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2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 1


(IA PREMIUM PLUS 1)
CAT. NO. IA3109 GTIN: 05055273207255 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 1975EC EXPIRY: 2023-04-28

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. Free PSA and Total PSA are stable for 2 days when stored
at +2°C to +8°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 Plus 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 Plus - 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 Plus 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.

Randox Teoranta, Meenmore,


Dungloe, Donegal,
F94 TV06, Ireland 18 Mar 21 me

PAGE 1 OF 12
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 2.83 2.12 3.54 Immunotech RIA
ng/ml 0.937 0.702 1.17
25-OH Vitamin D nmol/l 42.2 31.7 52.8 Siemens Centaur XP/XPT/Classic
nmol/l 23.7 17.8 29.6 Roche Vitamin D Total
nmol/l 25.3 19.0 31.6 Abbott Architect
nmol/l 111 83.3 139 Vitros ECi
nmol/l 31.8 23.9 39.8 BioMerieux Vidas
nmol/l 41.0 30.8 51.3 Beckman DxI 600/800
nmol/l 24.9 18.7 31.1 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 24.8 18.6 31.0 Roche Vitamin D Total II
ACTH pmol/l 6.65 4.99 8.31 Siemens Immulite 2000/2500
pg/ml 30.2 22.7 37.7
pmol/l 11.2 8.40 14.0 Roche Cobas E411
pg/ml 50.9 38.2 63.6
pmol/l 10.5 7.88 13.1 Roche Cobas 6000/8000
pg/ml 47.7 35.8 59.6
pmol/l 8.57 6.43 10.7 Siemens Immulite 1000
pg/ml 39.0 29.2 48.8
pmol/l 12.7 9.53 15.9 Diasorin Liaison XL
pg/ml 57.7 43.3 72.1
Alphafoetoprotein KIU/l = lU/ml 9.01 7.21 10.8 BioMerieux Vidas
ng/ml 10.9 8.72 13.1
KIU/l = lU/ml 9.46 7.57 11.4 Vitros ECi
ng/ml 9.84 7.87 11.8
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 8.18 6.54 9.82 Siemens Immulite 2000/2500
ng/ml 9.90 7.91 11.9
KIU/l = lU/ml 8.50 6.80 10.2 Abbott Architect
ng/ml 10.3 8.23 12.4
KIU/l = lU/ml 8.44 6.75 10.1 Beckman DxI800
ng/ml 10.2 8.17 12.2
KIU/l = lU/ml 9.32 7.46 11.2 Roche Cobas 6000/8000
ng/ml 11.3 9.03 13.6
KIU/l = lU/ml 9.12 7.30 10.9 Roche Cobas E411
ng/ml 11.0 8.83 13.2
Amikacin µmol/l 6.40 5.12 7.68 Gravimetric
µg/ml 3.75 3.00 4.50
Androstenedione nmol/l 4.58 3.44 5.73 Siemens Immulite 2000
ng/ml 1.31 0.987 1.63
Beta-2-microglobulin µg/ml = mg/l 0.928 0.742 1.11 BioMerieux Vidas
µg/ml = mg/l 0.922 0.738 1.11 Siemens Immulite 2000/2500

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Beta-2-microglobulin µg/ml = mg/l 0.896 0.717 1.08 Abbott Architect
µg/ml = mg/l 1.05 0.840 1.26 Roche Cobas 6000/8000
C-Peptide nmol/l 0.602 0.452 0.753 Siemens Immulite 2000/2500
ng/ml 1.82 1.36 2.28
nmol/l 0.794 0.596 0.993 Roche Cobas 6000/8000
ng/ml 2.40 1.80 3.00
nmol/l 0.659 0.494 0.824 Abbott Architect
ng/ml 1.99 1.49 2.49
CA 15-3 U/ml 23.5 15.5 31.5 Siemens Centaur XP/XPT/Classic
U/ml 24.7 19.8 29.6 Abbott Architect
U/ml 22.8 18.2 27.4 Siemens Immulite 2000/2500
U/ml 20.1 16.1 24.1 Vitros ECi
U/ml 9.75 7.80 11.7 Beckman DxI800
U/ml 22.5 18.0 27.0 Roche Cobas 6000/8000
U/ml 22.4 17.9 26.9 Roche Cobas E411
CA 19-9 U/ml 13.2 10.6 15.8 BioMerieux Vidas
U/ml 15.8 10.4 21.2 Siemens Centaur XP/XPT/Classic
U/ml 78.1 62.5 93.7 Siemens Immulite 2000/2500
U/ml 33.3 26.6 40.0 Vitros ECi
U/ml 95.9 76.7 115 Beckman DxI800
U/ml 24.4 19.5 29.3 Abbott Architect XR/XR2 kit
U/ml 22.6 18.1 27.1 Roche Cobas 6000/8000
U/ml 22.6 18.1 27.1 Roche Cobas E411
CA125 U/ml 14.7 11.8 17.6 BioMerieux Vidas
U/ml 7.62 6.10 9.14 Siemens Immulite 2000/2500
U/ml 9.74 7.79 11.7 Vitros ECi
U/ml 18.2 14.6 21.8 Abbott Architect
U/ml 9.65 6.37 12.9 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 4.13 3.30 4.96 Beckman Access
U/ml 4.66 3.73 5.59 Beckman DxI800
U/ml 19.0 15.2 22.8 Roche Cobas E411
U/ml 19.1 15.3 22.9 Roche Cobas 6000/8000
Carbamazepine µmol/l 17.2 12.4 22.0 Siemens Centaur XP/XPT/Classic
µg/ml 4.07 2.93 5.21
µmol/l 12.4 9.92 14.9 Siemens Immulite 2000/2500
µg/ml 2.93 2.35 3.51
µmol/l 15.3 12.2 18.4 Abbott Architect
µg/ml 3.62 2.88 4.36
µmol/l 14.4 11.5 17.3 Roche Cobas 6000/8000
µg/ml 3.40 2.72 4.08
µmol/l 15.4 12.3 18.5 Gravimetric
µg/ml 3.64 2.91 4.37
Carcinoembryonic ng/ml = µg/l 3.78 3.02 4.54 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 3.97 3.18 4.76 Vitros ECi
ng/ml = µg/l 3.94 3.15 4.73 Beckman Access
ng/ml = µg/l 4.65 3.07 6.23 Siemens Centaur XP/XPT/Classic

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Carcinoembryonic ng/ml = µg/l 4.86 3.89 5.83 Siemens Immulite 2000/2500
Antigen (CEA)
ng/ml = µg/l 4.69 3.75 5.63 Abbott Architect
ng/ml = µg/l 3.94 3.15 4.73 Beckman DxI800
ng/ml = µg/l 4.09 3.27 4.91 Roche Cobas 6000/8000
ng/ml = µg/l 4.27 3.42 5.12 Roche Cobas E411
Cortisol nmol/l 176 116 236 Siemens Centaur XP/XPT/Classic
µg/dl 6.34 4.18 8.50
nmol/l 192 144 240 Siemens Immulite 2000/2500
µg/dl 6.91 5.18 8.64
nmol/l 134 101 168 Vitros ECi
µg/dl 4.82 3.64 6.00
nmol/l 207 155 259 Abbott Architect
µg/dl 7.45 5.58 9.32
nmol/l 194 146 243 Beckman DxI800
µg/dl 6.98 5.26 8.70
nmol/l 191 143 239 Roche Cobas 6000/8000
µg/dl 6.88 5.15 8.61
nmol/l 196 147 245 Roche Cobas E411
µg/dl 7.06 5.29 8.83
nmol/l 197 148 246 Roche Cobas 4000/e411 Gen II
µg/dl 7.09 5.33 8.85
nmol/l 180 135 225 Roche Cobas 6000/8000 Gen II
µg/dl 6.48 4.86 8.10
DHEA-S µmol/l 1.91 1.53 2.29 Siemens Immulite 2000/2500
µmol/l 2.53 2.02 3.04 Abbott Architect
µmol/l 2.43 1.58 3.28 Siemens Centaur XP/XPT/Classic
µmol/l 3.23 2.58 3.88 Roche Cobas E411
µmol/l 3.03 2.42 3.64 Roche Cobas 6000/8000
Digoxin nmol/l 0.680 0.544 0.816 Siemens Immulite 2000/2500
ng/ml 0.531 0.425 0.637
nmol/l 0.618 0.494 0.742 Abbott Architect
ng/ml 0.483 0.386 0.580
nmol/l 0.781 0.625 0.937 Beckman DxI800
ng/ml 0.610 0.488 0.732
nmol/l 0.896 0.720 1.08 Gravimetric
ng/ml 0.700 0.560 0.840
Ethosuximide µmol/l 226 181 271 Gravimetric
µg/ml 32.0 25.7 38.4
Ferritin ng/ml = µg/l 19.1 15.3 22.9 BioMerieux Vidas
ng/ml = µg/l 19.0 15.2 22.8 Roche Elecsys
ng/ml = µg/l 11.6 9.28 13.9 Beckman Access
ng/ml = µg/l 12.7 10.2 15.2 Vitros ECi
ng/ml = µg/l 15.0 11.3 18.7 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 16.1 12.9 19.3 Siemens Immulite 2000/2500
ng/ml = µg/l 18.0 14.4 21.6 Abbott Architect
ng/ml = µg/l 18.9 15.1 22.7 Roche Modular E170

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 12.3 9.84 14.8 Beckman DxI800
ng/ml = µg/l 18.9 15.1 22.7 Roche Cobas E411
Folate nmol/l 4.81 3.66 5.96 Siemens Immulite 2000
ng/ml 2.12 1.61 2.63
nmol/l 4.71 3.58 5.84 Vitros ECi
ng/ml 2.08 1.58 2.58
nmol/l 6.01 4.57 7.45 Abbott Architect
ng/ml 2.65 2.02 3.28
nmol/l 13.8 7.59 20.0 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 6.09 3.35 8.83
nmol/l 5.68 4.32 7.04 Beckman DxI800
ng/ml 2.50 1.91 3.09
Free T3 pmol/l 3.28 2.46 4.10 Roche Elecsys
ng/dl 0.213 0.160 0.266
pg/ml 2.14 1.60 2.68
pmol/l 2.82 2.12 3.53 Beckman Access
ng/dl 0.183 0.138 0.228
pg/ml 1.84 1.38 2.30
pmol/l 5.32 3.99 6.65 Vitros ECi
ng/dl 0.346 0.259 0.433
pg/ml 3.46 2.60 4.32
pmol/l 2.77 1.66 3.88 Siemens Centaur XP/XPT/Classic
ng/dl 0.180 0.108 0.252
pg/ml 1.80 1.08 2.52
pmol/l 2.27 1.70 2.84 Siemens Immulite 2000/2500
ng/dl 0.148 0.111 0.185
pg/ml 1.48 1.11 1.85
pmol/l 2.37 1.78 2.96 Abbott Architect
ng/dl 0.154 0.116 0.192
pg/ml 1.54 1.16 1.92
pmol/l 2.84 2.13 3.55 Beckman DxI800
ng/dl 0.185 0.138 0.232
pg/ml 1.85 1.39 2.31
pmol/l 3.30 2.48 4.13 Roche Cobas E411
ng/dl 0.215 0.161 0.269
pg/ml 2.15 1.61 2.69
pmol/l 3.01 2.26 3.76 Roche Cobas 6000/8000
ng/dl 0.196 0.147 0.245
pg/ml 1.96 1.47 2.45
Free T4 pmol/l 13.9 10.4 17.4 Siemens Immulite 1000
ng/dl 1.08 0.811 1.35
pg/ml 10.8 8.11 13.5
pmol/l 10.2 7.65 12.8 Beckman Access
ng/dl 0.796 0.597 0.995
pg/ml 7.96 5.97 9.95
pmol/l 15.2 11.4 19.0 Vitros ECi
ng/dl 1.19 0.889 1.49
pg/ml 11.9 8.89 14.9

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 8.27 6.20 10.3 Siemens Centaur XP/XPT/Classic
ng/dl 0.645 0.484 0.806
pg/ml 6.45 4.84 8.06
pmol/l 13.5 10.1 16.9 Siemens Immulite 2000/2500
ng/dl 1.05 0.788 1.31
pg/ml 10.5 7.88 13.1
pmol/l 9.43 7.07 11.8 Abbott Architect
ng/dl 0.736 0.551 0.921
pg/ml 7.36 5.51 9.21
pmol/l 10.2 7.65 12.8 Beckman DxI800
ng/dl 0.796 0.597 0.995
pg/ml 7.96 5.97 9.95
pmol/l 12.5 9.38 15.6 Roche Cobas 6000/8000
ng/dl 0.975 0.732 1.22
pg/ml 9.75 7.32 12.2
pmol/l 12.6 9.45 15.8 Roche Cobas E411
ng/dl 0.983 0.737 1.23
pg/ml 9.83 7.37 12.3
pmol/l 9.53 7.15 11.9 Biomerieux Vidas FT4N Kit
ng/dl 0.743 0.558 0.928
pg/ml 7.43 5.58 9.28
FSH mU/ml 6.23 4.98 7.48 BioMerieux Vidas
mU/ml 5.96 4.77 7.15 Beckman Access
mU/ml 4.72 3.78 5.66 Vitros ECi
mU/ml 8.24 5.77 10.7 Siemens Centaur XP/XPT/Classic
mU/ml 6.43 5.14 7.72 Siemens Immulite 2000/2500
mU/ml 5.26 4.21 6.31 Abbott Architect
mU/ml 6.56 5.25 7.87 Beckman DxI800
mU/ml 5.85 4.68 7.02 Roche Cobas E411
mU/ml 5.54 4.43 6.65 Roche Cobas 6000/8000
Gentamicin µmol/l 4.85 3.88 5.82 Gravimetric
µg/ml 2.32 1.85 2.78
Growth Hormone (GH) µU/ml 4.81 3.85 5.77 Siemens Immulite 2000/2500
ng/ml 1.60 1.28 1.92
µU/ml 3.47 2.78 4.16 Beckman DxI800
ng/ml 1.16 0.926 1.39
µU/ml 4.25 3.40 5.10 Roche Cobas 6000/8000
ng/ml 1.42 1.13 1.71
µU/ml 3.60 2.88 4.32 Diasorin Liaison XL
ng/ml 1.20 0.959 1.44
Immunoglobulin E KIU/l = IU/ml 285 228 342 Siemens Immulite 1000
KIU/l = IU/ml 213 170 256 BioMerieux Vidas
KIU/l = IU/ml 271 163 379 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 269 215 323 Siemens Immulite 2000/2500

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 244 195 293 Abbott Architect
KIU/l = IU/ml 262 210 314 Roche Cobas E411
KIU/l = IU/ml 260 208 312 Roche Cobas 6000/8000
Insulin mU/l 1.27 0.953 1.59 Siemens Centaur XP/XPT/Classic
µU/ml 1.27 0.953 1.59
mU/l 0.963 0.722 1.20 Abbott Architect
µU/ml 0.963 0.722 1.20
mU/l 1.81 1.36 2.26 Roche Cobas E411
µU/ml 1.81 1.36 2.26
mU/l 1.79 1.34 2.24 Roche Cobas 6000/8000
µU/ml 1.79 1.34 2.24
mU/l 0.553 0.415 0.691 Beckman DxI 600/800
µU/ml 0.553 0.415 0.691
Luteinising Hormone (LH) mU/ml 2.22 1.78 2.66 Beckman Access
mU/ml 2.90 2.32 3.48 BioMerieux Vidas
mU/ml 5.41 4.33 6.49 Vitros ECi
mU/ml 3.00 2.25 3.75 Siemens Centaur XP/XPT/Classic
mU/ml 5.95 4.76 7.14 Siemens Immulite 2000
mU/ml 2.44 1.95 2.93 Abbott Architect
mU/ml 2.27 1.82 2.72 Beckman DxI800
mU/ml 3.98 3.18 4.78 Roche Cobas E411
mU/ml 3.80 3.04 4.56 Roche Cobas 6000/8000
Oestradiol pmol/l 293 234 352 BioMerieux Vidas
pg/ml 79.7 63.6 95.8
pmol/l 101 80.8 121 Vitros ECi
pg/ml 27.5 22.0 33.0
pmol/l 210 168 252 Abbott Architect
pg/ml 57.1 45.7 68.5
pmol/l 235 188 282 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 63.9 51.1 76.7
pmol/l 205 164 246 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 55.8 44.6 67.0
pmol/l 190 114 266 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 51.7 31.0 72.4
pmol/l 218 174 262 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 59.3 47.3 71.3
pmol/l 209 167 251 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 56.8 45.4 68.2
pmol/l 174 139 209 Beckman Access / Access 2 Sensitive B84493
pg/ml 47.3 37.8 56.8
pmol/l 161 129 193 Beckman DxI600/800 Sensitive B84493
pg/ml 43.8 35.1 52.5
Paracetamol mmol/l 0.158 0.126 0.190 Roche Cobas 6000/8000
mg/l 23.9 19.1 28.7
mmol/l 0.166 0.130 0.200 Gravimetric
mg/l 25.1 19.7 30.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Phenobarbital µmol/l 35.5 28.4 42.6 Abbott Architect
µg/ml 8.24 6.59 9.89
µmol/l 36.1 28.9 43.3 Siemens Immulite 2000/2500
µg/ml 8.38 6.70 10.1
µmol/l 34.5 27.6 41.4 Gravimetric
µg/ml 8.00 6.40 9.60
Phenytoin µmol/l 19.3 15.4 23.2 Abbott Architect
µg/ml 4.87 3.89 5.85
µmol/l 18.3 14.6 22.0 Roche Cobas 6000/8000
µg/ml 4.62 3.69 5.55
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 4.19 3.35 5.03 BioMerieux Vidas
ng/ml 1.31 1.05 1.57
nmol/l 2.55 2.04 3.06 Vitros ECi
ng/ml 0.798 0.639 0.957
nmol/l 2.57 1.41 3.73 Siemens Centaur XP/XPT/Classic
ng/ml 0.804 0.442 1.17
nmol/l 2.69 2.15 3.23 Siemens Immulite 2000/2500
ng/ml 0.842 0.673 1.01
nmol/l 3.07 2.46 3.68 Abbott Architect
ng/ml 0.961 0.770 1.15
nmol/l 2.53 2.02 3.04 Beckman DxI Prog Cal 33555
ng/ml 0.792 0.632 0.952
nmol/l 3.39 2.71 4.07 Roche Cobas 4000/e411 (Prog. II)
ng/ml 1.06 0.848 1.27
nmol/l 3.13 2.50 3.76 Roche Cobas 6000/8000 (Prog. II)
ng/ml 0.980 0.783 1.18
nmol/l 1.76 1.41 2.11 Beckman DxI Prog DE Cal A80773
ng/ml 0.551 0.441 0.661
nmol/l 3.49 2.79 4.19 Roche Cobas 6000/8000 (Prog. III)
ng/ml 1.09 0.873 1.31
nmol/l 3.47 2.78 4.16 Roche Cobas 4000/e411 (Prog. III)
ng/ml 1.09 0.870 1.31
Prolactin µU/ml 127 102 152 Beckman Access
µU/ml 135 108 162 BioMerieux Vidas
µU/ml 215 172 258 Vitros ECi
µU/ml 134 93.8 174 Siemens Centaur XP/XPT/Classic
µU/ml 136 109 163 Siemens Immulite 2000/2500
µU/ml 152 122 182 Abbott Architect
µU/ml 131 105 157 Beckman DxI800
µU/ml 125 100 150 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 132 106 158 Roche Cobas E411
µU/ml 124 99.0 149 Roche Cobas 6000/8000

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
PSA Free ng/ml = µg/l 1.23 0.923 1.54 Abbott Architect
ng/ml = µg/l 1.28 0.960 1.60 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.55 1.16 1.94 Beckman DXI standardised to Hybritech
ng/ml = µg/l 1.07 0.803 1.34 Roche Cobas E411
ng/ml = µg/l 1.13 0.848 1.41 Roche Cobas 6000/8000
PSA Total ng/ml = µg/l 1.54 1.16 1.93 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.32 0.990 1.65 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.72 1.29 2.15 bioMerieux VIDAS TPSA
ng/ml = µg/l 1.15 0.863 1.44 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 1.25 0.938 1.56 Abbott Architect
ng/ml = µg/l 1.57 1.18 1.96 Vitros ECi
ng/ml = µg/l 1.47 1.10 1.84 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 1.25 0.938 1.56 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 1.56 1.17 1.95 Roche Cobas E411
ng/ml = µg/l 1.65 1.24 2.06 Roche Cobas 6000/8000
ng/ml = µg/l 1.53 1.15 1.91 Ortho Vitros 3600/5600/ECi PSA II
Salicylic Acid mmol/l 0.286 0.230 0.340 Gravimetric
mg/dl 3.95 3.18 4.70
SHBG nmol/l 11.8 9.44 14.2 Siemens Immulite 2000/2500
nmol/l 10.4 8.32 12.5 Abbott Architect
nmol/l 10.4 8.32 12.5 Beckman DxI800
T Uptake %U 32.8 26.9 38.7 Siemens Immulite 2000
Testosterone nmol/l 1.59 1.03 2.15 Siemens Centaur XP/XPT/Classic
ng/ml 0.458 0.298 0.618
ng/dl 45.8 29.8 61.8
nmol/l 2.02 1.62 2.42 Abbott Architect
ng/ml 0.582 0.467 0.697
ng/dl 58.2 46.7 69.7
nmol/l 1.42 1.14 1.70 Beckman DxI800
ng/ml 0.409 0.328 0.490
ng/dl 40.9 32.8 49.0
nmol/l 1.80 1.44 2.16 Roche Cobas 4000/e411 Test II
ng/ml 0.518 0.415 0.621
ng/dl 51.8 41.5 62.1
nmol/l 1.67 1.34 2.00 Roche Cobas 6000 Test 2
ng/ml 0.481 0.386 0.576
ng/dl 48.1 38.6 57.6
nmol/l 2.00 1.60 2.40 Abbott Architect 2nd Generation
ng/ml 0.576 0.461 0.691
ng/dl 57.6 46.1 69.1
nmol/l 1.65 1.07 2.23 Siemens Centaur TST II
ng/ml 0.475 0.309 0.641
ng/dl 47.5 30.9 64.1
Theophylline µmol/l 28.3 22.6 34.0 Gravimetric
µg/ml 5.10 4.07 6.13
Thyroglobulin ng/ml 0.692 0.519 0.865 Siemens Immulite 2000

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Thyroglobulin ng/ml 3.11 2.33 3.89 Roche Cobas 6000/8000
ng/ml 3.09 2.32 3.86 Roche Cobas 6000 TGII
ng/ml 2.97 2.23 3.71 Roche Cobas 4000/E411 TGII
Thyroid Stimulating µU/ml = mlU/l 0.100 0.080 0.120 Siemens Immulite 1000
Hormone
µU/ml = mlU/l 0.067 0.054 0.080 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 0.076 0.052 0.100 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 0.067 0.054 0.080 Siemens Immulite 2000/2500
µU/ml = mlU/l 0.066 0.053 0.079 Abbott Architect
µU/ml = mlU/l 0.103 0.082 0.124 Roche Cobas E411
µU/ml = mlU/l 0.100 0.080 0.120 Roche Cobas 6000/8000
µU/ml = mlU/l 0.063 0.050 0.076 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 0.079 0.054 0.104 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 0.065 0.052 0.078 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 17.3 13.8 20.8 BioMerieux Vidas
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 9.96 7.97 12.0 Roche Cobas Core EIA
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 18.6 14.9 22.3 Vitros ECi
IU/ml 0.019 0.015 0.023
mU/ml=IU/l 15.0 9.00 21.0 Siemens Centaur XP/XPT/Classic
IU/ml 0.015 0.009 0.021
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 10.1 8.08 12.1 Abbott Architect
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 17.8 14.2 21.4 Siemens Dimension
IU/ml 0.018 0.014 0.022
mU/ml=IU/l 11.4 9.12 13.7 Beckman DxI800
IU/ml 0.011 0.009 0.013
mU/ml=IU/l 13.7 11.0 16.4 Roche STAT (Intact)
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 10.6 8.48 12.7 Roche hCG+Beta
IU/ml 0.011 0.008 0.014
mU/ml=IU/l 11.6 9.28 13.9 Beckman Access Total BhCG (5th IS)
IU/ml 0.012 0.009 0.015
mU/ml=IU/l 11.5 9.20 13.8 Beckman DxI Total BhCG (5th IS)
IU/ml 0.012 0.009 0.015
Total T3 nmol/l 0.403 0.302 0.504 Siemens Centaur XP/XPT/Classic
ng/ml 0.262 0.197 0.327
ng/dl 26.2 19.7 32.7
nmol/l 0.616 0.462 0.770 Siemens Immulite 2000/2500
ng/ml 0.401 0.301 0.501
ng/dl 40.1 30.1 50.1
nmol/l 0.658 0.494 0.823 Abbott Architect
ng/ml 0.428 0.322 0.534
ng/dl 42.8 32.2 53.4

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 0.519 0.389 0.649 Vitros ECi
ng/ml 0.338 0.253 0.423
ng/dl 33.8 25.3 42.3
nmol/l 1.16 0.870 1.45 Roche Cobas E411
ng/ml 0.755 0.566 0.944
ng/dl 75.5 56.6 94.4
nmol/l 0.872 0.654 1.09 Roche Cobas 6000/8000
ng/ml 0.568 0.426 0.710
ng/dl 56.8 42.6 71.0
Total T4 nmol/l 28.5 21.4 35.6 Vitros ECi
µg/dl 2.22 1.67 2.77
ng/ml 22.2 16.7 27.7
nmol/l 31.5 23.6 39.4 BioMerieux Vidas
µg/dl 2.46 1.84 3.08
ng/ml 24.6 18.4 30.8
nmol/l 22.7 15.9 29.5 Siemens Centaur XP/XPT/Classic
µg/dl 1.77 1.24 2.30
ng/ml 17.7 12.4 23.0
nmol/l 22.5 16.9 28.1 Siemens Immulite 2000/2500
µg/dl 1.76 1.32 2.20
ng/ml 17.6 13.2 22.0
nmol/l 31.8 23.9 39.8 Abbott Architect
µg/dl 2.48 1.86 3.10
ng/ml 24.8 18.6 31.0
nmol/l 38.3 28.7 47.9 Roche Cobas E411
µg/dl 2.99 2.24 3.74
ng/ml 29.9 22.4 37.4
nmol/l 37.1 27.8 46.4 Roche Cobas 6000/8000
µg/dl 2.89 2.17 3.61
ng/ml 28.9 21.7 36.1
Valproic Acid µmol/l 166 133 199 Siemens Immulite 2000/2500
µg/ml 24.0 19.2 28.8
µmol/l 212 148 276 Siemens Centaur XP/XPT/Classic
µg/ml 30.6 21.4 39.8
µmol/l 202 162 242 Siemens Dimension
µg/ml 29.1 23.4 34.8
µmol/l 162 130 194 Abbott Architect
µg/ml 23.4 18.8 28.0
µmol/l 206 165 247 Roche Cobas 6000/8000
µg/ml 29.7 23.8 35.6
µmol/l 243 194 292 Gravimetric
µg/ml 35.1 28.0 42.1
Vancomycin µmol/l 3.16 2.53 3.79 Abbott Architect
µg/ml 4.69 3.76 5.62

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 12
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 1975EC Size 12 x 5ml / 4 x 5ml Expiry 2023-04-28
Range
Analyte unit Target low high methods
Vancomycin µmol/l 2.78 2.22 3.34 Roche Cobas 6000/8000
µg/ml 4.13 3.30 4.96
µmol/l 3.43 2.74 4.12 Gravimetric
µg/ml 5.10 4.07 6.12
Vitamin B12 pmol/l 108 86.4 130 Beckman Access
pg/ml 146 117 175
pmol/l 148 104 192 Siemens Centaur XP/XPT/Classic
pg/ml 201 141 261
pmol/l 116 92.8 139 Siemens Immulite 2000
pg/ml 157 126 188
pmol/l 168 134 202 Abbott Architect
pg/ml 228 182 274
pmol/l 150 120 180 Vitros ECi
pg/ml 203 163 243
pmol/l 104 83.2 125 Beckman DxI800
pg/ml 141 113 169

___________________________________________________________________________________________________

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

IA3110 / IA3112

2026EC

The reconstituted stability for Immunoassay Premium Plus Level 2 lot 2026EC for Free PSA and
Total PSA is 2 days when stored at +2°C to +8°C
Free PSA and Total PSA are stable for 28 days when frozen once and stored at -20°C.

CCS6934

Page 1 of 1 FORM NO. 8373-GP


REVISION (2)
2 Aug 2019
2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 2


(IA PREMIUM PLUS 2)
CAT. NO. IA3110 GTIN: 05055273207262 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 2026EC EXPIRY: 2023-11-28

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. Free PSA and Total PSA are stable for 2 days when stored
at +2°C to +8°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 Plus 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 Plus - 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 Plus 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.

Randox Teoranta, Meenmore,


Dungloe, Donegal,
F94 TV06, Ireland
11 Mar 21 me

PAGE 1 OF 29
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 9.86 7.40 12.3 Immunotech RIA
ng/ml 3.26 2.45 4.07
nmol/l 6.76 5.07 8.45 Novatec ELISA
ng/ml 2.24 1.68 2.80
nmol/l 14.3 10.7 17.9 DRG ELISA
ng/ml 4.73 3.54 5.92
nmol/l 11.9 8.93 14.9 DIAsource RIA
ng/ml 3.94 2.96 4.92
nmol/l 15.6 11.7 19.5 DIAsource ELISA
ng/ml 5.16 3.87 6.45
nmol/l 12.9 9.68 16.1 IBL ELISA
ng/ml 4.27 3.20 5.34
nmol/l 12.3 9.23 15.4 LC/MS
ng/ml 4.07 3.06 5.08
nmol/l 10.5 7.88 13.1 Beckman Coulter RIA
ng/ml 3.48 2.61 4.35
nmol/l 10.5 7.88 13.1 DBC ELISA
ng/ml 3.48 2.61 4.35
25-OH Vitamin D nmol/l 61.1 45.8 76.4 Diasorin Liaison
nmol/l 82.3 61.7 103 Siemens Centaur XP/XPT/Classic
nmol/l 52.7 39.5 65.9 Roche Vitamin D Total
nmol/l 52.4 39.3 65.5 Abbott Architect (3L52)
nmol/l 80.3 60.2 100 Vitros ECi
nmol/l 62.9 47.2 78.6 Tosoh Series
nmol/l 65.5 49.1 81.9 BioMerieux Vidas
nmol/l 52.4 39.3 65.5 Beckman DxI 600/800
nmol/l 56.0 42.0 70.0 Fujirebio Lumipulse G Series
nmol/l 57.3 43.0 71.6 Beckman Access 25 OH Vitamin D Total
nmol/l 55.7 41.8 69.6 LC/MS
nmol/l 53.1 39.8 66.4 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 65.4 49.1 81.8 Diasorin Liaison XL
nmol/l 55.4 41.6 69.3 Roche Vitamin D Total II
nmol/l 55.2 41.4 69.0 Abbott Alinity i
nmol/l 77.3 58.0 96.6 Siemens Atellica IM
nmol/l 57.3 43.0 71.6 Roche Vitamin D Total II e801
ACTH pmol/l 8.45 6.34 10.6 Siemens Immulite 2000/2500
pg/ml 38.4 28.8 48.0
pmol/l 9.38 7.04 11.7 Roche Cobas 4000/E411
pg/ml 42.6 32.0 53.2
pmol/l 9.71 7.28 12.1 Roche Cobas e601/602
pg/ml 44.1 33.1 55.1
pmol/l 13.6 10.2 17.0 CIS IRMA
pg/ml 61.8 46.4 77.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
ACTH pmol/l 8.14 6.11 10.2 Siemens Immulite 1000
pg/ml 37.0 27.8 46.2
pmol/l 13.4 10.1 16.8 Diasorin Liaison
pg/ml 60.9 45.9 75.9
pmol/l 10.3 7.73 12.9 Roche Cobas e801
pg/ml 46.8 35.1 58.5
Aldosterone pmol/l 19.4 14.6 24.3 CIS RIA
pg/ml 7.00 5.27 8.73
pmol/l 274 206 343 Immunotech RIA
pg/ml 98.9 74.3 124
pmol/l 160 120 200 Diasorin Liaison
pg/ml 57.7 43.3 72.1
pmol/l 170 128 213 Diasorin Liaison XL
pg/ml 61.3 46.2 76.4
Alphafoetoprotein KIU/l = lU/ml 44.7 35.8 53.6 Abbott Architect
ng/ml 54.1 43.3 64.9
KIU/l = lU/ml 41.1 32.9 49.3 BioMerieux Vidas
ng/ml 49.7 39.8 59.6
KIU/l = lU/ml 53.7 42.4 65.0 Siemens Centaur XP/XPT/Classic
ng/ml 65.0 51.4 78.6
KIU/l = lU/ml 44.4 35.5 53.3 Siemens Immulite 2000/2500
ng/ml 53.7 43.0 64.4
KIU/l = lU/ml 46.1 36.9 55.3 Siemens Immulite 1000
ng/ml 55.8 44.6 67.0
KIU/l = lU/ml 43.3 34.6 52.0 Beckman DxI800
ng/ml 52.4 41.9 62.9
KIU/l = lU/ml 48.7 39.0 58.4 Roche Elecsys
ng/ml 58.9 47.2 70.6
KIU/l = lU/ml 48.4 38.7 58.1 Diasorin Liaison
ng/ml 58.6 46.8 70.4
KIU/l = lU/ml 44.6 35.7 53.5 Beckman Access
ng/ml 54.0 43.2 64.8
KIU/l = lU/ml 45.4 36.3 54.5 Tosoh Series
ng/ml 54.9 43.9 65.9
KIU/l = lU/ml 47.1 37.7 56.5 Vitros ECi
ng/ml 49.0 39.2 58.8
KIU/l = lU/ml 50.7 40.6 60.8 Roche Cobas e601/602
ng/ml 61.3 49.1 73.5
KIU/l = lU/ml 75.4 60.3 90.5 CIS IRMA
ng/ml 91.2 73.0 109
KIU/l = lU/ml 50.4 40.3 60.5 Roche Cobas 4000/E411
ng/ml 61.0 48.8 73.2
KIU/l = lU/ml 50.5 40.4 60.6 Siemens Dimension
ng/ml 61.1 48.9 73.3
KIU/l = lU/ml 55.2 43.6 66.8 Siemens Centaur CP
ng/ml 66.8 52.8 80.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Alphafoetoprotein KIU/l = lU/ml 50.2 40.2 60.2 Diasorin Liaison XL
ng/ml 60.7 48.6 72.8
KIU/l = lU/ml 53.3 42.6 64.0 Siemens Atellica IM
ng/ml 64.5 51.5 77.5
KIU/l = lU/ml 44.7 35.8 53.6 Abbott Alinity i
ng/ml 54.1 43.3 64.9
KIU/l = lU/ml 49.7 39.8 59.6 Roche Cobas e801
ng/ml 60.1 48.2 72.0
Amikacin µmol/l 14.4 11.5 17.3 Roche Cobas 6000/8000
µg/ml 8.43 6.73 10.1
µmol/l 15.0 12.0 18.0 Thermo Scientific QMS Amikacin
µg/ml 8.78 7.03 10.5
µmol/l 15.7 12.6 18.8 Abbott Architect
µg/ml 9.19 7.38 11.0
µmol/l 15.2 12.2 18.2 Gravimetric
µg/ml 8.90 7.14 10.7
Androstenedione nmol/l 6.05 4.54 7.56 Beckman Coulter RIA
ng/ml 1.74 1.30 2.18
nmol/l 13.2 9.90 16.5 Siemens Immulite 2000
ng/ml 3.79 2.84 4.74
nmol/l 11.5 8.63 14.4 Siemens Immulite 1000
ng/ml 3.30 2.48 4.12
nmol/l 5.58 4.19 6.98 LC/MS
ng/ml 1.60 1.20 2.00
nmol/l 7.68 5.76 9.60 Diasorin Liaison XL
ng/ml 2.20 1.65 2.75
Beta-2-microglobulin µg/ml = mg/l 3.10 2.48 3.72 Abbott Architect
µg/ml = mg/l 3.23 2.58 3.88 BioMerieux Vidas
µg/ml = mg/l 2.89 2.31 3.47 Behring Nephelometer
µg/ml = mg/l 2.67 2.14 3.20 Siemens Immulite 2000/2500
µg/ml = mg/l 3.04 2.43 3.65 Tosoh Series
µg/ml = mg/l 3.09 2.47 3.71 Roche Cobas 6000/8000
µg/ml = mg/l 2.79 2.23 3.35 Diasorin Liaison XL
µg/ml = mg/l 3.07 2.46 3.68 Siemens Atellica CH
µg/ml = mg/l 3.07 2.46 3.68 Abbott Alinity
C-Peptide nmol/l 2.190 1.640 2.740 Siemens Immulite 2000/2500
ng/ml 6.61 4.95 8.27
nmol/l 2.190 1.640 2.740 Roche Elecsys
ng/ml 6.61 4.95 8.27
nmol/l 2.280 1.710 2.850 Roche Cobas e601/602
ng/ml 6.88 5.16 8.60
nmol/l 2.210 1.660 2.760 Siemens Immulite 1000
ng/ml 6.67 5.01 8.33
nmol/l 2.240 1.680 2.800 Diasorin Liaison
ng/ml 6.76 5.07 8.45

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
C-Peptide nmol/l 2.230 1.670 2.790 Roche Cobas 4000/E411
ng/ml 6.73 5.04 8.42
nmol/l 2.060 1.550 2.580 Abbott Architect
ng/ml 6.22 4.68 7.76
nmol/l 1.640 1.230 2.050 Siemens Centaur XP/XPT/Classic
ng/ml 4.95 3.71 6.19
nmol/l 2.280 1.710 2.850 Tosoh Series
ng/ml 6.88 5.16 8.60
nmol/l 2.350 1.760 2.940 Diasorin Liaison XL
ng/ml 7.09 5.31 8.87
nmol/l 2.230 1.670 2.790 Roche Cobas e801
ng/ml 6.73 5.04 8.42
nmol/l 1.690 1.270 2.110 Siemens Atellica IM
ng/ml 5.10 3.83 6.37
nmol/l 1.940 1.460 2.430 Abbott Alinity i
ng/ml 5.86 4.41 7.31
CA 15-3 U/ml 50.0 40.0 60.0 Abbott Architect
U/ml 38.8 31.0 46.6 BioMerieux Vidas
U/ml 44.0 29.9 58.1 Siemens Centaur XP/XPT/Classic
U/ml 45.2 36.2 54.2 Siemens Immulite 2000/2500
U/ml 54.8 43.8 65.8 Siemens Immulite 1000
U/ml 19.6 15.7 23.5 Beckman DxI800
U/ml 41.4 33.1 49.7 Roche Elecsys
U/ml 47.1 37.7 56.5 Diasorin Liaison
U/ml 20.3 16.2 24.4 Beckman Access
U/ml 45.6 36.5 54.7 Tosoh Series
U/ml 38.3 30.6 46.0 Vitros ECi
U/ml 42.7 34.2 51.2 Roche Cobas e601/602
U/ml 42.2 33.8 50.6 Roche Cobas 4000/E411
U/ml 44.2 30.1 58.3 Siemens Centaur CP
U/ml 23.4 18.7 28.1 Mindray CL-2000i
U/ml 42.8 34.2 51.4 Diasorin Liaison XL
U/ml 46.0 36.8 55.2 Siemens Atellica IM
U/ml 41.0 32.8 49.2 Roche Cobas e801
U/ml 50.1 40.1 60.1 Abbott Alinity i
CA 19-9 U/ml 43.2 34.6 51.8 BioMerieux Vidas
U/ml 66.1 44.9 87.3 Siemens Centaur XP/XPT/Classic
U/ml 494 395 593 Siemens Immulite 2000/2500
U/ml 639 511 767 Siemens Immulite 1000
U/ml 476 381 571 Beckman DxI800
U/ml 76.8 61.4 92.2 Roche Elecsys
U/ml 115 92.0 138 Diasorin Liaison
U/ml 540 432 648 Beckman Access
U/ml 63.0 50.4 75.6 Tosoh Series
U/ml 103 82.4 124 Vitros ECi
U/ml 89.0 71.2 107 Abbott Architect XR/XR2/XRL

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
CA 19-9 U/ml 77.1 61.7 92.5 Roche Cobas e601/602
U/ml 77.9 62.3 93.5 Roche Cobas 4000/E411
U/ml 61.9 42.1 81.7 Siemens Centaur CP
U/ml 50.9 40.7 61.1 Mindray CL-2000i
U/ml 124 99.0 149 Diasorin Liaison XL
U/ml 67.1 53.7 80.5 Siemens Atellica IM
U/ml 73.7 59.0 88.4 Roche Cobas e801
U/ml 85.6 68.5 103 Abbott Alinity XR/XR2/XRL
CA125 U/ml 73.7 59.0 88.4 Abbott Architect
U/ml 56.6 45.3 67.9 BioMerieux Vidas
U/ml 47.4 32.2 62.6 Siemens Centaur XP/XPT/Classic OV Kit
U/ml 47.4 32.2 62.6 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 32.3 25.8 38.8 Siemens Immulite 2000/2500
U/ml 35.3 28.2 42.4 Siemens Immulite 1000
U/ml 23.9 19.1 28.7 Beckman DxI800
U/ml 77.2 61.8 92.6 Roche Elecsys
U/ml 94.4 75.5 113 Diasorin Liaison
U/ml 24.3 19.4 29.2 Beckman Access
U/ml 109 87.2 131 Tosoh Series
U/ml 48.4 38.7 58.1 Vitros ECi
U/ml 78.3 62.6 94.0 Roche Cobas 4000/E411
U/ml 77.6 62.1 93.1 Roche Cobas e601/602
U/ml 65.9 52.7 79.1 Fujirebio Lumipulse G Series
U/ml 47.0 32.0 62.0 Siemens Centaur CP CA125 II kit
U/ml 31.9 25.5 38.3 Mindray CL-2000i
U/ml 81.7 65.4 98.0 Diasorin Liaison XL
U/ml 58.9 47.1 70.7 Siemens Atellica IM
U/ml 70.2 56.2 84.2 Roche Cobas e801
U/ml 74.0 59.2 88.8 Abbott Alinity i
Carbamazepine µmol/l 37.2 29.8 44.6 Abbott AXSYM
µg/ml 8.79 7.04 10.5
µmol/l 37.5 30.0 45.0 Abbott Architect (CMIA)
µg/ml 8.87 7.09 10.7
µmol/l 39.2 27.4 51.0 Siemens Centaur XP/XPT/Classic
µg/ml 9.27 6.49 12.1
µmol/l 35.6 28.5 42.7 Siemens Dimension
µg/ml 8.42 6.74 10.1
µmol/l 33.0 26.4 39.6 Siemens Immulite 2000/2500
µg/ml 7.80 6.24 9.36
µmol/l 34.7 27.8 41.6 Siemens Immulite 1000
µg/ml 8.20 6.57 9.83
µmol/l 38.1 30.5 45.7 Roche Integra
µg/ml 9.01 7.21 10.8
µmol/l 34.2 27.4 41.0 Vitros
µg/ml 8.08 6.48 9.68
µmol/l 37.4 29.9 44.9 Roche Cobas 6000/8000
µg/ml 8.84 7.07 10.6

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 36.9 29.5 44.3 Beckman DxC
µg/ml 8.72 6.97 10.5
µmol/l 38.6 30.9 46.3 Beckman AU400/600/640/2700/5400
µg/ml 9.13 7.30 11.0
µmol/l 32.4 25.9 38.9 Abbott Architect (PETINA)
µg/ml 7.66 6.12 9.20
µmol/l 38.6 30.9 46.3 EMIT
µg/ml 9.13 7.30 11.0
µmol/l 36.7 29.4 44.0 Siemens Atellica CH
µg/ml 8.68 6.95 10.4
µmol/l 30.8 24.6 37.0 Abbott Alinity (PETINA)
µg/ml 7.28 5.82 8.74
µmol/l 38.5 30.8 46.2 Gravimetric
µg/ml 9.10 7.28 10.9
Carcinoembryonic ng/ml = µg/l 30.1 24.1 36.1 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 25.3 20.2 30.4 BioMerieux Vidas
ng/ml = µg/l 27.1 18.4 35.8 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 22.7 18.2 27.2 CIS RIA Coated tube
ng/ml = µg/l 35.3 28.2 42.4 Siemens Immulite 2000/2500
ng/ml = µg/l 35.9 28.7 43.1 Siemens Immulite 1000
ng/ml = µg/l 24.0 19.2 28.8 Beckman DxI800
ng/ml = µg/l 22.6 18.1 27.1 Roche Elecsys
ng/ml = µg/l 22.8 18.2 27.4 Diasorin Liaison
ng/ml = µg/l 25.3 20.2 30.4 Beckman Access
ng/ml = µg/l 37.8 30.2 45.4 Tosoh Series
ng/ml = µg/l 28.0 22.4 33.6 Vitros ECi
ng/ml = µg/l 22.3 17.8 26.8 Roche Cobas e601/602
ng/ml = µg/l 22.9 18.3 27.5 Roche Cobas 4000/E411
ng/ml = µg/l 28.1 19.1 37.1 Siemens Centaur CP
ng/ml = µg/l 19.3 15.4 23.2 Mindray CL-2000i
ng/ml = µg/l 24.2 19.4 29.0 Diasorin Liaison XL
ng/ml = µg/l 27.3 21.8 32.8 Siemens Atellica IM
ng/ml = µg/l 22.6 18.1 27.1 Roche Cobas e801
ng/ml = µg/l 29.5 23.6 35.4 Abbott Alinity i
Cortisol nmol/l 538 404 673 Abbott Architect
µg/dl 19.4 14.5 24.3
nmol/l 565 424 706 BioMerieux Vidas
µg/dl 20.3 15.3 25.3
nmol/l 700 483 917 Siemens Centaur XP/XPT/Classic
µg/dl 25.2 17.4 33.0
nmol/l 514 386 643 CIS RIA
µg/dl 18.5 13.9 23.1
nmol/l 563 422 704 Siemens Immulite 2000/2500
µg/dl 20.3 15.2 25.4
nmol/l 630 473 788 Siemens Immulite 1000
µg/dl 22.7 17.0 28.4

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 596 447 745 Beckman DxI800
µg/dl 21.5 16.1 26.9
nmol/l 617 463 771 Roche Elecsys
µg/dl 22.2 16.7 27.7
nmol/l 618 464 773 Diasorin Liaison
µg/dl 22.2 16.7 27.7
nmol/l 652 489 815 Beckman Access
µg/dl 23.5 17.6 29.4
nmol/l 646 485 808 Tosoh Series
µg/dl 23.3 17.5 29.1
nmol/l 569 427 711 Vitros ECi
µg/dl 20.5 15.4 25.6
nmol/l 595 446 744 Roche Cobas e601/602
µg/dl 21.4 16.1 26.7
nmol/l 644 483 805 Roche Cobas 4000/E411
µg/dl 23.2 17.4 29.0
nmol/l 700 483 917 Siemens Centaur CP
µg/dl 25.2 17.4 33.0
nmol/l 634 476 793 Roche Cobas 4000/e411 Gen II
µg/dl 22.8 17.1 28.5
nmol/l 586 440 733 Roche Cobas e601/602 Gen II
µg/dl 21.1 15.8 26.4
nmol/l 621 466 776 Roche Elecsys Gen II
µg/dl 22.4 16.8 28.0
nmol/l 724 543 905 Siemens Atellica IM
µg/dl 26.1 19.5 32.7
nmol/l 578 434 723 Roche Cobas e801
µg/dl 20.8 15.6 26.0
nmol/l 538 404 673 Abbott Alinity i
µg/dl 19.4 14.5 24.3
DHEA-S µmol/l 12.7 10.2 15.2 Abbott Architect
µmol/l 11.2 8.96 13.4 Siemens Immulite 2000/2500
µmol/l 10.8 8.64 13.0 Siemens Immulite 1000
µmol/l 10.8 8.64 13.0 Beckman DxI800
µmol/l 16.5 13.2 19.8 Roche Elecsys
µmol/l 11.8 9.44 14.2 Beckman Access
µmol/l 10.1 8.08 12.1 Diasorin Liaison
µmol/l 10.8 7.02 14.6 Siemens Centaur XP/XPT/Classic
µmol/l 15.7 12.6 18.8 Roche Cobas 4000/E411
µmol/l 15.4 12.3 18.5 Roche Cobas e601/602
µmol/l 10.2 8.16 12.2 Diasorin Liaison XL
µmol/l 11.2 8.96 13.4 Siemens Atellica IM
µmol/l 14.7 11.8 17.6 Roche Cobas e801
Digoxin nmol/l 2.35 1.88 2.82 Abbott Architect (CMIA)
ng/ml 1.84 1.47 2.21

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 2.72 2.18 3.26 BioMerieux Vidas
ng/ml 2.12 1.70 2.54
nmol/l 3.11 2.39 3.83 Siemens Centaur XP/XPT/Classic
ng/ml 2.43 1.87 2.99
nmol/l 2.75 2.20 3.30 Siemens Dimension
ng/ml 2.15 1.72 2.58
nmol/l 2.88 2.30 3.46 Siemens Immulite 2000/2500
ng/ml 2.25 1.80 2.70
nmol/l 2.78 2.22 3.34 Beckman DxI800
ng/ml 2.17 1.73 2.61
nmol/l 2.98 2.38 3.58 Roche Integra
ng/ml 2.33 1.86 2.80
nmol/l 2.73 2.18 3.28 Roche Cobas e601/602
ng/ml 2.13 1.70 2.56
nmol/l 2.81 2.25 3.37 Beckman AU400/600/640/2700/5400
ng/ml 2.19 1.76 2.62
nmol/l 2.78 2.22 3.34 Roche Cobas 4000/E411
ng/ml 2.17 1.73 2.61
nmol/l 2.29 1.83 2.75 Abbott Architect (PETINA)
ng/ml 1.79 1.43 2.15
nmol/l 2.77 2.22 3.32 Roche Cobas e801
ng/ml 2.16 1.73 2.59
nmol/l 3.13 2.50 3.76 Siemens Atellica IM
ng/ml 2.44 1.95 2.93
nmol/l 2.82 2.26 3.38 Siemens Atellica CH
ng/ml 2.20 1.77 2.63
nmol/l 2.49 1.99 2.99 Abbott Alinity (PETINA)
ng/ml 1.94 1.55 2.33
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 120 96.0 144 Abbott Architect
ng/ml = µg/l 91.8 73.4 110 BioMerieux Vidas
ng/ml = µg/l 94.0 70.5 118 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 107 85.6 128 Siemens Dimension
ng/ml = µg/l 98.6 78.9 118 Siemens Immulite 2000/2500
ng/ml = µg/l 86.9 69.5 104 Siemens Immulite 1000
ng/ml = µg/l 76.0 60.8 91.2 Beckman DxI800
ng/ml = µg/l 120 96.0 144 Roche Elecsys/Cobas e411
ng/ml = µg/l 102 81.6 122 Diasorin Liaison
ng/ml = µg/l 118 94.4 142 Roche Modular E170 / Roche Cobas e601/602
ng/ml = µg/l 79.5 63.6 95.4 Beckman Access
ng/ml = µg/l 76.1 60.9 91.3 Tosoh Series
ng/ml = µg/l 71.3 57.0 85.6 Vitros ECi
ng/ml = µg/l 122 97.6 146 Roche Cobas 4000/c311

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 91.6 73.3 110 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 86.8 65.1 109 Siemens Centaur CP
ng/ml = µg/l 110 88.0 132 Diasorin Liaison XL
ng/ml = µg/l 121 96.8 145 Abbott Alinity i
ng/ml = µg/l 95.7 76.6 115 Siemens Atellica IM
ng/ml = µg/l 119 95.2 143 Roche Cobas e801
Folate nmol/l 10.6 8.06 13.1 Abbott Architect
ng/ml 4.67 3.55 5.79
nmol/l 22.5 14.6 30.4 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 9.92 6.45 13.4
nmol/l 9.30 7.07 11.5 Siemens Immulite 2000
ng/ml 4.10 3.12 5.08
nmol/l 12.5 9.50 15.5 Beckman DxI 600 / 800 - A14208
ng/ml 5.51 4.19 6.83
nmol/l 12.7 9.65 15.7 Beckman Access
ng/ml 5.60 4.26 6.94
nmol/l 7.68 5.84 9.52 Vitros ECi
ng/ml 3.39 2.58 4.20
nmol/l 7.26 5.52 9.00 Siemens Dimension
ng/ml 3.20 2.43 3.97
nmol/l 12.7 9.65 15.7 Beckman DxI 600 / 800 - A98032
ng/ml 5.60 4.26 6.94
nmol/l 28.0 18.2 37.8 Siemens Centaur CP (enhanced kit)
ng/ml 12.3 8.00 16.6
nmol/l 12.7 9.65 15.7 Roche Folate III - 04476433
ng/ml 5.60 4.26 6.94
nmol/l 12.4 9.42 15.4 Roche Elecsys Folate
ng/ml 5.47 4.15 6.79
nmol/l 12.3 9.35 15.3 Roche Folate III - 07559992
ng/ml 5.42 4.12 6.72
nmol/l 21.1 16.0 26.2 Siemens Atellica IM
ng/ml 9.31 7.06 11.6
nmol/l 11.4 8.66 14.1 Abbott Alinity i
ng/ml 5.03 3.82 6.24
nmol/l 12.4 9.42 15.4 Roche Cobas e801
ng/ml 5.47 4.15 6.79
Free T3 pmol/l 10.2 7.65 12.8 Abbott Architect, 2 point calibration
ng/dl 0.663 0.497 0.829
pg/ml 6.64 4.98 8.30
pmol/l 11.7 8.78 14.6 BioMerieux Vidas
ng/dl 0.761 0.571 0.951
pg/ml 7.62 5.72 9.52
pmol/l 11.3 6.78 15.8 Siemens Centaur XP/XPT/Classic
ng/dl 0.735 0.441 1.03
pg/ml 7.36 4.42 10.3
pmol/l 9.38 7.04 11.7 Siemens Immulite 2000/2500
ng/dl 0.610 0.458 0.762
pg/ml 6.11 4.58 7.64

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 9.50 7.13 11.9 Siemens Immulite 1000
ng/dl 0.618 0.463 0.773
pg/ml 6.18 4.64 7.72
pmol/l 8.30 6.23 10.4 Beckman DxI800
ng/dl 0.540 0.405 0.675
pg/ml 5.40 4.06 6.74
pmol/l 13.2 9.90 16.5 Roche Elecsys
ng/dl 0.858 0.644 1.07
pg/ml 8.59 6.44 10.7
pmol/l 14.0 10.5 17.5 Diasorin Liaison
ng/dl 0.910 0.683 1.14
pg/ml 9.11 6.84 11.4
pmol/l 9.44 7.08 11.8 Beckman Access
ng/dl 0.614 0.460 0.768
pg/ml 6.15 4.61 7.69
pmol/l 15.8 11.9 19.8 Tosoh Series
ng/dl 1.03 0.774 1.29
pg/ml 10.3 7.75 12.9
pmol/l 27.0 20.3 33.8 Vitros ECi
ng/dl 1.76 1.32 2.20
pg/ml 17.6 13.2 22.0
pmol/l 13.1 9.83 16.4 Roche Cobas 4000/E411
ng/dl 0.852 0.639 1.07
pg/ml 8.53 6.40 10.7
pmol/l 13.4 10.1 16.8 Roche Cobas e601/602
ng/dl 0.871 0.657 1.09
pg/ml 8.72 6.58 10.9
pmol/l 11.0 6.60 15.4 Siemens Centaur CP
ng/dl 0.715 0.429 1.00
pg/ml 7.16 4.30 10.0
pmol/l 11.2 8.40 14.0 Mindray CL-2000i
ng/dl 0.728 0.546 0.910
pg/ml 7.29 5.47 9.11
pmol/l 14.9 11.2 18.6 Diasorin Liaison XL
ng/dl 0.969 0.728 1.21
pg/ml 9.70 7.29 12.1
pmol/l 11.3 8.48 14.1 Siemens Atellica IM
ng/dl 0.735 0.551 0.919
pg/ml 7.36 5.52 9.20
pmol/l 10.4 7.80 13.0 Abbott Alinity, 2 point cal
ng/dl 0.676 0.507 0.845
pg/ml 6.77 5.08 8.46
pmol/l 10.1 7.58 12.6 Abbott Architect, 6 point calibration
ng/dl 0.657 0.493 0.821
pg/ml 6.58 4.93 8.23

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 13.1 9.83 16.4 Roche Cobas e801
ng/dl 0.852 0.639 1.07
pg/ml 8.53 6.40 10.7
pmol/l 10.0 7.50 12.5 Abbott Alinity, 6 point cal
ng/dl 0.650 0.488 0.812
pg/ml 6.51 4.88 8.14
Free T4 pmol/l 20.5 15.4 25.6 Abbott Architect
ng/dl 1.60 1.20 2.00
pg/ml 16.0 12.0 20.0
pmol/l 20.7 15.5 25.9 Siemens Centaur XP/XPT/Classic
ng/dl 1.61 1.21 2.01
pg/ml 16.1 12.1 20.1
pmol/l 28.9 21.7 36.1 CIS RIA Coated tube
ng/dl 2.25 1.69 2.81
pg/ml 22.5 16.9 28.1
pmol/l 30.1 22.6 37.6 Siemens Immulite 2000/2500
ng/dl 2.35 1.76 2.94
pg/ml 23.5 17.6 29.4
pmol/l 30.9 23.2 38.6 Siemens Immulite 1000
ng/dl 2.41 1.81 3.01
pg/ml 24.1 18.1 30.1
pmol/l 23.2 17.4 29.0 Beckman DxI800
ng/dl 1.81 1.36 2.26
pg/ml 18.1 13.6 22.6
pmol/l 27.4 20.6 34.3 Roche Elecsys
ng/dl 2.14 1.61 2.67
pg/ml 21.4 16.1 26.7
pmol/l 29.8 22.4 37.3 Diasorin Liaison
ng/dl 2.32 1.75 2.89
pg/ml 23.2 17.5 28.9
pmol/l 23.8 17.9 29.8 Beckman Access
ng/dl 1.86 1.40 2.32
pg/ml 18.6 14.0 23.2
pmol/l 28.1 21.1 35.1 Tosoh Series
ng/dl 2.19 1.65 2.73
pg/ml 21.9 16.5 27.3
pmol/l 57.8 43.4 72.3 Vitros ECi
ng/dl 4.51 3.39 5.63
pg/ml 45.1 33.9 56.3
pmol/l 27.0 20.3 33.8 Roche Cobas e601/602
ng/dl 2.11 1.58 2.64
pg/ml 21.1 15.8 26.4
pmol/l 22.3 16.7 27.9 Immunotech IRMA
ng/dl 1.74 1.30 2.18
pg/ml 17.4 13.0 21.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 27.1 20.3 33.9 Roche Cobas 4000/E411
ng/dl 2.11 1.58 2.64
pg/ml 21.1 15.8 26.4
pmol/l 21.4 16.1 26.8 Monobind Inc. ELISA / CLIA
ng/dl 1.67 1.26 2.08
pg/ml 16.7 12.6 20.8
pmol/l 29.9 22.4 37.4 Biomerieux Vidas FT4N Kit
ng/dl 2.33 1.75 2.91
pg/ml 23.3 17.5 29.1
pmol/l 24.8 18.6 31.0 Siemens Dimension ExI LOCI
ng/dl 1.93 1.45 2.41
pg/ml 19.3 14.5 24.1
pmol/l 21.0 15.8 26.3 Siemens Centaur CP
ng/dl 1.64 1.23 2.05
pg/ml 16.4 12.3 20.5
pmol/l 25.9 19.4 32.4 Mindray CL-2000i
ng/dl 2.02 1.51 2.53
pg/ml 20.2 15.1 25.3
pmol/l 33.2 24.9 41.5 Diasorin Liaison XL
ng/dl 2.59 1.94 3.24
pg/ml 25.9 19.4 32.4
pmol/l 21.2 15.9 26.5 Siemens Atellica IM
ng/dl 1.65 1.24 2.06
pg/ml 16.5 12.4 20.6
pmol/l 20.0 15.0 25.0 Abbott Alinity i
ng/dl 1.56 1.17 1.95
pg/ml 15.6 11.7 19.5
pmol/l 28.0 21.0 35.0 Roche Cobas e801
ng/dl 2.18 1.64 2.72
pg/ml 21.8 16.4 27.2
FSH mU/ml 26.9 21.5 32.3 Abbott Architect
mU/ml 30.6 24.5 36.7 BioMerieux Vidas
mU/ml 35.6 26.7 44.5 Siemens Centaur XP/XPT/Classic
mU/ml 26.1 20.9 31.3 Siemens Immulite 2000/2500
mU/ml 26.8 21.4 32.2 Siemens Immulite 1000
mU/ml 30.9 24.7 37.1 Beckman DxI800
mU/ml 26.2 21.0 31.4 Roche/BM Elecsys
mU/ml 39.9 31.9 47.9 Diasorin Liaison
mU/ml 31.5 25.2 37.8 Beckman Access
mU/ml 31.7 25.4 38.0 Tosoh Series
mU/ml 22.9 18.3 27.5 Vitros ECi
mU/ml 28.2 22.6 33.8 Roche Cobas 4000/E411
mU/ml 26.0 20.8 31.2 Roche Cobas e601/602
mU/ml 24.1 19.3 28.9 Fujirebio Lumipulse G Series
mU/ml 29.5 22.1 36.9 Siemens Centaur CP
mU/ml 32.1 25.7 38.5 Mindray CL-2000i

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
FSH mU/ml 45.8 36.6 55.0 Diasorin Liaison XL
mU/ml 37.4 29.9 44.9 Siemens Atellica IM
mU/ml 26.4 21.1 31.7 Abbott Alinity i
mU/ml 27.1 21.7 32.5 Roche Cobas e801
Gentamicin µmol/l 8.09 6.47 9.71 Roche Integra
µg/ml 3.87 3.09 4.65
µmol/l 8.54 6.06 11.0 Siemens Centaur XP/XPT/Classic
µg/ml 4.08 2.90 5.26
µmol/l 8.04 6.43 9.65 Abbott Architect (CMIA)
µg/ml 3.84 3.07 4.61
µmol/l 6.41 5.13 7.69 Roche Cobas 6000/8000 Online KIMS
µg/ml 3.06 2.45 3.67
µmol/l 10.1 8.08 12.1 Beckman DxC
µg/ml 4.83 3.86 5.80
µmol/l 7.21 5.77 8.65 Roche Cobas 6000/8000 CEDIA
µg/ml 3.45 2.76 4.14
µmol/l 9.22 7.38 11.1 EMIT
µg/ml 4.41 3.53 5.29
µmol/l 8.14 6.51 9.77 Siemens Atellica CH
µg/ml 3.89 3.11 4.67
µmol/l 8.62 6.90 10.3 Abbott Alinity (PETINA)
µg/ml 4.12 3.30 4.94
µmol/l 8.16 6.53 9.79 Gravimetric
µg/ml 3.90 3.12 4.68
Growth Hormone (GH) µU/ml 19.2 15.4 23.0 Siemens Immulite 2000/2500
ng/ml 6.39 5.13 7.65
µU/ml 17.0 13.6 20.4 Siemens Immulite 1000
ng/ml 5.66 4.53 6.79
µU/ml 14.9 11.9 17.9 Beckman DxI800
ng/ml 4.96 3.96 5.96
µU/ml 16.2 13.0 19.4 Beckman Access
ng/ml 5.39 4.33 6.45
µU/ml 19.0 15.2 22.8 Tosoh Series
ng/ml 6.33 5.06 7.60
µU/ml 15.3 12.2 18.4 Diasorin Liaison
ng/ml 5.09 4.06 6.12
µU/ml 17.5 14.0 21.0 Roche Cobas 4000/E411
ng/ml 5.83 4.66 7.00
µU/ml 17.3 13.8 20.8 Roche Cobas e601/602
ng/ml 5.76 4.60 6.92
µU/ml 17.6 14.1 21.1 IDS iSYS
ng/ml 5.86 4.70 7.02
µU/ml 16.4 13.1 19.7 Diasorin Liaison XL
ng/ml 5.46 4.36 6.56
µU/ml 17.7 14.2 21.2 Roche Cobas e801
ng/ml 5.89 4.73 7.05

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 103 82.4 124 Abbott Architect
KIU/l = IU/ml 100 80.0 120 BioMerieux Vidas
KIU/l = IU/ml 114 68.4 160 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 117 93.6 140 Siemens Immulite 2000/2500
KIU/l = IU/ml 125 100 150 Siemens Immulite 1000
KIU/l = IU/ml 129 103 155 Roche Elecsys
KIU/l = IU/ml 117 93.6 140 Pharmacia Unicap
KIU/l = IU/ml 107 85.6 128 Tosoh Series
KIU/l = IU/ml 133 106 160 Roche Cobas 4000/E411
KIU/l = IU/ml 128 102 154 Roche Cobas e601/602
KIU/l = IU/ml 121 72.6 169 Siemens Centaur CP
KIU/l = IU/ml 111 88.8 133 Siemens Atellica IM
KIU/l = IU/ml 130 104 156 Roche Cobas e801
KIU/l = IU/ml 103 82.4 124 Abbott Alinity i
Insulin mU/l 14.5 10.9 18.1 Siemens Centaur XP/XPT/Classic
µU/ml 14.5 10.9 18.1
mU/l 13.9 10.4 17.4 Roche Elecsys
µU/ml 13.9 10.4 17.4
mU/l 12.4 9.30 15.5 Beckman Access
µU/ml 12.4 9.30 15.5
mU/l 12.5 9.38 15.6 Abbott Architect
µU/ml 12.5 9.38 15.6
mU/l 14.5 10.9 18.1 Tosoh Series
µU/ml 14.5 10.9 18.1
mU/l 14.1 10.6 17.6 Roche Cobas 4000/E411
µU/ml 14.1 10.6 17.6
mU/l 11.7 8.78 14.6 Beckman DxI 600/800
µU/ml 11.7 8.78 14.6
mU/l 16.8 12.6 21.0 Diasorin Liaison
µU/ml 16.8 12.6 21.0
mU/l 13.9 10.4 17.4 Roche Cobas 6000/8000
µU/ml 13.9 10.4 17.4
mU/l 12.9 9.68 16.1 Fujirebio Lumipulse G Series
µU/ml 12.9 9.68 16.1
mU/l 14.4 10.8 18.0 Siemens Centaur CP
µU/ml 14.4 10.8 18.0
mU/l 18.8 14.1 23.5 Diasorin Liaison XL
µU/ml 18.8 14.1 23.5
mU/l 14.9 11.2 18.6 Siemens Atellica IM
µU/ml 14.9 11.2 18.6
mU/l 11.2 8.40 14.0 Abbott Alinity i
µU/ml 11.2 8.40 14.0
Luteinising Hormone (LH) mU/ml 29.3 23.4 35.2 Abbott Architect
mU/ml 35.8 28.6 43.0 BioMerieux Vidas
mU/ml 34.6 26.6 42.6 Siemens Centaur XP/XPT/Classic
mU/ml 51.1 40.9 61.3 Siemens Immulite 2000

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Luteinising Hormone (LH) mU/ml 52.8 42.2 63.4 Siemens Immulite 1000
mU/ml 29.2 23.4 35.0 Beckman DxI800
mU/ml 36.9 29.5 44.3 Roche Elecsys
mU/ml 46.5 37.2 55.8 Diasorin Liaison
mU/ml 29.4 23.5 35.3 Beckman Access
mU/ml 33.0 26.4 39.6 Tosoh Series
mU/ml 46.8 37.4 56.2 Vitros ECi
mU/ml 38.4 30.7 46.1 Roche Cobas 4000/E411
mU/ml 38.4 30.7 46.1 Roche Cobas e601/602
mU/ml 32.4 25.9 38.9 Fujirebio Lumipulse G Series
mU/ml 34.4 26.5 42.3 Siemens Centaur CP
mU/ml 38.6 30.9 46.3 Mindray CL-2000i
mU/ml 46.2 37.0 55.4 Diasorin Liaison XL
mU/ml 35.9 28.7 43.1 Siemens Atellica IM
mU/ml 28.8 23.0 34.6 Abbott Alinity i
mU/ml 38.8 31.0 46.6 Roche Cobas e801
Oestradiol pmol/l 681 545 817 Abbott Architect
pg/ml 185 148 222
pmol/l 1217 974 1460 BioMerieux Vidas
pg/ml 331 265 397
pmol/l 994 596 1392 Siemens Centaur XP/XPT/Classic
pg/ml 270 162 378
pmol/l 1034 827 1241 Siemens Immulite 2000/2500
pg/ml 281 225 337
pmol/l 1141 913 1369 Siemens Immulite 1000
pg/ml 310 248 372
pmol/l 827 662 992 Beckman DxI800
pg/ml 225 180 270
pmol/l 726 581 871 Roche Elecsys (Estradiol II)
pg/ml 197 158 236
pmol/l 898 718 1078 Beckman Access
pg/ml 244 195 293
pmol/l 849 679 1019 Tosoh (E2)
pg/ml 231 185 277
pmol/l 1066 853 1279 Vitros ECi
pg/ml 290 232 348
pmol/l 750 600 900 Roche Cobas e601/602 (Estradiol II)
pg/ml 204 163 245
pmol/l 737 590 884 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 200 160 240
pmol/l 985 591 1379 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 268 161 375
pmol/l 758 606 910 Tosoh (iE2-hsE2)
pg/ml 206 165 247
pmol/l 1031 619 1443 Siemens Centaur CP
pg/ml 280 168 392

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 963 578 1348 Siemens Centaur CP Enhanced (eE2)
pg/ml 262 157 367
pmol/l 760 608 912 Roche Cobas e601/602 (Estradiol III)
pg/ml 207 165 249
pmol/l 741 593 889 Roche Elecsys (Estradiol III)
pg/ml 202 161 243
pmol/l 725 580 870 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 197 158 236
pmol/l 612 490 734 Diasorin Liaison XL
pg/ml 166 133 199
pmol/l 834 667 1001 Beckman Access / Access 2 Sensitive B84493
pg/ml 227 181 273
pmol/l 759 607 911 Beckman DxI600/800 Sensitive B84493
pg/ml 206 165 247
pmol/l 1016 813 1219 Siemens Atellica IM
pg/ml 276 221 331
pmol/l 683 546 820 Abbott Alinity i
pg/ml 186 149 223
pmol/l 749 599 899 Roche Cobas e801 (Estradiol III)
pg/ml 204 163 245
Paracetamol mmol/l 0.326 0.261 0.391 Abbott Architect
mg/l 49.3 39.5 59.1
mmol/l 0.330 0.264 0.396 EMIT
mg/l 49.9 39.9 59.9
mmol/l 0.348 0.280 0.420 Beckman AU Instruments
mg/l 52.7 42.4 63.5
mmol/l 0.320 0.260 0.380 Roche Cobas c501/502/503/701/702
mg/l 48.4 39.3 57.5
mmol/l 0.348 0.280 0.420 Gravimetric
mg/l 52.7 42.4 63.5
Phenobarbital µmol/l 78.2 62.6 93.8 Abbott Architect (CMIA)
µg/ml 18.1 14.5 21.7
µmol/l 75.0 60.0 90.0 Roche Cobas e601/602/801
µg/ml 17.4 13.9 20.9
µmol/l 78.5 62.8 94.2 Siemens Immulite 2000/2500
µg/ml 18.2 14.6 21.8
µmol/l 73.1 58.5 87.7 Beckman AU400/600/640/2700/5400
µg/ml 17.0 13.6 20.4
µmol/l 102 73.4 131 Siemens Centaur XP/XPT/Classic
µg/ml 23.7 17.1 30.3
µmol/l 76.9 61.5 92.3 Roche Integra
µg/ml 17.8 14.3 21.3
µmol/l 76.9 61.5 92.3 Siemens Immulite 1000
µg/ml 17.8 14.3 21.3
µmol/l 71.0 56.8 85.2 Abbott Architect (PETINA)
µg/ml 16.5 13.2 19.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Phenobarbital µmol/l 75.4 60.3 90.5 Siemens Atellica CH
µg/ml 17.5 14.0 21.0
µmol/l 74.0 59.2 88.8 Abbott Alinity (PETINA)
µg/ml 17.2 13.7 20.7
µmol/l 77.6 62.1 93.1 Gravimetric
µg/ml 18.0 14.4 21.6
Phenytoin µmol/l 67.5 54.0 81.0 Abbott Architect
µg/ml 17.0 13.6 20.4
µmol/l 75.9 59.2 92.6 Siemens Centaur XP/XPT/Classic
µg/ml 19.2 15.0 23.4
µmol/l 72.0 57.6 86.4 Siemens Dimension
µg/ml 18.2 14.5 21.9
µmol/l 63.2 50.6 75.8 Siemens Immulite 2000/2500
µg/ml 16.0 12.8 19.2
µmol/l 64.7 51.8 77.6 Roche Integra
µg/ml 16.3 13.1 19.5
µmol/l 70.3 56.2 84.4 Vitros
µg/ml 17.8 14.2 21.4
µmol/l 65.1 52.1 78.1 Roche Cobas 6000/8000
µg/ml 16.4 13.2 19.6
µmol/l 69.0 55.2 82.8 EMIT
µg/ml 17.4 13.9 20.9
µmol/l 66.6 53.3 79.9 Abbott Alinity
µg/ml 16.8 13.5 20.1
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 28.1 22.5 33.7 Abbott Architect
ng/ml 8.80 7.04 10.6
nmol/l 40.9 32.7 49.1 BioMerieux Vidas
ng/ml 12.8 10.2 15.4
nmol/l 24.2 16.9 31.5 Siemens Centaur XP/XPT/Classic
ng/ml 7.57 5.30 9.84
nmol/l 26.4 21.1 31.7 Siemens Immulite 2000/2500
ng/ml 8.26 6.60 9.92
nmol/l 31.2 25.0 37.4 Siemens Immulite 1000
ng/ml 9.77 7.83 11.7
nmol/l 32.3 25.8 38.8 Beckman DxI Prog Cal 33555
ng/ml 10.1 8.08 12.1
nmol/l 33.5 26.8 40.2 Roche Elecsys (Prog. II)
ng/ml 10.5 8.39 12.6
nmol/l 33.2 26.6 39.8 Beckman Access Prog Cal 33555
ng/ml 10.4 8.33 12.5
nmol/l 39.8 31.8 47.8 Tosoh Series
ng/ml 12.5 9.95 15.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 34.7 27.8 41.6 Vitros ECi
ng/ml 10.9 8.70 13.1
nmol/l 34.2 27.4 41.0 Roche Cobas 4000/e411 (Prog. II)
ng/ml 10.7 8.58 12.8
nmol/l 34.5 27.6 41.4 Roche Cobas e601/602 (Prog. II)
ng/ml 10.8 8.64 13.0
nmol/l 28.0 22.4 33.6 Diasorin Liaison
ng/ml 8.76 7.01 10.5
nmol/l 29.7 23.8 35.6 Beckman DxI Prog DE Cal A80773
ng/ml 9.30 7.45 11.2
nmol/l 30.0 24.0 36.0 Beckman Access Prog DE Cal A80773
ng/ml 9.39 7.51 11.3
nmol/l 26.4 18.5 34.3 Siemens Centaur CP
ng/ml 8.26 5.78 10.7
nmol/l 34.6 27.7 41.5 Roche Cobas e601/602 (Prog. III)
ng/ml 10.8 8.67 12.9
nmol/l 34.2 27.4 41.0 Roche Elecsys (Prog. III)
ng/ml 10.7 8.58 12.8
nmol/l 34.1 27.3 40.9 Roche Cobas 4000/e411 (Prog. III)
ng/ml 10.7 8.54 12.9
nmol/l 25.7 20.6 30.8 Abbott Alinity i
ng/ml 8.04 6.45 9.63
nmol/l 33.5 26.8 40.2 Roche Cobas e801 (Prog. III)
ng/ml 10.5 8.39 12.6
Prolactin µU/ml 659 527 791 Abbott Architect
µU/ml 797 638 956 BioMerieux Vidas
µU/ml 551 430 672 Siemens Centaur XP/XPT/Classic
µU/ml 515 412 618 Siemens Immulite 2000/2500
µU/ml 567 454 680 Siemens Immulite 1000
µU/ml 543 434 652 Beckman DxI800
µU/ml 650 520 780 Roche Elecsys
µU/ml 691 553 829 Diasorin Liaison
µU/ml 564 451 677 Beckman Access
µU/ml 606 485 727 Tosoh Series
µU/ml 563 450 676 Vitros ECi
µU/ml 634 507 761 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 615 492 738 Immunotech IRMA
µU/ml 659 527 791 Roche Cobas 4000/E411
µU/ml 645 516 774 Roche Cobas e601/602
µU/ml 746 597 895 Fujirebio Lumipulse G Series
µU/ml 518 404 632 Siemens Centaur CP
µU/ml 787 630 944 Mindray CL-2000i
µU/ml 710 568 852 Diasorin Liaison XL
µU/ml 546 437 655 Siemens Atellica IM
µU/ml 653 522 784 Abbott Alinity i
µU/ml 621 497 745 Roche Cobas e801 PRL II

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
PSA Free ng/ml = µg/l 7.63 5.72 9.54 Abbott Architect
ng/ml = µg/l 7.78 5.84 9.73 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 6.39 4.79 7.99 Siemens Immulite 2000/2500
ng/ml = µg/l 6.25 4.69 7.81 Siemens Immulite 1000
ng/ml = µg/l 8.89 6.67 11.1 Beckman DXI standardised to Hybritech
ng/ml = µg/l 7.55 5.66 9.44 Roche Elecsys
ng/ml = µg/l 4.92 3.69 6.15 Diasorin Liaison
ng/ml = µg/l 9.24 6.93 11.6 Beckman Access standardised to Hybritech
ng/ml = µg/l 6.89 5.17 8.61 Tosoh Series
ng/ml = µg/l 7.47 5.60 9.34 Roche Cobas 4000/E411
ng/ml = µg/l 7.44 5.58 9.30 Roche Cobas e601/602
ng/ml = µg/l 8.00 6.00 10.0 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 8.97 6.73 11.2 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 6.92 5.19 8.65 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 6.44 4.83 8.05 Fujirebio Lumipulse G Series
ng/ml = µg/l 5.18 3.89 6.48 Diasorin Liaison XL
ng/ml = µg/l 7.84 5.88 9.80 Siemens Atellica IM
ng/ml = µg/l 7.74 5.81 9.68 Abbott Alinity i
ng/ml = µg/l 7.32 5.49 9.15 Roche Cobas e801
PSA Total ng/ml = µg/l 6.96 5.22 8.70 Abbott Architect
ng/ml = µg/l 8.23 6.17 10.3 BioMerieux Vidas
ng/ml = µg/l 8.89 6.67 11.1 bioMerieux VIDAS TPSA
ng/ml = µg/l 8.23 6.17 10.3 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 8.31 6.23 10.4 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 8.83 6.62 11.0 Siemens Immulite 2000/2500 3rd generation
ng/ml = µg/l 8.09 6.07 10.1 Siemens Immulite 1000 1st generation
ng/ml = µg/l 8.65 6.49 10.8 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 6.44 4.83 8.05 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 9.01 6.76 11.3 Roche Elecsys
ng/ml = µg/l 6.35 4.76 7.94 Diasorin Liaison
ng/ml = µg/l 8.82 6.62 11.0 Beckman Access standardised to Hybritech
ng/ml = µg/l 9.02 6.77 11.3 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 6.85 5.14 8.56 Tosoh Series
ng/ml = µg/l 9.13 6.85 11.4 Vitros ECi
ng/ml = µg/l 9.08 6.81 11.4 CIS RIA Coated tube
ng/ml = µg/l 9.49 7.12 11.9 Roche Cobas 4000/E411
ng/ml = µg/l 9.22 6.92 11.5 Roche Cobas e601/602
ng/ml = µg/l 6.60 4.95 8.25 Fujirebio Lumipulse G Series
ng/ml = µg/l 9.02 6.77 11.3 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 7.69 5.77 9.61 Siemens Centaur CP
ng/ml = µg/l 6.02 4.52 7.53 Diasorin Liaison XL
ng/ml = µg/l 8.52 6.39 10.7 Siemens Atellica IM
ng/ml = µg/l 7.22 5.42 9.03 Abbott Alinity i
ng/ml = µg/l 9.00 6.75 11.3 Roche Cobas e801
Salicylic Acid mmol/l 1.16 0.928 1.39 Roche Integra
mg/dl 16.0 12.8 19.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Salicylic Acid mmol/l 1.18 0.944 1.42 Abbott Architect
mg/dl 16.3 13.0 19.6
mmol/l 1.21 0.968 1.45 EMIT
mg/dl 16.7 13.4 20.0
mmol/l 1.15 0.920 1.38 Roche Cobas c501/502/503
mg/dl 15.9 12.7 19.1
mmol/l 1.22 0.980 1.46 Gravimetric
mg/dl 16.9 13.5 20.2
SHBG nmol/l 39.3 31.4 47.2 Siemens Centaur XP/XPT/Classic
nmol/l 37.7 30.2 45.2 Siemens Immulite 1000
nmol/l 37.7 30.2 45.2 Siemens Immulite 2000/2500
nmol/l 36.9 29.5 44.3 Abbott Architect
nmol/l 37.7 30.2 45.2 Beckman DxI800
nmol/l 36.2 29.0 43.4 Siemens Atellica IM
nmol/l 34.3 27.4 41.2 Roche analysers - 413417/15
nmol/l 35.0 28.0 42.0 Roche Cobas e801 - 413429
nmol/l 37.4 29.9 44.9 Abbott Alinity i
T Uptake %U 32.6 26.7 38.5 Siemens Immulite 2000
Testosterone nmol/l 13.0 10.4 15.6 Abbott Architect
ng/ml 3.74 3.00 4.48
ng/dl 374 300 448
nmol/l 9.90 7.92 11.9 BioMerieux Vidas
ng/ml 2.85 2.28 3.42
ng/dl 285 228 342
nmol/l 13.8 9.66 17.9 Siemens Centaur XP/XPT/Classic
ng/ml 3.97 2.78 5.16
ng/dl 397 278 516
nmol/l 16.1 12.9 19.3 Siemens Immulite 2000/2500
ng/ml 4.64 3.72 5.56
ng/dl 464 372 556
nmol/l 19.5 15.6 23.4 Siemens Immulite 1000
ng/ml 5.62 4.49 6.75
ng/dl 562 449 675
nmol/l 11.7 9.36 14.0 Beckman DxI800
ng/ml 3.37 2.70 4.04
ng/dl 337 270 404
nmol/l 12.9 10.3 15.5 Beckman Access
ng/ml 3.72 2.97 4.47
ng/dl 372 297 447
nmol/l 16.4 13.1 19.7 Tosoh Series
ng/ml 4.72 3.77 5.67
ng/dl 472 377 567
nmol/l 17.3 13.8 20.8 Vitros ECi
ng/ml 4.98 3.97 5.99
ng/dl 498 397 599
nmol/l 14.0 11.2 16.8 Roche Cobas e601/602 Test II
ng/ml 4.03 3.23 4.83
ng/dl 403 323 483

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 13.8 11.0 16.6 Roche Elecsys Test II
ng/ml 3.97 3.17 4.77
ng/dl 397 317 477
nmol/l 14.0 11.2 16.8 Roche Cobas 4000/e411 Test II
ng/ml 4.03 3.23 4.83
ng/dl 403 323 483
nmol/l 12.9 10.3 15.5 Abbott Architect 2nd Generation
ng/ml 3.72 2.97 4.47
ng/dl 372 297 447
nmol/l 8.93 7.14 10.7 Boditech Med Inc i-CHROMA
ng/ml 2.57 2.06 3.08
ng/dl 257 206 308
nmol/l 9.95 7.96 11.9 BioMerieux Vidas Testosterone II
ng/ml 2.87 2.29 3.45
ng/dl 287 229 345
nmol/l 19.5 15.6 23.4 Mindray CL-2000i
ng/ml 5.62 4.49 6.75
ng/dl 562 449 675
nmol/l 13.7 9.59 17.8 Siemens Centaur TST II
ng/ml 3.95 2.77 5.13
ng/dl 395 277 513
nmol/l 5.87 4.70 7.04 Diasorin Liaison XL
ng/ml 1.69 1.35 2.03
ng/dl 169 135 203
nmol/l 13.5 10.8 16.2 Siemens Atellica IM
ng/ml 3.89 3.11 4.67
ng/dl 389 311 467
nmol/l 14.1 11.3 16.9 Roche Cobas e801 Test II
ng/ml 4.06 3.25 4.87
ng/dl 406 325 487
nmol/l 13.4 10.7 16.1 Abbott Alinity i
ng/ml 3.86 3.08 4.64
ng/dl 386 308 464
Theophylline µmol/l 80.3 64.2 96.4 Siemens Centaur XP/XPT/Classic
µg/ml 14.5 11.6 17.4
µmol/l 83.8 67.0 101 Roche Integra
µg/ml 15.1 12.1 18.1
µmol/l 73.5 58.8 88.2 Abbott Architect (CMIA)
µg/ml 13.2 10.6 15.8
µmol/l 77.2 61.8 92.6 Roche Cobas 6000/8000
µg/ml 13.9 11.1 16.7
µmol/l 81.6 65.3 97.9 Beckman AU400/600/640/2700/5400
µg/ml 14.7 11.8 17.6
µmol/l 83.8 67.0 101 Gravimetric
µg/ml 15.1 12.1 18.2

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Thyroglobulin ng/ml 13.3 9.98 16.6 Siemens Immulite 1000
ng/ml 15.5 11.6 19.4 Siemens Immulite 2000
ng/ml 40.6 30.5 50.8 Roche Elecsys
ng/ml 32.8 24.6 41.0 Beckman DxI800
ng/ml 38.7 29.0 48.4 Roche Cobas 4000/E411
ng/ml 14.6 11.0 18.3 Diesse Chorus
ng/ml 38.7 29.0 48.4 Roche Cobas e601/602
ng/ml 34.9 26.2 43.6 Beckman Access
ng/ml 42.1 31.6 52.6 Abbott Architect 2000i
ng/ml 38.4 28.8 48.0 Tosoh Series
ng/ml 39.1 29.3 48.9 Roche Cobas e601/602 Tg II
ng/ml 39.6 29.7 49.5 Roche Elecsys TGII
ng/ml 39.8 29.9 49.8 Roche Cobas 4000/E411 TGII
ng/ml 37.9 28.4 47.4 Diasorin Liaison XL
ng/ml 43.8 32.9 54.8 Roche Cobas e801 Tg II
Thyroid Stimulating µU/ml = mlU/l 1.95 1.56 2.34 Abbott Architect
Hormone
µU/ml = mlU/l 2.06 1.65 2.47 bioMerieux VIDAS TSH
µU/ml = mlU/l 2.02 1.62 2.42 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 2.26 1.54 2.98 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 2.91 2.33 3.49 CIS IRMA
µU/ml = mlU/l 2.15 1.46 2.84 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 2.24 1.79 2.69 Siemens Immulite 2000/2500
µU/ml = mlU/l 2.26 1.81 2.71 Siemens Immulite 1000
µU/ml = mlU/l 2.05 1.64 2.46 Beckman DxI800 Fast TSH
µU/ml = mlU/l 2.04 1.63 2.45 Beckman DxI800
µU/ml = mlU/l 2.33 1.86 2.80 Roche Elecsys
µU/ml = mlU/l 3.24 2.59 3.89 Diasorin Liaison
µU/ml = mlU/l 2.01 1.61 2.41 Beckman Access Fast TSH
µU/ml = mlU/l 2.08 1.66 2.50 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 2.46 1.97 2.95 Tosoh Series
µU/ml = mlU/l 2.52 2.02 3.02 Vitros ECi
µU/ml = mlU/l 2.39 1.91 2.87 Roche Cobas 4000/E411
µU/ml = mlU/l 2.39 1.91 2.87 Roche Cobas e601/602
µU/ml = mlU/l 2.03 1.62 2.44 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 1.85 1.48 2.22 Siemens Dimension Vista LOCI
µU/ml = mlU/l 2.20 1.50 2.90 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 2.23 1.52 2.94 Siemens Centaur CP
µU/ml = mlU/l 2.21 1.50 2.92 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 2.84 2.27 3.41 Mindray CL-2000i
µU/ml = mlU/l 2.03 1.62 2.44 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 3.27 2.62 3.92 Diasorin Liaison XL
µU/ml = mlU/l 2.19 1.75 2.63 Siemens Atellica IM
µU/ml = mlU/l 1.91 1.53 2.29 Abbott Alinity i
µU/ml = mlU/l 2.24 1.79 2.69 Roche Cobas e801
Tobramycin µmol/l 7.16 5.73 8.59 Gravimetric
µg/ml 3.35 2.68 4.02

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 21.7 17.4 26.0 Abbott Architect
IU/ml 0.022 0.017 0.027
mU/ml=IU/l 45.2 36.2 54.2 BioMerieux Vidas
IU/ml 0.045 0.036 0.054
mU/ml=IU/l 23.2 13.9 32.5 Siemens Centaur XP/XPT/Classic
IU/ml 0.023 0.014 0.032
mU/ml=IU/l 45.5 36.4 54.6 Siemens Dimension
IU/ml 0.046 0.036 0.056
mU/ml=IU/l 57.7 46.2 69.2 Siemens Immulite 2000
IU/ml 0.058 0.046 0.070
mU/ml=IU/l 59.3 47.4 71.2 Siemens Immulite 1000
IU/ml 0.059 0.047 0.071
mU/ml=IU/l 25.3 20.2 30.4 Beckman DxI800
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 23.5 18.8 28.2 Diasorin Liaison
IU/ml 0.024 0.019 0.029
mU/ml=IU/l 28.0 22.4 33.6 Roche Cobas Core EIA
IU/ml 0.028 0.022 0.034
mU/ml=IU/l 24.6 19.7 29.5 Beckman Access
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 44.6 35.7 53.5 Tosoh Series
IU/ml 0.045 0.036 0.054
mU/ml=IU/l 48.6 38.9 58.3 Vitros ECi
IU/ml 0.049 0.039 0.059
mU/ml=IU/l 31.3 25.0 37.6 Roche hCG STAT (Intact)
IU/ml 0.031 0.025 0.037
mU/ml=IU/l 27.4 21.9 32.9 Roche hCG+Beta
IU/ml 0.027 0.022 0.032
mU/ml=IU/l 24.7 19.8 29.6 Beckman Access Total BhCG (5th IS)
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 24.9 19.9 29.9 Beckman DxI Total BhCG (5th IS)
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 23.5 14.1 32.9 Siemens Centaur CP
IU/ml 0.024 0.014 0.034
mU/ml=IU/l 22.8 18.2 27.4 Diasorin Liaison XL
IU/ml 0.023 0.018 0.028
mU/ml=IU/l 25.0 20.0 30.0 Siemens Atellica IM
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 21.4 17.1 25.7 Abbott Alinity i
IU/ml 0.021 0.017 0.025
mU/ml=IU/l 26.7 21.4 32.0 Roche hCG+Beta e801
IU/ml 0.027 0.021 0.033
Total T3 nmol/l 2.96 2.22 3.70 Abbott Architect
ng/ml 1.93 1.45 2.41
ng/dl 193 145 241

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 3.57 2.68 4.46 BioMerieux Vidas
ng/ml 2.32 1.74 2.90
ng/dl 232 174 290
nmol/l 3.86 2.90 4.83 Siemens Centaur XP/XPT/Classic
ng/ml 2.51 1.89 3.13
ng/dl 251 189 313
nmol/l 3.20 2.40 4.00 Siemens Immulite 2000/2500
ng/ml 2.08 1.56 2.60
ng/dl 208 156 260
nmol/l 3.52 2.64 4.40 Siemens Immulite 1000
ng/ml 2.29 1.72 2.86
ng/dl 229 172 286
nmol/l 3.10 2.33 3.88 Beckman DxI800
ng/ml 2.02 1.52 2.52
ng/dl 202 152 252
nmol/l 3.76 2.82 4.70 Roche Elecsys
ng/ml 2.45 1.84 3.06
ng/dl 245 184 306
nmol/l 2.97 2.23 3.71 Diasorin Liaison
ng/ml 1.93 1.45 2.41
ng/dl 193 145 241
nmol/l 3.14 2.36 3.93 Beckman Access
ng/ml 2.04 1.54 2.54
ng/dl 204 154 254
nmol/l 3.36 2.52 4.20 Tosoh Series
ng/ml 2.19 1.64 2.74
ng/dl 219 164 274
nmol/l 3.80 2.85 4.75 Vitros ECi
ng/ml 2.47 1.86 3.08
ng/dl 247 186 308
nmol/l 2.30 1.73 2.88 CIS RIA Coated tube
ng/ml 1.50 1.13 1.87
ng/dl 150 113 187
nmol/l 3.77 2.83 4.71 Roche Cobas 4000/E411
ng/ml 2.45 1.84 3.06
ng/dl 245 184 306
nmol/l 3.72 2.79 4.65 Roche Cobas e601/602
ng/ml 2.42 1.82 3.02
ng/dl 242 182 302
nmol/l 3.91 2.93 4.89 Siemens Centaur CP
ng/ml 2.55 1.91 3.19
ng/dl 255 191 319
nmol/l 2.09 1.57 2.61 Boditech Med Inc i-CHROMA
ng/ml 1.36 1.02 1.70
ng/dl 136 102 170
nmol/l 2.58 1.94 3.23 Diasorin Liaison XL
ng/ml 1.68 1.26 2.10
ng/dl 168 126 210

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 25 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 3.00 2.25 3.75 Abbott Alinity i
ng/ml 1.95 1.46 2.44
ng/dl 195 146 244
nmol/l 3.79 2.84 4.74 Siemens Atellica IM
ng/ml 2.47 1.85 3.09
ng/dl 247 185 309
nmol/l 3.85 2.89 4.81 Roche Cobas e801
ng/ml 2.51 1.88 3.14
ng/dl 251 188 314
Total T4 nmol/l 101 75.8 126 Abbott Architect
µg/dl 7.88 5.91 9.85
ng/ml 78.8 59.1 98.5
nmol/l 117 87.8 146 BioMerieux Vidas
µg/dl 9.13 6.85 11.4
ng/ml 91.3 68.5 114
nmol/l 105 68.3 142 Siemens Centaur XP/XPT/Classic
µg/dl 8.19 5.32 11.1
ng/ml 81.9 53.2 111
nmol/l 105 78.8 131 Siemens Immulite 2000/2500
µg/dl 8.19 6.15 10.2
ng/ml 81.9 61.5 102
nmol/l 118 88.5 148 Siemens Immulite 1000
µg/dl 9.20 6.90 11.5
ng/ml 92.0 69.0 115
nmol/l 110 82.5 138 Beckman DxI800
µg/dl 8.58 6.44 10.7
ng/ml 85.8 64.4 107
nmol/l 108 81.0 135 Roche Elecsys
µg/dl 8.42 6.32 10.5
ng/ml 84.2 63.2 105
nmol/l 112 84.0 140 Beckman Access
µg/dl 8.74 6.55 10.9
ng/ml 87.4 65.5 109
nmol/l 103 77.3 129 Tosoh Series
µg/dl 8.03 6.03 10.0
ng/ml 80.3 60.3 100
nmol/l 107 80.3 134 Vitros ECi
µg/dl 8.35 6.26 10.4
ng/ml 83.5 62.6 104
nmol/l 107 80.3 134 CIS RIA Coated tube
µg/dl 8.35 6.26 10.4
ng/ml 83.5 62.6 104
nmol/l 110 82.5 138 Roche Cobas 4000/E411
µg/dl 8.58 6.44 10.7
ng/ml 85.8 64.4 107

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 26 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 105 78.8 131 Roche Cobas e601/602
µg/dl 8.19 6.15 10.2
ng/ml 81.9 61.5 102
nmol/l 88.3 66.2 110 Immunotech IRMA
µg/dl 6.89 5.16 8.62
ng/ml 68.9 51.6 86.2
nmol/l 164 123 205 Boditech Med Inc i-CHROMA
µg/dl 12.8 9.59 16.0
ng/ml 128 95.9 160
nmol/l 118 76.7 159 Siemens Centaur CP
µg/dl 9.20 5.98 12.4
ng/ml 92.0 59.8 124
nmol/l 83.2 62.4 104 Diasorin Liaison XL
µg/dl 6.49 4.87 8.11
ng/ml 64.9 48.7 81.1
nmol/l 101 75.8 126 Abbott Alinity i
µg/dl 7.88 5.91 9.85
ng/ml 78.8 59.1 98.5
nmol/l 104 78.0 130 Siemens Atellica IM
µg/dl 8.11 6.08 10.1
ng/ml 81.1 60.8 101
nmol/l 101 75.8 126 Roche Cobas e801
µg/dl 7.88 5.91 9.85
ng/ml 78.8 59.1 98.5
Valproic Acid µmol/l 517 414 620 Abbott Architect (CMIA)
µg/ml 74.6 59.7 89.5
µmol/l 555 444 666 Siemens Centaur XP/XPT/Classic
µg/ml 80.1 64.1 96.1
µmol/l 542 434 650 Siemens Dimension
µg/ml 78.2 62.6 93.8
µmol/l 533 426 640 Siemens Immulite 2000/2500
µg/ml 76.9 61.5 92.3
µmol/l 528 422 634 Siemens Immulite 1000
µg/ml 76.2 60.9 91.5
µmol/l 522 418 626 Roche Integra
µg/ml 75.3 60.3 90.3
µmol/l 552 442 662 Vitros
µg/ml 79.7 63.8 95.6
µmol/l 538 430 646 Roche Cobas 6000/8000
µg/ml 77.6 62.0 93.2
µmol/l 521 417 625 Beckman DxC
µg/ml 75.2 60.2 90.2
µmol/l 551 441 661 Beckman AU400/600/640/2700/5400
µg/ml 79.5 63.6 95.4
µmol/l 570 456 684 Siemens ADVIA 1200/1650/1800/2400
µg/ml 82.3 65.8 98.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 27 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 513 410 616 Abbott Architect (PETINA)
µg/ml 74.0 59.2 88.8
µmol/l 559 447 671 EMIT
µg/ml 80.7 64.5 96.9
µmol/l 555 444 666 Siemens Atellica CH
µg/ml 80.1 64.1 96.1
µmol/l 509 407 611 Abbott Alinity (PETINA)
µg/ml 73.4 58.7 88.1
µmol/l 638 510 766 Gravimetric
µg/ml 92.1 73.6 111
Vancomycin µmol/l 7.31 5.85 8.77 Roche Integra
µg/ml 10.9 8.69 13.1
µmol/l 6.13 4.90 7.36 Ortho Vitros Microslide Systems
µg/ml 9.11 7.28 10.9
µmol/l 7.85 6.28 9.42 Abbott Architect (CMIA)
µg/ml 11.7 9.33 14.1
µmol/l 6.57 5.12 8.02 Siemens Centaur XP/XPT/Classic
µg/ml 9.76 7.61 11.9
µmol/l 7.46 5.97 8.95 Siemens Dimension
µg/ml 11.1 8.87 13.3
µmol/l 6.95 5.56 8.34 Roche Cobas 6000/8000
µg/ml 10.3 8.26 12.3
µmol/l 6.77 5.42 8.12 Thermo Scientific QMS Vancomycin
µg/ml 10.1 8.05 12.2
µmol/l 6.87 5.50 8.24 Abbott Architect (PETINA)
µg/ml 10.2 8.17 12.2
µmol/l 7.09 5.67 8.51 Siemens Atellica CH
µg/ml 10.5 8.42 12.6
µmol/l 6.92 5.54 8.30 Abbott Alinity (PETINA)
µg/ml 10.3 8.23 12.4
µmol/l 7.10 5.68 8.52 Gravimetric
µg/ml 10.5 8.44 12.7
Vitamin B12 pmol/l 370 296 444 Abbott Architect
pg/ml 501 401 601
pmol/l 421 316 526 Siemens Centaur XP/XPT/Classic
pg/ml 570 428 712
pmol/l 380 304 456 Siemens Immulite 2000
pg/ml 515 412 618
pmol/l 314 251 377 Beckman DxI800
pg/ml 425 340 510
pmol/l 398 318 478 Roche Elecsys
pg/ml 539 431 647
pmol/l 338 270 406 Beckman Access
pg/ml 458 366 550
pmol/l 506 405 607 Tosoh Series
pg/ml 686 549 823

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 28 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2026EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 396 317 475 Vitros ECi
pg/ml 537 430 644
pmol/l 443 332 554 Siemens Centaur CP
pg/ml 600 450 750
pmol/l 404 323 485 Roche Cobas 4000/e411 Gen II
pg/ml 547 438 656
pmol/l 424 339 509 Roche Cobas e601/602 Gen II
pg/ml 575 459 691
pmol/l 454 363 545 Siemens Atellica IM
pg/ml 615 492 738
pmol/l 369 295 443 Abbott Alinity i
pg/ml 500 400 600
pmol/l 429 343 515 Roche Cobas e801 Gen II
pg/ml 581 465 697

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 29 OF 29
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
PRODUCT INFORMATION

IA3111 / IA3112

2028EC

The reconstituted stability for Immunoassay Premium Plus Level 3 lot 2028EC for Free PSA and
Total PSA is 2 days when stored at +2°C to +8°C.
Free PSA and Total PSA are stable for 28 days when frozen once and stored at -20°C.

CCS6934

Page 1 of 1 FORM NO. 8373-GP


REVISION (2)
2 Aug 2019
2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 3


(IA PREMIUM PLUS 3)
CAT. NO. IA3111 GTIN: 05055273207279 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 2028EC EXPIRY: 2023-11-28
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. Free PSA and Total PSA are stable for 2 days at +2°C to
+8°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 Plus 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 Plus - 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 Plus 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.

Randox Teoranta, Meenmore,


Dungloe, Donegal,
F94 TV06, Ireland
31 Mar 21 pl

PAGE 1 OF 14
a
IMMUNOASSAY PREMIUM PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 53.8 40.4 67.3 DIAsource ELISA
ng/ml 17.8 13.4 22.2
25-OH Vitamin D nmol/l 139 104 174 Siemens Centaur XP/XPT/Classic
nmol/l 78.9 59.2 98.6 Roche Vitamin D Total
nmol/l 92.0 69.0 115 Abbott Architect (3L52)
nmol/l 112 84.0 140 Vitros ECi
nmol/l 92.0 69.0 115 BioMerieux Vidas
nmol/l 97.8 73.4 122 Beckman DxI 600/800
nmol/l 92.6 69.5 116 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 104 78.0 130 Roche Vitamin D Total II
nmol/l 97.6 73.2 122 Abbott Alinity i
nmol/l 104 78.0 130 Roche Vitamin D Total II e801
ACTH pmol/l 29.8 22.4 37.3 Siemens Immulite 2000/2500
pg/ml 135 102 168
pmol/l 21.5 16.1 26.9 Roche Cobas 4000/E411
pg/ml 97.7 73.2 122
pmol/l 21.3 16.0 26.6 Roche Cobas e601/602
pg/ml 96.8 72.7 121
pmol/l 23.0 17.3 28.8 Roche Cobas e801
pg/ml 105 78.6 131
Aldosterone pmol/l 168 126 210 Diasorin Liaison XL
pg/ml 60.6 45.5 75.7
Alphafoetoprotein KIU/l = lU/ml 192 154 230 BioMerieux Vidas
ng/ml 232 186 278
KIU/l = lU/ml 190 152 228 Vitros ECi
ng/ml 198 158 238
KIU/l = lU/ml 203 160 246 Siemens Centaur XP/XPT/Classic
ng/ml 246 194 298
KIU/l = lU/ml 163 130 196 Siemens Immulite 2000/2500
ng/ml 197 157 237
KIU/l = lU/ml 170 136 204 Abbott Architect
ng/ml 206 165 247
KIU/l = lU/ml 171 137 205 Beckman DxI800
ng/ml 207 166 248
KIU/l = lU/ml 196 157 235 Roche Cobas e601/602
ng/ml 237 190 284
KIU/l = lU/ml 205 164 246 Roche Cobas 4000/E411
ng/ml 248 198 298
KIU/l = lU/ml 172 138 206 Abbott Alinity i
ng/ml 208 167 249
KIU/l = lU/ml 190 152 228 Roche Cobas e801
ng/ml 230 184 276

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Amikacin µmol/l 24.1 19.3 28.9 Gravimetric
µg/ml 14.1 11.3 16.9
Androstenedione nmol/l 30.7 23.0 38.4 Siemens Immulite 2000
ng/ml 8.81 6.60 11.0
Beta-2-microglobulin µg/ml = mg/l 6.42 5.14 7.70 Abbott Architect
µg/ml = mg/l 6.35 5.08 7.62 Roche Cobas 6000/8000
C-Peptide nmol/l 3.540 2.660 4.430 Siemens Immulite 2000/2500
ng/ml 10.7 8.03 13.4
nmol/l 3.560 2.670 4.450 Roche Cobas e601/602
ng/ml 10.7 8.06 13.3
nmol/l 3.390 2.540 4.240 Roche Cobas e801
ng/ml 10.2 7.67 12.7
CA 15-3 U/ml 80.2 55.3 105 Siemens Centaur XP/XPT/Classic
U/ml 91.1 72.9 109 Abbott Architect
U/ml 34.3 27.4 41.2 Beckman Access
U/ml 32.6 26.1 39.1 Beckman DxI800
U/ml 77.2 61.8 92.6 Roche Cobas e601/602
U/ml 76.8 61.4 92.2 Roche Cobas 4000/E411
U/ml 75.0 60.0 90.0 Roche Cobas e801
U/ml 86.9 69.5 104 Abbott Alinity i
CA 19-9 U/ml 169 117 221 Siemens Centaur XP/XPT/Classic
U/ml 950 760 1140 Siemens Immulite 2000/2500
U/ml 233 186 280 Vitros ECi
U/ml 1135 908 1362 Beckman DxI800
U/ml 199 159 239 Abbott Architect XR/XR2/XRL
U/ml 167 134 200 Roche Cobas e601/602
U/ml 164 131 197 Roche Cobas 4000/E411
U/ml 164 131 197 Roche Cobas e801
U/ml 204 163 245 Abbott Alinity XR/XR2/XRL
CA125 U/ml 144 115 173 BioMerieux Vidas
U/ml 72.1 57.7 86.5 Siemens Immulite 2000/2500
U/ml 107 85.6 128 Vitros ECi
U/ml 159 127 191 Abbott Architect
U/ml 99.0 68.3 130 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 47.9 38.3 57.5 Beckman Access
U/ml 50.8 40.6 61.0 Beckman DxI800
U/ml 175 140 210 Roche Cobas 4000/E411
U/ml 177 142 212 Roche Cobas e601/602
U/ml 160 128 192 Roche Cobas e801
U/ml 168 134 202 Abbott Alinity i
Carbamazepine µmol/l 67.1 41.6 92.6 Siemens Centaur XP/XPT/Classic
µg/ml 15.9 9.86 21.9
µmol/l 64.4 51.5 77.3 Abbott Architect
µg/ml 15.2 12.2 18.2
µmol/l 63.1 50.5 75.7 Roche Cobas 6000/8000
µg/ml 14.9 11.9 17.9

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 72.2 57.8 86.6 Gravimetric
µg/ml 17.1 13.7 20.5
Carcinoembryonic ng/ml = µg/l 56.0 44.8 67.2 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 63.5 50.8 76.2 Vitros ECi
ng/ml = µg/l 54.7 43.8 65.6 Beckman Access
ng/ml = µg/l 57.8 39.9 75.7 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 74.4 59.5 89.3 Siemens Immulite 2000/2500
ng/ml = µg/l 68.4 54.7 82.1 Abbott Architect
ng/ml = µg/l 53.3 42.6 64.0 Beckman DxI800
ng/ml = µg/l 47.0 37.6 56.4 Roche Cobas e601/602
ng/ml = µg/l 48.5 38.8 58.2 Roche Cobas 4000/E411
ng/ml = µg/l 54.0 43.2 64.8 Siemens Atellica IM
ng/ml = µg/l 47.9 38.3 57.5 Roche Cobas e801
ng/ml = µg/l 68.3 54.6 82.0 Abbott Alinity i
Cortisol nmol/l 999 749 1249 Siemens Immulite 1000
µg/dl 36.0 27.0 45.0
nmol/l 1057 729 1385 Siemens Centaur XP/XPT/Classic
µg/dl 38.1 26.3 49.9
nmol/l 857 643 1071 Siemens Immulite 2000/2500
µg/dl 30.9 23.1 38.7
nmol/l 867 650 1084 Vitros ECi
µg/dl 31.2 23.4 39.0
nmol/l 824 618 1030 Abbott Architect
µg/dl 29.7 22.2 37.2
nmol/l 939 704 1174 Beckman DxI800
µg/dl 33.8 25.3 42.3
nmol/l 1027 770 1284 Roche Cobas e601/602
µg/dl 37.0 27.7 46.3
nmol/l 1040 780 1300 Roche Cobas 4000/E411
µg/dl 37.4 28.1 46.7
nmol/l 970 728 1213 Roche Cobas 4000/e411 Gen II
µg/dl 34.9 26.2 43.6
nmol/l 882 662 1103 Roche Cobas e601/602 Gen II
µg/dl 31.8 23.8 39.8
nmol/l 901 676 1126 Roche Cobas e801
µg/dl 32.4 24.3 40.5
nmol/l 827 620 1034 Abbott Alinity i
µg/dl 29.8 22.3 37.3
nmol/l 882 662 1103 Roche Cobas e801 Gen II
µg/dl 31.8 23.8 39.7
DHEA-S µmol/l 17.7 14.2 21.2 Siemens Immulite 2000/2500
µmol/l 20.4 16.3 24.5 Abbott Architect
µmol/l 16.4 13.1 19.7 Beckman DxI800
µmol/l 15.4 9.24 21.6 Siemens Centaur XP/XPT/Classic
µmol/l 24.6 19.7 29.5 Roche Cobas 4000/E411
µmol/l 25.3 20.2 30.4 Roche Cobas e601/602

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
DHEA-S µmol/l 24.7 19.8 29.6 Roche Cobas e801
Digoxin nmol/l 4.00 3.20 4.80 Abbott Architect
ng/ml 3.12 2.50 3.74
nmol/l 4.36 3.49 5.23 Beckman DxI800
ng/ml 3.41 2.73 4.09
nmol/l 4.70 3.76 5.64 Roche Cobas e801
ng/ml 3.67 2.94 4.40
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 282 226 338 BioMerieux Vidas
ng/ml = µg/l 359 287 431 Roche Elecsys/Cobas e411
ng/ml = µg/l 254 203 305 Beckman Access
ng/ml = µg/l 217 174 260 Vitros ECi
ng/ml = µg/l 310 242 378 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 295 236 354 Siemens Immulite 2000/2500
ng/ml = µg/l 393 314 472 Abbott Architect
ng/ml = µg/l 350 280 420 Roche Modular E170 / Roche Cobas e601/602
ng/ml = µg/l 244 195 293 Beckman DxI800
ng/ml = µg/l 279 218 340 Siemens Centaur CP
ng/ml = µg/l 390 312 468 Abbott Alinity i
ng/ml = µg/l 354 283 425 Roche Cobas e801
Folate nmol/l 23.0 17.5 28.5 Beckman Access
ng/ml 10.1 7.72 12.5
nmol/l 16.6 12.6 20.6 Siemens Immulite 2000
ng/ml 7.32 5.56 9.08
nmol/l 13.6 10.3 16.9 Vitros ECi
ng/ml 6.00 4.54 7.46
nmol/l 18.6 14.1 23.1 Abbott Architect
ng/ml 8.20 6.22 10.2
nmol/l 35.7 21.4 50.0 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 15.7 9.42 22.0
nmol/l 24.1 18.3 29.9 Roche Folate III - 07559992
ng/ml 10.6 8.07 13.1
nmol/l 20.7 15.7 25.7 Abbott Alinity i
ng/ml 9.13 6.92 11.3
nmol/l 23.4 17.8 29.0 Roche Cobas e801
ng/ml 10.3 7.85 12.8
nmol/l 22.9 17.4 28.4 Beckman DxI 600 / 800 - A98032
ng/ml 10.1 7.67 12.5
Free T3 pmol/l 27.6 20.7 34.5 Roche Elecsys
ng/dl 1.79 1.35 2.23
pg/ml 18.0 13.5 22.5
pmol/l 18.6 14.0 23.3 Beckman Access
ng/dl 1.21 0.910 1.51
pg/ml 12.1 9.11 15.1

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 21.1 12.7 29.5 Siemens Centaur XP/XPT/Classic
ng/dl 1.37 0.822 1.92
pg/ml 13.7 8.22 19.2
pmol/l 15.0 11.3 18.8 Siemens Immulite 2000/2500
ng/dl 0.975 0.735 1.22
pg/ml 9.77 7.36 12.2
pmol/l 15.9 11.9 19.9 Beckman DxI800
ng/dl 1.03 0.774 1.29
pg/ml 10.4 7.75 13.1
pmol/l 27.4 20.6 34.3 Roche Cobas 4000/E411
ng/dl 1.78 1.34 2.22
pg/ml 17.8 13.4 22.2
pmol/l 27.9 20.9 34.9 Roche Cobas e601/602
ng/dl 1.81 1.36 2.26
pg/ml 18.2 13.6 22.8
pmol/l 22.2 16.7 27.8 Siemens Atellica IM
ng/dl 1.44 1.09 1.79
pg/ml 14.5 10.9 18.1
pmol/l 27.4 20.6 34.3 Roche Cobas e801
ng/dl 1.78 1.34 2.22
pg/ml 17.8 13.4 22.2
pmol/l 22.6 17.0 28.3 Abbott Alinity, 6 point cal
ng/dl 1.47 1.11 1.83
pg/ml 14.7 11.1 18.3
pmol/l 22.3 16.7 27.9 Abbott Architect, 2 point calibration
ng/dl 1.45 1.09 1.81
pg/ml 14.5 10.9 18.2
pmol/l 22.4 16.8 28.0 Abbott Architect, 6 point calibration
ng/dl 1.46 1.09 1.82
pg/ml 14.6 10.9 18.2
Free T4 pmol/l 45.4 34.1 56.8 Beckman Access
ng/dl 3.54 2.66 4.42
pg/ml 35.4 26.6 44.2
pmol/l 40.7 30.5 50.9 Siemens Centaur XP/XPT/Classic
ng/dl 3.17 2.38 3.96
pg/ml 31.7 23.8 39.6
pmol/l 64.9 48.7 81.1 Siemens Immulite 2000/2500
ng/dl 5.06 3.80 6.32
pg/ml 50.6 38.0 63.2
pmol/l 41.9 31.4 52.4 Abbott Architect
ng/dl 3.27 2.45 4.09
pg/ml 32.7 24.5 40.9
pmol/l 52.3 39.2 65.4 Beckman DxI800
ng/dl 4.08 3.06 5.10
pg/ml 40.8 30.6 51.0

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 58.3 43.7 72.9 Roche Cobas e601/602
ng/dl 4.55 3.41 5.69
pg/ml 45.5 34.1 56.9
pmol/l 59.3 44.5 74.1 Roche Cobas 4000/E411
ng/dl 4.63 3.47 5.79
pg/ml 46.3 34.7 57.9
pmol/l 44.4 33.3 55.5 Siemens Atellica IM
ng/dl 3.46 2.60 4.32
pg/ml 34.6 26.0 43.2
pmol/l 39.9 29.9 49.9 Abbott Alinity i
ng/dl 3.11 2.33 3.89
pg/ml 31.1 23.3 38.9
pmol/l 60.5 45.4 75.6 Roche Cobas e801
ng/dl 4.72 3.54 5.90
pg/ml 47.2 35.4 59.0
FSH mU/ml 58.7 47.0 70.4 BioMerieux Vidas
mU/ml 67.4 53.9 80.9 Beckman Access
mU/ml 44.9 35.9 53.9 Vitros ECi
mU/ml 79.5 62.0 97.0 Siemens Centaur XP/XPT/Classic
mU/ml 54.9 43.9 65.9 Siemens Immulite 2000/2500
mU/ml 54.3 43.4 65.2 Abbott Architect
mU/ml 61.0 48.8 73.2 Beckman DxI800
mU/ml 54.2 43.4 65.0 Roche Cobas 4000/E411
mU/ml 50.3 40.2 60.4 Roche Cobas e601/602
mU/ml 83.9 67.1 101 Siemens Atellica IM
mU/ml 53.2 42.6 63.8 Abbott Alinity i
mU/ml 53.2 42.6 63.8 Roche Cobas e801
Gentamicin µmol/l 11.7 9.36 14.0 Gravimetric
µg/ml 5.59 4.47 6.69
Growth Hormone (GH) µU/ml 42.1 33.7 50.5 Siemens Immulite 2000/2500
ng/ml 14.0 11.2 16.8
µU/ml 38.1 30.5 45.7 Roche Cobas e601/602
ng/ml 12.7 10.2 15.2
µU/ml 38.5 30.8 46.2 Diasorin Liaison XL
ng/ml 12.8 10.3 15.3
µU/ml 37.7 30.2 45.2 Roche Cobas e801
ng/ml 12.6 10.1 15.1
Immunoglobulin E KIU/l = IU/ml 574 344 804 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 592 474 710 Siemens Immulite 2000/2500
KIU/l = IU/ml 525 420 630 Abbott Architect
KIU/l = IU/ml 603 482 724 Roche Cobas 4000/E411
KIU/l = IU/ml 576 461 691 Roche Cobas e601/602
KIU/l = IU/ml 587 470 704 Roche Cobas e801
Insulin mU/l 26.5 19.9 33.1 Siemens Centaur XP/XPT/Classic
µU/ml 26.5 19.9 33.1
mU/l 8.37 6.28 10.5 Siemens Immulite 2000
µU/ml 8.37 6.28 10.5

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Insulin mU/l 24.8 18.6 31.0 Beckman Access
µU/ml 24.8 18.6 31.0
mU/l 22.8 17.1 28.5 Abbott Architect
µU/ml 22.8 17.1 28.5
mU/l 29.6 22.2 37.0 Roche Cobas 4000/E411
µU/ml 29.6 22.2 37.0
mU/l 29.5 22.1 36.9 Roche Cobas 6000/8000
µU/ml 29.5 22.1 36.9
mU/l 23.5 17.6 29.4 Beckman DxI 600/800
µU/ml 23.5 17.6 29.4
mU/l 21.1 15.8 26.4 Abbott Alinity i
µU/ml 21.1 15.8 26.4
Luteinising Hormone (LH) mU/ml 56.3 45.0 67.6 BioMerieux Vidas
mU/ml 59.4 47.5 71.3 Vitros ECi
mU/ml 51.5 39.7 63.3 Siemens Centaur XP/XPT/Classic
mU/ml 74.1 59.3 88.9 Siemens Immulite 2000
mU/ml 46.3 37.0 55.6 Abbott Architect
mU/ml 43.1 34.5 51.7 Beckman DxI800
mU/ml 58.1 46.5 69.7 Roche Cobas 4000/E411
mU/ml 57.2 45.8 68.6 Roche Cobas e601/602
mU/ml 53.4 42.7 64.1 Siemens Atellica IM
mU/ml 45.3 36.2 54.4 Abbott Alinity i
mU/ml 57.6 46.1 69.1 Roche Cobas e801
Oestradiol pmol/l 2548 2038 3058 BioMerieux Vidas
pg/ml 693 554 832
pmol/l 2257 1806 2708 Vitros ECi
pg/ml 614 491 737
pmol/l 2160 1339 2981 Siemens Centaur XP/XPT/Classic
pg/ml 588 365 811
pmol/l 1116 893 1339 Abbott Architect
pg/ml 304 243 365
pmol/l 1341 1073 1609 Beckman DxI800
pg/ml 365 292 438
pmol/l 1310 1048 1572 Roche Cobas e601/602 (Estradiol II)
pg/ml 356 285 427
pmol/l 1297 1038 1556 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 353 282 424
pmol/l 2159 1339 2979 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 587 364 810
pmol/l 1329 1063 1595 Roche Cobas e601/602 (Estradiol III)
pg/ml 361 289 433
pmol/l 1315 1052 1578 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 358 286 430
pmol/l 1384 1107 1661 Beckman Access / Access 2 Sensitive B84493
pg/ml 376 301 451

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 1296 1037 1555 Beckman DxI600/800 Sensitive B84493
pg/ml 353 282 424
pmol/l 2188 1750 2626 Siemens Atellica IM
pg/ml 595 476 714
pmol/l 1058 846 1270 Abbott Alinity i
pg/ml 288 230 346
pmol/l 1309 1047 1571 Roche Cobas e801 (Estradiol III)
pg/ml 356 285 427
Paracetamol 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 130 104 156 Siemens Immulite 2000/2500
µg/ml 30.2 24.1 36.3
µmol/l 121 96.8 145 Beckman AU400/600/640/2700/5400
µg/ml 28.1 22.5 33.7
µmol/l 121 96.8 145 Gravimetric
µg/ml 28.1 22.5 33.6
Phenytoin µmol/l 94.3 75.4 113 Abbott Architect
µg/ml 23.8 19.0 28.6
µmol/l 93.8 75.0 113 Roche Cobas 6000/8000
µg/ml 23.7 18.9 28.5
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 148 118 178 BioMerieux Vidas
ng/ml 46.3 36.9 55.7
nmol/l 102 81.6 122 Vitros ECi
ng/ml 31.9 25.5 38.3
nmol/l 71.2 50.6 91.8 Siemens Centaur XP/XPT/Classic
ng/ml 22.3 15.8 28.8
nmol/l 77.2 61.8 92.6 Siemens Immulite 2000/2500
ng/ml 24.2 19.3 29.1
nmol/l 90.1 72.1 108 Abbott Architect
ng/ml 28.2 22.6 33.8
nmol/l 97.2 77.8 117 Roche Cobas 4000/e411 (Prog. II)
ng/ml 30.4 24.4 36.4
nmol/l 99.6 79.7 120 Roche Cobas e601/602 (Prog. II)
ng/ml 31.2 24.9 37.5
nmol/l 85.8 68.6 103 Beckman DxI Prog DE Cal A80773
ng/ml 26.9 21.5 32.3
nmol/l 99.4 79.5 119 Roche Cobas e601/602 (Prog. III)
ng/ml 31.1 24.9 37.3
nmol/l 99.4 79.5 119 Roche Cobas 4000/e411 (Prog. III)
ng/ml 31.1 24.9 37.3

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 84.9 67.9 102 Abbott Alinity i
ng/ml 26.6 21.3 31.9
nmol/l 98.5 78.8 118 Roche Cobas e801 (Prog. III)
ng/ml 30.8 24.7 36.9
Prolactin µU/ml 1308 1046 1570 BioMerieux Vidas
µU/ml 914 731 1097 Vitros ECi
µU/ml 900 675 1125 Siemens Centaur XP/XPT/Classic
µU/ml 890 712 1068 Siemens Immulite 2000/2500
µU/ml 1109 887 1331 Abbott Architect
µU/ml 858 686 1030 Beckman DxI800
µU/ml 1114 891 1337 Roche Cobas 4000/E411
µU/ml 1072 858 1286 Roche Cobas e601/602
µU/ml 936 749 1123 Siemens Atellica IM
µU/ml 1096 877 1315 Abbott Alinity i
µU/ml 1027 822 1232 Roche Cobas e801 PRL II
PSA Free ng/ml = µg/l 16.5 12.4 20.6 Abbott Architect
ng/ml = µg/l 19.7 14.8 24.6 Beckman Access standardised to Hybritech
ng/ml = µg/l 16.3 12.2 20.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 15.1 11.3 18.9 Roche Cobas 4000/E411
ng/ml = µg/l 15.2 11.4 19.0 Roche Cobas e601/602
ng/ml = µg/l 15.0 11.3 18.8 Roche Cobas e801
PSA Total ng/ml = µg/l 19.2 14.4 24.0 Beckman Access standardised to Hybritech
ng/ml = µg/l 17.0 12.8 21.3 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 18.2 13.7 22.8 bioMerieux VIDAS TPSA
ng/ml = µg/l 16.5 12.4 20.6 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 14.3 10.7 17.9 Abbott Architect
ng/ml = µg/l 18.1 13.6 22.6 Vitros ECi
ng/ml = µg/l 17.8 13.4 22.3 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 13.9 10.4 17.4 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 19.2 14.4 24.0 Roche Cobas 4000/E411
ng/ml = µg/l 18.6 14.0 23.3 Roche Cobas e601/602
ng/ml = µg/l 18.2 13.7 22.8 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 14.5 10.9 18.1 Abbott Alinity i
ng/ml = µg/l 18.5 13.9 23.1 Roche Cobas e801
Salicylate mmol/l 2.88 2.30 3.46 Gravimetric
mg/dl 39.7 31.7 47.7
SHBG nmol/l 37.6 30.1 45.1 Siemens Immulite 2000/2500
nmol/l 38.0 30.4 45.6 Abbott Architect
nmol/l 37.9 30.3 45.5 Beckman DxI800
nmol/l 34.3 27.4 41.2 Roche Cobas e801 - 413429
nmol/l 34.7 27.8 41.6 Roche analysers - 413417/15
T Uptake %U 37.7 30.9 44.5 Siemens Immulite 2000
Testosterone nmol/l 38.7 31.0 46.4 Vitros ECi
ng/ml 11.1 8.93 13.3
ng/dl 1115 893 1337
nmol/l 35.6 28.5 42.7 Siemens Immulite 2000/2500
ng/ml 10.3 8.21 12.4
ng/dl 1025 821 1229

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 28.2 22.6 33.8 Abbott Architect
ng/ml 8.12 6.51 9.73
ng/dl 812 651 973
nmol/l 22.1 17.7 26.5 Beckman DxI800
ng/ml 6.36 5.10 7.62
ng/dl 636 510 762
nmol/l 29.4 23.5 35.3 Roche Cobas 4000/e411 Test II
ng/ml 8.47 6.77 10.2
ng/dl 847 677 1017
nmol/l 28.7 23.0 34.4 Roche Cobas e601/602 Test II
ng/ml 8.27 6.62 9.92
ng/dl 827 662 992
nmol/l 27.7 22.2 33.2 Abbott Architect 2nd Generation
ng/ml 7.98 6.39 9.57
ng/dl 798 639 957
nmol/l 25.3 18.5 32.1 Siemens Centaur TST II
ng/ml 7.29 5.32 9.26
ng/dl 729 832 926
nmol/l 28.1 22.5 33.7 Roche Cobas e801 Test II
ng/ml 8.09 6.48 9.71
ng/dl 809 648 971
Theophylline µmol/l 156 125 187 Roche Cobas 6000/8000
µg/ml 28.1 22.5 33.7
µmol/l 166 133 199 Gravimetric
µg/ml 29.9 24.0 35.9
Thyroglobulin ng/ml 31.7 23.8 39.6 Siemens Immulite 2000
ng/ml 69.1 51.8 86.4 Roche Cobas e601/602
ng/ml 69.8 52.4 87.3 Roche Cobas e601/602 Tg II
ng/ml 79.7 59.8 100 Roche Cobas e801 Tg II
Thyroid Stimulating µU/ml = mlU/l 13.9 11.1 16.7 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 19.3 15.4 23.2 Roche Elecsys
µU/ml = mlU/l 18.5 14.8 22.2 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 28.1 22.5 33.7 Vitros ECi
µU/ml = mlU/l 21.8 14.8 28.8 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 19.4 15.5 23.3 Siemens Immulite 2000/2500
µU/ml = mlU/l 17.5 14.0 21.0 Abbott Architect
µU/ml = mlU/l 18.1 14.5 21.7 Beckman Access Fast TSH
µU/ml = mlU/l 19.8 15.8 23.8 Roche Cobas 4000/E411
µU/ml = mlU/l 19.5 15.6 23.4 Roche Cobas e601/602
µU/ml = mlU/l 21.3 14.5 28.1 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 17.7 14.2 21.2 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 20.6 16.5 24.7 Siemens Atellica IM
µU/ml = mlU/l 16.9 13.5 20.3 Abbott Alinity i
µU/ml = mlU/l 19.0 15.2 22.8 Roche Cobas e801

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
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 602 482 722 BioMerieux Vidas
IU/ml 0.602 0.482 0.722
mU/ml=IU/l 599 479 719 Vitros ECi
IU/ml 0.599 0.479 0.719
mU/ml=IU/l 240 144 336 Siemens Centaur XP/XPT/Classic
IU/ml 0.240 0.144 0.336
mU/ml=IU/l 687 550 824 Siemens Immulite 2000
IU/ml 0.687 0.550 0.824
mU/ml=IU/l 270 216 324 Abbott Architect
IU/ml 0.270 0.216 0.324
mU/ml=IU/l 568 454 682 Siemens Dimension
IU/ml 0.568 0.454 0.682
mU/ml=IU/l 269 215 323 Beckman DxI800
IU/ml 0.269 0.215 0.323
mU/ml=IU/l 356 285 427 Roche hCG+Beta
IU/ml 0.356 0.285 0.427
mU/ml=IU/l 289 231 347 Beckman Access Total BhCG (5th IS)
IU/ml 0.289 0.231 0.347
mU/ml=IU/l 283 226 340 Beckman DxI Total BhCG (5th IS)
IU/ml 0.283 0.226 0.340
mU/ml=IU/l 264 211 317 Abbott Alinity i
IU/ml 0.264 0.211 0.317
mU/ml=IU/l 344 275 413 Roche hCG+Beta e801
IU/ml 0.344 0.275 0.413
Total T3 nmol/l 5.39 4.04 6.74 Beckman Access
ng/ml 3.51 2.63 4.39
ng/dl 351 263 439
nmol/l 6.77 5.08 8.46 Siemens Centaur XP/XPT/Classic
ng/ml 4.41 3.31 5.51
ng/dl 441 331 551
nmol/l 5.07 3.80 6.34 Abbott Architect
ng/ml 3.30 2.47 4.13
ng/dl 330 247 413
nmol/l 6.81 5.11 8.51 Vitros ECi
ng/ml 4.43 3.33 5.53
ng/dl 443 333 553
nmol/l 6.49 4.87 8.11 Roche Cobas 4000/E411
ng/ml 4.22 3.17 5.27
ng/dl 422 317 527
nmol/l 6.20 4.65 7.75 Roche Cobas e601/602
ng/ml 4.04 3.03 5.05
ng/dl 404 303 505
nmol/l 5.02 3.77 6.28 Abbott Alinity i
ng/ml 3.27 2.45 4.09
ng/dl 327 245 409

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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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 6.33 4.75 7.91 Roche Cobas e801
ng/ml 4.12 3.09 5.15
ng/dl 412 309 515
Total T4 nmol/l 197 148 246 Vitros ECi
µg/dl 15.4 11.5 19.3
ng/ml 154 115 193
nmol/l 174 122 226 Siemens Centaur XP/XPT/Classic
µg/dl 13.6 9.52 17.7
ng/ml 136 95.2 177
nmol/l 191 143 239 Siemens Immulite 2000/2500
µg/dl 14.9 11.2 18.6
ng/ml 149 112 186
nmol/l 165 124 206 Abbott Architect
µg/dl 12.9 9.67 16.1
ng/ml 129 96.7 161
nmol/l 177 133 221 Roche Cobas 4000/E411
µg/dl 13.8 10.4 17.2
ng/ml 138 104 172
nmol/l 169 127 211 Roche Cobas e601/602
µg/dl 13.2 9.91 16.5
ng/ml 132 99.1 165
nmol/l 165 124 206 Abbott Alinity i
µg/dl 12.9 9.67 16.1
ng/ml 129 96.7 161
nmol/l 158 119 198 Roche Cobas e801
µg/dl 12.3 9.28 15.3
ng/ml 123 92.8 153
Valproic Acid µmol/l 1023 818 1228 Siemens Centaur XP/XPT/Classic
µg/ml 148 118 178
µmol/l 932 746 1118 Abbott Architect
µg/ml 134 108 160
µmol/l 934 747 1121 Roche Cobas 6000/8000
µg/ml 135 108 162
µmol/l 1116 893 1339 Gravimetric
µg/ml 161 129 193
Vancomycin µmol/l 11.6 9.28 13.9 Abbott Architect
µg/ml 17.2 13.8 20.6
µmol/l 9.89 7.91 11.9 Roche Cobas 6000/8000
µg/ml 14.7 11.8 17.6
µmol/l 10.8 8.64 13.0 Gravimetric
µg/ml 16.0 12.8 19.3
Vitamin B12 pmol/l 581 465 697 Beckman Access
pg/ml 787 630 944
pmol/l 741 556 926 Siemens Centaur XP/XPT/Classic
pg/ml 1004 753 1255

___________________________________________________________________________________________________

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 PLUS LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2028EC Size 12 x 5ml / 4 x 5ml Expiry 2023-11-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 643 514 772 Siemens Immulite 2000
pg/ml 871 696 1046
pmol/l 634 507 761 Abbott Architect
pg/ml 859 687 1031
pmol/l 655 524 786 Vitros ECi
pg/ml 888 710 1066
pmol/l 587 470 704 Beckman DxI800
pg/ml 795 637 953
pmol/l 694 555 833 Roche Cobas 4000/e411 Gen II
pg/ml 940 752 1128
pmol/l 719 575 863 Roche Cobas e601/602 Gen II
pg/ml 974 779 1169
pmol/l 538 430 646 Abbott Alinity i
pg/ml 729 583 875
pmol/l 717 574 860 Roche Cobas e801 Gen II
pg/ml 972 778 1166

___________________________________________________________________________________________________

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

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