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. 2124EC EXPIRY: 2024-10-28

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
10 Dec ‘21 me

PAGE 1 OF 28
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 9.60 7.20 12.0 DRG ELISA
ng/ml 3.18 2.38 3.98
nmol/l 9.01 6.76 11.3 DBC ELISA
ng/ml 2.98 2.24 3.72
25-OH Vitamin D nmol/l 55.9 41.9 69.9 Diasorin Liaison
nmol/l 68.3 51.2 85.4 Siemens Centaur XP/XPT/Classic
nmol/l 47.2 35.4 59.0 Roche Vitamin D Total
nmol/l 47.9 35.9 59.9 Abbott Architect (3L52)
nmol/l 68.5 51.4 85.6 Vitros ECi
nmol/l 51.9 38.9 64.9 Tosoh Series
nmol/l 62.6 47.0 78.3 BioMerieux Vidas
nmol/l 38.8 29.1 48.5 Beckman DxI 600/800
nmol/l 48.6 36.5 60.8 Fujirebio Lumipulse G Series
nmol/l 41.8 31.4 52.3 Beckman Access 25 OH Vitamin D Total
nmol/l 51.3 38.5 64.1 LC/MS
nmol/l 46.9 35.2 58.6 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 54.4 40.8 68.0 Diasorin Liaison XL
nmol/l 48.6 36.5 60.8 Roche Vitamin D Total II
nmol/l 49.1 36.8 61.4 Abbott Alinity i
nmol/l 66.6 50.0 83.3 Siemens Atellica IM
nmol/l 48.5 36.4 60.6 Roche Vitamin D Total II e801
ACTH pmol/l 12.0 9.00 15.0 Siemens Immulite 2000/2500
pg/ml 54.5 40.9 68.1
pmol/l 12.2 9.15 15.3 Roche Cobas 4000/E411
pg/ml 55.4 41.6 69.2
pmol/l 12.2 9.15 15.3 Roche Cobas e601/602
pg/ml 55.4 41.6 69.2
pmol/l 20.8 15.6 26.0 CIS IRMA
pg/ml 94.5 70.9 118
pmol/l 18.1 13.6 22.6 Diasorin Liaison
pg/ml 82.3 61.8 103
pmol/l 18.6 14.0 23.3 Diasorin Liaison XL
pg/ml 84.5 63.6 105
pmol/l 12.4 9.30 15.5 Roche Cobas e801
pg/ml 56.4 42.3 70.5
Aldosterone pmol/l 685 514 856 DRG ELISA
pg/ml 247 185 309
pmol/l 145 109 181 CIS RIA
pg/ml 52.3 39.3 65.3
pmol/l 412 309 515 Diasorin Liaison
pg/ml 149 111 187
pmol/l 399 299 499 Diasorin Liaison XL
pg/ml 144 108 180

_________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Alphafoetoprotein KIU/l = lU/ml 43.1 34.5 51.7 Abbott Architect
ng/ml 52.2 41.7 62.7
KIU/l = lU/ml 42.4 33.9 50.9 BioMerieux Vidas
ng/ml 51.3 41.0 61.6
KIU/l = lU/ml 48.1 38.5 57.7 Siemens Centaur XP/XPT/Classic
ng/ml 58.2 46.6 69.8
KIU/l = lU/ml 43.6 34.9 52.3 Siemens Immulite 2000/2500
ng/ml 52.8 42.2 63.4
KIU/l = lU/ml 44.8 35.8 53.8 Siemens Immulite 1000
ng/ml 54.2 43.3 65.1
KIU/l = lU/ml 41.1 32.9 49.3 Beckman DxI800
ng/ml 49.7 39.8 59.6
KIU/l = lU/ml 48.2 38.6 57.8 Roche Elecsys
ng/ml 58.3 46.7 69.9
KIU/l = lU/ml 43.5 34.8 52.2 Beckman Access
ng/ml 52.6 42.1 63.1
KIU/l = lU/ml 42.9 34.3 51.5 Tosoh Series
ng/ml 51.9 41.5 62.3
KIU/l = lU/ml 45.7 36.6 54.8 Vitros ECi
ng/ml 47.5 38.0 57.0
KIU/l = lU/ml 48.1 38.5 57.7 Roche Cobas e601/602
ng/ml 58.2 46.6 69.8
KIU/l = lU/ml 72.2 57.8 86.6 CIS IRMA
ng/ml 87.4 69.9 105
KIU/l = lU/ml 47.6 38.1 57.1 Roche Cobas 4000/E411
ng/ml 57.6 46.1 69.1
KIU/l = lU/ml 46.9 37.5 56.3 Fujirebio Lumipulse G Series
ng/ml 56.7 45.4 68.0
KIU/l = lU/ml 46.5 37.2 55.8 Siemens Dimension
ng/ml 56.3 45.0 67.6
KIU/l = lU/ml 48.2 38.6 57.8 Siemens Centaur CP
ng/ml 58.3 46.7 69.9
KIU/l = lU/ml 47.1 37.7 56.5 Diasorin Liaison XL
ng/ml 57.0 45.6 68.4
KIU/l = lU/ml 48.2 38.6 57.8 Siemens Atellica IM
ng/ml 58.3 46.7 69.9
KIU/l = lU/ml 43.3 34.6 52.0 Abbott Alinity i
ng/ml 52.4 41.9 62.9
KIU/l = lU/ml 46.3 37.0 55.6 Roche Cobas e801
ng/ml 56.0 44.8 67.2
Amikacin µmol/l 14.6 11.7 17.5 Roche Cobas 6000/8000
µg/ml 8.55 6.85 10.3
µmol/l 15.7 12.6 18.8 Abbott Architect
µg/ml 9.19 7.38 11.0
µmol/l 15.6 12.5 18.7 Thermo Scientific QMS Amikacin
µg/ml 9.14 7.32 11.0

_________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Amikacin µmol/l 15.5 12.4 18.6 Abbott Alinity
µg/ml 9.08 7.26 10.9
µmol/l 15.2 12.2 18.2 Gravimetric
µg/ml 8.90 7.14 10.7
Androstenedione nmol/l 16.6 12.5 20.8 Siemens Immulite 2000
ng/ml 4.76 3.59 5.93
nmol/l 14.7 11.0 18.4 Siemens Immulite 1000
ng/ml 4.22 3.16 5.28
nmol/l 8.71 6.53 10.9 DRG ELISA
ng/ml 2.50 1.87 3.13
nmol/l 9.14 6.86 11.4 Diasorin Liaison XL
ng/ml 2.62 1.97 3.27
Beta-2-microglobulin µg/ml = mg/l 3.05 2.44 3.66 Abbott Architect
µg/ml = mg/l 3.38 2.70 4.06 BioMerieux Vidas
µg/ml = mg/l 3.03 2.42 3.64 Behring Nephelometer
µg/ml = mg/l 2.83 2.26 3.40 Siemens Immulite 2000/2500
µg/ml = mg/l 3.43 2.74 4.12 Tosoh Series
µg/ml = mg/l 3.08 2.46 3.70 Roche Cobas 6000/8000
µg/ml = mg/l 2.82 2.26 3.38 Diasorin Liaison XL
µg/ml = mg/l 3.04 2.43 3.65 Siemens Atellica CH
µg/ml = mg/l 3.09 2.47 3.71 Abbott Alinity
C-Peptide nmol/l 2.270 1.700 2.840 Siemens Immulite 2000/2500
ng/ml 6.85 5.13 8.57
nmol/l 2.400 1.800 3.000 Roche Elecsys
ng/ml 7.25 5.43 9.07
nmol/l 2.360 1.770 2.950 Roche Cobas e601/602
ng/ml 7.12 5.34 8.90
nmol/l 2.410 1.810 3.010 Diasorin Liaison
ng/ml 7.28 5.46 9.10
nmol/l 2.370 1.780 2.960 Roche Cobas 4000/E411
ng/ml 7.16 5.37 8.95
nmol/l 2.100 1.580 2.630 Abbott Architect
ng/ml 6.34 4.77 7.91
nmol/l 1.510 1.130 1.890 Siemens Centaur XP/XPT/Classic
ng/ml 4.56 3.41 5.71
nmol/l 2.070 1.550 2.590 Tosoh Series
ng/ml 6.25 4.68 7.82
nmol/l 2.460 1.850 3.080 Diasorin Liaison XL
ng/ml 7.43 5.59 9.27
nmol/l 2.250 1.690 2.810 Roche Cobas e801
ng/ml 6.79 5.10 8.48
nmol/l 1.520 1.140 1.900 Siemens Atellica IM
ng/ml 4.59 3.44 5.74
nmol/l 2.080 1.560 2.600 Abbott Alinity i
ng/ml 6.28 4.71 7.85

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
CA 15-3 U/ml 50.6 40.5 60.7 Abbott Architect
U/ml 38.9 31.1 46.7 BioMerieux Vidas
U/ml 40.1 32.1 48.1 Siemens Centaur XP/XPT/Classic
U/ml 45.1 36.1 54.1 Siemens Immulite 2000/2500
U/ml 48.3 38.6 58.0 Siemens Immulite 1000
U/ml 19.9 15.9 23.9 Beckman DxI800
U/ml 45.1 36.1 54.1 Roche Elecsys
U/ml 40.9 32.7 49.1 Diasorin Liaison
U/ml 19.8 15.8 23.8 Beckman Access
U/ml 43.3 34.6 52.0 Tosoh Series
U/ml 37.3 29.8 44.8 Vitros ECi
U/ml 46.1 36.9 55.3 Roche Cobas e601/602
U/ml 45.4 36.3 54.5 Roche Cobas 4000/E411
U/ml 41.6 33.3 49.9 Siemens Centaur CP
U/ml 23.1 18.5 27.7 Mindray CL-2000i
U/ml 41.8 33.4 50.2 Diasorin Liaison XL
U/ml 43.8 35.0 52.6 Siemens Atellica IM
U/ml 41.7 33.4 50.0 Roche Cobas e801
U/ml 48.3 38.6 58.0 Abbott Alinity i
CA 19-9 U/ml 76.5 61.2 91.8 BioMerieux Vidas
U/ml 109 87.2 131 Siemens Centaur XP/XPT/Classic
U/ml 236 189 283 Siemens Immulite 2000/2500
U/ml 302 242 362 Siemens Immulite 1000
U/ml 239 191 287 Beckman DxI800
U/ml 76.6 61.3 91.9 Roche Elecsys
U/ml 104 83.2 125 Diasorin Liaison
U/ml 269 215 323 Beckman Access
U/ml 65.7 52.6 78.8 Tosoh Series
U/ml 135 108 162 Vitros ECi
U/ml 147 118 176 Abbott Architect XR/XR2/XRL
U/ml 77.4 61.9 92.9 Roche Cobas e601/602
U/ml 78.3 62.6 94.0 Roche Cobas 4000/E411
U/ml 142 114 170 Fujirebio Lumipulse G Series
U/ml 90.6 72.5 109 Siemens Centaur CP
U/ml 54.0 43.2 64.8 Mindray CL-2000i
U/ml 125 100 150 Diasorin Liaison XL
U/ml 108 86.4 130 Siemens Atellica IM
U/ml 75.9 60.7 91.1 Roche Cobas e801
U/ml 148 118 178 Abbott Alinity XR/XR2/XRL
CA125 U/ml 121 96.8 145 Abbott Architect
U/ml 88.1 70.5 106 BioMerieux Vidas
U/ml 96.3 77.0 116 Siemens Centaur XP/XPT/Classic OV Kit
U/ml 100 80.0 120 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 84.0 67.2 101 Siemens Immulite 2000/2500
U/ml 95.3 76.2 114 Siemens Immulite 1000
U/ml 77.3 61.8 92.8 Beckman DxI800

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
CA125 U/ml 83.4 66.7 100 Roche Elecsys
U/ml 78.9 63.1 94.7 Beckman Access
U/ml 140 112 168 Tosoh Series
U/ml 86.0 68.8 103 Vitros ECi
U/ml 85.2 68.2 102 Roche Cobas 4000/E411
U/ml 86.8 69.4 104 Roche Cobas e601/602
U/ml 78.8 63.0 94.6 Fujirebio Lumipulse G Series
U/ml 102 81.6 122 Siemens Centaur CP CA125 II kit
U/ml 128 102 154 Mindray CL-2000i
U/ml 115 92.0 138 Diasorin Liaison XL
U/ml 114 91.2 137 Siemens Atellica IM
U/ml 82.8 66.2 99.0 Roche Cobas e801
U/ml 126 101 151 Abbott Alinity i
Carbamazepine µmol/l 39.8 31.8 47.8 Abbott Architect (CMIA)
µg/ml 9.41 7.52 11.3
µmol/l 42.8 34.2 51.4 Siemens Centaur XP/XPT/Classic
µg/ml 10.1 8.08 12.1
µmol/l 37.0 29.6 44.4 Siemens Dimension
µg/ml 8.75 7.00 10.5
µmol/l 34.9 27.9 41.9 Siemens Immulite 2000/2500
µg/ml 8.25 6.60 9.90
µmol/l 36.2 29.0 43.4 Siemens Immulite 1000
µg/ml 8.56 6.86 10.3
µmol/l 40.0 32.0 48.0 Roche Integra
µg/ml 9.46 7.56 11.4
µmol/l 39.6 31.7 47.5 Roche Cobas 6000/8000
µg/ml 9.36 7.49 11.2
µmol/l 41.5 33.2 49.8 Beckman AU400/600/640/2700/5400
µg/ml 9.81 7.85 11.8
µmol/l 33.7 27.0 40.4 Abbott Architect (PETINA)
µg/ml 7.97 6.38 9.56
µmol/l 40.3 32.2 48.4 EMIT
µg/ml 9.53 7.61 11.5
µmol/l 35.9 28.7 43.1 Siemens Atellica CH
µg/ml 8.49 6.78 10.2
µmol/l 31.7 25.4 38.0 Abbott Alinity (PETINA)
µg/ml 7.49 6.00 8.98
µmol/l 38.5 30.8 46.2 Gravimetric
µg/ml 9.10 7.28 10.9
Carcinoembryonic ng/ml = µg/l 33.8 27.0 40.6 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 28.7 23.0 34.4 BioMerieux Vidas
ng/ml = µg/l 31.5 25.2 37.8 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 23.2 18.6 27.8 CIS RIA Coated tube
ng/ml = µg/l 39.2 31.4 47.0 Siemens Immulite 2000/2500
ng/ml = µg/l 40.5 32.4 48.6 Siemens Immulite 1000
ng/ml = µg/l 27.2 21.8 32.6 Beckman DxI800

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Carcinoembryonic ng/ml = µg/l 26.1 20.9 31.3 Roche Elecsys
Antigen (CEA)
ng/ml = µg/l 27.0 21.6 32.4 Diasorin Liaison
ng/ml = µg/l 28.5 22.8 34.2 Beckman Access
ng/ml = µg/l 37.6 30.1 45.1 Tosoh Series
ng/ml = µg/l 31.3 25.0 37.6 Vitros ECi
ng/ml = µg/l 25.8 20.6 31.0 Roche Cobas e601/602
ng/ml = µg/l 26.6 21.3 31.9 Roche Cobas 4000/E411
ng/ml = µg/l 37.1 29.7 44.5 Fujirebio Lumipulse G Series
ng/ml = µg/l 39.0 31.2 46.8 Boditech Med Inc i-CHROMA
ng/ml = µg/l 32.4 25.9 38.9 Siemens Centaur CP
ng/ml = µg/l 19.3 15.4 23.2 Mindray CL-2000i
ng/ml = µg/l 27.9 22.3 33.5 Diasorin Liaison XL
ng/ml = µg/l 31.1 24.9 37.3 Siemens Atellica IM
ng/ml = µg/l 25.7 20.6 30.8 Roche Cobas e801
ng/ml = µg/l 33.5 26.8 40.2 Abbott Alinity i
Cortisol nmol/l 586 440 733 Abbott Architect
µg/dl 21.1 15.8 26.4
nmol/l 615 461 769 BioMerieux Vidas
µg/dl 22.1 16.6 27.6
nmol/l 742 557 928 Siemens Centaur XP/XPT/Classic
µg/dl 26.7 20.1 33.3
nmol/l 485 364 606 CIS RIA
µg/dl 17.5 13.1 21.9
nmol/l 627 470 784 Siemens Immulite 2000/2500
µg/dl 22.6 16.9 28.3
nmol/l 663 497 829 Siemens Immulite 1000
µg/dl 23.9 17.9 29.9
nmol/l 649 487 811 Beckman DxI800
µg/dl 23.4 17.5 29.3
nmol/l 645 484 806 Roche Elecsys
µg/dl 23.2 17.4 29.0
nmol/l 709 532 886 Beckman Access
µg/dl 25.5 19.2 31.8
nmol/l 718 539 898 Tosoh Series
µg/dl 25.8 19.4 32.2
nmol/l 595 446 744 Vitros ECi
µg/dl 21.4 16.1 26.7
nmol/l 638 479 798 Roche Cobas e601/602
µg/dl 23.0 17.2 28.8
nmol/l 673 505 841 Roche Cobas 4000/E411
µg/dl 24.2 18.2 30.2
nmol/l 730 548 913 Siemens Centaur CP
µg/dl 26.3 19.7 32.9
nmol/l 666 500 833 Roche Cobas 4000/e411 Gen II
µg/dl 24.0 18.0 30.0
nmol/l 636 477 795 Roche Cobas e601/602 Gen II
µg/dl 22.9 17.2 28.6

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 642 482 803 Roche Elecsys Gen II
µg/dl 23.1 17.4 28.8
nmol/l 649 487 811 Diasorin Liaison XL
µg/dl 23.4 17.5 29.3
nmol/l 830 623 1038 Siemens Atellica IM
µg/dl 29.9 22.4 37.4
nmol/l 636 477 795 Roche Cobas e801
µg/dl 22.9 17.2 28.6
nmol/l 581 436 726 Abbott Alinity i
µg/dl 20.9 15.7 26.1
DHEA-S µmol/l 14.3 11.4 17.2 Abbott Architect
µmol/l 12.0 9.60 14.4 Siemens Immulite 2000/2500
µmol/l 11.9 9.52 14.3 Siemens Immulite 1000
µmol/l 11.9 9.52 14.3 Beckman DxI800
µmol/l 18.0 14.4 21.6 Roche Elecsys
µmol/l 12.0 9.60 14.4 Beckman Access
µmol/l 10.2 8.16 12.2 Diasorin Liaison
µmol/l 12.4 9.92 14.9 Siemens Centaur XP/XPT/Classic
µmol/l 17.6 14.1 21.1 Roche Cobas 4000/E411
µmol/l 17.2 13.8 20.6 Roche Cobas e601/602
µmol/l 10.7 8.56 12.8 Diasorin Liaison XL
µmol/l 11.7 9.36 14.0 Siemens Atellica IM
µmol/l 16.7 13.4 20.0 Roche Cobas e801
µmol/l 14.6 11.7 17.5 Abbott Alinity i
Digoxin nmol/l 2.41 1.93 2.89 Abbott Architect (CMIA)
ng/ml 1.88 1.51 2.25
nmol/l 2.67 2.14 3.20 BioMerieux Vidas
ng/ml 2.09 1.67 2.51
nmol/l 3.25 2.60 3.90 Siemens Centaur XP/XPT/Classic
ng/ml 2.54 2.03 3.05
nmol/l 2.79 2.23 3.35 Siemens Dimension
ng/ml 2.18 1.74 2.62
nmol/l 2.85 2.28 3.42 Beckman DxI800
ng/ml 2.23 1.78 2.68
nmol/l 2.83 2.26 3.40 Roche Integra
ng/ml 2.21 1.77 2.65
nmol/l 2.83 2.26 3.40 Roche Cobas e601/602
ng/ml 2.21 1.77 2.65
nmol/l 3.02 2.42 3.62 Beckman AU400/600/640/2700/5400
ng/ml 2.36 1.89 2.83
nmol/l 2.98 2.38 3.58 Roche Cobas 4000/E411
ng/ml 2.33 1.86 2.80
nmol/l 2.58 2.06 3.10 Abbott Architect (PETINA)
ng/ml 2.01 1.61 2.41
nmol/l 2.86 2.29 3.43 Roche Cobas e801
ng/ml 2.23 1.79 2.67

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 3.30 2.64 3.96 Siemens Atellica IM
ng/ml 2.58 2.06 3.10
nmol/l 2.71 2.17 3.25 Siemens Atellica CH
ng/ml 2.12 1.69 2.55
nmol/l 2.74 2.19 3.29 Abbott Alinity (CMIA)
ng/ml 2.14 1.71 2.57
nmol/l 2.72 2.18 3.26 Abbott Alinity (PETINA)
ng/ml 2.12 1.70 2.54
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 99.0 79.2 119 Abbott Architect
ng/ml = µg/l 74.3 59.4 89.2 BioMerieux Vidas
ng/ml = µg/l 70.0 56.0 84.0 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 88.4 70.7 106 Siemens Dimension
ng/ml = µg/l 85.9 68.7 103 Siemens Immulite 2000/2500
ng/ml = µg/l 75.3 60.2 90.4 Siemens Immulite 1000
ng/ml = µg/l 64.2 51.4 77.0 Beckman DxI800
ng/ml = µg/l 102 81.6 122 Roche Elecsys/Cobas e411
ng/ml = µg/l 89.2 71.4 107 Diasorin Liaison
ng/ml = µg/l 100 80.0 120 Roche Modular E170 / Roche Cobas e601/602
ng/ml = µg/l 64.7 51.8 77.6 Beckman Access
ng/ml = µg/l 64.1 51.3 76.9 Tosoh Series
ng/ml = µg/l 59.0 47.2 70.8 Vitros ECi
ng/ml = µg/l 101 80.8 121 Roche Cobas 4000/c311
ng/ml = µg/l 81.8 65.4 98.2 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 98.8 79.0 119 Roche Cobas c501/502/503/701/702
ng/ml = µg/l 69.8 55.8 83.8 Siemens Centaur CP
ng/ml = µg/l 94.5 75.6 113 Diasorin Liaison XL
ng/ml = µg/l 101 80.8 121 Abbott Alinity i
ng/ml = µg/l 66.3 53.0 79.6 Siemens Atellica IM
ng/ml = µg/l 98.3 78.6 118 Roche Cobas e801
Folate nmol/l 9.78 7.43 12.1 Abbott Architect
ng/ml 4.31 3.28 5.34
nmol/l 20.9 15.9 25.9 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 9.22 7.01 11.4
nmol/l 8.89 6.76 11.0 Siemens Immulite 2000
ng/ml 3.92 2.98 4.86
nmol/l 11.9 9.04 14.8 Beckman DxI 600 / 800 - A14208
ng/ml 5.25 3.99 6.51
nmol/l 11.8 8.97 14.6 Beckman Access
ng/ml 5.20 3.96 6.44
nmol/l 17.6 13.4 21.8 Tosoh Series
ng/ml 7.76 5.91 9.61

_________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Folate nmol/l 7.67 5.83 9.51 Vitros ECi
ng/ml 3.38 2.57 4.19
nmol/l 7.03 5.34 8.72 Siemens Dimension
ng/ml 3.10 2.35 3.85
nmol/l 12.1 9.20 15.0 Beckman DxI 600 / 800 - A98032
ng/ml 5.34 4.06 6.62
nmol/l 23.5 17.9 29.1 Siemens Centaur CP (enhanced kit)
ng/ml 10.4 7.89 12.9
nmol/l 11.1 8.44 13.8 Roche Folate III - 04476433
ng/ml 4.90 3.72 6.08
nmol/l 12.2 9.27 15.1 Roche Elecsys Folate
ng/ml 5.38 4.09 6.67
nmol/l 11.1 8.44 13.8 Roche Folate III - 07559992
ng/ml 4.90 3.72 6.08
nmol/l 9.35 7.11 11.6 Diasorin Liaison XL
ng/ml 4.12 3.14 5.10
nmol/l 20.5 15.6 25.4 Siemens Atellica IM
ng/ml 9.04 6.88 11.2
nmol/l 10.6 8.06 13.1 Abbott Alinity i
ng/ml 4.67 3.55 5.79
nmol/l 11.7 8.89 14.5 Roche Folate 07027290 e801
ng/ml 5.16 3.92 6.40
Free T3 pmol/l 12.0 9.00 15.0 Abbott Architect, 2 point calibration
ng/dl 0.780 0.585 0.975
pg/ml 7.81 5.86 9.76
pmol/l 12.8 9.60 16.0 BioMerieux Vidas
ng/dl 0.832 0.624 1.04
pg/ml 8.33 6.25 10.4
pmol/l 12.9 9.68 16.1 Siemens Centaur XP/XPT/Classic
ng/dl 0.839 0.629 1.05
pg/ml 8.40 6.30 10.5
pmol/l 9.55 7.16 11.9 Siemens Immulite 2000/2500
ng/dl 0.621 0.465 0.777
pg/ml 6.22 4.66 7.78
pmol/l 10.2 7.65 12.8 Siemens Immulite 1000
ng/dl 0.663 0.497 0.829
pg/ml 6.64 4.98 8.30
pmol/l 9.24 6.93 11.6 Beckman DxI800
ng/dl 0.601 0.450 0.752
pg/ml 6.02 4.51 7.53
pmol/l 15.3 11.5 19.1 Roche Elecsys
ng/dl 0.995 0.748 1.24
pg/ml 9.96 7.49 12.4
pmol/l 15.9 11.9 19.9 Diasorin Liaison
ng/dl 1.03 0.774 1.29
pg/ml 10.4 7.75 13.1

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 10.2 7.65 12.8 Beckman Access
ng/dl 0.663 0.497 0.829
pg/ml 6.64 4.98 8.30
pmol/l 16.8 12.6 21.0 Tosoh Series
ng/dl 1.09 0.819 1.36
pg/ml 10.9 8.20 13.6
pmol/l 29.6 22.2 37.0 Vitros ECi
ng/dl 1.92 1.44 2.40
pg/ml 19.3 14.5 24.1
pmol/l 15.3 11.5 19.1 Roche Cobas 4000/E411
ng/dl 0.995 0.748 1.24
pg/ml 9.96 7.49 12.4
pmol/l 15.3 11.5 19.1 Roche Cobas e601/602
ng/dl 0.995 0.748 1.24
pg/ml 9.96 7.49 12.4
pmol/l 14.2 10.7 17.8 Siemens Dimension
ng/dl 0.923 0.696 1.15
pg/ml 9.24 6.97 11.5
pmol/l 13.5 10.1 16.9 Siemens Centaur CP
ng/dl 0.878 0.657 1.10
pg/ml 8.79 6.58 11.0
pmol/l 13.5 10.1 16.9 Mindray CL-2000i
ng/dl 0.878 0.657 1.10
pg/ml 8.79 6.58 11.0
pmol/l 16.8 12.6 21.0 Diasorin Liaison XL
ng/dl 1.09 0.819 1.36
pg/ml 10.9 8.20 13.6
pmol/l 13.4 10.1 16.8 Siemens Atellica IM
ng/dl 0.871 0.657 1.09
pg/ml 8.72 6.58 10.9
pmol/l 12.1 9.08 15.1 Abbott Alinity, 2 point cal
ng/dl 0.787 0.590 0.984
pg/ml 7.88 5.91 9.85
pmol/l 12.1 9.08 15.1 Abbott Architect, 6 point calibration
ng/dl 0.787 0.590 0.984
pg/ml 7.88 5.91 9.85
pmol/l 15.1 11.3 18.9 Roche Cobas e801
ng/dl 0.982 0.735 1.23
pg/ml 9.83 7.36 12.3
pmol/l 12.0 9.00 15.0 Abbott Alinity, 6 point cal
ng/dl 0.780 0.585 0.975
pg/ml 7.81 5.86 9.76
Free T4 pmol/l 22.3 16.7 27.9 Abbott Architect
ng/dl 1.74 1.30 2.18
pg/ml 17.4 13.0 21.8
pmol/l 23.3 17.5 29.1 Siemens Centaur XP/XPT/Classic
ng/dl 1.82 1.37 2.27
pg/ml 18.2 13.7 22.7

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 31.3 23.5 39.1 CIS RIA Coated tube
ng/dl 2.44 1.83 3.05
pg/ml 24.4 18.3 30.5
pmol/l 32.9 24.7 41.1 Siemens Immulite 2000/2500
ng/dl 2.57 1.93 3.21
pg/ml 25.7 19.3 32.1
pmol/l 33.9 25.4 42.4 Siemens Immulite 1000
ng/dl 2.64 1.98 3.30
pg/ml 26.4 19.8 33.0
pmol/l 24.4 18.3 30.5 Beckman DxI800
ng/dl 1.90 1.43 2.37
pg/ml 19.0 14.3 23.7
pmol/l 28.9 21.7 36.1 Roche Elecsys
ng/dl 2.25 1.69 2.81
pg/ml 22.5 16.9 28.1
pmol/l 34.2 25.7 42.8 Diasorin Liaison
ng/dl 2.67 2.00 3.34
pg/ml 26.7 20.0 33.4
pmol/l 25.4 19.1 31.8 Beckman Access
ng/dl 1.98 1.49 2.47
pg/ml 19.8 14.9 24.7
pmol/l 30.8 23.1 38.5 Tosoh Series
ng/dl 2.40 1.80 3.00
pg/ml 24.0 18.0 30.0
pmol/l 64.0 48.0 80.0 Vitros ECi
ng/dl 4.99 3.74 6.24
pg/ml 49.9 37.4 62.4
pmol/l 29.5 22.1 36.9 Roche Cobas e601/602
ng/dl 2.30 1.72 2.88
pg/ml 23.0 17.2 28.8
pmol/l 22.6 17.0 28.3 Immunotech IRMA
ng/dl 1.76 1.33 2.19
pg/ml 17.6 13.3 21.9
pmol/l 29.7 22.3 37.1 Roche Cobas 4000/E411
ng/dl 2.32 1.74 2.90
pg/ml 23.2 17.4 29.0
pmol/l 32.3 24.2 40.4 Biomerieux Vidas FT4N Kit
ng/dl 2.52 1.89 3.15
pg/ml 25.2 18.9 31.5
pmol/l 24.4 18.3 30.5 Siemens Dimension ExI LOCI
ng/dl 1.90 1.43 2.37
pg/ml 19.0 14.3 23.7
pmol/l 23.5 17.6 29.4 Siemens Centaur CP
ng/dl 1.83 1.37 2.29
pg/ml 18.3 13.7 22.9

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 30.4 22.8 38.0 Mindray CL-2000i
ng/dl 2.37 1.78 2.96
pg/ml 23.7 17.8 29.6
pmol/l 37.4 28.1 46.8 Diasorin Liaison XL
ng/dl 2.92 2.19 3.65
pg/ml 29.2 21.9 36.5
pmol/l 23.7 17.8 29.6 Siemens Atellica IM
ng/dl 1.85 1.39 2.31
pg/ml 18.5 13.9 23.1
pmol/l 21.3 16.0 26.6 Abbott Alinity i
ng/dl 1.66 1.25 2.07
pg/ml 16.6 12.5 20.7
pmol/l 29.9 22.4 37.4 Roche Cobas e801
ng/dl 2.33 1.75 2.91
pg/ml 23.3 17.5 29.1
FSH mU/ml 31.4 25.1 37.7 Abbott Architect
mU/ml 38.4 30.7 46.1 BioMerieux Vidas
mU/ml 41.8 33.4 50.2 Siemens Centaur XP/XPT/Classic
mU/ml 35.0 28.0 42.0 Siemens Immulite 2000/2500
mU/ml 35.6 28.5 42.7 Siemens Immulite 1000
mU/ml 36.6 29.3 43.9 Beckman DxI800
mU/ml 34.1 27.3 40.9 Roche/BM Elecsys
mU/ml 38.8 31.0 46.6 Diasorin Liaison
mU/ml 36.5 29.2 43.8 Beckman Access
mU/ml 37.5 30.0 45.0 Tosoh Series
mU/ml 27.3 21.8 32.8 Vitros ECi
mU/ml 35.2 28.2 42.2 Roche Cobas 4000/E411
mU/ml 32.8 26.2 39.4 Roche Cobas e601/602
mU/ml 30.0 24.0 36.0 Fujirebio Lumipulse G Series
mU/ml 39.1 31.3 46.9 Siemens Centaur CP
mU/ml 40.0 32.0 48.0 Mindray CL-2000i
mU/ml 48.2 38.6 57.8 Diasorin Liaison XL
mU/ml 41.9 33.5 50.3 Siemens Atellica IM
mU/ml 31.0 24.8 37.2 Abbott Alinity i
mU/ml 32.9 26.3 39.5 Roche Cobas e801
Gentamicin µmol/l 12.5 10.0 15.0 Siemens Centaur XP/XPT/Classic
µg/ml 5.98 4.78 7.18
µmol/l 10.9 8.72 13.1 Abbott Architect (CMIA)
µg/ml 5.21 4.17 6.25
µmol/l 7.98 6.38 9.58 Roche Cobas 6000/8000 Online KIMS
µg/ml 3.81 3.05 4.57
µmol/l 9.61 7.69 11.5 Roche Cobas 6000/8000 CEDIA
µg/ml 4.59 3.68 5.50
µmol/l 10.9 8.72 13.1 Siemens Atellica CH
µg/ml 5.21 4.17 6.25

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Gentamicin µmol/l 10.8 8.64 13.0 Abbott Alinity (PETINA)
µg/ml 5.16 4.13 6.19
µmol/l 8.16 6.53 9.79 Gravimetric
µg/ml 3.90 3.12 4.68
Growth Hormone (GH) µU/ml 18.8 15.0 22.6 Siemens Immulite 2000/2500
ng/ml 6.26 5.00 7.52
µU/ml 15.9 12.7 19.1 Siemens Immulite 1000
ng/ml 5.29 4.23 6.35
µU/ml 13.8 11.0 16.6 Beckman DxI800
ng/ml 4.60 3.66 5.54
µU/ml 15.0 12.0 18.0 Beckman Access
ng/ml 5.00 4.00 6.00
µU/ml 17.1 13.7 20.5 Tosoh Series
ng/ml 5.69 4.56 6.82
µU/ml 13.9 11.1 16.7 Diasorin Liaison
ng/ml 4.63 3.70 5.56
µU/ml 16.1 12.9 19.3 Roche Cobas 4000/E411
ng/ml 5.36 4.30 6.42
µU/ml 16.5 13.2 19.8 Roche Cobas e601/602
ng/ml 5.49 4.40 6.58
µU/ml 15.8 12.6 19.0 IDS iSYS
ng/ml 5.26 4.20 6.32
µU/ml 14.4 11.5 17.3 Diasorin Liaison XL
ng/ml 4.80 3.83 5.77
µU/ml 16.8 13.4 20.2 Roche Cobas e801
ng/ml 5.59 4.46 6.72
Immunoglobulin E KIU/l = IU/ml 83.6 66.9 100 Abbott Architect
KIU/l = IU/ml 96.9 77.5 116 Beckman Immage
KIU/l = IU/ml 89.3 71.4 107 BioMerieux Vidas
KIU/l = IU/ml 95.9 76.7 115 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 103 82.4 124 Siemens Immulite 2000/2500
KIU/l = IU/ml 107 85.6 128 Siemens Immulite 1000
KIU/l = IU/ml 115 92.0 138 Roche Elecsys
KIU/l = IU/ml 102 81.6 122 Pharmacia Unicap
KIU/l = IU/ml 91.7 73.4 110 Tosoh Series
KIU/l = IU/ml 114 91.2 137 Roche Cobas 4000/E411
KIU/l = IU/ml 111 88.8 133 Roche Cobas e601/602
KIU/l = IU/ml 95.6 76.5 115 Siemens Atellica IM
KIU/l = IU/ml 112 89.6 134 Roche Cobas e801
KIU/l = IU/ml 81.5 65.2 97.8 Abbott Alinity
Insulin mU/l 9.83 7.37 12.3 Siemens Centaur XP/XPT/Classic
µU/ml 9.83 7.37 12.3
mU/l 12.1 9.08 15.1 Roche Elecsys
µU/ml 12.1 9.08 15.1
mU/l 8.91 6.68 11.1 Beckman Access
µU/ml 8.91 6.68 11.1

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Insulin mU/l 9.03 6.77 11.3 Abbott Architect
µU/ml 9.03 6.77 11.3
mU/l 11.9 8.93 14.9 Tosoh Series
µU/ml 11.9 8.93 14.9
mU/l 12.3 9.23 15.4 Roche Cobas 4000/E411
µU/ml 12.3 9.23 15.4
mU/l 8.34 6.26 10.4 Beckman DxI 600/800
µU/ml 8.34 6.26 10.4
mU/l 12.3 9.23 15.4 Diasorin Liaison
µU/ml 12.3 9.23 15.4
mU/l 12.0 9.00 15.0 Roche Cobas 6000/8000
µU/ml 12.0 9.00 15.0
mU/l 10.3 7.73 12.9 Fujirebio Lumipulse G Series
µU/ml 10.3 7.73 12.9
mU/l 13.2 9.90 16.5 Diasorin Liaison XL
µU/ml 13.2 9.90 16.5
mU/l 9.79 7.34 12.2 Siemens Atellica IM
µU/ml 9.79 7.34 12.2
mU/l 8.04 6.03 10.1 Abbott Alinity i
µU/ml 8.04 6.03 10.1
Luteinising Hormone (LH) mU/ml 27.4 21.9 32.9 Abbott Architect
mU/ml 32.3 25.8 38.8 BioMerieux Vidas
mU/ml 34.6 27.7 41.5 Siemens Centaur XP/XPT/Classic
mU/ml 49.0 39.2 58.8 Siemens Immulite 2000
mU/ml 49.6 39.7 59.5 Siemens Immulite 1000
mU/ml 28.3 22.6 34.0 Beckman DxI800
mU/ml 36.5 29.2 43.8 Roche Elecsys
mU/ml 42.7 34.2 51.2 Diasorin Liaison
mU/ml 28.4 22.7 34.1 Beckman Access
mU/ml 31.6 25.3 37.9 Tosoh Series
mU/ml 46.7 37.4 56.0 Vitros ECi
mU/ml 37.5 30.0 45.0 Roche Cobas 4000/E411
mU/ml 37.3 29.8 44.8 Roche Cobas e601/602
mU/ml 31.1 24.9 37.3 Fujirebio Lumipulse G Series
mU/ml 34.9 27.9 41.9 Siemens Centaur CP
mU/ml 37.6 30.1 45.1 Mindray CL-2000i
mU/ml 42.8 34.2 51.4 Diasorin Liaison XL
mU/ml 35.1 28.1 42.1 Siemens Atellica IM
mU/ml 26.6 21.3 31.9 Abbott Alinity i
mU/ml 37.4 29.9 44.9 Roche Cobas e801
Oestradiol pmol/l 755 604 906 Abbott Architect
pg/ml 205 164 246
pmol/l 1343 1074 1612 BioMerieux Vidas
pg/ml 365 292 438
pmol/l 1037 830 1244 Siemens Centaur XP/XPT/Classic
pg/ml 282 226 338

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 1117 894 1340 Siemens Immulite 2000/2500
pg/ml 304 243 365
pmol/l 1103 882 1324 Siemens Immulite 1000
pg/ml 300 240 360
pmol/l 803 642 964 Beckman DxI800
pg/ml 218 175 261
pmol/l 794 635 953 Roche Elecsys (Estradiol II)
pg/ml 216 173 259
pmol/l 945 756 1134 Beckman Access
pg/ml 257 206 308
pmol/l 1157 926 1388 Vitros ECi
pg/ml 315 252 378
pmol/l 626 501 751 Diasorin Liaison
pg/ml 170 136 204
pmol/l 809 647 971 Roche Cobas e601/602 (Estradiol II)
pg/ml 220 176 264
pmol/l 803 642 964 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 218 175 261
pmol/l 1060 848 1272 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 288 231 345
pmol/l 779 623 935 Tosoh (iE2-hsE2)
pg/ml 212 169 255
pmol/l 1051 841 1261 Siemens Centaur CP Enhanced (eE2)
pg/ml 286 229 343
pmol/l 1041 833 1249 Fujirebio Lumipulse G Series
pg/ml 283 227 339
pmol/l 812 650 974 Roche Cobas e601/602 (Estradiol III)
pg/ml 221 177 265
pmol/l 793 634 952 Roche Elecsys (Estradiol III)
pg/ml 216 172 260
pmol/l 805 644 966 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 219 175 263
pmol/l 644 515 773 Diasorin Liaison XL
pg/ml 175 140 210
pmol/l 872 698 1046 Beckman Access / Access 2 Sensitive B84493
pg/ml 237 190 284
pmol/l 793 634 952 Beckman DxI600/800 Sensitive B84493
pg/ml 216 172 260
pmol/l 1112 890 1334 Siemens Atellica IM
pg/ml 302 242 362
pmol/l 742 594 890 Abbott Alinity i
pg/ml 202 162 242
pmol/l 803 642 964 Roche Cobas e801 (Estradiol III)
pg/ml 218 175 261
Paracetamol mmol/l 0.333 0.266 0.400 Abbott Architect
mg/l 50.4 40.2 60.6

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Paracetamol mmol/l 0.312 0.250 0.374 Roche Cobas c501/502/503/701/702
mg/l 47.2 37.8 56.6
mmol/l 0.337 0.270 0.404 Beckman AU Instruments
mg/l 51.0 40.9 61.1
mmol/l 0.352 0.282 0.422 EMIT
mg/l 53.3 42.7 63.9
mmol/l 0.341 0.273 0.409 Abbott Alinity
mg/l 51.6 41.3 61.9
mmol/l 0.348 0.280 0.420 Gravimetric
mg/l 52.7 42.4 63.5
Phenobarbital µmol/l 81.9 65.5 98.3 Abbott Architect (CMIA)
µg/ml 19.0 15.2 22.8
µmol/l 72.9 58.3 87.5 Roche Cobas e601/602/801
µg/ml 16.9 13.5 20.3
µmol/l 76.9 61.5 92.3 Beckman AU400/600/640/2700/5400
µg/ml 17.8 14.3 21.3
µmol/l 105 84.0 126 Siemens Centaur XP/XPT/Classic
µg/ml 24.4 19.5 29.3
µmol/l 77.2 61.8 92.6 Roche Integra
µg/ml 17.9 14.3 21.5
µmol/l 81.1 64.9 97.3 Siemens Atellica CH
µg/ml 18.8 15.1 22.5
µmol/l 70.0 56.0 84.0 Abbott Alinity (PETINA)
µg/ml 16.2 13.0 19.4
µmol/l 77.6 62.1 93.1 Gravimetric
µg/ml 18.0 14.4 21.6
Phenytoin µmol/l 66.3 53.0 79.6 Abbott Architect
µg/ml 16.7 13.4 20.0
µmol/l 82.7 66.2 99.0 Siemens Centaur XP/XPT/Classic
µg/ml 20.9 16.7 25.1
µmol/l 73.5 58.8 88.2 Siemens Dimension
µg/ml 18.6 14.8 22.4
µmol/l 65.2 52.2 78.2 Siemens Immulite 2000/2500
µg/ml 16.5 13.2 19.8
µmol/l 66.1 52.9 79.3 Roche Integra
µg/ml 16.7 13.4 20.0
µmol/l 67.4 53.9 80.9 Vitros
µg/ml 17.0 13.6 20.4
µmol/l 67.1 53.7 80.5 Roche Cobas 6000/8000
µg/ml 16.9 13.6 20.2
µmol/l 66.5 53.2 79.8 EMIT
µg/ml 16.8 13.4 20.2
µmol/l 70.8 56.6 85.0 Siemens Atellica CH
µg/ml 17.9 14.3 21.5
µmol/l 70.6 56.5 84.7 Abbott Alinity
µg/ml 17.8 14.3 21.3

_________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Phenytoin 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 29.3 23.4 35.2 Abbott Architect
ng/ml 9.17 7.32 11.0
nmol/l 45.8 36.6 55.0 BioMerieux Vidas
ng/ml 14.3 11.5 17.1
nmol/l 25.8 20.6 31.0 Siemens Centaur XP/XPT/Classic
ng/ml 8.08 6.45 9.71
nmol/l 27.7 22.2 33.2 Siemens Immulite 2000/2500
ng/ml 8.67 6.95 10.4
nmol/l 30.5 24.4 36.6 Siemens Immulite 1000
ng/ml 9.55 7.64 11.5
nmol/l 32.4 25.9 38.9 Beckman DxI Prog Cal 33555
ng/ml 10.1 8.11 12.1
nmol/l 36.1 28.9 43.3 Roche Elecsys (Prog. II)
ng/ml 11.3 9.05 13.6
nmol/l 32.8 26.2 39.4 Beckman Access Prog Cal 33555
ng/ml 10.3 8.20 12.4
nmol/l 40.3 32.2 48.4 Tosoh Series
ng/ml 12.6 10.1 15.1
nmol/l 36.4 29.1 43.7 Vitros ECi
ng/ml 11.4 9.11 13.7
nmol/l 35.4 28.3 42.5 Roche Cobas 4000/e411 (Prog. II)
ng/ml 11.1 8.86 13.3
nmol/l 35.8 28.6 43.0 Roche Cobas e601/602 (Prog. II)
ng/ml 11.2 8.95 13.5
nmol/l 30.3 24.2 36.4 Diasorin Liaison
ng/ml 9.48 7.57 11.4
nmol/l 29.7 23.8 35.6 Beckman DxI Prog DE Cal A80773
ng/ml 9.30 7.45 11.2
nmol/l 28.3 22.6 34.0 Beckman Access Prog DE Cal A80773
ng/ml 8.86 7.07 10.7
nmol/l 26.8 21.4 32.2 Siemens Centaur CP
ng/ml 8.39 6.70 10.1
nmol/l 47.1 37.7 56.5 Mindray CL-2000i
ng/ml 14.7 11.8 17.6
nmol/l 35.9 28.7 43.1 Roche Cobas e601/602 (Prog. III)
ng/ml 11.2 8.98 13.4
nmol/l 35.8 28.6 43.0 Roche Elecsys (Prog. III)
ng/ml 11.2 8.95 13.5
nmol/l 35.6 28.5 42.7 Roche Cobas 4000/e411 (Prog. III)
ng/ml 11.1 8.92 13.3
nmol/l 32.8 26.2 39.4 Diasorin Liaison XL
ng/ml 10.3 8.20 12.4

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 28.3 22.6 34.0 Abbott Alinity i
ng/ml 8.86 7.07 10.7
nmol/l 35.9 28.7 43.1 Roche Cobas e801 (Prog. III)
ng/ml 11.2 8.98 13.4
Prolactin µU/ml 587 470 704 Abbott Architect
µU/ml 658 526 790 BioMerieux Vidas
µU/ml 477 382 572 Siemens Centaur XP/XPT/Classic
µU/ml 500 400 600 Siemens Immulite 2000/2500
µU/ml 557 446 668 Siemens Immulite 1000
µU/ml 493 394 592 Beckman DxI800
µU/ml 638 510 766 Roche Elecsys
µU/ml 661 529 793 Diasorin Liaison
µU/ml 508 406 610 Beckman Access
µU/ml 548 438 658 Tosoh Series
µU/ml 528 422 634 Vitros ECi
µU/ml 616 493 739 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 574 459 689 Immunotech IRMA
µU/ml 649 519 779 Roche Cobas 4000/E411
µU/ml 619 495 743 Roche Cobas e601/602
µU/ml 645 516 774 Fujirebio Lumipulse G Series
µU/ml 465 372 558 Siemens Centaur CP
µU/ml 660 528 792 Mindray CL-2000i
µU/ml 624 499 749 Diasorin Liaison XL
µU/ml 471 377 565 Siemens Atellica IM
µU/ml 609 487 731 Abbott Alinity i
µU/ml 614 491 737 Roche Cobas e801 PRL II
PSA Free ng/ml = µg/l 11.8 8.85 14.8 Abbott Architect
ng/ml = µg/l 13.2 9.90 16.5 BioMerieux Vidas
ng/ml = µg/l 9.92 7.44 12.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 8.54 6.41 10.7 Siemens Immulite 2000/2500
ng/ml = µg/l 8.04 6.03 10.1 Siemens Immulite 1000
ng/ml = µg/l 12.9 9.68 16.1 Beckman DXI standardised to Hybritech
ng/ml = µg/l 10.2 7.65 12.8 Roche Elecsys
ng/ml = µg/l 9.05 6.79 11.3 Diasorin Liaison
ng/ml = µg/l 13.2 9.90 16.5 Beckman Access standardised to Hybritech
ng/ml = µg/l 9.62 7.22 12.0 Tosoh Series
ng/ml = µg/l 9.91 7.43 12.4 Roche Cobas 4000/E411
ng/ml = µg/l 9.78 7.34 12.2 Roche Cobas e601/602
ng/ml = µg/l 8.77 6.58 11.0 Siemens Dimension Vista
ng/ml = µg/l 11.7 8.78 14.6 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 12.1 9.08 15.1 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 9.54 7.16 11.9 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 8.05 6.04 10.1 Fujirebio Lumipulse G Series
ng/ml = µg/l 10.0 7.50 12.5 Diasorin Liaison XL
ng/ml = µg/l 10.5 7.88 13.1 Siemens Atellica IM
ng/ml = µg/l 11.2 8.40 14.0 Abbott Alinity i

__________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
PSA Free ng/ml = µg/l 9.39 7.04 11.7 Roche Cobas e801
PSA Total ng/ml = µg/l 9.97 7.48 12.5 Abbott Architect
ng/ml = µg/l 11.3 8.48 14.1 BioMerieux Vidas
ng/ml = µg/l 11.8 8.85 14.8 bioMerieux VIDAS TPSA
ng/ml = µg/l 11.5 8.63 14.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 9.95 7.46 12.4 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 9.53 7.15 11.9 Siemens Immulite 1000 3rd generation
ng/ml = µg/l 10.3 7.73 12.9 Siemens Immulite 1000 1st generation
ng/ml = µg/l 12.0 9.00 15.0 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 10.1 7.58 12.6 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 12.5 9.38 15.6 Roche Elecsys
ng/ml = µg/l 12.1 9.08 15.1 Diasorin Liaison
ng/ml = µg/l 12.5 9.38 15.6 Beckman Access standardised to Hybritech
ng/ml = µg/l 12.1 9.08 15.1 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 9.10 6.83 11.4 Tosoh Series
ng/ml = µg/l 12.8 9.60 16.0 Vitros ECi
ng/ml = µg/l 14.1 10.6 17.6 CIS RIA Coated tube
ng/ml = µg/l 13.0 9.75 16.3 Roche Cobas 4000/E411
ng/ml = µg/l 12.6 9.45 15.8 Roche Cobas e601/602
ng/ml = µg/l 9.15 6.86 11.4 Fujirebio Lumipulse G Series
ng/ml = µg/l 12.9 9.68 16.1 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 11.1 8.33 13.9 Siemens Centaur CP
ng/ml = µg/l 11.5 8.63 14.4 Diasorin Liaison XL
ng/ml = µg/l 12.2 9.15 15.3 Siemens Atellica IM
ng/ml = µg/l 10.0 7.50 12.5 Abbott Alinity i
ng/ml = µg/l 12.2 9.15 15.3 Roche Cobas e801
Salicylic Acid mmol/l 1.21 0.968 1.45 Abbott Architect
mg/dl 16.7 13.4 20.0
mmol/l 1.20 0.960 1.44 Roche Cobas c501/502/503
mg/dl 16.6 13.3 19.9
mmol/l 1.26 1.01 1.51 EMIT
mg/dl 17.4 14.0 20.8
mmol/l 1.22 0.980 1.46 Gravimetric
mg/dl 16.9 13.5 20.2
SHBG nmol/l 39.6 31.7 47.5 Siemens Immulite 2000/2500
nmol/l 42.8 34.2 51.4 Abbott Architect
nmol/l 42.1 33.7 50.5 Beckman Access
nmol/l 41.4 33.1 49.7 Beckman DxI800
nmol/l 41.4 33.1 49.7 Siemens Atellica IM
nmol/l 39.3 31.4 47.2 Roche analysers - 413417/15
nmol/l 37.0 29.6 44.4 Roche Cobas e801 - 413429
nmol/l 42.3 33.8 50.8 Abbott Alinity i
T Uptake %U 33.3 27.3 39.3 Siemens Immulite 2000
Testosterone nmol/l 14.0 11.2 16.8 Abbott Architect
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 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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Testosterone 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 14.5 11.6 17.4 Siemens Centaur XP/XPT/Classic
ng/ml 4.18 3.34 5.02
ng/dl 418 334 502
nmol/l 14.2 11.4 17.0 CIS RIA Coated tube
ng/ml 4.09 3.28 4.90
ng/dl 409 328 490
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 16.8 13.4 20.2 Siemens Immulite 1000
ng/ml 4.84 3.86 5.82
ng/dl 484 386 582
nmol/l 12.5 10.0 15.0 Beckman DxI800
ng/ml 3.60 2.88 4.32
ng/dl 360 288 432
nmol/l 13.7 11.0 16.4 Beckman Access
ng/ml 3.95 3.17 4.73
ng/dl 395 317 473
nmol/l 18.4 14.7 22.1 Tosoh Series
ng/ml 5.30 4.23 6.37
ng/dl 530 423 637
nmol/l 17.5 14.0 21.0 Vitros ECi
ng/ml 5.04 4.03 6.05
ng/dl 504 403 605
nmol/l 14.6 11.7 17.5 Roche Cobas e601/602 Test II
ng/ml 4.20 3.37 5.03
ng/dl 420 337 503
nmol/l 14.9 11.9 17.9 Roche Elecsys Test II
ng/ml 4.29 3.43 5.15
ng/dl 429 343 515
nmol/l 14.6 11.7 17.5 Roche Cobas 4000/e411 Test II
ng/ml 4.20 3.37 5.03
ng/dl 420 337 503
nmol/l 13.8 11.0 16.6 Abbott Architect 2nd Generation
ng/ml 3.97 3.17 4.77
ng/dl 397 317 477
nmol/l 12.3 9.84 14.8 BioMerieux Vidas Testosterone II
ng/ml 3.54 2.83 4.25
ng/dl 354 283 425
nmol/l 20.9 16.7 25.1 Mindray CL-2000i
ng/ml 6.02 4.81 7.23
ng/dl 602 481 723
nmol/l 14.4 11.5 17.3 Siemens Centaur TST II
ng/ml 4.15 3.31 4.99
ng/dl 415 331 499

_________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 8.46 6.77 10.2 Diasorin Liaison XL
ng/ml 2.44 1.95 2.93
ng/dl 244 195 293
nmol/l 14.5 11.6 17.4 Siemens Atellica IM
ng/ml 4.18 3.34 5.02
ng/dl 418 334 502
nmol/l 14.7 11.8 17.6 Roche Cobas e801 Test II
ng/ml 4.23 3.40 5.06
ng/dl 423 340 506
nmol/l 14.2 11.4 17.0 Abbott Alinity i
ng/ml 4.09 3.28 4.90
ng/dl 409 328 490
Theophylline µmol/l 82.5 66.0 99.0 Siemens Centaur XP/XPT/Classic
µg/ml 14.9 11.9 17.9
µmol/l 86.0 68.8 103 Roche Integra
µg/ml 15.5 12.4 18.6
µmol/l 77.3 61.8 92.8 Abbott Architect (CMIA)
µg/ml 13.9 11.1 16.7
µmol/l 80.9 64.7 97.1 Roche Cobas 6000/8000
µg/ml 14.6 11.7 17.5
µmol/l 81.2 65.0 97.4 Beckman AU400/600/640/2700/5400
µg/ml 14.6 11.7 17.5
µmol/l 82.2 65.8 98.6 Abbott Alinity Enzyme-Immu
µg/ml 14.8 11.9 17.7
µmol/l 83.8 67.0 101 Gravimetric
µg/ml 15.1 12.1 18.2
Thyroglobulin ng/ml 18.9 14.2 23.6 Siemens Immulite 1000
ng/ml 18.7 14.0 23.4 Siemens Immulite 2000
ng/ml 40.8 30.6 51.0 Roche Elecsys
ng/ml 35.6 26.7 44.5 Beckman DxI800
ng/ml 41.3 31.0 51.6 Roche Cobas 4000/E411
ng/ml 39.3 29.5 49.1 Roche Cobas e601/602
ng/ml 36.8 27.6 46.0 Beckman Access
ng/ml 44.2 33.2 55.3 Abbott Architect 2000i
ng/ml 39.9 29.9 49.9 Tosoh Series
ng/ml 39.6 29.7 49.5 Roche Cobas e601/602 Tg II
ng/ml 41.1 30.8 51.4 Roche Elecsys TGII
ng/ml 40.3 30.2 50.4 Roche Cobas 4000/E411 TGII
ng/ml 35.8 26.9 44.8 Diasorin Liaison XL
ng/ml 41.2 30.9 51.5 Roche Cobas e801 Tg II
ng/ml 35.6 26.7 44.5 DiaSorin Liaison TG II Gen
ng/ml 36.2 27.2 45.3 DiaSorin Liaison XL TG II Gen
ng/ml 43.6 32.7 54.5 Abbott Alinity i
Thyroid Stimulating µU/ml = mlU/l 2.18 1.74 2.62 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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 2.67 2.14 3.20 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 2.46 1.97 2.95 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 2.62 2.10 3.14 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 3.19 2.55 3.83 CIS IRMA
µU/ml = mlU/l 2.62 2.10 3.14 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 2.72 2.18 3.26 Siemens Immulite 2000/2500
µU/ml = mlU/l 2.58 2.06 3.10 Siemens Immulite 1000
µU/ml = mlU/l 2.49 1.99 2.99 Beckman DxI800 Fast TSH
µU/ml = mlU/l 2.43 1.94 2.92 Beckman DxI800
µU/ml = mlU/l 2.84 2.27 3.41 Roche Elecsys
µU/ml = mlU/l 3.00 2.40 3.60 Diasorin Liaison
µU/ml = mlU/l 2.41 1.93 2.89 Beckman Access Fast TSH
µU/ml = mlU/l 2.41 1.93 2.89 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 2.74 2.19 3.29 Tosoh Series
µU/ml = mlU/l 2.81 2.25 3.37 Vitros ECi
µU/ml = mlU/l 2.85 2.28 3.42 Roche Cobas 4000/E411
µU/ml = mlU/l 2.86 2.29 3.43 Roche Cobas e601/602
µU/ml = mlU/l 2.75 2.20 3.30 ELISA
µU/ml = mlU/l 2.46 1.97 2.95 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 2.41 1.93 2.89 Siemens Dimension Vista LOCI
µU/ml = mlU/l 2.62 2.10 3.14 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 2.50 2.00 3.00 Siemens Centaur CP
µU/ml = mlU/l 2.33 1.86 2.80 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 3.10 2.48 3.72 Mindray CL-2000i
µU/ml = mlU/l 2.42 1.94 2.90 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 3.18 2.54 3.82 Diasorin Liaison XL
µU/ml = mlU/l 2.54 2.03 3.05 Siemens Atellica IM
µU/ml = mlU/l 2.19 1.75 2.63 Abbott Alinity i
µU/ml = mlU/l 2.72 2.18 3.26 Roche Cobas 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 17.0 13.6 20.4 Abbott Architect
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 27.9 22.3 33.5 BioMerieux Vidas
IU/ml 0.028 0.022 0.034
mU/ml=IU/l 18.1 14.5 21.7 Siemens Centaur XP/XPT/Classic
IU/ml 0.018 0.015 0.021
mU/ml=IU/l 30.5 24.4 36.6 Siemens Dimension
IU/ml 0.031 0.024 0.038
mU/ml=IU/l 37.3 29.8 44.8 Siemens Immulite 2000
IU/ml 0.037 0.030 0.044
mU/ml=IU/l 37.6 30.1 45.1 Siemens Immulite 1000
IU/ml 0.038 0.030 0.046
mU/ml=IU/l 18.9 15.1 22.7 Beckman DxI800
IU/ml 0.019 0.015 0.023
mU/ml=IU/l 14.7 11.8 17.6 Diasorin Liaison
IU/ml 0.015 0.012 0.018

_________________________________________________________________________________________________

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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 19.4 15.5 23.3 Roche Cobas Core EIA
IU/ml 0.019 0.016 0.022
mU/ml=IU/l 18.6 14.9 22.3 Beckman Access
IU/ml 0.019 0.015 0.023
mU/ml=IU/l 29.5 23.6 35.4 Tosoh Series
IU/ml 0.030 0.024 0.036
mU/ml=IU/l 31.8 25.4 38.2 Vitros ECi
IU/ml 0.032 0.025 0.039
mU/ml=IU/l 14.7 11.8 17.6 Roche hCG STAT (Intact)
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 19.4 15.5 23.3 Roche hCG+Beta
IU/ml 0.019 0.016 0.022
mU/ml=IU/l 18.4 14.7 22.1 Beckman Access Total BhCG (5th IS)
IU/ml 0.018 0.015 0.021
mU/ml=IU/l 19.1 15.3 22.9 Beckman DxI Total BhCG (5th IS)
IU/ml 0.019 0.015 0.023
mU/ml=IU/l 18.3 14.6 22.0 Siemens Centaur CP
IU/ml 0.018 0.015 0.021
mU/ml=IU/l 16.3 13.0 19.6 Diasorin Liaison XL
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 19.6 15.7 23.5 Siemens Atellica IM
IU/ml 0.020 0.016 0.024
mU/ml=IU/l 17.3 13.8 20.8 Abbott Alinity i
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 18.8 15.0 22.6 Roche hCG+Beta e801
IU/ml 0.019 0.015 0.023
Total T3 nmol/l 3.31 2.48 4.14 Abbott Architect
ng/ml 2.15 1.61 2.69
ng/dl 215 161 269
nmol/l 3.87 2.90 4.84 BioMerieux Vidas
ng/ml 2.52 1.89 3.15
ng/dl 252 189 315
nmol/l 4.19 3.14 5.24 Siemens Centaur XP/XPT/Classic
ng/ml 2.73 2.04 3.42
ng/dl 273 204 342
nmol/l 3.47 2.60 4.34 Siemens Immulite 2000/2500
ng/ml 2.26 1.69 2.83
ng/dl 226 169 283
nmol/l 3.43 2.57 4.29 Siemens Immulite 1000
ng/ml 2.23 1.67 2.79
ng/dl 223 167 279
nmol/l 3.52 2.64 4.40 Beckman DxI800
ng/ml 2.29 1.72 2.86
ng/dl 229 172 286
nmol/l 4.03 3.02 5.04 Roche Elecsys
ng/ml 2.62 1.97 3.27
ng/dl 262 197 327

_________________________________________________________________________________________________

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]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 3.55 2.66 4.44 Beckman Access
ng/ml 2.31 1.73 2.89
ng/dl 231 173 289
nmol/l 3.70 2.78 4.63 Tosoh Series
ng/ml 2.41 1.81 3.01
ng/dl 241 181 301
nmol/l 4.36 3.27 5.45 Vitros ECi
ng/ml 2.84 2.13 3.55
ng/dl 284 213 355
nmol/l 3.01 2.26 3.76 CIS RIA Coated tube
ng/ml 1.96 1.47 2.45
ng/dl 196 147 245
nmol/l 3.84 2.88 4.80 Roche Cobas 4000/E411
ng/ml 2.50 1.87 3.13
ng/dl 250 187 313
nmol/l 3.85 2.89 4.81 Roche Cobas e601/602
ng/ml 2.51 1.88 3.14
ng/dl 251 188 314
nmol/l 4.42 3.32 5.53 Siemens Centaur CP
ng/ml 2.88 2.16 3.60
ng/dl 288 216 360
nmol/l 2.91 2.18 3.64 Diasorin Liaison XL
ng/ml 1.89 1.42 2.36
ng/dl 189 142 236
nmol/l 3.33 2.50 4.16 Abbott Alinity i
ng/ml 2.17 1.63 2.71
ng/dl 217 163 271
nmol/l 4.19 3.14 5.24 Siemens Atellica IM
ng/ml 2.73 2.04 3.42
ng/dl 273 204 342
nmol/l 4.11 3.08 5.14 Roche Cobas e801
ng/ml 2.68 2.01 3.35
ng/dl 268 201 335
Total T4 nmol/l 115 86.3 144 Abbott Architect
µg/dl 8.97 6.73 11.2
ng/ml 89.7 67.3 112
nmol/l 121 90.8 151 BioMerieux Vidas
µg/dl 9.44 7.08 11.8
ng/ml 94.4 70.8 118
nmol/l 123 92.3 154 Siemens Centaur XP/XPT/Classic
µg/dl 9.59 7.20 12.0
ng/ml 95.9 72.0 120
nmol/l 115 86.3 144 Siemens Immulite 2000/2500
µg/dl 8.97 6.73 11.2
ng/ml 89.7 67.3 112

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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]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 117 87.8 146 Siemens Immulite 1000
µg/dl 9.13 6.85 11.4
ng/ml 91.3 68.5 114
nmol/l 120 90.0 150 Beckman DxI800
µg/dl 9.36 7.02 11.7
ng/ml 93.6 70.2 117
nmol/l 109 81.8 136 Roche Elecsys
µg/dl 8.50 6.38 10.6
ng/ml 85.0 63.8 106
nmol/l 122 91.5 153 Beckman Access
µg/dl 9.52 7.14 11.9
ng/ml 95.2 71.4 119
nmol/l 112 84.0 140 Tosoh Series
µg/dl 8.74 6.55 10.9
ng/ml 87.4 65.5 109
nmol/l 123 92.3 154 Vitros ECi
µg/dl 9.59 7.20 12.0
ng/ml 95.9 72.0 120
nmol/l 113 84.8 141 CIS RIA Coated tube
µg/dl 8.81 6.61 11.0
ng/ml 88.1 66.1 110
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
nmol/l 107 80.3 134 Roche Cobas e601/602
µg/dl 8.35 6.26 10.4
ng/ml 83.5 62.6 104
nmol/l 91.4 68.6 114 Immunotech IRMA
µg/dl 7.13 5.35 8.91
ng/ml 71.3 53.5 89.1
nmol/l 126 94.5 158 Siemens Centaur CP
µg/dl 9.83 7.37 12.3
ng/ml 98.3 73.7 123
nmol/l 103 77.3 129 Diasorin Liaison XL
µg/dl 8.03 6.03 10.0
ng/ml 80.3 60.3 100
nmol/l 112 84.0 140 Abbott Alinity i
µg/dl 8.74 6.55 10.9
ng/ml 87.4 65.5 109
nmol/l 134 101 168 Siemens Atellica IM
µg/dl 10.5 7.88 13.1
ng/ml 105 78.8 131
nmol/l 108 81.0 135 Roche Cobas e801
µg/dl 8.42 6.32 10.5
ng/ml 84.2 63.2 105

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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]
A
IMMUNOASSAY PREMIUM PLUS LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot. No. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 516 413 619 Abbott Architect (CMIA)
µg/ml 74.5 59.6 89.4
µmol/l 559 447 671 Siemens Centaur XP/XPT/Classic
µg/ml 80.7 64.5 96.9
µmol/l 555 444 666 Siemens Dimension
µg/ml 80.1 64.1 96.1
µmol/l 558 446 670 Siemens Immulite 2000/2500
µg/ml 80.5 64.4 96.6
µmol/l 610 488 732 Siemens Immulite 1000
µg/ml 88.0 70.4 106
µmol/l 525 420 630 Roche Integra
µg/ml 75.8 60.6 91.0
µmol/l 545 436 654 Roche Cobas 6000/8000
µg/ml 78.6 62.9 94.3
µmol/l 536 429 643 Beckman DxC
µg/ml 77.3 61.9 92.7
µmol/l 574 459 689 Beckman AU400/600/640/2700/5400
µg/ml 82.8 66.2 99.4
µmol/l 506 405 607 Abbott Architect (PETINA)
µg/ml 73.0 58.4 87.6
µmol/l 587 470 704 EMIT
µg/ml 84.7 67.8 102
µmol/l 545 436 654 Siemens Atellica CH
µg/ml 78.6 62.9 94.3
µmol/l 506 405 607 Abbott Alinity (CMIA)
µg/ml 73.0 58.4 87.6
µmol/l 516 413 619 Abbott Alinity (PETINA)
µg/ml 74.5 59.6 89.4
µmol/l 638 510 766 Gravimetric
µg/ml 92.1 73.6 111
Vancomycin µmol/l 7.49 5.99 8.99 Roche Integra
µg/ml 11.1 8.90 13.3
µmol/l 6.32 5.06 7.58 Ortho Vitros Microslide Systems
µg/ml 9.39 7.52 11.3
µmol/l 8.34 6.67 10.0 Abbott Architect (CMIA)
µg/ml 12.4 9.91 14.9
µmol/l 7.04 5.63 8.45 Siemens Centaur XP/XPT/Classic
µg/ml 10.5 8.36 12.6
µmol/l 7.95 6.36 9.54 Siemens Dimension
µg/ml 11.8 9.45 14.2
µmol/l 7.47 5.98 8.96 Roche Cobas 6000/8000
µg/ml 11.1 8.88 13.3
µmol/l 7.88 6.30 9.46 Thermo Scientific QMS Vancomycin
µg/ml 11.7 9.36 14.0
µmol/l 7.44 5.95 8.93 Siemens Atellica CH
µg/ml 11.1 8.84 13.4

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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. 2124EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Vancomycin µmol/l 7.40 5.92 8.88 Abbott Alinity (PETINA)
µg/ml 11.0 8.80 13.2
µmol/l 7.10 5.68 8.52 Gravimetric
µg/ml 10.5 8.44 12.7
Vitamin B12 pmol/l 354 283 425 Abbott Architect
pg/ml 480 383 577
pmol/l 403 322 484 Siemens Centaur XP/XPT/Classic
pg/ml 546 436 656
pmol/l 413 330 496 Siemens Immulite 2000
pg/ml 560 447 673
pmol/l 300 240 360 Beckman DxI800
pg/ml 407 325 489
pmol/l 412 330 494 Roche Elecsys
pg/ml 558 447 669
pmol/l 314 251 377 Beckman Access
pg/ml 425 340 510
pmol/l 505 404 606 Tosoh Series
pg/ml 684 547 821
pmol/l 402 322 482 Vitros ECi
pg/ml 545 436 654
pmol/l 353 282 424 Siemens Dimension
pg/ml 478 382 574
pmol/l 434 347 521 Siemens Centaur CP
pg/ml 588 470 706
pmol/l 382 306 458 Roche Cobas 4000/e411 Gen II
pg/ml 518 415 621
pmol/l 414 331 497 Roche Cobas e601/602 Gen II
pg/ml 561 449 673
pmol/l 311 249 373 Diasorin Liaison XL
pg/ml 421 337 505
pmol/l 436 349 523 Siemens Atellica IM
pg/ml 591 473 709
pmol/l 332 266 398 Abbott Alinity i
pg/ml 450 360 540
pmol/l 419 335 503 Roche Cobas e801 Gen II
pg/ml 568 454 682

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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]