25 4.69 7.81
pg/ml 62.5 46.9 78.1
pmol/l 57.7 43.3 72.1 Beckman DxI800
ng/dl 4.50 3.38 5.62
pg/ml 45.0 33.8 56.2
pmol/l 77.2 57.9 96.5 Roche Cobas 6000/8000
ng/dl 6.02 4.52 7.52
pg/ml 60.2 45.2 75.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 75.6 56.7 94.5 Roche Cobas E411
ng/dl 5.90 4.42 7.38
pg/ml 59.0 44.2 73.8
pmol/l 78.1 58.6 97.6 Biomerieux Vidas FT4N Kit
ng/dl 6.09 4.57 7.61
pg/ml 60.9 45.7 76.1
pmol/l 56.8 42.6 71.0 Siemens Centaur CP
ng/dl 4.43 3.32 5.54
pg/ml 44.3 33.2 55.4
FSH mU/ml 55.4 44.3 66.5 Siemens Immulite 1000
mU/ml 68.9 55.1 82.7 BioMerieux Vidas
mU/ml 61.0 48.8 73.2 Beckman Access
mU/ml 57.5 46.0 69.0 Roche/BM Elecsys
mU/ml 45.4 36.3 54.5 Vitros ECi
mU/ml 72.5 56.6 88.4 Siemens Centaur XP/XPT/Classic
mU/ml 61.2 49.0 73.4 Siemens Immulite 2000/2500
mU/ml 50.3 40.2 60.4 Abbott Architect
mU/ml 86.5 66.5 107 Diasorin Liaison
mU/ml 56.5 45.2 67.8 Roche Modular E170
mU/ml 60.2 48.2 72.2 Beckman DxI800
mU/ml 57.7 46.2 69.2 Roche Cobas E411
mU/ml 55.8 44.6 67.0 Roche Cobas 6000/8000
Gentamicin µmol/l 8.10 6.48 9.72 Roche Cobas 6000/8000
µg/ml 3.87 3.10 4.64
µmol/l 11.7 9.36 14.0 Gravimetric
µg/ml 5.59 4.47 6.69
Growth Hormone (GH) µU/ml 47.4 37.9 56.9 Siemens Immulite 1000
ng/ml 15.8 12.6 19.0
µU/ml 50.9 40.7 61.1 Siemens Immulite 2000/2500
ng/ml 16.9 13.6 20.2
µU/ml 41.4 33.1 49.7 Beckman DxI800
ng/ml 13.8 11.0 16.6
µU/ml 42.7 34.2 51.2 Diasorin Liaison
ng/ml 14.2 11.4 17.0
µU/ml 44.7 35.8 53.6 Roche Cobas E411
ng/ml 14.9 11.9 17.9
µU/ml 44.8 35.8 53.8 Roche Cobas 6000/8000
ng/ml 14.9 11.9 17.9
Immunoglobulin E KIU/l = IU/ml 456 365 547 Siemens Immulite 1000
KIU/l = IU/ml 369 295 443 BioMerieux Vidas
KIU/l = IU/ml 416 333 499 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 472 378 566 Siemens Immulite 2000/2500
KIU/l = IU/ml 456 365 547 Abbott Architect
KIU/l = IU/ml 472 378 566 Roche Cobas E411

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 479 383 575 Roche Cobas 6000/8000
Insulin mU/l 30.9 23.2 38.6 Siemens Centaur XP/XPT/Classic
pmol/l 215 161 269
mU/l 30.6 23.0 38.3 Roche Modular E170
pmol/l 213 160 266
mU/l 9.27 6.95 11.6 Siemens Immulite 2000
pmol/l 64.4 48.3 80.5
mU/l 23.3 17.5 29.1 Abbott Architect
pmol/l 162 122 202
mU/l 30.7 23.0 38.4 Roche Cobas E411
pmol/l 213 160 266
mU/l 31.0 23.3 38.8 Roche Cobas 6000/8000
pmol/l 215 162 268
mU/l 23.4 17.6 29.3 Beckman DxI 600/800
pmol/l 163 122 204
Luteinising Hormone mU/ml 29.6 23.7 35.5 Beckman Access
(LH)
mU/ml 43.5 34.8 52.2 BioMerieux Vidas
mU/ml 68.2 54.6 81.8 Siemens Immulite 1000
mU/ml 47.0 37.6 56.4 Roche Elecsys
mU/ml 54.6 43.7 65.5 Vitros ECi
mU/ml 44.4 34.2 54.6 Siemens Centaur XP/XPT/Classic
mU/ml 68.6 54.9 82.3 Siemens Immulite 2000
mU/ml 36.9 29.5 44.3 Abbott Architect
mU/ml 59.9 47.9 71.9 Diasorin Liaison
mU/ml 47.1 37.7 56.5 Roche Modular E170
mU/ml 30.2 24.2 36.2 Beckman DxI800
mU/ml 47.5 38.0 57.0 Roche Cobas E411
mU/ml 47.6 38.1 57.1 Roche Cobas 6000/8000
Oestradiol pmol/l 2443 1954 2932 BioMerieux Vidas
pg/ml 664 531 797
pmol/l 1239 991 1487 Roche Elecsys (Estradiol II)
pg/ml 337 270 404
pmol/l 1918 1534 2302 Vitros ECi
pg/ml 522 417 627
pmol/l 1947 1558 2336 Beckman Access
pg/ml 530 424 636
pmol/l 2163 1341 2985 Siemens Centaur XP/XPT/Classic
pg/ml 568 365 811
pmol/l 1863 1490 2236 Siemens Immulite 2000/2500
pg/ml 507 405 609
pmol/l 1080 864 1296 Abbott Architect
pg/ml 294 235 353
pmol/l 1818 1454 2182 Beckman DxI800
pg/ml 494 395 593
pmol/l 1254 1003 1505 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 341 273 409

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 1245 996 1494 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 339 271 407
pmol/l 2029 1258 2800 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 552 342 762
pmol/l 1244 995 1493 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 338 271 405
pmol/l 1284 1027 1541 Roche Elecsys (Estradiol III)
pg/ml 349 279 419
pmol/l 1230 984 1476 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 335 268 402
pmol/l 1245 996 1494 Roche Modular E170 (Estradiol III)
pg/ml 339 271 407
Paracetamol mmol/l 0.470 0.376 0.564 Roche Cobas 6000/8000
mg/l 71.1 56.9 85.3
mmol/l 0.529 0.420 0.630 Gravimetric
mg/l 80.0 63.5 95.3
Phenobarbital µmol/l 123 98.4 148 Abbott Architect
µg/ml 28.5 22.8 34.2
µmol/l 126 101 151 Beckman AU400/600/640/2700/5400
µg/ml 29.2 23.4 35.0
µmol/l 121 96.8 145 Gravimetric
µg/ml 28.1 22.5 33.6
Phenytoin µmol/l 90.9 72.7 109 Vitros
µg/ml 23.0 18.4 27.6
µmol/l 91.4 73.1 110 Abbott Architect
µg/ml 23.1 18.5 27.7
µmol/l 90.7 72.6 109 Roche Cobas 6000/8000
µg/ml 22.9 18.3 27.5
µmol/l 99.8 79.8 120 Gravimetric
µg/ml 25.2 20.1 30.3
Primidone µmol/l 32.7 26.2 39.2 Gravimetric
µg/ml 7.14 5.72 8.56
Progesterone nmol/l 78.6 62.9 94.3 Siemens Immulite 1000
ng/ml 24.6 19.7 29.5
nmol/l 138 110 166 BioMerieux Vidas
ng/ml 43.2 34.4 52.0
nmol/l 98.0 71.9 124 Roche Elecsys (Prog. II)
ng/ml 30.7 22.5 38.9
nmol/l 98.5 78.8 118 Vitros ECi
ng/ml 30.8 24.7 36.9
nmol/l 72.1 51.2 93.0 Siemens Centaur XP/XPT/Classic
ng/ml 22.6 16.0 29.2
nmol/l 72.7 58.2 87.2 Siemens Immulite 2000/2500
ng/ml 22.8 18.2 27.4
nmol/l 88.4 70.7 106 Abbott Architect
ng/ml 27.7 22.1 33.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 102 81.6 122 Beckman DxI Prog Cal 33555
ng/ml 31.9 25.5 38.3
nmol/l 98.0 78.4 118 Roche Cobas 4000/e411 (Prog. II)
ng/ml 30.7 24.5 36.9
nmol/l 97.2 77.8 117 Roche Cobas 6000/8000 (Prog. II)
ng/ml 30.4 24.4 36.4
nmol/l 82.6 66.1 99.0 Beckman DxI Prog DE Cal A80773
ng/ml 25.9 20.7 31.1
nmol/l 94.1 75.3 113 Roche Cobas 6000/8000 (Prog. III)
ng/ml 29.5 23.6 35.4
nmol/l 94.2 75.4 113 Roche Cobas 4000/e411 (Prog. III)
ng/ml 29.5 23.6 35.4
Prolactin µU/ml 1265 1012 1518 Beckman Access
µU/ml 1699 1359 2039 BioMerieux Vidas
µU/ml 1470 1176 1764 Siemens Immulite 1000
µU/ml 1701 1361 2041 Roche Elecsys
µU/ml 1310 1048 1572 Vitros ECi
µU/ml 1266 950 1582 Siemens Centaur XP/XPT/Classic
µU/ml 1423 1138 1708 Siemens Immulite 2000/2500
µU/ml 1535 1228 1842 Abbott Architect
µU/ml 1736 1389 2083 Diasorin Liaison
µU/ml 1622 1298 1946 Roche Modular E170
µU/ml 1286 1029 1543 Beckman DxI800
µU/ml 1614 1291 1937 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 1695 1356 2034 Roche Cobas E411
µU/ml 1625 1300 1950 Roche Cobas 6000/8000
µU/ml 1495 1196 1794 Abbott Architect restandardised
PSA Free ng/ml = µg/l 15.1 11.3 18.9 Siemens Immulite 2000/2500
ng/ml = µg/l 22.0 16.5 27.5 Abbott Architect
ng/ml = µg/l 24.8 18.6 31.0 Beckman Access standardised to Hybritech
ng/ml = µg/l 20.3 15.2 25.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 19.1 14.3 23.9 Roche Modular E170
ng/ml = µg/l 24.9 18.7 31.1 Beckman DXI standardised to Hybritech
ng/ml = µg/l 18.9 14.2 23.6 Roche Cobas E411
ng/ml = µg/l 19.0 14.3 23.8 Roche Cobas 6000/8000
PSA Total ng/ml = µg/l 19.5 14.6 24.4 Siemens Immulite 1000 1st generation
ng/ml = µg/l 27.8 20.9 34.8 Roche Elecsys
ng/ml = µg/l 24.8 18.6 31.0 Beckman Access standardised to Hybritech
ng/ml = µg/l 21.7 16.3 27.1 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 27.0 20.3 33.8 bioMerieux VIDAS TPSA
ng/ml = µg/l 22.6 17.0 28.3 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 22.1 16.6 27.6 Abbott Architect
ng/ml = µg/l 25.3 19.0 31.6 Vitros ECi
ng/ml = µg/l 24.8 18.6 31.0 Roche Modular E170
ng/ml = µg/l 23.9 17.9 29.9 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 17.3 13.0 21.6 Beckman DxI800 standardised to WHO IRP96/670

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
PSA Total ng/ml = µg/l 27.7 20.8 34.6 Roche Cobas E411
ng/ml = µg/l 26.4 19.8 33.0 Roche Cobas 6000/8000
ng/ml = µg/l 25.3 19.0 31.6 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 20.7 15.5 25.9 Siemens Centaur CP
Salicylic Acid mmol/l 2.82 2.26 3.38 Abbott Architect
mg/dl 38.9 31.2 46.6
mmol/l 2.88 2.30 3.46 Gravimetric
mg/dl 39.7 31.7 47.7
SHBG nmol/l 35.3 28.2 42.4 Siemens Immulite 2000/2500
nmol/l 35.9 28.7 43.1 Roche Modular E170
nmol/l 36.0 28.8 43.2 Abbott Architect
nmol/l 38.0 30.4 45.6 Roche Cobas E411
nmol/l 37.2 29.8 44.6 Roche Cobas 6000/8000
nmol/l 34.6 27.7 41.5 Beckman DxI800
T Uptake %U 43.1 35.3 50.9 Siemens Immulite 2000
Testosterone nmol/l 39.6 31.7 47.5 Vitros ECi
ng/ml 11.4 9.13 13.7
ng/dl 1140 913 1367
nmol/l 24.2 17.7 30.7 Siemens Centaur XP/XPT/Classic
ng/ml 6.97 5.09 8.85
ng/dl 697 509 885
nmol/l 33.5 25.9 41.1 Siemens Immulite 2000/2500
ng/ml 9.65 7.46 11.8
ng/dl 965 746 1184
nmol/l 29.2 23.4 35.0 Abbott Architect
ng/ml 8.41 6.74 10.1
ng/dl 841 674 1008
nmol/l 26.1 20.9 31.3 Beckman Access
ng/ml 7.52 6.02 9.02
ng/dl 752 602 902
nmol/l 23.6 18.9 28.3 Beckman DxI800
ng/ml 6.80 5.44 8.16
ng/dl 680 544 816
nmol/l 27.2 21.8 32.6 Roche Elecsys Test II
ng/ml 7.83 6.28 9.38
ng/dl 783 628 938
nmol/l 28.7 23.0 34.4 Roche Modular E170 Test II
ng/ml 8.27 6.62 9.92
ng/dl 827 662 992
nmol/l 28.2 22.6 33.8 Roche Cobas 4000/e411 Test II
ng/ml 8.12 6.51 9.73
ng/dl 812 651 973
nmol/l 28.7 23.0 34.4 Roche Cobas 6000 Test 2
ng/ml 8.27 6.62 9.92
ng/dl 827 662 992
nmol/l 28.3 22.6 34.0 Abbott Architect 2nd Generation
ng/ml 8.15 6.51 9.79
ng/dl 815 651 979

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 22.0 17.6 26.4 BioMerieux Vidas Testosterone II
ng/ml 6.34 5.07 7.61
ng/dl 634 507 761
Theophylline µmol/l 153 122 184 Siemens Centaur XP/XPT/Classic
µg/ml 27.6 22.0 33.2
µmol/l 152 117 187 Abbott Architect
µg/ml 27.4 21.1 33.7
µmol/l 166 133 199 Gravimetric
µg/ml 29.9 24.0 35.9
Thyroglobulin ng/ml 35.1 26.3 43.9 Siemens Immulite 2000
ng/ml 59.9 44.9 74.9 Roche Cobas E411
ng/ml 52.8 39.6 66.0 Roche Cobas 6000/8000
ng/ml 53.3 40.0 66.6 Roche Cobas 6000 TGII
ng/ml 55.8 41.9 69.8 Roche Cobas 4000/E411 TGII
Thyroid Stimulating µU/ml = mlU/l 20.9 16.7 25.1 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 19.8 15.8 23.8 Siemens Immulite 1000
µU/ml = mlU/l 19.7 15.8 23.6 Roche Elecsys
µU/ml = mlU/l 18.7 15.0 22.4 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 21.5 17.2 25.8 Tosoh AIA360
µU/ml = mlU/l 28.1 22.5 33.7 Vitros ECi
µU/ml = mlU/l 21.1 14.3 27.9 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 19.9 15.9 23.9 Siemens Immulite 2000/2500
µU/ml = mlU/l 17.2 13.8 20.6 Abbott Architect
µU/ml = mlU/l 22.4 16.7 28.1 Diasorin Liaison
µU/ml = mlU/l 19.0 15.2 22.8 Roche Modular E170
µU/ml = mlU/l 19.6 14.3 24.9 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 18.2 14.6 21.8 Beckman Access Fast TSH
µU/ml = mlU/l 19.8 15.8 23.8 Roche Cobas E411
µU/ml = mlU/l 19.2 15.4 23.0 Roche Cobas 6000/8000
µU/ml = mlU/l 19.4 15.5 23.3 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 21.4 14.6 28.2 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 21.3 17.0 25.6 Siemens Centaur CP
µU/ml = mlU/l 17.6 14.1 21.1 Beckman DxI 600/800 Access (3rd IS)
Tobramycin µmol/l 10.3 8.24 12.4 Gravimetric
µg/ml 4.82 3.86 5.80
Total Beta hCG mU/ml=IU/l 514 411 617 BioMerieux Vidas
IU/ml 0.514 0.411 0.617
mU/ml=IU/l 600 480 720 Siemens Immulite 1000
IU/ml 0.600 0.480 0.720
mU/ml=IU/l 379 303 455 Roche Cobas Core EIA
IU/ml 0.379 0.303 0.455
mU/ml=IU/l 322 258 386 Beckman Access
IU/ml 0.322 0.258 0.386
mU/ml=IU/l 536 429 643 Vitros ECi
IU/ml 0.536 0.429 0.643

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 313 188 438 Siemens Centaur XP/XPT/Classic
IU/ml 0.310 0.188 0.438
mU/ml=IU/l 606 485 727 Siemens Immulite 2000
IU/ml 0.606 0.485 0.727
mU/ml=IU/l 319 255 383 Abbott Architect
IU/ml 0.319 0.255 0.383
mU/ml=IU/l 328 234 422 Diasorin Liaison
IU/ml 0.328 0.234 0.420
mU/ml=IU/l 531 425 637 Siemens Dimension
IU/ml 0.531 0.425 0.637
mU/ml=IU/l 325 260 390 Beckman DxI800
IU/ml 0.325 0.260 0.390
mU/ml=IU/l 376 301 451 Roche STAT (Intact)
IU/ml 0.376 0.301 0.451
mU/ml=IU/l 376 301 451 Roche hCG+Beta
IU/ml 0.376 0.301 0.451
mU/ml=IU/l 334 267 401 Beckman Access Total BhCG (5th IS)
IU/ml 0.334 0.267 0.401
mU/ml=IU/l 335 268 402 Beckman DxI Total BhCG (5th IS)
IU/ml 0.335 0.268 0.402
Total T3 nmol/l 6.44 4.83 8.05 BioMerieux Vidas
ng/ml 4.19 3.14 5.24
ng/dl 419 314 524
nmol/l 6.94 5.21 8.68 Siemens Immulite 1000
ng/ml 4.52 3.39 5.65
ng/dl 452 339 565
nmol/l 5.76 4.32 7.20 Beckman Access
ng/ml 3.75 2.81 4.69
ng/dl 375 281 469
nmol/l 6.50 4.88 8.13 Tosoh AIA360
ng/ml 4.23 3.18 5.28
ng/dl 423 318 528
nmol/l 7.71 5.78 9.64 Siemens Centaur XP/XPT/Classic
ng/ml 5.02 3.77 6.27
ng/dl 502 377 627
nmol/l 6.52 4.89 8.15 Siemens Immulite 2000/2500
ng/ml 4.24 3.18 5.30
ng/dl 424 318 530
nmol/l 5.24 3.93 6.55 Abbott Architect
ng/ml 3.41 2.56 4.26
ng/dl 341 256 426
nmol/l 8.38 6.29 10.5 Vitros ECi
ng/ml 5.46 4.09 6.83
ng/dl 546 409 683
nmol/l 6.89 5.17 8.61 Roche Cobas E411
ng/ml 4.49 3.37 5.61
ng/dl 449 337 561

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 6.66 5.00 8.33 Roche Cobas 6000/8000
ng/ml 4.34 3.26 5.42
ng/dl 434 326 542
Total T4 nmol/l 203 152 254 Vitros ECi
µg/dl 15.8 11.9 19.7
ng/ml 158 119 197
nmol/l 218 164 273 BioMerieux Vidas
µg/dl 17.0 12.8 21.2
ng/ml 170 128 212
nmol/l 188 141 235 Siemens Immulite 1000
µg/dl 14.7 11.0 18.4
ng/ml 147 110 184
nmol/l 207 155 259 Beckman Access
µg/dl 16.1 12.1 20.1
ng/ml 161 121 201
nmol/l 210 147 273 Siemens Centaur XP/XPT/Classic
µg/dl 16.4 11.5 21.3
ng/ml 164 115 213
nmol/l 194 146 243 Siemens Immulite 2000/2500
µg/dl 15.1 11.4 18.8
ng/ml 151 114 188
nmol/l 181 136 226 Abbott Architect
µg/dl 14.1 10.6 17.6
ng/ml 141 106 176
nmol/l 183 137 229 Roche Cobas E411
µg/dl 14.3 10.7 17.9
ng/ml 143 107 179
nmol/l 178 134 223 Roche Cobas 6000/8000
µg/dl 13.9 10.5 17.3
ng/ml 139 105 173
Valproic Acid µmol/l 938 750 1126 Siemens Immulite 2000/2500
µg/ml 135 108 162
µmol/l 921 737 1105 Siemens Centaur XP/XPT/Classic
µg/ml 133 106 160
µmol/l 912 730 1094 Abbott Architect
µg/ml 132 105 159
µmol/l 933 746 1120 Roche Cobas 6000/8000
µg/ml 135 108 162
µmol/l 1116 893 1339 Gravimetric
µg/ml 161 129 193
Vancomycin µmol/l 11.5 9.20 13.8 Abbott Architect
µg/ml 17.1 13.7 20.5
µmol/l 10.5 8.40 12.6 Roche Cobas 6000/8000
µg/ml 15.6 12.5 18.7

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)
Cat. No. IA2640 / IA2633 Lot No. 1722EC Size: 12 x 5 ml / 4 x 5 ml Expiry: 2020-04-28
Range
Analyte unit Target low high methods
Vancomycin µmol/l 10.8 8.64 13.0 Gravimetric
µg/ml 16.0 12.8 19.3
Vitamin B12 pmol/l 704 563 845 Roche Elecsys
pg/ml 954 763 1145
pmol/l 613 490 736 Beckman Access
pg/ml 831 664 998
pmol/l 723 542 904 Siemens Centaur XP/XPT/Classic
pg/ml 980 735 1225
pmol/l 651 521 781 Siemens Immulite 2000
pg/ml 882 706 1058
pmol/l 703 562 844 Abbott Architect
pg/ml 953 762 1144
pmol/l 670 536 804 Vitros ECi
pg/ml 908 726 1090
pmol/l 745 596 894 Roche Modular E170
pg/ml 1009 808 1210
pmol/l 612 490 734 Beckman DxI800
pg/ml 829 664 994
pmol/l 735 588 882 Roche Cobas E411
pg/ml 996 797 1195
pmol/l 750 600 900 Roche Cobas 6000/8000
pg/ml 1016 813 1219

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

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