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. 2180EC EXPIRY: 2025-06-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS

For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.

Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency
Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-
REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

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

STORAGE AND STABILITY

OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. C-Peptide is stable for 1 day at +2°C to +8°C.
Thyroglobulin should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored at –
20°C.

ACTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for ACTH,
Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE
RETURNED to the original vial.

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

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

PREPARATION
Immunoassay Premium 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. 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
[Link]@[Link].

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland
Rev. 24 Apr '23 me

PAGE 1 OF 28
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 13.0 9.75 16.3 ELISA
ng/ml 4.30 3.23 5.37
nmol/l 14.6 11.0 18.3 DRG ELISA
ng/ml 4.83 3.64 6.02
nmol/l 12.7 9.53 15.9 DIAsource RIA
ng/ml 4.20 3.15 5.25
25-OH Vitamin D nmol/l 62.7 47.0 78.4 Diasorin Liaison
nmol/l 75.8 56.9 94.8 Siemens Centaur XP/XPT/Classic
nmol/l 52.2 39.2 65.3 Roche Vitamin D Total
nmol/l 54.6 41.0 68.3 Abbott Architect (3L52)
nmol/l 76.3 57.2 95.4 Vitros ECi
nmol/l 60.5 45.4 75.6 Tosoh Series
nmol/l 66.6 50.0 83.3 BioMerieux Vidas
nmol/l 47.6 35.7 59.5 Beckman DxI 600/800
nmol/l 61.3 46.0 76.6 Fujirebio Lumipulse G Series
nmol/l 51.2 38.4 64.0 Beckman Access 25 OH Vitamin D Total
nmol/l 54.5 40.9 68.1 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 65.0 48.8 81.3 Diasorin Liaison XL
nmol/l 50.7 38.0 63.4 Roche Vitamin D Total II
nmol/l 55.7 41.8 69.6 Abbott Alinity i
nmol/l 76.1 57.1 95.1 Siemens Atellica IM
nmol/l 47.5 35.6 59.4 Roche Vitamin D Total II e801
nmol/l 46.1 34.6 57.6 Roche Vitamin D Total III
ACTH pmol/l 8.76 6.57 11.0 Siemens Immulite 2000/2500
pg/ml 39.8 29.9 49.7
pmol/l 5.56 4.17 6.95 Roche Cobas e402/e801
pg/ml 25.3 19.0 31.6
Aldosterone pmol/l 508 381 635 Immunotech RIA
pg/ml 183 137 229
pmol/l 261 196 326 IDS iSYS
pg/ml 94.2 70.7 118
pmol/l 325 244 406 Diasorin Liaison
pg/ml 117 88.0 146
pmol/l 342 257 428 Diasorin Liaison XL
pg/ml 123 92.7 153
Alphafoetoprotein KIU/l = lU/ml 47.8 38.2 57.4 Abbott AFP-EIA
ng/ml 57.8 46.2 69.4
KIU/l = lU/ml 44.6 35.7 53.5 Abbott Architect
ng/ml 54.0 43.2 64.8
KIU/l = lU/ml 46.9 37.5 56.3 BioMerieux Vidas
ng/ml 56.7 45.4 68.0
KIU/l = lU/ml 51.6 41.3 61.9 Siemens Centaur XP/XPT/Classic
ng/ml 62.4 50.0 74.8

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Alphafoetoprotein KIU/l = lU/ml 44.8 35.8 53.8 Siemens Immulite 2000/2500
ng/ml 54.2 43.3 65.1
KIU/l = lU/ml 51.1 40.9 61.3 Siemens Immulite 1000
ng/ml 61.8 49.5 74.1
KIU/l = lU/ml 42.5 34.0 51.0 Beckman DxI800
ng/ml 51.4 41.1 61.7
KIU/l = lU/ml 49.4 39.5 59.3 Roche Elecsys
ng/ml 59.8 47.8 71.8
KIU/l = lU/ml 52.1 41.7 62.5 Diasorin Liaison
ng/ml 63.0 50.5 75.5
KIU/l = lU/ml 45.1 36.1 54.1 Beckman Access
ng/ml 54.6 43.7 65.5
KIU/l = lU/ml 44.4 35.5 53.3 Tosoh Series
ng/ml 53.7 43.0 64.4
KIU/l = lU/ml 45.1 36.1 54.1 Vitros ECi
ng/ml 46.9 37.5 56.3
KIU/l = lU/ml 50.4 40.3 60.5 Roche Cobas e601/602
ng/ml 61.0 48.8 73.2
KIU/l = lU/ml 50.2 40.2 60.2 Roche Cobas 4000/E411
ng/ml 60.7 48.6 72.8
KIU/l = lU/ml 48.3 38.6 58.0 Fujirebio Lumipulse G Series
ng/ml 58.4 46.7 70.1
KIU/l = lU/ml 47.7 38.2 57.2 Siemens Dimension
ng/ml 57.7 46.2 69.2
KIU/l = lU/ml 52.5 42.0 63.0 Siemens Centaur CP
ng/ml 63.5 50.8 76.2
KIU/l = lU/ml 47.8 38.2 57.4 Immunotech IRMA
ng/ml 57.8 46.2 69.4
KIU/l = lU/ml 48.3 38.6 58.0 Sysmex HISCL Series
ng/ml 58.4 46.7 70.1
KIU/l = lU/ml 46.2 37.0 55.4 Mindray CL Series
ng/ml 55.9 44.8 67.0
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 51.0 40.8 61.2 Siemens Atellica IM
ng/ml 61.7 49.4 74.0
KIU/l = lU/ml 44.6 35.7 53.5 Abbott Alinity i
ng/ml 54.0 43.2 64.8
KIU/l = lU/ml 48.0 38.4 57.6 Roche Cobas e402/e801
ng/ml 58.1 46.5 69.7
KIU/l = lU/ml 42.0 33.6 50.4 Tosoh AIA-CL Series
ng/ml 50.8 40.7 60.9
Amikacin µmol/l 14.0 11.2 16.8 EMIT
µg/ml 8.20 6.56 9.84
µmol/l 14.6 11.7 17.5 Roche Cobas 6000/8000
µg/ml 8.55 6.85 10.3

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Amikacin µmol/l 15.7 12.6 18.8 Thermo Scientific QMS Amikacin
µg/ml 9.19 7.38 11.0
µmol/l 15.6 12.5 18.7 Abbott Alinity
µg/ml 9.14 7.32 11.0
µmol/l 15.2 12.2 18.2 Gravimetric
µg/ml 8.90 7.14 10.7
Androstenedione nmol/l 5.62 4.22 7.03 Beckman Coulter RIA
ng/ml 1.61 1.21 2.01
nmol/l 14.2 10.7 17.8 Siemens Immulite 2000
ng/ml 4.08 3.07 5.09
nmol/l 10.6 7.95 13.3 Siemens Immulite 1000
ng/ml 3.04 2.28 3.80
nmol/l 9.46 7.10 11.8 DRG ELISA
ng/ml 2.72 2.04 3.40
nmol/l 7.15 5.36 8.94 Diasorin Liaison XL
ng/ml 2.05 1.54 2.56
Beta-2-microglobulin µg/ml = mg/l 2.85 2.28 3.42 Abbott Architect
µg/ml = mg/l 3.18 2.54 3.82 BioMerieux Vidas
µg/ml = mg/l 2.79 2.23 3.35 Behring Nephelometer
µg/ml = mg/l 2.62 2.10 3.14 Siemens Immulite 2000/2500
µg/ml = mg/l 2.75 2.20 3.30 Siemens Immulite 1000
µg/ml = mg/l 3.09 2.47 3.71 Tosoh Series
µg/ml = mg/l 2.89 2.31 3.47 Roche Cobas 6000/8000
µg/ml = mg/l 2.80 2.24 3.36 Diasorin Liaison XL
µg/ml = mg/l 2.78 2.22 3.34 Siemens Atellica CH
µg/ml = mg/l 2.87 2.30 3.44 Abbott Alinity
C-Peptide nmol/l 1.940 1.460 2.430 Siemens Immulite 2000/2500
ng/ml 5.86 4.41 7.31
nmol/l 2.190 1.640 2.740 Roche Elecsys
ng/ml 6.61 4.95 8.27
nmol/l 2.040 1.530 2.550 Roche Cobas e601/602
ng/ml 6.16 4.62 7.70
nmol/l 1.960 1.470 2.450 Siemens Immulite 1000
ng/ml 5.92 4.44 7.40
nmol/l 2.230 1.670 2.790 Diasorin Liaison
ng/ml 6.73 5.04 8.42
nmol/l 2.060 1.550 2.580 Roche Cobas 4000/E411
ng/ml 6.22 4.68 7.76
nmol/l 1.910 1.430 2.390 Abbott Architect
ng/ml 5.77 4.32 7.22
nmol/l 1.400 1.050 1.750 Siemens Centaur XP/XPT/Classic
ng/ml 4.23 3.17 5.29
nmol/l 1.930 1.450 2.410 Tosoh Series
ng/ml 5.83 4.38 7.28
nmol/l 2.340 1.760 2.930 Diasorin Liaison XL
ng/ml 7.06 5.31 8.81

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
C-Peptide nmol/l 2.020 1.520 2.530 Roche Cobas e402/e801
ng/ml 6.10 4.59 7.61
nmol/l 1.360 1.020 1.700 Siemens Atellica IM
ng/ml 4.11 3.08 5.14
nmol/l 2.090 1.570 2.610 Vitros ECi
ng/ml 6.31 4.74 7.88
nmol/l 1.230 0.923 1.540 Beckman Access
ng/ml 3.71 2.79 4.63
nmol/l 1.880 1.410 2.350 Abbott Alinity i
ng/ml 5.68 4.26 7.10
CA 15-3 U/ml 41.9 33.5 50.3 Abbott Architect
U/ml 39.0 31.2 46.8 BioMerieux Vidas
U/ml 39.4 31.5 47.3 Siemens Centaur XP/XPT/Classic
U/ml 41.7 33.4 50.0 Siemens Immulite 2000/2500
U/ml 19.6 15.7 23.5 Beckman DxI800
U/ml 42.7 34.2 51.2 Roche Elecsys
U/ml 19.6 15.7 23.5 Beckman Access
U/ml 42.9 34.3 51.5 Tosoh Series
U/ml 36.0 28.8 43.2 Vitros ECi
U/ml 44.2 35.4 53.0 Roche Cobas e601/602
U/ml 40.0 32.0 48.0 Immunotech IRMA
U/ml 43.3 34.6 52.0 Roche Cobas 4000/E411
U/ml 47.1 37.7 56.5 Fujirebio Lumipulse G Series
U/ml 39.9 31.9 47.9 Siemens Centaur CP
U/ml 22.0 17.6 26.4 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
U/ml 39.7 31.8 47.6 Diasorin Liaison XL
U/ml 41.2 33.0 49.4 Siemens Atellica IM
U/ml 42.3 33.8 50.8 Roche Cobas e402/e801
U/ml 41.2 33.0 49.4 Abbott Alinity i
CA 19-9 U/ml 115 92.0 138 BioMerieux Vidas
U/ml 167 134 200 Siemens Centaur XP/XPT/Classic
U/ml 147 118 176 Siemens Immulite 2000/2500
U/ml 158 126 190 Beckman DxI800
U/ml 78.3 62.6 94.0 Roche Elecsys
U/ml 127 102 152 Diasorin Liaison
U/ml 176 141 211 Beckman Access
U/ml 59.9 47.9 71.9 Tosoh Series
U/ml 151 121 181 Vitros ECi
U/ml 229 183 275 Abbott Architect XR/XR2/XRL
U/ml 76.2 61.0 91.4 Roche Cobas e601/602
U/ml 77.5 62.0 93.0 Roche Cobas 4000/E411
U/ml 162 130 194 Fujirebio Lumipulse G Series
U/ml 89.7 71.8 108 Izotop RIA
U/ml 145 116 174 Siemens Centaur CP
U/ml 40.3 32.2 48.4 Immunotech IRMA

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
CA 19-9 U/ml 65.6 52.5 78.7 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
U/ml 130 104 156 Diasorin Liaison XL
U/ml 166 133 199 Siemens Atellica IM
U/ml 77.2 61.8 92.6 Roche Cobas e402/e801
U/ml 236 189 283 Abbott Alinity XR/XR2/XRL
CA125 U/ml 112 89.6 134 Abbott Architect
U/ml 86.1 68.9 103 BioMerieux Vidas
U/ml 93.9 75.1 113 Siemens Centaur XP/XPT/Classic OV Kit
U/ml 96.0 76.8 115 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 81.7 65.4 98.0 Siemens Immulite 2000/2500
U/ml 94.4 75.5 113 Siemens Immulite 1000
U/ml 73.6 58.9 88.3 Beckman DxI800
U/ml 83.1 66.5 100 Roche Elecsys
U/ml 74.7 59.8 89.6 Beckman Access
U/ml 156 125 187 Tosoh Series
U/ml 82.9 66.3 99.0 Vitros ECi
U/ml 84.3 67.4 101 Roche Cobas 4000/E411
U/ml 84.5 67.6 101 Roche Cobas e601/602
U/ml 46.4 37.1 55.7 Immunotech IRMA
U/ml 74.0 59.2 88.8 Fujirebio Lumipulse G Series
U/ml 96.1 76.9 115 Siemens Centaur CP CA125 II kit
U/ml 144 115 173 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
U/ml 105 84.0 126 Diasorin Liaison XL
U/ml 106 84.8 127 Siemens Atellica IM
U/ml 79.0 63.2 94.8 Roche Cobas e402/e801
U/ml 115 92.0 138 Abbott Alinity i
Carbamazepine µmol/l 39.4 31.5 47.3 Abbott Architect (CMIA)
µg/ml 9.31 7.45 11.2
µmol/l 41.6 33.3 49.9 Siemens Centaur XP/XPT/Classic
µg/ml 9.83 7.87 11.8
µmol/l 36.0 28.8 43.2 Siemens Dimension
µg/ml 8.51 6.81 10.2
µmol/l 33.3 26.6 40.0 Siemens Immulite 2000/2500
µg/ml 7.87 6.29 9.45
µmol/l 39.4 31.5 47.3 Roche Integra
µg/ml 9.31 7.45 11.2
µmol/l 39.9 31.9 47.9 Roche Cobas 6000/8000
µg/ml 9.43 7.54 11.3
µmol/l 36.9 29.5 44.3 Beckman AU400/600/640/2700/5400
µg/ml 8.72 6.97 10.5
µmol/l 32.7 26.2 39.2 Abbott Architect (PETINA)
µg/ml 7.73 6.19 9.27
µmol/l 36.8 29.4 44.2 EMIT
µg/ml 8.70 6.95 10.5
µmol/l 36.6 29.3 43.9 Siemens Atellica CH
µg/ml 8.65 6.93 10.4

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 32.2 25.8 38.6 Abbott Alinity (PETINA)
µg/ml 7.61 6.10 9.12
µmol/l 38.5 30.8 46.2 Gravimetric
µg/ml 9.10 7.28 10.9
Carcinoembryonic ng/ml = µg/l 30.3 24.2 36.4 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 23.3 18.6 28.0 BioMerieux Vidas
ng/ml = µg/l 24.4 19.5 29.3 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 34.7 27.8 41.6 Siemens Immulite 2000/2500
ng/ml = µg/l 32.0 25.6 38.4 Siemens Immulite 1000
ng/ml = µg/l 23.1 18.5 27.7 Beckman DxI800
ng/ml = µg/l 23.9 19.1 28.7 Roche Elecsys
ng/ml = µg/l 21.3 17.0 25.6 Diasorin Liaison
ng/ml = µg/l 24.6 19.7 29.5 Beckman Access
ng/ml = µg/l 36.8 29.4 44.2 Tosoh Series
ng/ml = µg/l 28.9 23.1 34.7 Vitros ECi
ng/ml = µg/l 23.8 19.0 28.6 Roche Cobas e601/602
ng/ml = µg/l 21.1 16.9 25.3 Immunotech IRMA
ng/ml = µg/l 23.7 19.0 28.4 Roche Cobas 4000/E411
ng/ml = µg/l 31.4 25.1 37.7 Fujirebio Lumipulse G Series
ng/ml = µg/l 25.9 20.7 31.1 Boditech Med Inc i-CHROMA
ng/ml = µg/l 24.8 19.8 29.8 Siemens Centaur CP
ng/ml = µg/l 19.3 15.4 23.2 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/ml = µg/l 22.9 18.3 27.5 Diasorin Liaison XL
ng/ml = µg/l 23.8 19.0 28.6 Siemens Atellica IM
ng/ml = µg/l 23.7 19.0 28.4 Roche Cobas e402/e801
ng/ml = µg/l 30.3 24.2 36.4 Abbott Alinity i
Cortisol nmol/l 587 440 734 Abbott Architect
µg/dl 21.1 15.8 26.4
nmol/l 630 473 788 BioMerieux Vidas
µg/dl 22.7 17.0 28.4
nmol/l 775 581 969 Siemens Centaur XP/XPT/Classic
µg/dl 27.9 20.9 34.9
nmol/l 611 458 764 Siemens Immulite 2000/2500
µg/dl 22.0 16.5 27.5
nmol/l 659 494 824 Siemens Immulite 1000
µg/dl 23.7 17.8 29.6
nmol/l 665 499 831 Beckman DxI800
µg/dl 23.9 18.0 29.8
nmol/l 659 494 824 Roche Elecsys
µg/dl 23.7 17.8 29.6
nmol/l 728 546 910 Beckman Access
µg/dl 26.2 19.7 32.7
nmol/l 692 519 865 Tosoh Series
µg/dl 24.9 18.7 31.1
nmol/l 606 455 758 Vitros ECi
µg/dl 21.8 16.4 27.2

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 670 503 838 Roche Cobas e601/602
µg/dl 24.1 18.1 30.1
nmol/l 703 527 879 Roche Cobas 4000/E411
µg/dl 25.3 19.0 31.6
nmol/l 769 577 961 Immunotech RIA
µg/dl 27.7 20.8 34.6
nmol/l 781 586 976 Siemens Centaur CP
µg/dl 28.1 21.1 35.1
nmol/l 690 518 863 Roche Cobas 4000/e411 Gen II
µg/dl 24.8 18.6 31.0
nmol/l 660 495 825 Roche Cobas e601/602 Gen II
µg/dl 23.8 17.8 29.8
nmol/l 693 520 866 Roche Elecsys Gen II
µg/dl 24.9 18.7 31.1
nmol/l 644 483 805 Diasorin Liaison XL
µg/dl 23.2 17.4 29.0
nmol/l 807 605 1009 Siemens Atellica IM
µg/dl 29.1 21.8 36.4
nmol/l 659 494 824 Roche Cobas e402/e801
µg/dl 23.7 17.8 29.6
nmol/l 719 539 899 Tosoh AIA-CL Series
µg/dl 25.9 19.4 32.4
nmol/l 583 437 729 Abbott Alinity i
µg/dl 21.0 15.7 26.3
DHEA-S µmol/l 14.3 11.4 17.2 Abbott Architect
µmol/l 12.4 9.92 14.9 Siemens Immulite 2000/2500
µmol/l 13.2 10.6 15.8 Siemens Immulite 1000
µmol/l 11.9 9.52 14.3 Beckman DxI800
µmol/l 12.8 10.2 15.4 Beckman Access
µmol/l 13.1 10.5 15.7 Diasorin Liaison
µmol/l 12.3 9.84 14.8 Siemens Centaur XP/XPT/Classic
µmol/l 17.9 14.3 21.5 Roche Cobas 4000/E411
µmol/l 17.5 14.0 21.0 Roche Cobas e601/602
µmol/l 11.7 9.36 14.0 Diasorin Liaison XL
µmol/l 11.6 9.28 13.9 Siemens Atellica IM
µmol/l 17.0 13.6 20.4 Roche Cobas e402/e801
µmol/l 14.5 11.6 17.4 Abbott Alinity i
Digoxin nmol/l 2.47 1.98 2.96 Abbott Architect (CMIA)
ng/ml 1.93 1.55 2.31
nmol/l 2.84 2.27 3.41 BioMerieux Vidas
ng/ml 2.22 1.77 2.67
nmol/l 3.26 2.61 3.91 Siemens Centaur XP/XPT/Classic
ng/ml 2.55 2.04 3.06
nmol/l 2.98 2.38 3.58 Siemens Dimension
ng/ml 2.33 1.86 2.80
nmol/l 3.03 2.42 3.64 Beckman DxI800
ng/ml 2.37 1.89 2.85

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 2.88 2.30 3.46 Roche Integra
ng/ml 2.25 1.80 2.70
nmol/l 3.02 2.42 3.62 Roche Cobas e601/602
ng/ml 2.36 1.89 2.83
nmol/l 3.17 2.54 3.80 Beckman AU400/600/640/2700/5400
ng/ml 2.48 1.98 2.98
nmol/l 3.11 2.49 3.73 Roche Cobas 4000/E411
ng/ml 2.43 1.94 2.92
nmol/l 2.81 2.25 3.37 Abbott Architect (PETINA)
ng/ml 2.19 1.76 2.62
nmol/l 2.98 2.38 3.58 Roche Cobas e402/e801
ng/ml 2.33 1.86 2.80
nmol/l 3.42 2.74 4.10 Siemens Atellica IM
ng/ml 2.67 2.14 3.20
nmol/l 2.91 2.33 3.49 Siemens Atellica CH
ng/ml 2.27 1.82 2.72
nmol/l 2.80 2.24 3.36 Abbott Alinity (CMIA)
ng/ml 2.19 1.75 2.63
nmol/l 2.88 2.30 3.46 Abbott Alinity (PETINA)
ng/ml 2.25 1.80 2.70
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 102 81.6 122 Abbott Architect
ng/ml = µg/l 76.6 61.3 91.9 BioMerieux Vidas
ng/ml = µg/l 70.1 56.1 84.1 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 92.8 74.2 111 Siemens Dimension
ng/ml = µg/l 88.4 70.7 106 Siemens Immulite 2000/2500
ng/ml = µg/l 74.3 59.4 89.2 Siemens Immulite 1000
ng/ml = µg/l 65.4 52.3 78.5 Beckman DxI800
ng/ml = µg/l 104 83.2 125 Roche Elecsys/Cobas e411
ng/ml = µg/l 90.2 72.2 108 Diasorin Liaison
ng/ml = µg/l 102 81.6 122 Roche Modular E170 / Roche Cobas e601/602
ng/ml = µg/l 67.7 54.2 81.2 Beckman Access
ng/ml = µg/l 66.0 52.8 79.2 Tosoh Series
ng/ml = µg/l 60.6 48.5 72.7 Vitros ECi
ng/ml = µg/l 105 84.0 126 Roche Cobas 4000/c311
ng/ml = µg/l 87.6 70.1 105 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 99.0 79.2 119 Roche Cobas c501/502/503/701/702
ng/ml = µg/l 68.9 55.1 82.7 Siemens Centaur CP
ng/ml = µg/l 96.5 77.2 116 Diasorin Liaison XL
ng/ml = µg/l 105 84.0 126 Abbott Alinity i
ng/ml = µg/l 68.2 54.6 81.8 Siemens Atellica IM
ng/ml = µg/l 101 80.8 121 Roche Cobas e402/e801

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Folate nmol/l 9.68 7.36 12.0 Abbott Architect
ng/ml 4.27 3.25 5.29
nmol/l 24.1 18.3 29.9 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 10.6 8.07 13.1
nmol/l 8.00 6.08 9.92 Siemens Immulite 2000
ng/ml 3.53 2.68 4.38
nmol/l 11.0 8.36 13.6 Beckman DxI 600 / 800 - A14208
ng/ml 4.85 3.69 6.01
nmol/l 11.4 8.66 14.1 Beckman Access
ng/ml 5.03 3.82 6.24
nmol/l 7.16 5.44 8.88 Vitros ECi
ng/ml 3.16 2.40 3.92
nmol/l 6.19 4.70 7.68 Siemens Dimension
ng/ml 2.73 2.07 3.39
nmol/l 11.3 8.59 14.0 Beckman DxI 600 / 800 - A98032
ng/ml 4.98 3.79 6.17
nmol/l 11.3 8.59 14.0 Roche Folate III - 04476433
ng/ml 4.98 3.79 6.17
nmol/l 11.0 8.36 13.6 Roche Elecsys Folate
ng/ml 4.85 3.69 6.01
nmol/l 11.1 8.44 13.8 Roche Folate III - 07559992
ng/ml 4.90 3.72 6.08
nmol/l 22.7 17.3 28.1 Siemens Atellica IM
ng/ml 10.0 7.63 12.4
nmol/l 10.4 7.90 12.9 Abbott Alinity i
ng/ml 4.59 3.48 5.70
nmol/l 10.9 8.28 13.5 Roche Folate 07027290 e801
ng/ml 4.81 3.65 5.97
Free T3 pmol/l 12.7 9.53 15.9 Abbott Architect, 2 point calibration
ng/dl 0.826 0.619 1.03
pg/ml 8.27 6.20 10.3
pmol/l 13.3 9.98 16.6 BioMerieux Vidas
ng/dl 0.865 0.649 1.08
pg/ml 8.66 6.50 10.8
pmol/l 13.3 9.98 16.6 Siemens Centaur XP/XPT/Classic
ng/dl 0.865 0.649 1.08
pg/ml 8.66 6.50 10.8
pmol/l 9.72 7.29 12.2 Siemens Immulite 2000/2500
ng/dl 0.632 0.474 0.790
pg/ml 6.33 4.75 7.91
pmol/l 10.1 7.58 12.6 Siemens Immulite 1000
ng/dl 0.657 0.493 0.821
pg/ml 6.58 4.93 8.23
pmol/l 9.41 7.06 11.8 Beckman DxI800
ng/dl 0.612 0.459 0.765
pg/ml 6.13 4.60 7.66

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 15.8 11.9 19.8 Roche Elecsys
ng/dl 1.03 0.774 1.29
pg/ml 10.3 7.75 12.9
pmol/l 16.4 12.3 20.5 Diasorin Liaison
ng/dl 1.07 0.800 1.34
pg/ml 10.7 8.01 13.4
pmol/l 10.4 7.80 13.0 Beckman Access
ng/dl 0.676 0.507 0.845
pg/ml 6.77 5.08 8.46
pmol/l 17.6 13.2 22.0 Tosoh Series
ng/dl 1.14 0.858 1.42
pg/ml 11.5 8.59 14.4
pmol/l 31.7 23.8 39.6 Vitros ECi
ng/dl 2.06 1.55 2.57
pg/ml 20.6 15.5 25.7
pmol/l 15.6 11.7 19.5 Roche Cobas 4000/E411
ng/dl 1.01 0.761 1.26
pg/ml 10.2 7.62 12.8
pmol/l 15.6 11.7 19.5 Roche Cobas e601/602
ng/dl 1.01 0.761 1.26
pg/ml 10.2 7.62 12.8
pmol/l 15.2 11.4 19.0 Fujirebio Lumipulse G Series
ng/dl 0.988 0.741 1.24
pg/ml 9.90 7.42 12.4
pmol/l 13.6 10.2 17.0 Siemens Centaur CP
ng/dl 0.884 0.663 1.11
pg/ml 8.85 6.64 11.1
pmol/l 13.7 10.3 17.1 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/dl 0.891 0.670 1.11
pg/ml 8.92 6.71 11.1
pmol/l 15.0 11.3 18.8 Sysmex HISCL Series
ng/dl 0.975 0.735 1.22
pg/ml 9.77 7.36 12.2
pmol/l 17.0 12.8 21.3 Diasorin Liaison XL
ng/dl 1.11 0.832 1.39
pg/ml 11.1 8.33 13.9
pmol/l 14.3 10.7 17.9 Siemens Atellica IM
ng/dl 0.930 0.696 1.16
pg/ml 9.31 6.97 11.7
pmol/l 13.4 10.1 16.8 Abbott Alinity, 2 point cal
ng/dl 0.871 0.657 1.09
pg/ml 8.72 6.58 10.9
pmol/l 12.7 9.53 15.9 Abbott Architect, 6 point calibration
ng/dl 0.826 0.619 1.03
pg/ml 8.27 6.20 10.3
pmol/l 15.6 11.7 19.5 Roche Cobas e402/e801
ng/dl 1.01 0.761 1.26
pg/ml 10.2 7.62 12.8

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 14.1 10.6 17.6 Tosoh AIA-CL Series
ng/dl 0.917 0.689 1.15
pg/ml 9.18 6.90 11.5
pmol/l 12.9 9.68 16.1 Abbott Alinity, 6 point cal
ng/dl 0.839 0.629 1.05
pg/ml 8.40 6.30 10.5
Free T4 pmol/l 22.5 16.9 28.1 Abbott Architect
ng/dl 1.76 1.32 2.20
pg/ml 17.6 13.2 22.0
pmol/l 22.6 17.0 28.3 Siemens Centaur XP/XPT/Classic
ng/dl 1.76 1.33 2.19
pg/ml 17.6 13.3 21.9
pmol/l 32.7 24.5 40.9 Siemens Immulite 2000/2500
ng/dl 2.55 1.91 3.19
pg/ml 25.5 19.1 31.9
pmol/l 33.3 25.0 41.6 Siemens Immulite 1000
ng/dl 2.60 1.95 3.25
pg/ml 26.0 19.5 32.5
pmol/l 25.8 19.4 32.3 Beckman DxI800
ng/dl 2.01 1.51 2.51
pg/ml 20.1 15.1 25.1
pmol/l 30.2 22.7 37.8 Roche Elecsys
ng/dl 2.36 1.77 2.95
pg/ml 23.6 17.7 29.5
pmol/l 33.5 25.1 41.9 Diasorin Liaison
ng/dl 2.61 1.96 3.26
pg/ml 26.1 19.6 32.6
pmol/l 26.6 20.0 33.3 Beckman Access
ng/dl 2.07 1.56 2.58
pg/ml 20.7 15.6 25.8
pmol/l 30.0 22.5 37.5 Tosoh Series
ng/dl 2.34 1.76 2.92
pg/ml 23.4 17.6 29.2
pmol/l 66.8 50.1 83.5 Vitros ECi
ng/dl 5.21 3.91 6.51
pg/ml 52.1 39.1 65.1
pmol/l 29.9 22.4 37.4 Roche Cobas e601/602
ng/dl 2.33 1.75 2.91
pg/ml 23.3 17.5 29.1
pmol/l 29.9 22.4 37.4 Roche Cobas 4000/E411
ng/dl 2.33 1.75 2.91
pg/ml 23.3 17.5 29.1
pmol/l 32.9 24.7 41.1 Biomerieux Vidas FT4N Kit
ng/dl 2.57 1.93 3.21
pg/ml 25.7 19.3 32.1

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 21.4 16.1 26.8 Immunotech RIA
ng/dl 1.67 1.26 2.08
pg/ml 16.7 12.6 20.8
pmol/l 25.6 19.2 32.0 Siemens Dimension ExI LOCI
ng/dl 2.00 1.50 2.50
pg/ml 20.0 15.0 25.0
pmol/l 23.2 17.4 29.0 Siemens Centaur CP
ng/dl 1.81 1.36 2.26
pg/ml 18.1 13.6 22.6
pmol/l 30.8 23.1 38.5 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/dl 2.40 1.80 3.00
pg/ml 24.0 18.0 30.0
pmol/l 31.4 23.6 39.3 Sysmex HISCL Series
ng/dl 2.45 1.84 3.06
pg/ml 24.5 18.4 30.6
pmol/l 36.7 27.5 45.9 Diasorin Liaison XL
ng/dl 2.86 2.15 3.57
pg/ml 28.6 21.5 35.7
pmol/l 23.3 17.5 29.1 Siemens Atellica IM
ng/dl 1.82 1.37 2.27
pg/ml 18.2 13.7 22.7
pmol/l 22.2 16.7 27.8 Abbott Alinity i
ng/dl 1.73 1.30 2.16
pg/ml 17.3 13.0 21.6
pmol/l 29.9 22.4 37.4 Roche Cobas e402/e801
ng/dl 2.33 1.75 2.91
pg/ml 23.3 17.5 29.1
pmol/l 30.0 22.5 37.5 Tosoh AIA-CL Series
ng/dl 2.34 1.76 2.92
pg/ml 23.4 17.6 29.2
FSH mU/ml 26.3 21.0 31.6 Abbott Architect
mU/ml 32.2 25.8 38.6 BioMerieux Vidas
mU/ml 33.8 27.0 40.6 Siemens Centaur XP/XPT/Classic
mU/ml 29.6 23.7 35.5 Siemens Immulite 2000/2500
mU/ml 29.9 23.9 35.9 Siemens Immulite 1000
mU/ml 31.7 25.4 38.0 Beckman DxI800
mU/ml 27.6 22.1 33.1 Roche/BM Elecsys
mU/ml 31.4 25.1 37.7 Beckman Access
mU/ml 32.5 26.0 39.0 Tosoh Series
mU/ml 22.7 18.2 27.2 Vitros ECi
mU/ml 28.9 23.1 34.7 Roche Cobas 4000/E411
mU/ml 27.0 21.6 32.4 Roche Cobas e601/602
mU/ml 32.8 26.2 39.4 Siemens Centaur CP
mU/ml 35.2 28.2 42.2 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
mU/ml 42.9 34.3 51.5 Diasorin Liaison XL

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
FSH mU/ml 34.1 27.3 40.9 Siemens Atellica IM
mU/ml 26.5 21.2 31.8 Abbott Alinity i
mU/ml 27.6 22.1 33.1 Roche Cobas e402/e801
Gentamicin µmol/l 7.38 5.90 8.86 Roche Integra
µg/ml 3.53 2.82 4.24
µmol/l 8.28 6.62 9.94 Siemens Centaur XP/XPT/Classic
µg/ml 3.96 3.16 4.76
µmol/l 8.11 6.49 9.73 Abbott Architect (CMIA)
µg/ml 3.88 3.10 4.66
µmol/l 5.64 4.51 6.77 Roche Cobas 6000/8000 Online KIMS
µg/ml 2.70 2.16 3.24
µmol/l 7.02 5.62 8.42 Roche Cobas 6000/8000 CEDIA
µg/ml 3.36 2.69 4.03
µmol/l 8.19 6.55 9.83 Siemens Atellica CH
µg/ml 3.91 3.13 4.69
µmol/l 8.74 6.99 10.5 Abbott Alinity (PETINA)
µg/ml 4.18 3.34 5.02
µmol/l 8.16 6.53 9.79 Gravimetric
µg/ml 3.90 3.12 4.68
Growth Hormone (GH) µU/ml 18.7 15.0 22.4 Siemens Immulite 2000/2500
ng/ml 6.23 5.00 7.46
µU/ml 17.1 13.7 20.5 Siemens Immulite 1000
ng/ml 5.69 4.56 6.82
µU/ml 13.8 11.0 16.6 Beckman DxI800
ng/ml 4.60 3.66 5.54
µU/ml 14.4 11.5 17.3 Beckman Access
ng/ml 4.80 3.83 5.77
µU/ml 18.6 14.9 22.3 Tosoh Series
ng/ml 6.19 4.96 7.42
µU/ml 14.0 11.2 16.8 Diasorin Liaison
ng/ml 4.66 3.73 5.59
µU/ml 16.5 13.2 19.8 Roche Cobas 4000/E411
ng/ml 5.49 4.40 6.58
µU/ml 16.5 13.2 19.8 Roche Cobas e601/602
ng/ml 5.49 4.40 6.58
µU/ml 13.7 11.0 16.4 Diasorin Liaison XL
ng/ml 4.56 3.66 5.46
µU/ml 16.9 13.5 20.3 Roche Cobas e402/e801
ng/ml 5.63 4.50 6.76
Immunoglobulin E KIU/l = IU/ml 83.4 66.7 100 Abbott Architect
KIU/l = IU/ml 87.3 69.8 105 BioMerieux Vidas
KIU/l = IU/ml 96.9 77.5 116 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 99.0 79.2 119 Siemens Immulite 2000/2500
KIU/l = IU/ml 107 85.6 128 Siemens Immulite 1000
KIU/l = IU/ml 104 83.2 125 Roche Elecsys
KIU/l = IU/ml 101 80.8 121 Pharmacia Unicap

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 89.6 71.7 108 Tosoh Series
KIU/l = IU/ml 109 87.2 131 Roche Cobas 4000/E411
KIU/l = IU/ml 108 86.4 130 Roche Cobas e601/602
KIU/l = IU/ml 84.8 67.8 102 Siemens Centaur CP
KIU/l = IU/ml 104 83.2 125 Agappe Mispa i2
KIU/l = IU/ml 98.2 78.6 118 Siemens Atellica IM
KIU/l = IU/ml 108 86.4 130 Roche Cobas e402/e801
KIU/l = IU/ml 82.0 65.6 98.4 Abbott Alinity
Insulin mU/l 18.3 13.7 22.9 Siemens Centaur XP/XPT/Classic
µU/ml 18.3 13.7 22.9
mU/l 6.54 4.91 8.18 Siemens Immulite 1000
µU/ml 6.54 4.91 8.17
mU/l 7.36 5.52 9.20 Siemens Immulite 2000
µU/ml 7.36 5.52 9.20
mU/l 16.0 12.0 20.0 Roche Elecsys
µU/ml 16.0 12.0 20.0
mU/l 15.9 11.9 19.9 Beckman Access
µU/ml 15.9 11.9 19.9
mU/l 14.6 11.0 18.3 Abbott Architect
µU/ml 14.6 11.0 18.2
mU/l 17.5 13.1 21.9 Tosoh Series
µU/ml 17.5 13.1 21.9
mU/l 16.7 12.5 20.9 Roche Cobas 4000/E411
µU/ml 16.7 12.5 20.9
mU/l 15.8 11.9 19.8 Beckman DxI 600/800
µU/ml 15.8 11.9 19.7
mU/l 18.1 13.6 22.6 Diasorin Liaison
µU/ml 18.1 13.6 22.6
mU/l 16.1 12.1 20.1 Roche Cobas 6000/8000
µU/ml 16.1 12.1 20.1
mU/l 16.0 12.0 20.0 Mindray CL Series
µU/ml 16.0 12.0 20.0
mU/l 19.9 14.9 24.9 Diasorin Liaison XL
µU/ml 19.9 14.9 24.9
mU/l 18.0 13.5 22.5 Siemens Atellica IM
µU/ml 18.0 13.5 22.5
mU/l 13.4 10.1 16.8 Abbott Alinity i
µU/ml 13.4 10.1 16.7
Luteinising Hormone (LH) mU/ml 24.9 19.9 29.9 Abbott Architect
mU/ml 29.6 23.7 35.5 BioMerieux Vidas
mU/ml 32.3 25.8 38.8 Siemens Centaur XP/XPT/Classic
mU/ml 47.6 38.1 57.1 Siemens Immulite 2000
mU/ml 45.6 36.5 54.7 Siemens Immulite 1000
mU/ml 26.0 20.8 31.2 Beckman DxI800
mU/ml 34.7 27.8 41.6 Roche Elecsys
mU/ml 40.4 32.3 48.5 Diasorin Liaison

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Luteinising Hormone (LH) mU/ml 26.9 21.5 32.3 Beckman Access
mU/ml 29.5 23.6 35.4 Tosoh Series
mU/ml 42.5 34.0 51.0 Vitros ECi
mU/ml 35.2 28.2 42.2 Roche Cobas 4000/E411
mU/ml 34.5 27.6 41.4 Roche Cobas e601/602
mU/ml 32.9 26.3 39.5 Siemens Centaur CP
mU/ml 36.5 29.2 43.8 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
mU/ml 39.5 31.6 47.4 Diasorin Liaison XL
mU/ml 33.0 26.4 39.6 Siemens Atellica IM
mU/ml 25.0 20.0 30.0 Abbott Alinity i
mU/ml 34.8 27.8 41.8 Roche Cobas e402/e801
Oestradiol pmol/l 755 604 906 Abbott Architect
pg/ml 205 164 246
pmol/l 1455 1164 1746 BioMerieux Vidas
pg/ml 396 317 475
pmol/l 1092 874 1310 Siemens Centaur XP/XPT/Classic
pg/ml 297 238 356
pmol/l 1177 942 1412 Siemens Immulite 2000/2500
pg/ml 320 256 384
pmol/l 1002 802 1202 Siemens Immulite 1000
pg/ml 273 218 328
pmol/l 789 631 947 Beckman DxI800
pg/ml 215 172 258
pmol/l 835 668 1002 Roche Elecsys (Estradiol II)
pg/ml 227 182 272
pmol/l 848 678 1018 Beckman Access
pg/ml 231 184 278
pmol/l 1257 1006 1508 Vitros ECi
pg/ml 342 274 410
pmol/l 837 670 1004 Roche Cobas e601/602 (Estradiol II)
pg/ml 228 182 274
pmol/l 825 660 990 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 224 180 268
pmol/l 1106 885 1327 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 301 241 361
pmol/l 783 626 940 Tosoh (iE2-hsE2)
pg/ml 213 170 256
pmol/l 1050 840 1260 Siemens Centaur CP
pg/ml 286 228 344
pmol/l 1103 882 1324 Siemens Centaur CP Enhanced (eE2)
pg/ml 300 240 360
pmol/l 839 671 1007 Roche Cobas e601/602 (Estradiol III)
pg/ml 228 183 273
pmol/l 831 665 997 Roche Elecsys (Estradiol III)
pg/ml 226 181 271
pmol/l 819 655 983 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 223 178 268

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 986 789 1183 Mindray CL Series
pg/ml 268 215 321
pmol/l 652 522 782 Diasorin Liaison XL
pg/ml 177 142 212
pmol/l 836 669 1003 Beckman Access / Access 2 Sensitive B84493
pg/ml 227 182 272
pmol/l 773 618 928 Beckman DxI600/800 Sensitive B84493
pg/ml 210 168 252
pmol/l 1159 927 1391 Siemens Atellica IM
pg/ml 315 252 378
pmol/l 738 590 886 Abbott Alinity i
pg/ml 201 160 242
pmol/l 841 673 1009 Roche Cobas e801 (Estradiol III)
pg/ml 229 183 275
pmol/l 912 730 1094 Tosoh AIA-CL Series
pg/ml 248 199 297
Paracetamol mmol/l 0.323 0.258 0.388 Roche Cobas c501/502/503/701/702
mg/l 48.9 39.0 58.8
mmol/l 0.326 0.261 0.391 Beckman AU Instruments
mg/l 49.3 39.5 59.1
mmol/l 0.332 0.266 0.398 Abbott Alinity
mg/l 50.2 40.2 60.2
mmol/l 0.348 0.280 0.420 Gravimetric
mg/l 52.7 42.4 63.5
Phenobarbital µmol/l 83.8 67.0 101 Abbott Architect (CMIA)
µg/ml 19.4 15.5 23.3
µmol/l 84.8 67.8 102 Siemens Immulite 2000/2500
µg/ml 19.7 15.7 23.7
µmol/l 72.2 57.8 86.6 Beckman AU400/600/640/2700/5400
µg/ml 16.8 13.4 20.2
µmol/l 114 91.2 137 Siemens Centaur XP/XPT/Classic
µg/ml 26.4 21.2 31.6
µmol/l 74.8 59.8 89.8 Roche Integra
µg/ml 17.4 13.9 20.9
µmol/l 75.0 60.0 90.0 Roche Cobas C303/501/502/503/701
µg/ml 17.4 13.9 20.9
µmol/l 71.9 57.5 86.3 Abbott Alinity (PETINA)
µg/ml 16.7 13.3 20.1
µmol/l 77.6 62.1 93.1 Gravimetric
µg/ml 18.0 14.4 21.6
Phenytoin µmol/l 68.3 54.6 82.0 Abbott Architect
µg/ml 17.2 13.8 20.6
µmol/l 80.2 64.2 96.2 Siemens Centaur XP/XPT/Classic
µg/ml 20.3 16.2 24.4
µmol/l 77.0 61.6 92.4 Siemens Dimension
µg/ml 19.4 15.6 23.2

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Phenytoin µmol/l 71.4 57.1 85.7 Roche Integra
µg/ml 18.0 14.4 21.6
µmol/l 72.0 57.6 86.4 Vitros
µg/ml 18.2 14.5 21.9
µmol/l 67.9 54.3 81.5 Roche Cobas 6000/8000
µg/ml 17.1 13.7 20.5
µmol/l 67.7 54.2 81.2 Beckman AU Instruments
µg/ml 17.1 13.7 20.5
µmol/l 68.6 54.9 82.3 EMIT
µg/ml 17.3 13.9 20.7
µmol/l 75.2 60.2 90.2 Siemens Atellica CH
µg/ml 19.0 15.2 22.8
µmol/l 69.7 55.8 83.6 Abbott Alinity
µg/ml 17.6 14.1 21.1
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 28.6 22.9 34.3 Abbott Architect
ng/ml 8.95 7.17 10.7
nmol/l 39.9 31.9 47.9 BioMerieux Vidas
ng/ml 12.5 9.98 15.0
nmol/l 23.9 19.1 28.7 Siemens Centaur XP/XPT/Classic
ng/ml 7.48 5.98 8.98
nmol/l 25.4 20.3 30.5 Siemens Immulite 2000/2500
ng/ml 7.95 6.35 9.55
nmol/l 29.1 23.3 34.9 Siemens Immulite 1000
ng/ml 9.11 7.29 10.9
nmol/l 30.6 24.5 36.7 Beckman DxI Prog Cal 33555
ng/ml 9.58 7.67 11.5
nmol/l 32.9 26.3 39.5 Roche Elecsys (Prog. II)
ng/ml 10.3 8.23 12.4
nmol/l 30.4 24.3 36.5 Beckman Access Prog Cal 33555
ng/ml 9.52 7.61 11.4
nmol/l 34.6 27.7 41.5 Tosoh Series
ng/ml 10.8 8.67 12.9
nmol/l 35.9 28.7 43.1 Vitros ECi
ng/ml 11.2 8.98 13.4
nmol/l 33.3 26.6 40.0 Roche Cobas 4000/e411 (Prog. II)
ng/ml 10.4 8.33 12.5
nmol/l 33.5 26.8 40.2 Roche Cobas e601/602 (Prog. II)
ng/ml 10.5 8.39 12.6
nmol/l 26.5 21.2 31.8 Beckman DxI Prog DE Cal A80773
ng/ml 8.29 6.64 9.94
nmol/l 32.5 26.0 39.0 Beckman Access Prog DE Cal A80773
ng/ml 10.2 8.14 12.3

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 23.4 18.7 28.1 Siemens Centaur CP
ng/ml 7.32 5.85 8.79
nmol/l 40.5 32.4 48.6 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/ml 12.7 10.1 15.3
nmol/l 33.1 26.5 39.7 Roche Cobas e601/602 (Prog. III)
ng/ml 10.4 8.29 12.5
nmol/l 33.0 26.4 39.6 Roche Elecsys (Prog. III)
ng/ml 10.3 8.26 12.3
nmol/l 32.9 26.3 39.5 Roche Cobas 4000/e411 (Prog. III)
ng/ml 10.3 8.23 12.4
nmol/l 27.5 22.0 33.0 Diasorin Liaison XL
ng/ml 8.61 6.89 10.3
nmol/l 26.8 21.4 32.2 Abbott Alinity i
ng/ml 8.39 6.70 10.1
nmol/l 24.8 19.8 29.8 Siemens Atellica IM
ng/ml 7.76 6.20 9.32
nmol/l 32.9 26.3 39.5 Roche Cobas e801 (Prog. III)
ng/ml 10.3 8.23 12.4
Prolactin µU/ml 588 470 706 Abbott Architect
µU/ml 649 519 779 BioMerieux Vidas
µU/ml 487 390 584 Siemens Centaur XP/XPT/Classic
µU/ml 495 396 594 Siemens Immulite 2000/2500
µU/ml 529 423 635 Siemens Immulite 1000
µU/ml 505 404 606 Beckman DxI800
µU/ml 713 570 856 Roche Elecsys
µU/ml 618 494 742 Diasorin Liaison
µU/ml 533 426 640 Beckman Access
µU/ml 573 458 688 Tosoh Series
µU/ml 502 402 602 Vitros ECi
µU/ml 709 567 851 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 627 502 752 Immunotech IRMA
µU/ml 725 580 870 Roche Cobas 4000/E411
µU/ml 703 562 844 Roche Cobas e601/602
µU/ml 477 382 572 Siemens Centaur CP
µU/ml 653 522 784 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
µU/ml 663 530 796 Diasorin Liaison XL
µU/ml 455 364 546 Siemens Atellica IM
µU/ml 610 488 732 Abbott Alinity i
µU/ml 690 552 828 Roche Cobas e801 PRL II
PSA Free ng/ml = µg/l 10.9 8.18 13.6 Abbott Architect
ng/ml = µg/l 13.0 9.75 16.3 BioMerieux Vidas
ng/ml = µg/l 9.42 7.07 11.8 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 8.84 6.63 11.1 Siemens Immulite 2000/2500
ng/ml = µg/l 11.8 8.85 14.8 Beckman DXI standardised to Hybritech
ng/ml = µg/l 9.01 6.76 11.3 Roche Elecsys

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
PSA Free ng/ml = µg/l 9.33 7.00 11.7 Diasorin Liaison
ng/ml = µg/l 12.2 9.15 15.3 Beckman Access standardised to Hybritech
ng/ml = µg/l 8.92 6.69 11.2 Tosoh Series
ng/ml = µg/l 9.05 6.79 11.3 Roche Cobas 4000/E411
ng/ml = µg/l 9.21 6.91 11.5 Roche Cobas e601/602
ng/ml = µg/l 8.38 6.29 10.5 Siemens Dimension Vista
ng/ml = µg/l 10.7 8.03 13.4 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 12.0 9.00 15.0 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 8.39 6.29 10.5 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 7.54 5.66 9.43 Fujirebio Lumipulse G Series
ng/ml = µg/l 9.18 6.89 11.5 Diasorin Liaison XL
ng/ml = µg/l 9.67 7.25 12.1 Siemens Atellica IM
ng/ml = µg/l 11.1 8.33 13.9 Abbott Alinity i
ng/ml = µg/l 8.84 6.63 11.1 Roche Cobas e402/e801
PSA Total ng/ml = µg/l 9.01 6.76 11.3 Abbott Architect
ng/ml = µg/l 10.9 8.18 13.6 BioMerieux Vidas
ng/ml = µg/l 10.7 8.03 13.4 bioMerieux VIDAS TPSA
ng/ml = µg/l 11.5 8.63 14.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 9.87 7.40 12.3 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 10.8 8.10 13.5 Siemens Immulite 1000 1st generation
ng/ml = µg/l 12.4 9.30 15.5 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 10.3 7.73 12.9 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 12.2 9.15 15.3 Roche Elecsys
ng/ml = µg/l 10.7 8.03 13.4 Diasorin Liaison
ng/ml = µg/l 12.7 9.53 15.9 Beckman Access standardised to Hybritech
ng/ml = µg/l 13.0 9.75 16.3 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 8.41 6.31 10.5 Tosoh Series
ng/ml = µg/l 11.9 8.93 14.9 Vitros ECi
ng/ml = µg/l 9.04 6.78 11.3 Immunotech IRMA
ng/ml = µg/l 12.2 9.15 15.3 Roche Cobas 4000/E411
ng/ml = µg/l 12.2 9.15 15.3 Roche Cobas e601/602
ng/ml = µg/l 8.31 6.23 10.4 Fujirebio Lumipulse G Series
ng/ml = µg/l 12.1 9.08 15.1 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 10.7 8.03 13.4 Siemens Centaur CP
ng/ml = µg/l 11.3 8.48 14.1 Diasorin Liaison XL
ng/ml = µg/l 11.9 8.93 14.9 Siemens Atellica IM
ng/ml = µg/l 9.21 6.91 11.5 Abbott Alinity i
ng/ml = µg/l 11.9 8.93 14.9 Roche Cobas e402/e801
Salicylic Acid mmol/l 1.19 0.952 1.43 Abbott Architect
mg/dl 16.4 13.1 19.7
mmol/l 1.21 0.968 1.45 Roche Cobas c501/502/503
mg/dl 16.7 13.4 20.0
mmol/l 1.18 0.944 1.42 EMIT
mg/dl 16.3 13.0 19.6
mmol/l 1.22 0.980 1.46 Gravimetric
mg/dl 16.9 13.5 20.2

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
SHBG nmol/l 35.8 28.6 43.0 Siemens Immulite 2000/2500
nmol/l 38.0 30.4 45.6 Abbott Architect
nmol/l 35.3 28.2 42.4 Beckman DxI800
nmol/l 36.0 28.8 43.2 Siemens Atellica IM
nmol/l 34.1 27.3 40.9 Roche analysers - 413417/15
nmol/l 32.6 26.1 39.1 Roche Cobas e801 - 413429
nmol/l 36.6 29.3 43.9 Abbott Alinity i
T Uptake %U 38.6 31.7 45.5 Siemens Immulite 2000
Testosterone nmol/l 13.8 11.0 16.6 Abbott Architect
ng/ml 3.97 3.17 4.77
ng/dl 397 317 477
nmol/l 12.4 9.92 14.9 BioMerieux Vidas
ng/ml 3.57 2.86 4.28
ng/dl 357 286 428
nmol/l 14.1 11.3 16.9 Siemens Centaur XP/XPT/Classic
ng/ml 4.06 3.25 4.87
ng/dl 406 325 487
nmol/l 16.0 12.8 19.2 Siemens Immulite 2000/2500
ng/ml 4.61 3.69 5.53
ng/dl 461 369 553
nmol/l 15.1 12.1 18.1 Siemens Immulite 1000
ng/ml 4.35 3.48 5.22
ng/dl 435 348 522
nmol/l 13.0 10.4 15.6 Beckman DxI800
ng/ml 3.74 3.00 4.48
ng/dl 374 300 448
nmol/l 13.9 11.1 16.7 Beckman Access
ng/ml 4.00 3.20 4.80
ng/dl 400 320 480
nmol/l 17.7 14.2 21.2 Tosoh Series
ng/ml 5.10 4.09 6.11
ng/dl 510 409 611
nmol/l 18.1 14.5 21.7 Vitros ECi
ng/ml 5.21 4.18 6.24
ng/dl 521 418 624
nmol/l 14.7 11.8 17.6 Roche Cobas e601/602 Test II
ng/ml 4.23 3.40 5.06
ng/dl 423 340 506
nmol/l 14.7 11.8 17.6 Roche Elecsys Test II
ng/ml 4.23 3.40 5.06
ng/dl 423 340 506
nmol/l 14.4 11.5 17.3 Roche Cobas 4000/e411 Test II
ng/ml 4.15 3.31 4.99
ng/dl 415 331 499
nmol/l 13.7 11.0 16.4 Abbott Architect 2nd Generation
ng/ml 3.95 3.17 4.73
ng/dl 395 317 473

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 12.5 10.0 15.0 BioMerieux Vidas Testosterone II
ng/ml 3.60 2.88 4.32
ng/dl 360 288 432
nmol/l 20.1 16.1 24.1 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/ml 5.79 4.64 6.94
ng/dl 579 464 694
nmol/l 14.5 11.6 17.4 Siemens Centaur TST II
ng/ml 4.18 3.34 5.02
ng/dl 418 334 502
nmol/l 14.8 11.8 17.8 Siemens Atellica IM
ng/ml 4.26 3.40 5.12
ng/dl 426 340 512
nmol/l 14.4 11.5 17.3 Roche Cobas e801 Test II
ng/ml 4.15 3.31 4.99
ng/dl 415 331 499
nmol/l 13.5 10.8 16.2 Abbott Alinity i
ng/ml 3.89 3.11 4.67
ng/dl 389 311 467
Theophylline µmol/l 84.3 67.4 101 Roche Integra
µg/ml 15.2 12.1 18.3
µmol/l 80.5 64.4 96.6 Roche Cobas 6000/8000
µg/ml 14.5 11.6 17.4
µmol/l 85.7 68.6 103 Beckman AU400/600/640/2700/5400
µg/ml 15.4 12.4 18.4
µmol/l 80.7 64.6 96.8 Abbott Alinity Enzyme-Immu
µg/ml 14.5 11.6 17.4
µmol/l 83.8 67.0 101 Gravimetric
µg/ml 15.1 12.1 18.2
Thyroglobulin ng/ml 13.8 10.4 17.3 Siemens Immulite 1000
ng/ml 13.8 10.4 17.3 Siemens Immulite 2000
ng/ml 33.7 25.3 42.1 Roche Elecsys
ng/ml 27.8 20.9 34.8 Beckman DxI800
ng/ml 34.1 25.6 42.6 Roche Cobas 4000/E411
ng/ml 34.3 25.7 42.9 Roche Cobas e601/602
ng/ml 28.4 21.3 35.5 Beckman Access
ng/ml 34.0 25.5 42.5 Abbott Architect 2000i
ng/ml 31.8 23.9 39.8 Tosoh Series
ng/ml 33.7 25.3 42.1 Roche Cobas e601/602 Tg II
ng/ml 34.0 25.5 42.5 Roche Elecsys TGII
ng/ml 34.6 26.0 43.3 Roche Cobas 4000/E411 TGII
ng/ml 31.2 23.4 39.0 Diasorin Liaison XL
ng/ml 33.1 24.8 41.4 Roche Cobas e801 Tg II
ng/ml 32.9 24.7 41.1 DiaSorin Liaison XL TG II Gen
ng/ml 34.2 25.7 42.8 Abbott Alinity i
Thyroid Stimulating µU/ml = mlU/l 1.88 1.50 2.26 Abbott Architect

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 2.25 1.80 2.70 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 2.09 1.67 2.51 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 2.36 1.89 2.83 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 2.23 1.78 2.68 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 2.30 1.84 2.76 Siemens Immulite 2000/2500
µU/ml = mlU/l 2.17 1.74 2.60 Siemens Immulite 1000
µU/ml = mlU/l 2.19 1.75 2.63 Beckman DxI800
µU/ml = mlU/l 2.52 2.02 3.02 Roche Elecsys
µU/ml = mlU/l 3.04 2.43 3.65 Diasorin Liaison
µU/ml = mlU/l 2.15 1.72 2.58 Beckman Access Fast TSH
µU/ml = mlU/l 2.16 1.73 2.59 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 3.14 2.51 3.77 Tosoh Series
µU/ml = mlU/l 2.40 1.92 2.88 Vitros ECi
µU/ml = mlU/l 2.30 1.84 2.76 Immunotech IRMA
µU/ml = mlU/l 2.56 2.05 3.07 Roche Cobas 4000/E411
µU/ml = mlU/l 2.54 2.03 3.05 Roche Cobas e601/602
µU/ml = mlU/l 2.15 1.72 2.58 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 2.00 1.60 2.40 Siemens Dimension Vista LOCI
µU/ml = mlU/l 2.29 1.83 2.75 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 2.19 1.75 2.63 Siemens Centaur CP
µU/ml = mlU/l 2.13 1.70 2.56 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 2.91 2.33 3.49 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
µU/ml = mlU/l 2.16 1.73 2.59 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 3.08 2.46 3.70 Diasorin Liaison XL
µU/ml = mlU/l 2.31 1.85 2.77 Siemens Atellica IM
µU/ml = mlU/l 1.92 1.54 2.30 Abbott Alinity i
µU/ml = mlU/l 2.40 1.92 2.88 Roche Cobas e402/e801
Tobramycin µmol/l 7.16 5.73 8.59 Gravimetric
µg/ml 3.35 2.68 4.02
Total Beta hCG mU/ml=IU/l 17.2 13.8 20.6 Abbott Architect
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 33.8 27.0 40.6 BioMerieux Vidas
IU/ml 0.034 0.027 0.041
mU/ml=IU/l 17.0 13.6 20.4 Siemens Centaur XP/XPT/Classic
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 44.4 35.5 53.3 Siemens Dimension
IU/ml 0.044 0.036 0.052
mU/ml=IU/l 72.6 58.1 87.1 Siemens Immulite 2000
IU/ml 0.073 0.058 0.088
mU/ml=IU/l 58.4 46.7 70.1 Siemens Immulite 1000
IU/ml 0.058 0.047 0.069
mU/ml=IU/l 21.0 16.8 25.2 Beckman DxI800
IU/ml 0.021 0.017 0.025
mU/ml=IU/l 18.0 14.4 21.6 Diasorin Liaison
IU/ml 0.018 0.014 0.022
mU/ml=IU/l 25.9 20.7 31.1 Roche Cobas Core EIA
IU/ml 0.026 0.021 0.031

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 19.9 15.9 23.9 Beckman Access
IU/ml 0.020 0.016 0.024
mU/ml=IU/l 40.0 32.0 48.0 Tosoh Series
IU/ml 0.040 0.032 0.048
mU/ml=IU/l 39.6 31.7 47.5 Vitros ECi
IU/ml 0.040 0.032 0.048
mU/ml=IU/l 6.10 4.88 7.32 Roche hCG STAT (Intact)
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 26.0 20.8 31.2 Roche hCG+Beta
IU/ml 0.026 0.021 0.031
mU/ml=IU/l 19.5 15.6 23.4 Beckman Access Total BhCG (5th IS)
IU/ml 0.020 0.016 0.024
mU/ml=IU/l 20.7 16.6 24.8 Beckman DxI Total BhCG (5th IS)
IU/ml 0.021 0.017 0.025
mU/ml=IU/l 16.9 13.5 20.3 Siemens Centaur CP
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 14.3 11.4 17.2 Mindray CL Series
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 17.9 14.3 21.5 Diasorin Liaison XL
IU/ml 0.018 0.014 0.022
mU/ml=IU/l 18.6 14.9 22.3 Siemens Atellica IM
IU/ml 0.019 0.015 0.023
mU/ml=IU/l 17.8 14.2 21.4 Abbott Alinity i
IU/ml 0.018 0.014 0.022
mU/ml=IU/l 26.2 21.0 31.4 Roche hCG+Beta e801
IU/ml 0.026 0.021 0.031
mU/ml=IU/l 51.9 41.5 62.3 Tosoh AIA-CL Series
IU/ml 0.052 0.042 0.062
Total T3 nmol/l 3.40 2.55 4.25 Abbott Architect
ng/ml 2.21 1.66 2.76
ng/dl 221 166 276
nmol/l 3.82 2.87 4.78 BioMerieux Vidas
ng/ml 2.49 1.87 3.11
ng/dl 249 187 311
nmol/l 4.21 3.16 5.26 Siemens Centaur XP/XPT/Classic
ng/ml 2.74 2.06 3.42
ng/dl 274 206 342
nmol/l 3.59 2.69 4.49 Siemens Immulite 2000/2500
ng/ml 2.34 1.75 2.93
ng/dl 234 175 293
nmol/l 3.38 2.54 4.23 Siemens Immulite 1000
ng/ml 2.20 1.65 2.75
ng/dl 220 165 275
nmol/l 3.59 2.69 4.49 Beckman DxI800
ng/ml 2.34 1.75 2.93
ng/dl 234 175 293

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
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IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 4.18 3.14 5.23 Roche Elecsys
ng/ml 2.72 2.04 3.40
ng/dl 272 204 340
nmol/l 3.73 2.80 4.66 Beckman Access
ng/ml 2.43 1.82 3.04
ng/dl 243 182 304
nmol/l 3.62 2.72 4.53 Tosoh Series
ng/ml 2.36 1.77 2.95
ng/dl 236 177 295
nmol/l 4.32 3.24 5.40 Vitros ECi
ng/ml 2.81 2.11 3.51
ng/dl 281 211 351
nmol/l 4.17 3.13 5.21 Roche Cobas 4000/E411
ng/ml 2.71 2.04 3.38
ng/dl 271 204 338
nmol/l 3.09 2.32 3.86 Immunotech RIA
ng/ml 2.01 1.51 2.51
ng/dl 201 151 251
nmol/l 4.04 3.03 5.05 Roche Cobas e601/602
ng/ml 2.63 1.97 3.29
ng/dl 263 197 329
nmol/l 4.25 3.19 5.31 Siemens Centaur CP
ng/ml 2.77 2.08 3.46
ng/dl 277 208 346
nmol/l 3.59 2.69 4.49 Mindray CL Series
ng/ml 2.34 1.75 2.93
ng/dl 234 175 293
nmol/l 2.84 2.13 3.55 Diasorin Liaison XL
ng/ml 1.85 1.39 2.31
ng/dl 185 139 231
nmol/l 3.46 2.60 4.33 Abbott Alinity i
ng/ml 2.25 1.69 2.81
ng/dl 225 169 281
nmol/l 4.37 3.28 5.46 Siemens Atellica IM
ng/ml 2.84 2.14 3.54
ng/dl 284 214 354
nmol/l 4.27 3.20 5.34 Roche Cobas e402/e801
ng/ml 2.78 2.08 3.48
ng/dl 278 208 348
Total T4 nmol/l 113 84.8 141 Abbott Architect
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
nmol/l 123 92.3 154 BioMerieux Vidas
µg/dl 9.59 7.20 12.0
ng/ml 95.9 72.0 120

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 25 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
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IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 131 98.3 164 Siemens Centaur XP/XPT/Classic
µg/dl 10.2 7.67 12.7
ng/ml 102 76.7 127
nmol/l 113 84.8 141 Siemens Immulite 2000/2500
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
nmol/l 118 88.5 148 Beckman DxI800
µg/dl 9.20 6.90 11.5
ng/ml 92.0 69.0 115
nmol/l 112 84.0 140 Roche Elecsys
µg/dl 8.74 6.55 10.9
ng/ml 87.4 65.5 109
nmol/l 126 94.5 158 Beckman Access
µg/dl 9.83 7.37 12.3
ng/ml 98.3 73.7 123
nmol/l 106 79.5 133 Tosoh Series
µg/dl 8.27 6.20 10.3
ng/ml 82.7 62.0 103
nmol/l 113 84.8 141 Vitros ECi
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
nmol/l 113 84.8 141 Roche Cobas 4000/E411
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
nmol/l 110 82.5 138 Roche Cobas e601/602
µg/dl 8.58 6.44 10.7
ng/ml 85.8 64.4 107
nmol/l 91.3 68.5 114 Immunotech IRMA
µg/dl 7.12 5.34 8.90
ng/ml 71.2 53.4 89.0
nmol/l 125 93.8 156 Siemens Centaur CP
µg/dl 9.75 7.32 12.2
ng/ml 97.5 73.2 122
nmol/l 137 103 171 Mindray CL Series
µg/dl 10.7 8.03 13.4
ng/ml 107 80.3 134
nmol/l 100 75.0 125 Diasorin Liaison XL
µg/dl 7.80 5.85 9.75
ng/ml 78.0 58.5 97.5
nmol/l 113 84.8 141 Abbott Alinity i
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
nmol/l 127 95.3 159 Siemens Atellica IM
µg/dl 9.91 7.43 12.4
ng/ml 99.1 74.3 124
nmol/l 107 80.3 134 Roche Cobas e402/e801
µg/dl 8.35 6.26 10.4
ng/ml 83.5 62.6 104

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 26 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
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IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 524 419 629 Abbott Architect (CMIA)
µg/ml 75.6 60.5 90.7
µmol/l 558 446 670 Siemens Centaur XP/XPT/Classic
µg/ml 80.5 64.4 96.6
µmol/l 550 440 660 Siemens Dimension
µg/ml 79.4 63.5 95.3
µmol/l 552 442 662 Siemens Immulite 2000/2500
µg/ml 79.7 63.8 95.6
µmol/l 529 423 635 Roche Integra
µg/ml 76.3 61.0 91.6
µmol/l 545 436 654 Vitros
µg/ml 78.6 62.9 94.3
µmol/l 541 433 649 Roche Cobas 6000/8000
µg/ml 78.1 62.5 93.7
µmol/l 567 454 680 Beckman AU400/600/640/2700/5400
µg/ml 81.8 65.5 98.1
µmol/l 524 419 629 Abbott Architect (PETINA)
µg/ml 75.6 60.5 90.7
µmol/l 593 474 712 EMIT
µg/ml 85.6 68.4 103
µmol/l 546 437 655 Siemens Atellica CH
µg/ml 78.8 63.1 94.5
µmol/l 536 429 643 Abbott Alinity (CMIA)
µg/ml 77.3 61.9 92.7
µmol/l 525 420 630 Abbott Alinity (PETINA)
µg/ml 75.8 60.6 91.0
µmol/l 638 510 766 Gravimetric
µg/ml 92.1 73.6 111
Vancomycin µmol/l 7.00 5.60 8.40 Roche Integra
µg/ml 10.4 8.32 12.5
µmol/l 6.60 5.28 7.92 Ortho Vitros Microslide Systems
µg/ml 9.81 7.84 11.8
µmol/l 8.10 6.48 9.72 Abbott Architect (CMIA)
µg/ml 12.0 9.63 14.4
µmol/l 6.08 4.86 7.30 Siemens Centaur XP/XPT/Classic
µg/ml 9.03 7.22 10.8
µmol/l 7.51 6.01 9.01 Siemens Dimension
µg/ml 11.2 8.93 13.5
µmol/l 7.26 5.81 8.71 Roche Cobas 6000/8000
µg/ml 10.8 8.63 13.0
µmol/l 5.81 4.65 6.97 Thermo Scientific QMS Vancomycin
µg/ml 8.63 6.91 10.4
µmol/l 7.53 6.02 9.04 Abbott Architect (PETINA)
µg/ml 11.2 8.94 13.5

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 27 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@[Link] Website: [Link]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2180EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Vancomycin µmol/l 7.35 5.88 8.82 Siemens Atellica CH
µg/ml 10.9 8.74 13.1
µmol/l 7.73 6.18 9.28 Abbott Alinity (CMIA)
µg/ml 11.5 9.18 13.8
µmol/l 7.32 5.86 8.78 Abbott Alinity (PETINA)
µg/ml 10.9 8.71 13.1
µmol/l 7.10 5.68 8.52 Gravimetric
µg/ml 10.5 8.44 12.7
Vitamin B12 pmol/l 358 286 430 Abbott Architect
pg/ml 485 388 582
pmol/l 354 283 425 Siemens Centaur XP/XPT/Classic
pg/ml 480 383 577
pmol/l 371 297 445 Siemens Immulite 2000
pg/ml 503 402 604
pmol/l 278 222 334 Beckman DxI800
pg/ml 377 301 453
pmol/l 410 328 492 Roche Elecsys
pg/ml 556 444 668
pmol/l 304 243 365 Beckman Access
pg/ml 412 329 495
pmol/l 492 394 590 Tosoh Series
pg/ml 667 534 800
pmol/l 382 306 458 Vitros ECi
pg/ml 518 415 621
pmol/l 361 289 433 Siemens Dimension
pg/ml 489 392 586
pmol/l 413 330 496 Siemens Centaur CP
pg/ml 560 447 673
pmol/l 396 317 475 Roche Cobas 4000/e411 Gen II
pg/ml 537 430 644
pmol/l 417 334 500 Roche Cobas e601/602 Gen II
pg/ml 565 453 677
pmol/l 454 363 545 Mindray CL Series
pg/ml 615 492 738
pmol/l 372 298 446 Siemens Atellica IM
pg/ml 504 404 604
pmol/l 379 303 455 Abbott Alinity i
pg/ml 514 411 617
pmol/l 406 325 487 Roche Cobas e801 Gen II
pg/ml 550 440 660

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