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2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 1


(IA PREMIUM PLUS 1)
CAT. NO. IA3109 GTIN: 05055273207255 SIZE: 12 x 5ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5ml
LOT NO. 1862EC EXPIRY: 2021-11-28

INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS


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

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

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

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. 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 5ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

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

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

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

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

22 May ’19 ne

PAGE 1 OF 23
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 2.34 1.76 2.93 Immunotech RIA
ng/ml 0.775 0.583 0.967
nmol/l 2.97 2.23 3.71 DRG ELISA
ng/ml 0.983 0.738 1.23
nmol/l 3.45 2.59 4.31 SNIBE Maglumi Analysers
ng/ml 1.14 0.857 1.42
25-OH Vitamin D nmol/l 38.3 28.7 47.9 Diasorin Liaison
nmol/l 27.8 20.9 34.8 Siemens Centaur XP/XPT/Classic
nmol/l 18.1 13.6 22.6 Roche Vitamin D Total
nmol/l 20.8 15.6 26.0 ELISA
nmol/l 22.2 16.7 27.8 Abbott Architect
nmol/l 20.8 15.6 26.0 IDS iSYS
nmol/l 35.9 26.9 44.9 SNIBE Maglumi Analysers
nmol/l 96.4 72.3 121 Vitros ECi
nmol/l 22.8 17.1 28.5 Tosoh Series
nmol/l 22.5 16.9 28.1 BioMerieux Vidas
nmol/l 39.8 29.9 49.8 Beckman DxI 600/800
nmol/l 43.7 32.8 54.7 Beckman Access 25 OH Vitamin D Total
nmol/l 20.3 15.2 25.4 Roche Vitamin D Total II
ACTH pmol/l 1.12 0.840 1.40 Siemens Immulite 2000/2500
pg/ml 5.09 3.82 6.36
pmol/l 2.20 1.65 2.75 Siemens Immulite 1000
pg/ml 10.0 7.50 12.5
Aldosterone pmol/l 13.9 10.4 17.4 SNIBE Maglumi Analysers
pg/ml 5.02 3.75 6.29
pmol/l 371 278 464 IDS iSYS
pg/ml 134 100 168
Alpha-fetoprotein KIU/l = lU/ml 9.79 7.83 11.7 Abbott Architect
ng/ml 11.8 9.47 14.1
KIU/l = lU/ml 10.9 8.72 13.1 BioMerieux Vidas
ng/ml 13.2 10.6 15.8
KIU/l = lU/ml 11.4 9.01 13.8 Siemens Centaur XP/XPT/Classic
ng/ml 13.8 10.9 16.7
KIU/l = lU/ml 9.92 7.94 11.9 Siemens Immulite 2000/2500
ng/ml 12.0 9.61 14.4
KIU/l = lU/ml 10.7 8.56 12.8 Siemens Immulite 1000
ng/ml 12.9 10.4 15.4
KIU/l = lU/ml 9.84 7.87 11.8 Beckman DxI800
ng/ml 11.9 9.52 14.3
KIU/l = lU/ml 10.7 8.56 12.8 Roche Elecsys
ng/ml 12.9 10.4 15.4
KIU/l = lU/ml 11.9 9.52 14.3 Diasorin Liaison
ng/ml 14.4 11.5 17.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Alpha-fetoprotein KIU/l = lU/ml 9.89 7.91 11.9 Beckman Access
ng/ml 12.0 9.57 14.4
KIU/l = lU/ml 10.4 8.32 12.5 Tosoh Series
ng/ml 12.6 10.1 15.1
KIU/l = lU/ml 10.7 8.56 12.8 Vitros ECi
ng/ml 11.1 8.88 13.3
KIU/l = lU/ml 11.0 8.80 13.2 Roche Cobas 6000/8000
ng/ml 13.3 10.6 16.0
KIU/l = lU/ml 17.9 14.3 21.5 CIS IRMA
ng/ml 21.7 17.3 26.1
KIU/l = lU/ml 10.9 8.72 13.1 Roche Cobas E411
ng/ml 13.2 10.6 15.8
KIU/l = lU/ml 10.4 8.32 12.5 SNIBE Maglumi Analysers
ng/ml 12.6 10.1 15.1
KIU/l = lU/ml 10.7 8.45 13.0 Siemens Centaur CP
ng/ml 12.9 10.2 15.6
KIU/l = lU/ml 11.1 8.85 13.3 Siemens Atellica IM
ng/ml 13.4 10.7 16.1
Amikacin µmol/l 6.66 5.33 7.99 Roche Integra
µg/ml 3.90 3.12 4.68
µmol/l 6.39 5.11 7.67 Roche Cobas 6000/8000
µg/ml 3.74 2.99 4.49
µmol/l 6.40 5.12 7.68 Gravimetric
µg/ml 3.75 3.00 4.50
Androstenedione nmol/l 4.85 3.64 6.06 Siemens Immulite 2000
ng/ml 1.39 1.04 1.74
nmol/l 2.38 1.79 2.98 DiaMetra ELISA
ng/ml 0.683 0.514 0.852
Beta-2-microglobulin µg/ml = mg/l 1.03 0.824 1.24 Abbott Architect
µg/ml = mg/l 1.03 0.824 1.24 BioMerieux Vidas
µg/ml = mg/l 1.01 0.808 1.21 Behring Nephelometer
µg/ml = mg/l 1.03 0.824 1.24 Siemens Immulite 2000/2500
µg/ml = mg/l 1.25 1.00 1.50 Siemens Immulite 1000
µg/ml = mg/l 0.900 0.720 1.08 Tosoh Series
µg/ml = mg/l 1.15 0.920 1.38 Roche Cobas 6000/8000
C-Peptide nmol/l 0.210 0.158 0.263 Siemens Immulite 2000/2500
ng/ml 0.634 0.477 0.791
nmol/l 0.360 0.270 0.450 Roche Cobas 6000/8000
ng/ml 1.09 0.815 1.37
nmol/l 0.120 0.090 0.150 Diasorin Liaison
ng/ml 0.362 0.272 0.452
nmol/l 0.330 0.248 0.413 Roche Cobas E411
ng/ml 0.996 0.749 1.24
nmol/l 0.280 0.210 0.350 Abbott Architect
ng/ml 0.845 0.634 1.06

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
C-Peptide nmol/l 0.199 0.139 0.259 Siemens Centaur XP/XPT/Classic
ng/ml 0.601 0.421 0.781
nmol/l 0.230 0.173 0.288 Tosoh Series
ng/ml 0.694 0.522 0.866
nmol/l 0.440 0.330 0.550 SNIBE Maglumi Analysers
ng/ml 1.33 0.996 1.66
CA 15-3 U/ml 24.7 19.8 29.6 Abbott Architect
U/ml 20.3 16.2 24.4 BioMerieux Vidas
U/ml 23.0 15.2 30.8 Siemens Centaur XP/XPT/Classic
U/ml 22.9 18.3 27.5 Siemens Immulite 2000/2500
U/ml 26.0 20.8 31.2 Siemens Immulite 1000
U/ml 9.51 7.61 11.4 Beckman DxI800
U/ml 20.6 16.5 24.7 Roche Elecsys
U/ml 25.2 20.2 30.2 Diasorin Liaison
U/ml 9.67 7.74 11.6 Beckman Access
U/ml 22.7 18.2 27.3 Tosoh Series
U/ml 19.7 15.8 23.6 Vitros ECi
U/ml 20.9 16.7 25.1 Roche Cobas 6000/8000
U/ml 20.8 16.6 25.0 Roche Cobas E411
U/ml 17.4 13.9 20.9 SNIBE Maglumi Analysers
U/ml 24.4 16.1 32.7 Siemens Centaur CP
U/ml 25.6 20.5 30.7 Siemens Atellica IM
CA 19-9 U/ml 47.0 37.6 56.4 BioMerieux Vidas
U/ml 83.3 55.0 112 Siemens Centaur XP/XPT/Classic
U/ml 24.8 19.8 29.8 Siemens Immulite 2000/2500
U/ml 26.6 21.3 31.9 Siemens Immulite 1000
U/ml 28.7 23.0 34.4 Beckman DxI800
U/ml 20.2 16.2 24.2 Roche Elecsys
U/ml 46.5 37.2 55.8 Diasorin Liaison
U/ml 21.4 17.1 25.7 Roche Modular E170
U/ml 30.8 24.6 37.0 Beckman Access
U/ml 17.3 13.8 20.8 Tosoh Series
U/ml 49.8 39.8 59.8 Vitros ECi
U/ml 230 184 276 Abbott Architect XR/XR2 kit
U/ml 19.9 15.9 23.9 Roche Cobas 6000/8000
U/ml 20.0 16.0 24.0 Roche Cobas E411
U/ml 15.3 12.2 18.4 SNIBE Maglumi Analysers
U/ml 87.5 57.8 117 Siemens Centaur CP
U/ml 76.5 61.2 91.7 Siemens Atellica IM
CA125 U/ml 29.9 23.9 35.9 Abbott Architect
U/ml 20.7 16.6 24.8 BioMerieux Vidas
U/ml 21.6 14.3 28.9 Siemens Centaur XP/XPT/Classic OV Kit
U/ml 21.6 14.3 28.9 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 19.1 15.3 22.9 Siemens Immulite 2000/2500
U/ml 19.0 15.2 22.8 Siemens Immulite 1000
U/ml 17.5 14.0 21.0 Beckman DxI800

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
CA125 U/ml 20.9 16.7 25.1 Roche Elecsys
U/ml 22.3 17.8 26.8 Diasorin Liaison
U/ml 20.9 16.7 25.1 Roche Modular E170
U/ml 17.3 13.8 20.8 Beckman Access
U/ml 37.2 29.8 44.6 Tosoh Series
U/ml 18.3 14.6 22.0 Vitros ECi
U/ml 21.9 17.5 26.3 Roche Cobas E411
U/ml 21.1 16.9 25.3 Roche Cobas 6000/8000
U/ml 33.8 27.0 40.6 SNIBE Maglumi Analysers
U/ml 19.1 15.3 22.9 Fujirebio Lumipulse G Series
U/ml 23.2 15.3 31.1 Siemens Centaur CP CA125 II kit
U/ml 39.9 31.9 47.9 Mindray CL-2000i
U/ml 27.8 22.2 33.3 Siemens Atellica IM
Carbamazepine µmol/l 15.8 12.6 19.0 Abbott Architect
µg/ml 3.74 2.98 4.50
µmol/l 18.7 13.5 23.9 Siemens Centaur XP/XPT/Classic
µg/ml 4.42 3.18 5.66
µmol/l 14.3 11.4 17.2 Siemens Dimension
µg/ml 3.38 2.69 4.07
µmol/l 12.9 10.3 15.5 Siemens Immulite 2000/2500
µg/ml 3.05 2.43 3.67
µmol/l 13.9 11.1 16.7 Siemens Immulite 1000
µg/ml 3.29 2.62 3.96
µmol/l 15.3 12.2 18.4 Roche Integra
µg/ml 3.62 2.88 4.36
µmol/l 13.8 11.0 16.6 Roche Cobas E411
µg/ml 3.26 2.60 3.92
µmol/l 14.2 11.4 17.0 Roche Cobas 6000/8000
µg/ml 3.36 2.69 4.03
µmol/l 14.2 11.4 17.0 Beckman DxC
µg/ml 3.36 2.69 4.03
µmol/l 16.7 13.4 20.0 Beckman AU400/600/640/2700/5400
µg/ml 3.95 3.17 4.73
µmol/l 15.8 12.6 19.0 Siemens ADVIA 1200/1650/1800/2400
µg/ml 3.74 2.98 4.50
µmol/l 15.4 12.3 18.4 Gravimetric
µg/ml 3.63 2.91 4.35
Carcinoembryonic ng/ml = µg/l 4.16 3.33 4.99 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 3.28 2.62 3.94 BioMerieux Vidas
ng/ml = µg/l 3.71 2.45 4.97 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 3.59 2.87 4.31 CIS RIA Coated tube
ng/ml = µg/l 4.34 3.47 5.21 Siemens Immulite 2000/2500
ng/ml = µg/l 4.79 3.83 5.75 Siemens Immulite 1000
ng/ml = µg/l 3.53 2.82 4.24 Beckman DxI800
ng/ml = µg/l 3.81 3.05 4.57 Roche Elecsys
ng/ml = µg/l 3.86 3.09 4.63 Diasorin Liaison

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Carcinoembryonic ng/ml = µg/l 3.92 3.14 4.70 Roche Modular E170
Antigen (CEA)
ng/ml = µg/l 3.54 2.83 4.25 Beckman Access
ng/ml = µg/l 5.34 4.27 6.41 Tosoh Series
ng/ml = µg/l 4.03 3.22 4.84 Vitros ECi
ng/ml = µg/l 3.76 3.01 4.51 Roche Cobas 6000/8000
ng/ml = µg/l 3.79 3.03 4.55 Roche Cobas E411
ng/ml = µg/l 5.68 4.54 6.82 SNIBE Maglumi Analysers
ng/ml = µg/l 5.08 4.06 6.10 Fujirebio Lumipulse G Series
ng/ml = µg/l 3.80 2.51 5.09 Siemens Centaur CP
ng/ml = µg/l 2.96 2.37 3.55 Mindray CL-2000i
ng/ml = µg/l 3.75 3.00 4.50 Siemens Atellica IM
Cortisol nmol/l 225 169 281 Abbott Architect
µg/dl 8.10 6.08 10.1
nmol/l 131 98.3 164 BioMerieux Vidas
µg/dl 4.72 3.54 5.90
nmol/l 206 136 276 Siemens Centaur XP/XPT/Classic
µg/dl 7.42 4.90 9.94
nmol/l 199 149 249 CIS RIA
µg/dl 7.16 5.36 8.96
nmol/l 204 153 255 Siemens Immulite 2000/2500
µg/dl 7.34 5.51 9.17
nmol/l 204 153 255 Siemens Immulite 1000
µg/dl 7.34 5.51 9.17
nmol/l 210 158 263 Beckman DxI800
µg/dl 7.56 5.69 9.43
nmol/l 197 148 246 Roche Elecsys
µg/dl 7.09 5.33 8.85
nmol/l 257 193 321 Diasorin Liaison
µg/dl 9.25 6.95 11.6
nmol/l 193 145 241 Roche Modular E170
µg/dl 6.95 5.22 8.68
nmol/l 214 161 268 Beckman Access
µg/dl 7.70 5.80 9.60
nmol/l 195 146 244 Tosoh Series
µg/dl 7.02 5.26 8.78
nmol/l 153 115 191 Vitros ECi
µg/dl 5.51 4.14 6.88
nmol/l 195 146 244 Roche Cobas 6000/8000
µg/dl 7.02 5.26 8.78
nmol/l 208 156 260 Roche Cobas E411
µg/dl 7.49 5.62 9.36
nmol/l 295 221 369 SNIBE Maglumi Analysers
µg/dl 10.6 7.96 13.2
nmol/l 247 163 331 Siemens Centaur CP
µg/dl 8.89 5.87 11.9
nmol/l 211 158 264 Roche Cobas 4000/e411 Gen II
µg/dl 7.60 5.69 9.51

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 190 143 238 Roche Cobas 6000/8000 Gen II
µg/dl 6.84 5.15 8.53
nmol/l 204 153 255 Roche Elecsys Gen II
µg/dl 7.34 5.51 9.17
nmol/l 221 165 276 Siemens Atellica IM
µg/dl 7.94 5.94 9.94
DHEA-S µmol/l 2.24 1.79 2.69 Abbott Architect
µmol/l 1.71 1.37 2.05 Siemens Immulite 2000/2500
µmol/l 1.72 1.38 2.06 Siemens Immulite 1000
µmol/l 2.03 1.62 2.44 Beckman DxI800
µmol/l 3.02 2.42 3.62 Roche Elecsys
µmol/l 2.11 1.69 2.53 Beckman Access
µmol/l 2.03 1.32 2.74 Siemens Centaur XP/XPT/Classic
µmol/l 2.82 2.26 3.38 Roche Cobas E411
µmol/l 2.72 2.18 3.26 Roche Cobas 6000/8000
µmol/l 1.99 1.59 2.39 SNIBE Maglumi Analysers
Digoxin nmol/l 0.640 0.512 0.768 Abbott Architect
ng/ml 0.500 0.400 0.600
nmol/l 0.670 0.536 0.804 BioMerieux Vidas
ng/ml 0.523 0.419 0.627
nmol/l 1.04 0.780 1.30 Siemens Centaur XP/XPT/Classic
ng/ml 0.810 0.609 1.02
nmol/l 0.790 0.632 0.948 Siemens Dimension
ng/ml 0.617 0.494 0.740
nmol/l 0.690 0.552 0.828 Siemens Immulite 2000/2500
ng/ml 0.539 0.431 0.647
nmol/l 0.860 0.688 1.03 Beckman DxI800
ng/ml 0.672 0.537 0.807
nmol/l 1.00 0.800 1.20 Roche Elecsys
ng/ml 0.781 0.625 0.937
nmol/l 0.850 0.680 1.02 Roche Integra
ng/ml 0.664 0.531 0.797
nmol/l 0.910 0.728 1.09 Roche Cobas 6000/8000
ng/ml 0.711 0.569 0.853
nmol/l 0.990 0.792 1.19 Beckman AU400/600/640/2700/5400
ng/ml 0.773 0.619 0.927
nmol/l 1.02 0.816 1.22 Roche Cobas 4000/E411
ng/ml 0.797 0.637 0.957
nmol/l 0.896 0.720 1.08 Gravimetric
ng/ml 0.700 0.560 0.840
Ethosuximide µmol/l 226 181 271 Gravimetric
µg/ml 32.0 25.7 38.4
Ferritin ng/ml = µg/l 16.1 12.9 19.3 Abbott Architect
ng/ml = µg/l 13.7 11.0 16.4 BioMerieux Vidas
ng/ml = µg/l 13.3 10.6 16.0 Roche Tinaquant

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 13.6 10.2 17.0 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 14.7 11.8 17.6 Siemens Dimension
ng/ml = µg/l 13.6 10.9 16.3 Siemens Immulite 2000/2500
ng/ml = µg/l 14.5 11.6 17.4 Siemens Immulite 1000
ng/ml = µg/l 10.7 8.56 12.8 Beckman DxI800
ng/ml = µg/l 16.2 13.0 19.4 Roche Elecsys
ng/ml = µg/l 15.2 12.2 18.2 Diasorin Liaison
ng/ml = µg/l 15.8 12.6 19.0 Roche Modular E170
ng/ml = µg/l 10.6 8.48 12.7 Beckman Access
ng/ml = µg/l 10.5 8.40 12.6 Tosoh Series
ng/ml = µg/l 11.8 9.44 14.2 Vitros ECi
ng/ml = µg/l 12.4 9.92 14.9 Immunotech IRMA
ng/ml = µg/l 16.8 13.4 20.2 Roche Cobas E411
ng/ml = µg/l 14.7 11.8 17.6 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 12.4 9.30 15.5 Siemens Centaur CP
ng/ml = µg/l 12.3 9.86 14.8 Siemens Atellica IM
Folate nmol/l 4.13 3.14 5.12 Abbott Architect
ng/ml 1.82 1.38 2.26
nmol/l 8.97 4.93 13.0 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 3.96 2.18 5.74
nmol/l 3.08 2.34 3.82 Siemens Immulite 2000
ng/ml 1.36 1.03 1.69
nmol/l 3.71 2.82 4.60 Beckman DxI800
ng/ml 1.64 1.24 2.04
nmol/l 4.14 3.15 5.13 Beckman Access
ng/ml 1.83 1.39 2.27
nmol/l 3.57 2.71 4.43 Vitros ECi
ng/ml 1.57 1.20 1.94
nmol/l 3.20 2.43 3.97 Roche Cobas E411
ng/ml 1.41 1.07 1.75
nmol/l 3.26 2.48 4.04 Roche Cobas 6000/8000
ng/ml 1.44 1.09 1.79
nmol/l 3.38 2.57 4.19 Roche Cobas 6000/8000 Folate III
ng/ml 1.49 1.13 1.85
nmol/l 2.97 2.26 3.68 Roche Cobas 4000/e411 Folate III
ng/ml 1.31 0.997 1.62
Free T3 pmol/l 2.92 2.19 3.65 Abbott Architect
ng/dl 0.190 0.142 0.238
pg/ml 1.90 1.43 2.37
pmol/l 2.66 2.00 3.33 BioMerieux Vidas
ng/dl 0.173 0.130 0.216
pg/ml 1.73 1.30 2.16
pmol/l 3.60 2.16 5.04 Siemens Centaur XP/XPT/Classic
ng/dl 0.234 0.140 0.328
pg/ml 2.34 1.40 3.28
pmol/l 2.91 2.18 3.64 Siemens Immulite 2000/2500
ng/dl 0.189 0.142 0.236
pg/ml 1.89 1.42 2.36

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 2.86 2.15 3.58 Siemens Immulite 1000
ng/dl 0.186 0.140 0.232
pg/ml 1.86 1.40 2.32
pmol/l 3.58 2.69 4.48 Beckman DxI800
ng/dl 0.233 0.175 0.291
pg/ml 2.33 1.75 2.91
pmol/l 4.14 3.11 5.18 Roche Elecsys
ng/dl 0.269 0.202 0.336
pg/ml 2.70 2.02 3.38
pmol/l 2.88 2.16 3.60 Diasorin Liaison
ng/dl 0.187 0.140 0.234
pg/ml 1.87 1.41 2.33
pmol/l 4.01 3.01 5.01 Roche Modular E170
ng/dl 0.261 0.196 0.326
pg/ml 2.61 1.96 3.26
pmol/l 3.46 2.60 4.33 Beckman Access
ng/dl 0.225 0.169 0.281
pg/ml 2.25 1.69 2.81
pmol/l 6.40 4.80 8.00 Vitros ECi
ng/dl 0.416 0.312 0.520
pg/ml 4.17 3.12 5.22
pmol/l 4.22 3.17 5.28 Roche Cobas E411
ng/dl 0.274 0.206 0.342
pg/ml 2.75 2.06 3.44
pmol/l 3.92 2.94 4.90 Roche Cobas 6000/8000
ng/dl 0.255 0.191 0.319
pg/ml 2.55 1.91 3.19
pmol/l 2.31 1.73 2.89 SNIBE Maglumi Analysers
ng/dl 0.150 0.112 0.188
pg/ml 1.50 1.13 1.87
pmol/l 3.79 2.27 5.31 Siemens Centaur CP
ng/dl 0.246 0.148 0.344
pg/ml 2.46 1.48 3.44
pmol/l 3.35 2.51 4.19 Mindray CL-2000i
ng/dl 0.218 0.163 0.273
pg/ml 2.18 1.63 2.73
pmol/l 3.90 2.93 4.88 Siemens Atellica IM
ng/dl 0.250 0.190 0.320
pg/ml 2.54 1.91 3.18
Free T4 pmol/l 9.55 7.16 11.9 Abbott AXSYM
ng/dl 0.745 0.558 0.932
pg/ml 7.45 5.58 9.32
pmol/l 9.22 6.92 11.5 Abbott Architect
ng/dl 0.719 0.540 0.898
pg/ml 7.19 5.40 8.98

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 8.20 6.15 10.3 Siemens Centaur XP/XPT/Classic
ng/dl 0.640 0.480 0.800
pg/ml 6.40 4.80 8.00
pmol/l 10.3 7.73 12.9 CIS RIA Coated tube
ng/dl 0.803 0.603 1.00
pg/ml 8.03 6.03 10.0
pmol/l 12.5 9.38 15.6 Siemens Immulite 2000/2500
ng/dl 0.975 0.732 1.22
pg/ml 9.75 7.32 12.2
pmol/l 12.3 9.23 15.4 Siemens Immulite 1000
ng/dl 0.959 0.720 1.20
pg/ml 9.59 7.20 12.0
pmol/l 9.47 7.10 11.8 Beckman DxI800
ng/dl 0.739 0.554 0.924
pg/ml 7.39 5.54 9.24
pmol/l 12.9 9.68 16.1 Roche Elecsys
ng/dl 1.01 0.755 1.27
pg/ml 10.1 7.55 12.7
pmol/l 10.8 8.10 13.5 Diasorin Liaison
ng/dl 0.842 0.632 1.05
pg/ml 8.42 6.32 10.5
pmol/l 9.41 7.06 11.8 Beckman Access
ng/dl 0.734 0.551 0.917
pg/ml 7.34 5.51 9.17
pmol/l 9.68 7.26 12.1 Tosoh Series
ng/dl 0.755 0.566 0.944
pg/ml 7.55 5.66 9.44
pmol/l 16.2 12.2 20.3 Vitros ECi
ng/dl 1.26 0.952 1.57
pg/ml 12.6 9.52 15.7
pmol/l 12.3 9.23 15.4 Roche Cobas 6000/8000
ng/dl 0.959 0.720 1.20
pg/ml 9.59 7.20 12.0
pmol/l 10.8 8.10 13.5 Immunotech IRMA
ng/dl 0.842 0.632 1.05
pg/ml 8.42 6.32 10.5
pmol/l 13.2 9.90 16.5 Roche Cobas E411
ng/dl 1.03 0.772 1.29
pg/ml 10.3 7.72 12.9
pmol/l 10.3 7.73 12.9 SNIBE Maglumi Analysers
ng/dl 0.803 0.603 1.00
pg/ml 8.03 6.03 10.0
pmol/l 9.65 7.24 12.1 Biomerieux Vidas FT4N Kit
ng/dl 0.753 0.565 0.941
pg/ml 7.53 5.65 9.41

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 8.81 6.61 11.0 Siemens Centaur CP
ng/dl 0.687 0.515 0.859
pg/ml 6.87 5.15 8.59
pmol/l 8.46 7.19 9.73 Mindray CL-2000i
ng/dl 0.660 0.560 0.760
pg/ml 6.60 5.61 7.59
pmol/l 9.78 7.34 12.2 Siemens Atellica IM
ng/dl 0.760 0.570 0.950
pg/ml 7.63 5.73 9.52
FSH mU/ml 5.27 4.22 6.32 Abbott Architect
mU/ml 6.50 5.20 7.80 BioMerieux Vidas
mU/ml 7.53 5.27 9.79 Siemens Centaur XP/XPT/Classic
mU/ml 6.05 4.84 7.26 Siemens Immulite 2000/2500
mU/ml 6.29 5.03 7.55 Siemens Immulite 1000
mU/ml 6.46 5.17 7.75 Beckman DxI800
mU/ml 5.99 4.79 7.19 Roche/BM Elecsys
mU/ml 7.64 6.11 9.17 Diasorin Liaison
mU/ml 5.80 4.64 6.96 Roche Modular E170
mU/ml 6.20 4.96 7.44 Beckman Access
mU/ml 6.68 5.34 8.02 Tosoh Series
mU/ml 4.90 3.92 5.88 Vitros ECi
mU/ml 6.02 4.82 7.22 Roche Cobas E411
mU/ml 5.67 4.54 6.80 Roche Cobas 6000/8000
mU/ml 6.73 5.38 8.08 SNIBE Maglumi Analysers
mU/ml 5.42 3.79 7.05 Siemens Centaur CP
mU/ml 6.88 5.50 8.26 Siemens Atellica IM
Gentamicin µmol/l 4.64 3.71 5.57 Roche Integra
µg/ml 2.22 1.77 2.67
µmol/l 4.20 3.36 5.04 Siemens Dimension Vista
µg/ml 2.01 1.61 2.41
µmol/l 3.41 2.73 4.09 Roche Cobas 6000/8000
µg/ml 1.63 1.30 1.96
µmol/l 5.17 4.14 6.20 Beckman DxC
µg/ml 2.47 1.98 2.96
µmol/l 4.85 3.88 5.82 Gravimetric
µg/ml 2.32 1.85 2.78
Growth Hormone (GH) µU/ml 3.51 2.81 4.21 CIS IRMA
ng/ml 1.17 0.936 1.40
µU/ml 5.44 4.35 6.53 Siemens Immulite 2000/2500
ng/ml 1.81 1.45 2.17
µU/ml 5.09 4.07 6.11 Siemens Immulite 1000
ng/ml 1.69 1.36 2.02
µU/ml 3.79 3.03 4.55 Beckman DxI800
ng/ml 1.26 1.01 1.51
µU/ml 3.94 3.15 4.73 Beckman Access
ng/ml 1.31 1.05 1.57

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Growth Hormone (GH) µU/ml 4.31 3.45 5.17 Tosoh Series
ng/ml 1.44 1.15 1.73
µU/ml 4.03 3.22 4.84 Diasorin Liaison
ng/ml 1.34 1.07 1.61
µU/ml 4.89 3.91 5.87 Roche Cobas E411
ng/ml 1.63 1.30 1.96
µU/ml 7.08 5.66 8.50 SNIBE Maglumi Analysers
ng/ml 2.36 1.88 2.84
µU/ml 4.80 3.84 5.76 Roche Cobas 6000/8000
ng/ml 1.60 1.28 1.92
µU/ml 4.59 3.67 5.51 IDS iSYS
ng/ml 1.53 1.22 1.84
Immunoglobulin E KIU/l = IU/ml 278 222 334 Abbott Architect
KIU/l = IU/ml 175 140 210 Beckman Immage
KIU/l = IU/ml 207 166 248 BioMerieux Vidas
KIU/l = IU/ml 235 141 329 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 246 197 295 Siemens Immulite 2000/2500
KIU/l = IU/ml 266 213 319 Siemens Immulite 1000
KIU/l = IU/ml 250 200 300 Beckman DxI800
KIU/l = IU/ml 249 199 299 Roche Elecsys
KIU/l = IU/ml 207 166 248 Pharmacia Unicap
KIU/l = IU/ml 228 182 274 Tosoh Series
KIU/l = IU/ml 238 190 286 Roche Cobas E411
KIU/l = IU/ml 235 188 282 Roche Cobas 6000/8000
KIU/l = IU/ml 205 164 246 SNIBE Maglumi Analysers
KIU/l = IU/ml 206 124 288 Siemens Centaur CP
Insulin mU/l 1.82 1.37 2.27 Siemens Centaur XP/XPT/Classic
µU/ml 1.82 1.37 2.27
mU/l 2.08 1.56 2.60 Roche Elecsys
µU/ml 2.08 1.56 2.60
mU/l 1.12 0.840 1.40 Beckman Access
µU/ml 1.12 0.840 1.40
mU/l 1.49 1.12 1.86 Abbott Architect
µU/ml 1.49 1.12 1.86
mU/l 2.30 1.73 2.88 Tosoh Series
µU/ml 2.30 1.73 2.87
mU/l 2.15 1.61 2.69 Roche Cobas E411
µU/ml 2.15 1.61 2.69
mU/l 1.11 0.833 1.39 Beckman DxI 600/800
µU/ml 1.11 0.833 1.39
mU/l 1.36 1.02 1.70 Diasorin Liaison
µU/ml 1.36 1.02 1.70
mU/l 2.27 1.70 2.84 Roche Cobas 6000/8000
µU/ml 2.27 1.70 2.84
mU/l 4.06 3.05 5.08 SNIBE Maglumi Analysers
µU/ml 4.06 3.05 5.07

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Insulin mU/l 1.67 1.25 2.09 Siemens Centaur CP
µU/ml 1.67 1.25 2.09
Luteinising Hormone mU/ml 2.15 1.72 2.58 Abbott Architect
(LH)
mU/ml 2.77 2.22 3.32 BioMerieux Vidas
mU/ml 2.58 1.94 3.22 Siemens Centaur XP/XPT/Classic
mU/ml 4.93 3.94 5.92 Siemens Immulite 2000
mU/ml 5.32 4.26 6.38 Siemens Immulite 1000
mU/ml 1.89 1.51 2.27 Beckman DxI800
mU/ml 3.66 2.93 4.39 Roche Elecsys
mU/ml 3.45 2.76 4.14 Diasorin Liaison
mU/ml 3.66 2.93 4.39 Roche Modular E170
mU/ml 1.85 1.48 2.22 Beckman Access
mU/ml 2.42 1.94 2.90 Tosoh Series
mU/ml 5.00 4.00 6.00 Vitros ECi
mU/ml 3.53 2.82 4.24 Roche Cobas E411
mU/ml 3.62 2.90 4.34 Roche Cobas 6000/8000
mU/ml 3.92 3.14 4.70 SNIBE Maglumi Analysers
mU/ml 2.53 1.90 3.16 Siemens Centaur CP
mU/ml 2.36 1.89 2.83 Siemens Atellica IM
Oestradiol pmol/l 225 180 270 Abbott Architect
pg/ml 61.2 49.0 73.4
pmol/l 233 186 280 BioMerieux Vidas
pg/ml 63.4 50.6 76.2
pmol/l 174 104 244 Siemens Centaur XP/XPT/Classic
pg/ml 47.3 28.4 66.2
pmol/l 137 110 164 Beckman DxI800
pg/ml 37.3 29.9 44.7
pmol/l 190 152 228 Roche Elecsys (Estradiol II)
pg/ml 51.7 41.3 62.1
pmol/l 24.6 19.7 29.5 Tosoh (E2)
pg/ml 6.69 5.36 8.02
pmol/l 78.2 62.6 93.8 Vitros ECi
pg/ml 21.3 17.0 25.6
pmol/l 194 155 233 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 52.8 42.2 63.4
pmol/l 184 147 221 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 50.0 40.0 60.0
pmol/l 179 107 251 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 48.7 29.2 68.2
pmol/l 166 133 199 SNIBE Maglumi Analysers
pg/ml 45.2 36.2 54.2
pmol/l 170 102 238 Siemens Centaur CP
pg/ml 46.2 27.7 64.7
pmol/l 194 155 233 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 52.8 42.2 63.4
pmol/l 192 154 230 Roche Elecsys (Estradiol III)
pg/ml 52.2 41.9 62.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 190 152 228 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 51.7 41.3 62.1
pmol/l 201 160 241 Siemens Atellica IM
pg/ml 54.5 43.5 65.6
Paracetamol mmol/l 0.160 0.128 0.192 Abbott Architect
mg/l 24.2 19.4 29.0
mmol/l 0.150 0.120 0.180 Roche Cobas 6000/8000
mg/l 22.7 18.2 27.2
mmol/l 0.166 0.130 0.200 Gravimetric
mg/l 25.1 19.7 30.3
Phenobarbital µmol/l 35.5 28.4 42.6 Abbott Architect
µg/ml 8.24 6.59 9.89
µmol/l 31.8 25.4 38.2 Roche Cobas 6000/8000
µg/ml 7.38 5.89 8.87
µmol/l 36.9 29.5 44.3 Siemens Immulite 2000/2500
µg/ml 8.56 6.84 10.3
µmol/l 32.8 26.2 39.4 Beckman AU400/600/640/2700/5400
µg/ml 7.61 6.08 9.14
µmol/l 36.7 29.4 44.0 Roche Integra
µg/ml 8.51 6.82 10.2
µmol/l 36.2 29.0 43.4 Siemens Immulite 1000
µg/ml 8.40 6.73 10.1
µmol/l 35.6 28.5 42.7 Beckman DxC
µg/ml 8.26 6.61 9.91
µmol/l 34.5 27.6 41.4 Gravimetric
µg/ml 8.00 6.40 9.60
Phenytoin µmol/l 19.9 15.9 23.9 Abbott Architect
µg/ml 5.02 4.01 6.03
µmol/l 19.3 14.5 24.1 Siemens Centaur XP/XPT/Classic
µg/ml 4.87 3.65 6.09
µmol/l 18.1 14.5 21.7 Siemens Dimension
µg/ml 4.57 3.66 5.48
µmol/l 19.0 15.2 22.8 Siemens Immulite 2000/2500
µg/ml 4.80 3.84 5.76
µmol/l 21.2 17.0 25.4 Siemens Immulite 1000
µg/ml 5.35 4.29 6.41
µmol/l 19.8 15.8 23.8 Roche Integra
µg/ml 5.00 3.99 6.01
µmol/l 19.2 15.4 23.0 Roche Cobas 6000/8000
µg/ml 4.85 3.89 5.81
µmol/l 20.1 16.1 24.1 Beckman DxC
µg/ml 5.08 4.07 6.09
µmol/l 20.2 16.2 24.2 Gravimetric
µg/ml 5.10 4.09 6.11
Primidone µmol/l 12.3 9.84 14.8 Gravimetric
µg/ml 2.69 2.15 3.23

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 3.12 2.50 3.74 Abbott Architect
ng/ml 0.977 0.783 1.17
nmol/l 4.60 3.68 5.52 BioMerieux Vidas
ng/ml 1.44 1.15 1.73
nmol/l 2.29 1.26 3.32 Siemens Centaur XP/XPT/Classic
ng/ml 0.720 0.394 1.04
nmol/l 3.03 2.42 3.64 Siemens Immulite 2000/2500
ng/ml 0.948 0.757 1.14
nmol/l 3.04 2.43 3.65 Siemens Immulite 1000
ng/ml 0.952 0.761 1.14
nmol/l 2.91 2.33 3.49 Beckman DxI Prog Cal 33555
ng/ml 0.911 0.729 1.09
nmol/l 3.48 2.78 4.18 Roche Elecsys (Prog. II)
ng/ml 1.09 0.870 1.31
nmol/l 2.97 2.38 3.56 Beckman Access Prog Cal 33555
ng/ml 0.930 0.745 1.12
nmol/l 2.29 1.83 2.75 Tosoh Series
ng/ml 0.717 0.573 0.861
nmol/l 2.64 2.11 3.17 Vitros ECi
ng/ml 0.826 0.660 0.992
nmol/l 3.50 2.80 4.20 Roche Cobas 4000/e411 (Prog. II)
ng/ml 1.10 0.876 1.32
nmol/l 3.47 2.78 4.16 Roche Cobas 6000/8000 (Prog. II)
ng/ml 1.09 0.870 1.31
nmol/l 2.29 1.83 2.75 Beckman DxI Prog DE Cal A80773
ng/ml 0.717 0.573 0.861
nmol/l 2.52 1.39 3.65 Siemens Centaur CP
ng/ml 0.789 0.434 1.14
nmol/l 3.36 2.69 4.03 Roche Cobas 6000/8000 (Prog. III)
ng/ml 1.05 0.842 1.26
nmol/l 3.28 2.62 3.94 Roche Elecsys (Prog. III)
ng/ml 1.03 0.820 1.24
nmol/l 3.46 2.77 4.15 Roche Cobas 4000/e411 (Prog. III)
ng/ml 1.08 0.867 1.29
Prolactin µU/ml 151 121 181 Abbott Architect
µU/ml 154 123 185 BioMerieux Vidas
µU/ml 140 98.0 182 Siemens Centaur XP/XPT/Classic
µU/ml 134 107 161 Siemens Immulite 2000/2500
µU/ml 146 117 175 Siemens Immulite 1000
µU/ml 126 101 151 Beckman DxI800
µU/ml 132 106 158 Roche Elecsys
µU/ml 154 123 185 Diasorin Liaison
µU/ml 129 103 155 Beckman Access
µU/ml 195 156 234 Vitros ECi
µU/ml 125 100 150 Roche Elecsys/E170/Cobas 6000/8000 PRLII

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Prolactin µU/ml 160 128 192 Immunotech IRMA
µU/ml 131 105 157 Roche Cobas E411
µU/ml 125 100 150 Roche Cobas 6000/8000
µU/ml 180 144 216 SNIBE Maglumi Analysers
µU/ml 152 122 182 Abbott Architect restandardised
µU/ml 136 95.2 177 Siemens Centaur CP
µU/ml 136 109 163 Siemens Atellica IM
PSA Free ng/ml = µg/l 1.33 0.998 1.66 Abbott Architect
ng/ml = µg/l 2.48 1.86 3.10 BioMerieux Vidas
ng/ml = µg/l 1.14 0.855 1.43 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.10 0.825 1.38 Siemens Immulite 2000/2500
ng/ml = µg/l 1.49 1.12 1.86 Beckman DXI standardised to Hybritech
ng/ml = µg/l 0.983 0.737 1.23 Roche Elecsys
ng/ml = µg/l 0.744 0.558 0.930 Diasorin Liaison
ng/ml = µg/l 1.50 1.13 1.88 Beckman Access standardised to Hybritech
ng/ml = µg/l 0.917 0.688 1.15 Tosoh Series
ng/ml = µg/l 0.973 0.730 1.22 Roche Cobas E411
ng/ml = µg/l 0.962 0.722 1.20 Roche Cobas 6000/8000
ng/ml = µg/l 1.26 0.945 1.58 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 0.694 0.521 0.868 SNIBE Maglumi Analysers
ng/ml = µg/l 0.578 0.434 0.723 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 1.13 0.850 1.41 Siemens Atellica IM
PSA Total ng/ml = µg/l 1.25 0.938 1.56 Abbott Architect
ng/ml = µg/l 1.63 1.22 2.04 BioMerieux Vidas
ng/ml = µg/l 1.73 1.30 2.16 bioMerieux VIDAS TPSA
ng/ml = µg/l 1.47 1.10 1.84 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 0.823 0.617 1.03 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 0.951 0.713 1.19 Siemens Immulite 1000 3rd generation
ng/ml = µg/l 0.948 0.711 1.19 Siemens Immulite 1000 1st generation
ng/ml = µg/l 1.86 1.40 2.33 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 1.58 1.19 1.98 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 1.77 1.33 2.21 Roche Elecsys
ng/ml = µg/l 0.925 0.694 1.16 Diasorin Liaison
ng/ml = µg/l 1.74 1.31 2.18 Roche Modular E170
ng/ml = µg/l 1.87 1.40 2.34 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.87 1.40 2.34 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 1.12 0.840 1.40 Tosoh Series
ng/ml = µg/l 1.62 1.22 2.03 Vitros ECi
ng/ml = µg/l 2.20 1.65 2.75 CIS RIA Coated tube
ng/ml = µg/l 1.76 1.32 2.20 Roche Cobas E411
ng/ml = µg/l 1.80 1.35 2.25 Roche Cobas 6000/8000
ng/ml = µg/l 1.84 1.38 2.30 SNIBE Maglumi Analysers
ng/ml = µg/l 1.18 0.885 1.48 Fujirebio Lumipulse G Series
ng/ml = µg/l 1.69 1.27 2.11 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 1.38 1.04 1.72 Siemens Centaur CP
ng/ml = µg/l 1.50 1.13 1.88 Siemens Atellica IM

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Salicylic Acid mmol/l 0.286 0.230 0.340 Gravimetric
mg/dl 3.95 3.18 4.70
SHBG nmol/l 11.5 9.20 13.8 Siemens Centaur XP/XPT/Classic
nmol/l 11.0 8.80 13.2 Siemens Immulite 2000/2500
nmol/l 12.9 10.3 15.5 Roche Elecsys
nmol/l 10.7 8.56 12.8 Abbott Architect
nmol/l 12.5 10.0 15.0 Roche Cobas E411
nmol/l 11.9 9.52 14.3 Roche Cobas 6000/8000
nmol/l 10.8 8.64 13.0 Beckman DxI800
T Uptake %U 33.8 27.7 39.9 Siemens Immulite 2000
Testosterone nmol/l 2.04 1.63 2.45 Abbott Architect
ng/ml 0.588 0.469 0.707
ng/dl 58.8 46.9 70.7
nmol/l 0.990 0.792 1.19 BioMerieux Vidas
ng/ml 0.285 0.228 0.342
ng/dl 28.5 22.8 34.2
nmol/l 1.62 1.05 2.19 Siemens Centaur XP/XPT/Classic
ng/ml 0.467 0.304 0.630
ng/dl 46.7 30.4 63.0
nmol/l 1.31 1.05 1.57 Siemens Immulite 1000
ng/ml 0.377 0.302 0.452
ng/dl 37.7 30.2 45.2
nmol/l 1.46 1.17 1.75 Beckman DxI800
ng/ml 0.420 0.337 0.503
ng/dl 42.0 33.7 50.3
nmol/l 1.62 1.30 1.94 Beckman Access
ng/ml 0.467 0.374 0.560
ng/dl 46.7 37.4 56.0
nmol/l 1.16 0.928 1.39 Tosoh Series
ng/ml 0.334 0.267 0.401
ng/dl 33.4 26.7 40.1
nmol/l 0.866 0.693 1.04 Vitros ECi
ng/ml 0.249 0.200 0.298
ng/dl 24.9 20.0 29.8
nmol/l 1.76 1.41 2.11 Roche Cobas 6000 Test 2
ng/ml 0.507 0.406 0.608
ng/dl 50.7 40.6 60.8
nmol/l 1.76 1.41 2.11 Roche Elecsys Test II
ng/ml 0.507 0.406 0.608
ng/dl 50.7 40.6 60.8
nmol/l 1.75 1.40 2.10 Roche Modular E170 Test II
ng/ml 0.504 0.403 0.605
ng/dl 50.4 40.3 60.5
nmol/l 1.86 1.49 2.23 Roche Cobas 4000/e411 Test II
ng/ml 0.536 0.429 0.643
ng/dl 53.6 42.9 64.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 0.557 0.446 0.668 SNIBE Maglumi Analysers
ng/ml 0.160 0.128 0.192
ng/dl 16.0 12.8 19.2
nmol/l 2.02 1.62 2.42 Abbott Architect 2nd Generation
ng/ml 0.582 0.467 0.697
ng/dl 58.2 46.7 69.7
nmol/l 1.65 1.07 2.23 Siemens Centaur CP
ng/ml 0.475 0.309 0.641
ng/dl 47.5 30.9 64.1
nmol/l 1.00 0.800 1.20 BioMerieux Vidas Testosterone II
ng/ml 0.288 0.230 0.346
ng/dl 28.8 23.0 34.6
nmol/l 1.60 0.960 2.24 Siemens Centaur TST II
ng/ml 0.461 0.277 0.645
ng/dl 46.1 27.7 64.5
Theophylline µmol/l 28.9 23.1 34.7 Roche Integra
µg/ml 5.21 4.16 6.26
µmol/l 23.7 19.0 28.4 Abbott Architect
µg/ml 4.27 3.42 5.12
µmol/l 27.0 21.6 32.4 Roche Cobas 6000/8000
µg/ml 4.87 3.89 5.85
µmol/l 25.0 20.0 30.0 Beckman DxC
µg/ml 4.51 3.60 5.42
µmol/l 28.3 22.6 34.0 Gravimetric
µg/ml 5.10 4.07 6.13
Thyroglobulin ng/ml 2.97 2.23 3.71 Roche Elecsys
ng/ml 2.11 1.58 2.64 Beckman DxI800
ng/ml 3.14 2.36 3.93 Roche Cobas E411
ng/ml 3.07 2.30 3.84 Roche Cobas 6000/8000
ng/ml 2.21 1.66 2.76 Beckman Access
ng/ml 3.15 2.36 3.94 Tosoh Series
ng/ml 3.09 2.32 3.86 Roche Cobas 6000 TGII
ng/ml 3.30 2.48 4.13 Roche Elecsys TGII
ng/ml 3.09 2.32 3.86 Roche Cobas 4000/E411 TGII
Thyroid Stimulating µU/ml = mlU/l 0.112 0.090 0.134 Abbott Architect
Hormone
µU/ml = mlU/l 0.081 0.065 0.097 bioMerieux VIDAS TSH
µU/ml = mlU/l 0.126 0.086 0.166 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 0.116 0.079 0.153 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 0.128 0.102 0.154 Siemens Immulite 2000/2500
µU/ml = mlU/l 0.155 0.124 0.186 Siemens Immulite 1000
µU/ml = mlU/l 0.103 0.082 0.124 Beckman DxI800 Fast TSH
µU/ml = mlU/l 0.104 0.083 0.125 Beckman DxI800
µU/ml = mlU/l 0.151 0.121 0.181 Roche Elecsys
µU/ml = mlU/l 0.146 0.117 0.175 Diasorin Liaison
µU/ml = mlU/l 0.108 0.086 0.130 Beckman Access Fast TSH
µU/ml = mlU/l 0.106 0.085 0.127 Beckman Access hyperTSH 3rd Generation

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 0.143 0.114 0.172 Tosoh Series
Hormone
µU/ml = mlU/l 0.254 0.203 0.305 Vitros ECi
µU/ml = mlU/l 0.149 0.119 0.179 Roche Cobas E411
µU/ml = mlU/l 0.155 0.124 0.186 Roche Cobas 6000/8000
µU/ml = mlU/l 0.103 0.082 0.124 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 0.165 0.132 0.198 SNIBE Maglumi Analysers
µU/ml = mlU/l 0.127 0.086 0.168 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 0.131 0.089 0.173 Siemens Centaur CP
µU/ml = mlU/l 0.131 0.089 0.173 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 0.104 0.083 0.125 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 0.118 0.090 0.140 Siemens Atellica IM
Tobramycin µmol/l 4.17 3.34 5.00 Gravimetric
µg/ml 1.95 1.56 2.34
Total Beta hCG mU/ml=IU/l 14.4 11.5 17.3 Abbott Architect
IU/ml 0.014 0.012 0.016
mU/ml=IU/l 20.5 16.4 24.6 BioMerieux Vidas
IU/ml 0.021 0.016 0.026
mU/ml=IU/l 19.1 11.5 26.7 Siemens Centaur XP/XPT/Classic
IU/ml 0.019 0.011 0.027
mU/ml=IU/l 22.4 17.9 26.9 Siemens Dimension
IU/ml 0.022 0.018 0.026
mU/ml=IU/l 26.9 21.5 32.3 Siemens Immulite 2000
IU/ml 0.027 0.022 0.032
mU/ml=IU/l 27.4 21.9 32.9 Siemens Immulite 1000
IU/ml 0.027 0.022 0.032
mU/ml=IU/l 16.0 12.8 19.2 Beckman DxI800
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 13.8 11.0 16.6 Diasorin Liaison
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 15.2 12.2 18.2 Roche Cobas Core EIA
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 15.6 12.5 18.7 Beckman Access
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 21.1 16.9 25.3 Tosoh Series
IU/ml 0.021 0.017 0.025
mU/ml=IU/l 22.9 18.3 27.5 Vitros ECi
IU/ml 0.023 0.018 0.028
mU/ml=IU/l 12.3 9.84 14.8 Roche STAT (Intact)
IU/ml 0.012 0.010 0.014
mU/ml=IU/l 14.6 11.7 17.5 Roche hCG+Beta
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 14.3 11.4 17.2 SNIBE Maglumi Analysers
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 14.2 11.4 17.0 Radiometer AQT90 Flex
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 15.9 12.7 19.1 Beckman Access Total BhCG (5th IS)
IU/ml 0.016 0.013 0.019

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 16.4 13.1 19.7 Beckman DxI Total BhCG (5th IS)
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 16.9 10.1 23.7 Siemens Centaur CP
IU/ml 0.017 0.010 0.024
mU/ml=IU/l 16.8 13.4 20.1 Siemens Atellica IM
IU/ml 0.020 0.010 0.020
Total T3 nmol/l 0.783 0.587 0.979 Abbott Architect
ng/ml 0.510 0.382 0.638
ng/dl 51.0 38.2 63.8
nmol/l 0.637 0.478 0.796 BioMerieux Vidas
ng/ml 0.415 0.311 0.519
ng/dl 41.5 31.1 51.9
nmol/l 0.662 0.497 0.827 Siemens Centaur XP/XPT/Classic
ng/ml 0.431 0.323 0.539
ng/dl 43.1 32.3 53.9
nmol/l 0.617 0.463 0.771 Siemens Immulite 2000/2500
ng/ml 0.402 0.301 0.503
ng/dl 40.2 30.1 50.3
nmol/l 0.617 0.463 0.771 Siemens Immulite 1000
ng/ml 0.402 0.301 0.503
ng/dl 40.2 30.1 50.3
nmol/l 0.914 0.686 1.14 Beckman DxI800
ng/ml 0.595 0.447 0.743
ng/dl 59.5 44.7 74.3
nmol/l 1.31 0.983 1.64 Roche Elecsys
ng/ml 0.853 0.640 1.07
ng/dl 85.3 64.0 107
nmol/l 1.06 0.795 1.33 Diasorin Liaison
ng/ml 0.690 0.518 0.862
ng/dl 69.0 51.8 86.2
nmol/l 0.920 0.690 1.15 Beckman Access
ng/ml 0.599 0.449 0.749
ng/dl 59.9 44.9 74.9
nmol/l 0.630 0.473 0.788 Tosoh Series
ng/ml 0.410 0.308 0.512
ng/dl 41.0 30.8 51.2
nmol/l 0.886 0.665 1.11 Vitros ECi
ng/ml 0.577 0.433 0.721
ng/dl 57.7 43.3 72.1
nmol/l 0.592 0.444 0.740 CIS RIA Coated tube
ng/ml 0.385 0.289 0.481
ng/dl 38.5 28.9 48.1
nmol/l 1.42 1.07 1.78 Roche Cobas E411
ng/ml 0.924 0.697 1.15
ng/dl 92.4 69.7 115

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 1.23 0.923 1.54 Roche Cobas 6000/8000
ng/ml 0.801 0.601 1.00
ng/dl 80.1 60.1 100
nmol/l 0.494 0.371 0.618 SNIBE Maglumi Analysers
ng/ml 0.322 0.242 0.402
ng/dl 32.2 24.2 40.2
Total T4 nmol/l 32.9 24.7 41.1 Abbott Architect
µg/dl 2.57 1.93 3.21
ng/ml 25.7 19.3 32.1
nmol/l 29.6 22.2 37.0 BioMerieux Vidas
µg/dl 2.31 1.73 2.89
ng/ml 23.1 17.3 28.9
nmol/l 20.8 14.6 27.0 Siemens Centaur XP/XPT/Classic
µg/dl 1.62 1.13 2.11
ng/ml 16.2 11.3 21.1
nmol/l 21.9 16.4 27.4 Siemens Immulite 2000/2500
µg/dl 1.71 1.28 2.14
ng/ml 17.1 12.8 21.4
nmol/l 20.9 15.7 26.1 Beckman DxI800
µg/dl 1.63 1.22 2.04
ng/ml 16.3 12.2 20.4
nmol/l 35.3 26.5 44.1 Roche Elecsys
µg/dl 2.75 2.07 3.43
ng/ml 27.5 20.7 34.3
nmol/l 24.2 18.2 30.3 Beckman Access
µg/dl 1.89 1.42 2.36
ng/ml 18.9 14.2 23.6
nmol/l 23.8 17.9 29.8 Tosoh Series
µg/dl 1.86 1.40 2.32
ng/ml 18.6 14.0 23.2
nmol/l 27.0 20.3 33.8 Vitros ECi
µg/dl 2.11 1.58 2.64
ng/ml 21.1 15.8 26.4
nmol/l 26.8 20.1 33.5 CIS RIA Coated tube
µg/dl 2.09 1.57 2.61
ng/ml 20.9 15.7 26.1
nmol/l 36.2 27.2 45.3 Roche Cobas E411
µg/dl 2.82 2.12 3.52
ng/ml 28.2 21.2 35.2
nmol/l 33.4 25.1 41.8 Roche Cobas 6000/8000
µg/dl 2.61 1.96 3.26
ng/ml 26.1 19.6 32.6
nmol/l 27.4 20.6 34.3 Immunotech IRMA
µg/dl 2.14 1.61 2.67
ng/ml 21.4 16.1 26.7
nmol/l 30.9 23.2 38.6 ELISA
µg/dl 2.41 1.81 3.01
ng/ml 24.1 18.1 30.1

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 30.2 22.7 37.8 SNIBE Maglumi Analysers
µg/dl 2.36 1.77 2.95
ng/ml 23.6 17.7 29.5
nmol/l 23.0 16.1 29.9 Siemens Centaur CP
µg/dl 1.79 1.25 2.33
ng/ml 17.9 12.5 23.3
Valproic Acid µmol/l 195 156 234 Abbott Architect
µg/ml 28.1 22.5 33.7
µmol/l 228 160 296 Siemens Centaur XP/XPT/Classic
µg/ml 32.9 23.0 42.8
µmol/l 201 161 241 Siemens Dimension
µg/ml 29.0 23.2 34.8
µmol/l 191 153 229 Siemens Immulite 2000/2500
µg/ml 27.6 22.1 33.1
µmol/l 199 159 239 Siemens Immulite 1000
µg/ml 28.7 22.9 34.5
µmol/l 200 160 240 Roche Integra
µg/ml 28.9 23.1 34.7
µmol/l 203 162 244 Roche Cobas 6000/8000
µg/ml 29.3 23.4 35.2
µmol/l 166 133 199 Beckman DxC
µg/ml 24.0 19.2 28.8
µmol/l 195 156 234 Beckman AU400/600/640/2700/5400
µg/ml 28.1 22.5 33.7
µmol/l 243 194 291 Gravimetric
µg/ml 35.0 28.0 42.0
Vancomycin µmol/l 4.04 3.23 4.85 Roche Integra
µg/ml 6.00 4.80 7.20
µmol/l 3.41 2.73 4.09 Ortho Vitros Microslide Systems
µg/ml 5.07 4.06 6.08
µmol/l 3.27 2.62 3.92 Abbott Architect
µg/ml 4.86 3.89 5.83
µmol/l 3.04 2.43 3.65 Siemens Dimension
µg/ml 4.52 3.61 5.43
µmol/l 3.39 2.71 4.07 Roche Cobas 6000/8000
µg/ml 5.04 4.03 6.05
µmol/l 3.16 2.53 3.79 Thermo Scientific QMS Vancomycin
µg/ml 4.69 3.76 5.62
µmol/l 3.43 2.74 4.12 Gravimetric
µg/ml 5.10 4.07 6.12
Vitamin B12 pmol/l 147 118 176 Abbott Architect
pg/ml 199 160 238
pmol/l 129 90.3 168 Siemens Centaur XP/XPT/Classic
pg/ml 175 123 227

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 1862EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 114 91.2 137 Siemens Immulite 2000
pg/ml 154 124 184
pmol/l 95.7 76.6 115 Beckman DxI800
pg/ml 130 104 156
pmol/l 166 133 199 Roche Elecsys
pg/ml 225 180 270
pmol/l 93.9 75.1 113 Beckman Access
pg/ml 127 102 152
pmol/l 147 118 176 Tosoh Series
pg/ml 199 160 238
pmol/l 149 119 179 Vitros ECi
pg/ml 202 161 243
pmol/l 114 91.2 137 MP Biomedicals RIA
pg/ml 154 124 184
pmol/l 181 145 217 Roche Cobas E411
pg/ml 245 196 294
pmol/l 137 110 164 Roche Cobas 6000/8000
pg/ml 186 149 223
pmol/l 132 92.4 172 Siemens Centaur CP
pg/ml 179 125 233

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 23
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
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. 1877EC EXPIRY: 2021-11-28

INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS


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

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

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

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


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

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

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

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

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

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

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

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

29 May ’19 ne

PAGE 1 OF 15
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 15.1 11.3 18.9 DIAsource ELISA
ng/ml 5.00 3.74 6.26
25-OH Vitamin D nmol/l 79.1 59.3 98.9 Siemens Centaur XP/XPT/Classic
nmol/l 45.0 33.8 56.3 Roche Vitamin D Total
nmol/l 47.1 35.3 58.9 Abbott Architect
nmol/l 73.2 54.9 91.5 Vitros ECi
nmol/l 57.5 43.1 71.9 BioMerieux Vidas
nmol/l 45.8 34.4 57.3 Beckman DxI 600/800
nmol/l 49.8 37.4 62.3 Roche Vitamin D Total II
nmol/l 61.9 46.4 77.4 Diasorin Liaison XL
ACTH pmol/l 4.86 3.65 6.08 Siemens Immulite 2000/2500
pg/ml 22.1 16.6 27.6
pmol/l 2.44 1.83 3.05 Roche Cobas E411
pg/ml 11.1 8.32 13.9
pmol/l 2.18 1.64 2.73 Roche Cobas 6000/8000
pg/ml 9.91 7.45 12.4
pmol/l 4.84 3.63 6.05 Siemens Immulite 1000
pg/ml 22.0 16.5 27.5
Aldosterone pmol/l 339 254 424 Diasorin Liaison XL
pg/ml 122 91.6 153
Alpha-fetoprotein KIU/l = lU/ml 47.3 37.8 56.8 BioMerieux Vidas
ng/ml 57.2 45.7 68.7
KIU/l = lU/ml 42.6 34.1 51.1 Beckman Access
ng/ml 51.5 41.3 61.7
KIU/l = lU/ml 49.0 39.2 58.8 Vitros ECi
ng/ml 51.0 40.8 61.2
KIU/l = lU/ml 52.2 41.2 63.2 Siemens Centaur XP/XPT/Classic
ng/ml 63.2 49.9 76.5
KIU/l = lU/ml 46.6 37.3 55.9 Siemens Immulite 2000/2500
ng/ml 56.4 45.1 67.7
KIU/l = lU/ml 45.2 36.2 54.2 Abbott Architect
ng/ml 54.7 43.8 65.6
KIU/l = lU/ml 41.2 33.0 49.4 Beckman DxI800
ng/ml 49.9 39.9 59.9
KIU/l = lU/ml 50.7 40.6 60.8 Roche Cobas 6000/8000
ng/ml 61.3 49.1 73.5
KIU/l = lU/ml 51.6 41.3 61.9 Roche Cobas E411
ng/ml 62.4 50.0 74.8
KIU/l = lU/ml 50.7 40.5 60.8 Siemens Atellica IM
ng/ml 61.3 49.0 73.6
Amikacin µmol/l 15.3 12.2 18.3 Gravimetric
µg/ml 8.93 7.14 10.7

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Androstenedione nmol/l 15.3 11.5 19.1 Siemens Immulite 2000
ng/ml 4.39 3.30 5.48
Beta-2-microglobulin µg/ml = mg/l 3.29 2.63 3.95 Siemens Immulite 1000
µg/ml = mg/l 2.92 2.34 3.50 Siemens Immulite 2000/2500
µg/ml = mg/l 3.28 2.62 3.94 Abbott Architect
µg/ml = mg/l 3.33 2.66 4.00 Roche Cobas 6000/8000
C-Peptide nmol/l 2.070 1.550 2.590 Siemens Immulite 2000/2500
ng/ml 6.25 4.68 7.82
nmol/l 2.050 1.540 2.560 Roche Cobas 6000/8000
ng/ml 6.19 4.65 7.73
nmol/l 2.020 1.520 2.530 Roche Cobas E411
ng/ml 6.10 4.59 7.61
nmol/l 2.140 1.605 2.675 Diasorin Liaison XL
ng/ml 6.46 4.85 8.08
CA 15-3 U/ml 44.0 29.9 58.1 Siemens Centaur XP/XPT/Classic
U/ml 47.9 38.3 57.5 Abbott Architect
U/ml 45.9 36.7 55.1 Siemens Immulite 2000/2500
U/ml 38.6 30.9 46.3 Vitros ECi
U/ml 18.6 14.9 22.3 Beckman DxI800
U/ml 42.0 33.6 50.4 Roche Cobas 6000/8000
U/ml 42.1 33.7 50.5 Roche Cobas E411
U/ml 46.2 37.0 55.5 Siemens Atellica IM
CA 19-9 U/ml 178 142 214 BioMerieux Vidas
U/ml 270 184 356 Siemens Centaur XP/XPT/Classic
U/ml 100 80.0 120 Siemens Immulite 2000/2500
U/ml 165 132 198 Vitros ECi
U/ml 114 91.2 137 Beckman Access
U/ml 96.9 77.5 116 Beckman DxI800
U/ml 773 618 928 Abbott Architect XR/XR2 kit
U/ml 61.7 49.4 74.0 Roche Cobas 6000/8000
U/ml 63.6 50.9 76.3 Roche Cobas E411
U/ml 241 193 289 Siemens Atellica IM
CA125 U/ml 95.9 76.7 115 BioMerieux Vidas
U/ml 94.4 75.5 113 Siemens Immulite 2000/2500
U/ml 90.8 72.6 109 Vitros ECi
U/ml 129 103 155 Abbott Architect
U/ml 98.6 67.0 130 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 79.6 63.7 95.5 Beckman Access
U/ml 81.4 65.1 97.7 Beckman DxI800
U/ml 99.4 79.5 119 Roche Cobas E411
U/ml 96.4 77.1 116 Roche Cobas 6000/8000
U/ml 117 93.6 140 Siemens Atellica IM
Carbamazepine µmol/l 40.7 28.5 52.9 Siemens Centaur XP/XPT/Classic
µg/ml 9.62 6.73 12.5
µmol/l 37.1 29.7 44.5 Abbott Architect
µg/ml 8.77 7.02 10.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Carbamazepine µmol/l 36.4 29.1 43.7 Roche Cobas 6000/8000
µg/ml 8.60 6.88 10.3
µmol/l 38.5 30.8 46.2 Gravimetric
µg/ml 9.10 7.28 10.9
Carcinoembryonic ng/ml = µg/l 23.7 19.0 28.4 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 30.7 24.6 36.8 Siemens Immulite 1000
ng/ml = µg/l 24.1 19.3 28.9 Vitros ECi
ng/ml = µg/l 22.8 18.2 27.4 Beckman Access
ng/ml = µg/l 25.5 17.3 33.7 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 28.3 22.6 34.0 Siemens Immulite 2000/2500
ng/ml = µg/l 26.6 21.3 31.9 Abbott Architect
ng/ml = µg/l 21.6 17.3 25.9 Beckman DxI800
ng/ml = µg/l 20.5 16.4 24.6 Roche Cobas 6000/8000
ng/ml = µg/l 20.7 16.6 24.8 Roche Cobas E411
ng/ml = µg/l 26.0 20.8 31.2 SNIBE Maglumi Analysers
ng/ml = µg/l 23.8 19.0 28.5 Siemens Atellica IM
Cortisol nmol/l 655 491 819 Siemens Immulite 1000
µg/dl 23.6 17.7 29.5
nmol/l 767 575 959 Roche Elecsys
µg/dl 27.6 20.7 34.5
nmol/l 718 495 941 Siemens Centaur XP/XPT/Classic
µg/dl 25.8 17.8 33.8
nmol/l 626 470 783 Siemens Immulite 2000/2500
µg/dl 22.5 16.9 28.1
nmol/l 584 438 730 Vitros ECi
µg/dl 21.0 15.8 26.2
nmol/l 553 415 691 Abbott Architect
µg/dl 19.9 14.9 24.9
nmol/l 600 450 750 Beckman DxI800
µg/dl 21.6 16.2 27.0
nmol/l 761 571 951 Roche Cobas 6000/8000
µg/dl 27.4 20.6 34.2
nmol/l 700 525 875 Roche Cobas E411
µg/dl 25.2 18.9 31.5
nmol/l 651 488 814 Roche Cobas 4000/e411 Gen II
µg/dl 23.4 17.6 29.2
nmol/l 602 452 753 Roche Cobas 6000/8000 Gen II
µg/dl 21.7 16.3 27.1
nmol/l 753 565 941 Siemens Atellica IM
µg/dl 27.1 20.3 33.9
DHEA-S µmol/l 11.2 8.96 13.4 Siemens Immulite 2000/2500
µmol/l 12.1 9.68 14.5 Abbott Architect
µmol/l 10.3 8.24 12.4 Beckman DxI800
µmol/l 11.1 7.22 15.0 Siemens Centaur XP/XPT/Classic
µmol/l 15.2 12.2 18.2 Roche Cobas E411
µmol/l 14.9 11.9 17.9 Roche Cobas 6000/8000

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
DHEA-S µmol/l 11.4 9.14 13.7 Siemens Atellica IM
Digoxin nmol/l 3.19 2.55 3.83 Siemens Immulite 2000/2500
ng/ml 2.49 1.99 2.99
nmol/l 3.22 2.48 3.96 Siemens Centaur XP/XPT/Classic
ng/ml 2.51 1.93 3.09
nmol/l 2.51 2.01 3.01 Abbott Architect
ng/ml 1.96 1.57 2.35
nmol/l 2.98 2.38 3.58 Beckman DxI800
ng/ml 2.33 1.86 2.80
nmol/l 3.07 2.46 3.68 Gravimetric
ng/ml 2.40 1.92 2.87
Ethosuximide µmol/l 360 288 431 Gravimetric
µg/ml 51.0 40.8 61.1
Ferritin ng/ml = µg/l 72.7 58.2 87.2 BioMerieux Vidas
ng/ml = µg/l 76.8 61.4 92.2 Siemens Immulite 1000
ng/ml = µg/l 109 87.2 131 Roche Elecsys
ng/ml = µg/l 68.5 54.8 82.2 Beckman Access
ng/ml = µg/l 62.9 50.3 75.5 Vitros ECi
ng/ml = µg/l 87.9 65.9 110 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 85.8 68.6 103 Siemens Immulite 2000/2500
ng/ml = µg/l 107 85.6 128 Abbott Architect
ng/ml = µg/l 104 83.2 125 Roche Modular E170
ng/ml = µg/l 67.7 54.2 81.2 Beckman DxI800
ng/ml = µg/l 88.0 70.4 106 Siemens Atellica IM
Folate nmol/l 13.7 10.4 17.0 Beckman Access
ng/ml 6.04 4.59 7.49
nmol/l 9.99 7.59 12.4 Siemens Immulite 2000
ng/ml 4.41 3.35 5.47
nmol/l 9.69 7.36 12.0 Vitros ECi
ng/ml 4.27 3.25 5.29
nmol/l 12.2 9.27 15.1 Abbott Architect
ng/ml 5.38 4.09 6.67
nmol/l 26.8 17.4 36.2 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 11.8 7.67 15.9
nmol/l 14.0 10.6 17.4 Beckman DxI800
ng/ml 6.17 4.67 7.67
nmol/l 13.0 9.88 16.1 Roche Cobas E411
ng/ml 5.73 4.36 7.10
nmol/l 12.7 9.65 15.7 Roche Cobas 6000/8000 Folate III
ng/ml 5.60 4.26 6.94
nmol/l 24.2 18.4 30.0 Siemens Atellica IM
ng/ml 10.7 8.11 13.2
Free T3 pmol/l 15.0 11.3 18.8 Roche Elecsys
ng/dl 0.975 0.735 1.22
pg/ml 9.77 7.36 12.2
pmol/l 11.0 8.25 13.8 Beckman Access
ng/dl 0.715 0.536 0.894
pg/ml 7.16 5.37 8.95

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 30.7 23.0 38.4 Vitros ECi
ng/dl 2.00 1.50 2.50
pg/ml 20.0 15.0 25.0
pmol/l 13.2 7.92 18.5 Siemens Centaur XP/XPT/Classic
ng/dl 0.858 0.515 1.20
pg/ml 8.59 5.15 12.0
pmol/l 9.32 6.99 11.7 Siemens Immulite 2000/2500
ng/dl 0.606 0.454 0.758
pg/ml 6.07 4.55 7.59
pmol/l 11.2 8.40 14.0 Abbott Architect
ng/dl 0.728 0.546 0.910
pg/ml 7.29 5.47 9.11
pmol/l 9.53 7.15 11.9 Beckman DxI800
ng/dl 0.619 0.465 0.773
pg/ml 6.20 4.65 7.75
pmol/l 14.9 11.2 18.6 Roche Cobas E411
ng/dl 0.969 0.728 1.21
pg/ml 9.70 7.29 12.1
pmol/l 15.0 11.3 18.8 Roche Cobas 6000/8000
ng/dl 0.975 0.735 1.22
pg/ml 9.77 7.36 12.2
pmol/l 12.3 9.23 15.4 SNIBE Maglumi Analysers
ng/dl 0.800 0.600 1.00
pg/ml 8.01 6.01 10.0
pmol/l 12.7 7.62 17.8 Siemens Centaur CP
ng/dl 0.826 0.496 1.16
pg/ml 8.27 4.96 11.6
pmol/l 13.4 10.0 16.7 Siemens Atellica IM
ng/dl 0.870 0.650 1.09
pg/ml 8.71 6.51 10.9
Free T4 pmol/l 45.9 34.4 57.4 Siemens Immulite 1000
ng/dl 3.58 2.68 4.48
pg/ml 35.8 26.8 44.8
pmol/l 43.0 32.3 53.8 Roche Elecsys
ng/dl 3.35 2.52 4.18
pg/ml 33.5 25.2 41.8
pmol/l 33.6 25.2 42.0 Beckman Access
ng/dl 2.62 1.97 3.27
pg/ml 26.2 19.7 32.7
pmol/l 78.0 58.5 97.5 Vitros ECi
ng/dl 6.08 4.56 7.60
pg/ml 60.8 45.6 76.0
pmol/l 30.2 22.7 37.8 Siemens Centaur XP/XPT/Classic
ng/dl 2.36 1.77 2.95
pg/ml 23.6 17.7 29.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 42.9 32.2 53.6 Siemens Immulite 2000/2500
ng/dl 3.35 2.51 4.19
pg/ml 33.5 25.1 41.9
pmol/l 29.7 22.3 37.1 Abbott Architect
ng/dl 2.32 1.74 2.90
pg/ml 23.2 17.4 29.0
pmol/l 34.5 25.9 43.1 Beckman DxI800
ng/dl 2.69 2.02 3.36
pg/ml 26.9 20.2 33.6
pmol/l 39.8 29.9 49.8 Roche Cobas 6000/8000
ng/dl 3.10 2.33 3.87
pg/ml 31.0 23.3 38.7
pmol/l 40.6 30.5 50.8 Roche Cobas E411
ng/dl 3.17 2.38 3.96
pg/ml 31.7 23.8 39.6
pmol/l 45.4 34.1 56.8 Biomerieux Vidas FT4N Kit
ng/dl 3.54 2.66 4.42
pg/ml 35.4 26.6 44.2
pmol/l 32.3 24.2 40.4 Siemens Centaur CP
ng/dl 2.52 1.89 3.15
pg/ml 25.2 18.9 31.5
pmol/l 32.5 24.4 40.6 Siemens Atellica IM
ng/dl 2.54 1.90 3.17
pg/ml 25.4 19.0 31.7
FSH mU/ml 29.8 23.8 35.8 BioMerieux Vidas
mU/ml 28.7 23.0 34.4 Beckman Access
mU/ml 25.7 20.6 30.8 Roche/BM Elecsys
mU/ml 21.1 16.9 25.3 Vitros ECi
mU/ml 35.6 26.7 44.5 Siemens Centaur XP/XPT/Classic
mU/ml 27.9 22.3 33.5 Siemens Immulite 2000/2500
mU/ml 24.1 19.3 28.9 Abbott Architect
mU/ml 29.7 23.8 35.6 Beckman DxI800
mU/ml 27.7 22.2 33.2 Roche Cobas E411
mU/ml 26.1 20.9 31.3 Roche Cobas 6000/8000
mU/ml 37.0 29.6 44.4 Siemens Atellica IM
Gentamicin µmol/l 8.16 6.53 9.79 Gravimetric
µg/ml 3.90 3.12 4.68
Growth Hormone (GH) µU/ml 18.4 14.7 22.1 Siemens Immulite 1000
ng/ml 6.13 4.90 7.36
µU/ml 19.3 15.4 23.2 Siemens Immulite 2000/2500
ng/ml 6.43 5.13 7.73
µU/ml 14.6 11.7 17.5 Beckman DxI800
ng/ml 4.86 3.90 5.82
µU/ml 16.8 13.4 20.2 Roche Cobas 6000/8000
ng/ml 5.59 4.46 6.72

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Immunoglobulin E KIU/l = IU/ml 108 86.4 130 Siemens Immulite 1000
KIU/l = IU/ml 98.9 79.1 119 BioMerieux Vidas
KIU/l = IU/ml 101 60.6 141 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 102 81.6 122 Siemens Immulite 2000/2500
KIU/l = IU/ml 101 80.8 121 Abbott Architect
KIU/l = IU/ml 112 89.6 134 Roche Cobas E411
KIU/l = IU/ml 112 89.6 134 Roche Cobas 6000/8000
KIU/l = IU/ml 103 82.0 123 Siemens Atellica IM
Insulin mU/l 18.2 13.7 22.7 Siemens Centaur XP/XPT/Classic
µU/ml 18.2 13.7 22.7
mU/l 15.3 11.5 19.1 Abbott Architect
µU/ml 15.3 11.5 19.1
mU/l 16.3 12.2 20.4 Roche Cobas E411
µU/ml 16.3 12.2 20.4
mU/l 16.6 12.5 20.8 Roche Cobas 6000/8000
µU/ml 16.6 12.5 20.7
mU/l 14.5 10.9 18.1 Beckman DxI 600/800
µU/ml 14.5 10.9 18.1
mU/l 18.5 13.8 23.1 Siemens Atellica IM
µU/ml 18.5 13.8 23.1
Luteinising Hormone mU/ml 23.7 19.0 28.4 Beckman Access
(LH)
mU/ml 29.6 23.7 35.5 BioMerieux Vidas
mU/ml 50.0 40.0 60.0 Siemens Immulite 1000
mU/ml 33.0 26.4 39.6 Roche Elecsys
mU/ml 47.0 37.6 56.4 Vitros ECi
mU/ml 33.8 26.0 41.6 Siemens Centaur XP/XPT/Classic
mU/ml 49.0 39.2 58.8 Siemens Immulite 2000
mU/ml 28.0 22.4 33.6 Abbott Architect
mU/ml 23.9 19.1 28.7 Beckman DxI800
mU/ml 36.0 28.8 43.2 Roche Cobas E411
mU/ml 36.4 29.1 43.7 Roche Cobas 6000/8000
mU/ml 39.5 31.6 47.4 Diasorin Liaison XL
mU/ml 34.8 27.9 41.8 Siemens Atellica IM
Oestradiol pmol/l 1361 1089 1633 BioMerieux Vidas
pg/ml 370 296 444
pmol/l 917 734 1100 Roche Elecsys (Estradiol II)
pg/ml 249 200 298
pmol/l 1207 966 1448 Vitros ECi
pg/ml 328 263 393
pmol/l 1241 993 1489 Beckman Access
pg/ml 338 270 406
pmol/l 1283 770 1796 Siemens Centaur XP/XPT/Classic
pg/ml 349 209 489
pmol/l 1159 927 1391 Siemens Immulite 2000/2500
pg/ml 315 252 378
pmol/l 837 670 1004 Abbott Architect
pg/ml 228 182 274

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 1214 971 1457 Beckman DxI800
pg/ml 330 264 396
pmol/l 948 758 1138 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 258 206 310
pmol/l 952 762 1142 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 259 207 311
pmol/l 1234 740 1728 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 336 202 470
pmol/l 925 740 1110 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 252 201 303
pmol/l 934 747 1121 Roche Elecsys (Estradiol III)
pg/ml 254 203 305
pmol/l 923 738 1108 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 251 201 301
pmol/l 1244 996 1493 Siemens Atellica IM
pg/ml 338 271 406
Paracetamol mmol/l 0.319 0.255 0.383 Roche Cobas 6000/8000
mg/l 48.3 38.6 58.0
mmol/l 0.348 0.280 0.420 Gravimetric
mg/l 52.6 42.4 63.5
Phenobarbital µmol/l 78.4 62.7 94.1 Abbott Architect
µg/ml 18.2 14.5 21.9
µmol/l 75.9 60.7 91.1 Siemens Immulite 2000/2500
µg/ml 17.6 14.1 21.1
µmol/l 76.7 61.4 92.0 Beckman AU400/600/640/2700/5400
µg/ml 17.8 14.2 21.4
µmol/l 77.6 62.1 93.1 Gravimetric
µg/ml 18.0 14.4 21.6
Phenytoin µmol/l 66.5 53.2 79.8 Abbott Architect
µg/ml 16.8 13.4 20.2
µmol/l 65.0 52.0 78.0 Roche Cobas 6000/8000
µg/ml 16.4 13.1 19.7
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 4.92 3.93 5.89
Progesterone nmol/l 24.9 19.9 29.9 Siemens Immulite 1000
ng/ml 7.79 6.23 9.35
nmol/l 43.2 34.6 51.8 BioMerieux Vidas
ng/ml 13.5 10.8 16.2
nmol/l 38.0 30.4 45.6 Vitros ECi
ng/ml 11.9 9.52 14.3
nmol/l 24.9 17.4 32.4 Siemens Centaur XP/XPT/Classic
ng/ml 7.79 5.45 10.1
nmol/l 24.1 19.3 28.9 Siemens Immulite 2000/2500
ng/ml 7.54 6.04 9.04

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 26.1 20.9 31.3 Abbott Architect
ng/ml 8.17 6.54 9.80
nmol/l 34.8 27.8 41.8 Beckman DxI Prog Cal 33555
ng/ml 10.9 8.70 13.1
nmol/l 33.9 27.1 40.7 Roche Cobas 4000/e411 (Prog. II)
ng/ml 10.6 8.48 12.7
nmol/l 33.9 27.1 40.7 Roche Cobas 6000/8000 (Prog. II)
ng/ml 10.6 8.48 12.7
nmol/l 26.7 21.4 32.0 Beckman DxI Prog DE Cal A80773
ng/ml 8.36 6.70 10.0
nmol/l 33.5 26.8 40.2 Roche Cobas 6000/8000 (Prog. III)
ng/ml 10.5 8.39 12.6
nmol/l 34.0 27.2 40.8 Roche Cobas 4000/e411 (Prog. III)
ng/ml 10.6 8.51 12.7
nmol/l 27.0 21.6 32.3 Siemens Atellica IM
ng/ml 8.44 6.76 10.1
Prolactin µU/ml 532 426 638 Beckman Access
µU/ml 809 647 971 BioMerieux Vidas
µU/ml 528 422 634 Siemens Immulite 1000
µU/ml 524 419 629 Vitros ECi
µU/ml 531 414 648 Siemens Centaur XP/XPT/Classic
µU/ml 580 464 696 Siemens Immulite 2000/2500
µU/ml 623 498 748 Abbott Architect
µU/ml 492 394 590 Beckman DxI800
µU/ml 601 481 721 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 633 506 760 Roche Cobas E411
µU/ml 596 477 715 Roche Cobas 6000/8000
µU/ml 612 490 734 Abbott Architect restandardised
µU/ml 494 396 593 Siemens Atellica IM
PSA Free ng/ml = µg/l 8.16 6.12 10.2 Siemens Immulite 2000/2500
ng/ml = µg/l 10.2 7.65 12.8 Abbott Architect
ng/ml = µg/l 10.4 7.80 13.0 Beckman Access standardised to Hybritech
ng/ml = µg/l 8.05 6.04 10.1 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 9.52 7.14 11.9 Beckman DXI standardised to Hybritech
ng/ml = µg/l 7.25 5.44 9.06 Roche Cobas E411
ng/ml = µg/l 6.97 5.23 8.71 Roche Cobas 6000/8000
ng/ml = µg/l 8.27 6.20 10.3 Siemens Atellica IM
PSA Total ng/ml = µg/l 6.02 4.52 7.53 Siemens Immulite 1000 1st generation
ng/ml = µg/l 12.7 9.53 15.9 Roche Elecsys
ng/ml = µg/l 14.1 10.6 17.6 Beckman Access standardised to Hybritech
ng/ml = µg/l 10.7 8.03 13.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 11.4 8.55 14.3 bioMerieux VIDAS TPSA
ng/ml = µg/l 5.75 4.31 7.19 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 9.48 7.11 11.9 Abbott Architect
ng/ml = µg/l 11.6 8.70 14.5 Vitros ECi

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
PSA Total ng/ml = µg/l 13.9 10.4 17.4 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 13.9 10.4 17.4 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 11.2 8.40 14.0 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 13.7 10.3 17.1 Roche Cobas E411
ng/ml = µg/l 13.1 9.83 16.4 Roche Cobas 6000/8000
ng/ml = µg/l 12.3 9.23 15.4 SNIBE Maglumi Analysers
ng/ml = µg/l 12.9 9.68 16.1 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 10.3 7.73 12.9 Siemens Centaur CP
ng/ml = µg/l 11.5 8.59 14.3 Siemens Atellica IM
Salicylate mmol/l 1.22 0.980 1.46 Gravimetric
mg/dl 16.8 13.5 20.1
SHBG nmol/l 37.7 30.2 45.2 Siemens Centaur XP/XPT/Classic
nmol/l 34.1 27.3 40.9 Siemens Immulite 2000/2500
nmol/l 33.5 26.8 40.2 Abbott Architect
nmol/l 37.4 29.9 44.9 Roche Cobas E411
nmol/l 36.0 28.8 43.2 Roche Cobas 6000/8000
nmol/l 32.5 26.0 39.0 Beckman DxI800
T Uptake %U 36.9 30.3 43.5 Siemens Immulite 2000
Testosterone nmol/l 21.1 16.9 25.3 Vitros ECi
ng/ml 6.08 4.87 7.29
ng/dl 608 487 729
nmol/l 14.3 10.0 18.6 Siemens Centaur XP/XPT/Classic
ng/ml 4.12 2.88 5.36
ng/dl 412 288 536
nmol/l 17.8 14.2 21.4 Siemens Immulite 2000/2500
ng/ml 5.13 4.09 6.17
ng/dl 513 409 617
nmol/l 15.6 12.5 18.7 Abbott Architect
ng/ml 4.49 3.60 5.38
ng/dl 449 360 538
nmol/l 15.9 12.7 19.1 Beckman Access
ng/ml 4.58 3.66 5.50
ng/dl 458 366 550
nmol/l 14.0 11.2 16.8 Beckman DxI800
ng/ml 4.03 3.23 4.83
ng/dl 403 323 483
nmol/l 17.5 14.0 21.0 Roche Elecsys Test II
ng/ml 5.04 4.03 6.05
ng/dl 504 403 605
nmol/l 17.5 14.0 21.0 Roche Cobas 4000/e411 Test II
ng/ml 5.04 4.03 6.05
ng/dl 504 403 605
nmol/l 17.5 14.0 21.0 Roche Cobas 6000 Test 2
ng/ml 5.04 4.03 6.05
ng/dl 504 403 605
nmol/l 16.1 12.9 19.3 Abbott Architect 2nd Generation
ng/ml 4.64 3.72 5.56
ng/dl 464 372 556

___________________________________________________________________________________________________

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

IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 12.6 10.1 15.1 BioMerieux Vidas Testosterone II
ng/ml 3.63 2.91 4.35
ng/dl 363 291 435
nmol/l 15.7 11.0 20.4 Siemens Centaur TST II
ng/ml 4.52 3.16 5.88
ng/dl 452 316 588
nmol/l 15.2 12.1 18.2 Siemens Atellica IM
ng/ml 4.37 3.48 5.24
ng/dl 437 348 524
Theophylline µmol/l 83.8 67.0 101 Gravimetric
µg/ml 15.1 12.1 18.2
Thyroglobulin ng/ml 16.9 12.7 21.1 Siemens Immulite 2000
ng/ml 34.0 25.5 42.5 Roche Cobas 6000/8000
ng/ml 33.6 25.2 42.0 Roche Cobas 6000 TGII
ng/ml 32.5 24.4 40.6 Roche Cobas 4000/E411 TGII
Thyroid Stimulating µU/ml = mlU/l 2.57 2.06 3.08 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 2.54 2.03 3.05 Siemens Immulite 1000
µU/ml = mlU/l 2.77 2.22 3.32 Roche Elecsys
µU/ml = mlU/l 2.46 1.97 2.95 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 3.14 2.51 3.77 Vitros ECi
µU/ml = mlU/l 2.72 1.85 3.59 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 2.74 2.19 3.29 Siemens Immulite 2000/2500
µU/ml = mlU/l 2.32 1.86 2.78 Abbott Architect
µU/ml = mlU/l 3.19 2.55 3.83 Diasorin Liaison
µU/ml = mlU/l 2.35 1.88 2.82 Beckman Access Fast TSH
µU/ml = mlU/l 2.75 2.20 3.30 Roche Cobas E411
µU/ml = mlU/l 2.81 2.25 3.37 Roche Cobas 6000/8000
µU/ml = mlU/l 2.46 1.97 2.95 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 2.85 2.28 3.42 SNIBE Maglumi Analysers
µU/ml = mlU/l 2.58 1.75 3.41 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 2.43 1.94 2.92 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 2.54 2.03 3.05 Siemens Atellica IM
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 33.1 26.5 39.7 BioMerieux Vidas
IU/ml 0.033 0.027 0.039
mU/ml=IU/l 43.7 35.0 52.4 Siemens Immulite 1000
IU/ml 0.044 0.035 0.053
mU/ml=IU/l 24.8 19.8 29.8 Beckman Access
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 38.6 30.9 46.3 Vitros ECi
IU/ml 0.039 0.031 0.047
mU/ml=IU/l 25.4 15.2 35.6 Siemens Centaur XP/XPT/Classic
IU/ml 0.025 0.015 0.036

___________________________________________________________________________________________________

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

IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 49.4 39.5 59.3 Siemens Immulite 2000
IU/ml 0.049 0.040 0.058
mU/ml=IU/l 22.3 17.8 26.8 Abbott Architect
IU/ml 0.022 0.018 0.026
mU/ml=IU/l 38.3 30.6 46.0 Siemens Dimension
IU/ml 0.038 0.031 0.045
mU/ml=IU/l 24.4 19.5 29.3 Beckman DxI800
IU/ml 0.024 0.020 0.028
mU/ml=IU/l 20.2 16.2 24.2 Roche STAT (Intact)
IU/ml 0.020 0.016 0.024
mU/ml=IU/l 25.0 20.0 30.0 Roche hCG+Beta
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 26.7 21.4 32.0 SNIBE Maglumi Analysers
IU/ml 0.027 0.021 0.033
mU/ml=IU/l 23.4 18.7 28.1 Radiometer AQT90 Flex
IU/ml 0.023 0.019 0.027
mU/ml=IU/l 24.7 19.8 29.6 Beckman Access Total BhCG (5th IS)
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 24.9 19.9 29.9 Beckman DxI Total BhCG (5th IS)
IU/ml 0.025 0.020 0.030
mU/ml=IU/l 26.2 21.0 31.5 Siemens Atellica IM
IU/ml 0.026 0.021 0.031
Total T3 nmol/l 3.79 2.84 4.74 BioMerieux Vidas
ng/ml 2.47 1.85 3.09
ng/dl 247 185 309
nmol/l 3.51 2.63 4.39 Siemens Immulite 1000
ng/ml 2.29 1.71 2.87
ng/dl 229 171 287
nmol/l 3.19 2.39 3.99 Beckman Access
ng/ml 2.08 1.56 2.60
ng/dl 208 156 260
nmol/l 4.10 3.08 5.12 Siemens Centaur XP/XPT/Classic
ng/ml 2.67 2.00 3.34
ng/dl 267 200 334
nmol/l 3.26 2.45 4.08 Siemens Immulite 2000/2500
ng/ml 2.12 1.59 2.65
ng/dl 212 159 265
nmol/l 3.20 2.40 4.00 Abbott Architect
ng/ml 2.08 1.56 2.60
ng/dl 208 156 260
nmol/l 4.28 3.21 5.35 Vitros ECi
ng/ml 2.79 2.09 3.49
ng/dl 279 209 349
nmol/l 3.32 2.49 4.15 Beckman DxI800
ng/ml 2.16 1.62 2.70
ng/dl 216 162 270

___________________________________________________________________________________________________

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

IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 4.12 3.09 5.15 Roche Cobas E411
ng/ml 2.68 2.01 3.35
ng/dl 268 201 335
nmol/l 3.88 2.91 4.85 Roche Cobas 6000/8000
ng/ml 2.53 1.89 3.17
ng/dl 253 189 317
nmol/l 4.34 3.26 5.43 Siemens Atellica IM
ng/ml 2.83 2.12 3.53
ng/dl 283 212 353
Total T4 nmol/l 135 101 169 Vitros ECi
µg/dl 10.5 7.88 13.1
ng/ml 105 78.8 131
nmol/l 155 116 194 BioMerieux Vidas
µg/dl 12.1 9.05 15.2
ng/ml 121 90.5 152
nmol/l 139 104 174 Beckman Access
µg/dl 10.8 8.11 13.5
ng/ml 108 81.1 135
nmol/l 136 88.4 184 Siemens Centaur XP/XPT/Classic
µg/dl 10.6 6.89 14.3
ng/ml 106 68.9 143
nmol/l 140 105 175 Siemens Immulite 2000/2500
µg/dl 10.9 8.19 13.6
ng/ml 109 81.9 136
nmol/l 132 99.0 165 Abbott Architect
µg/dl 10.3 7.72 12.9
ng/ml 103 77.2 129
nmol/l 128 96.0 160 Roche Cobas E411
µg/dl 9.98 7.49 12.5
ng/ml 100 74.9 125
nmol/l 125 93.8 156 Roche Cobas 6000/8000
µg/dl 9.75 7.32 12.2
ng/ml 97.5 73.2 122
Valproic Acid µmol/l 548 438 658 Siemens Centaur XP/XPT/Classic
µg/ml 79.1 63.2 95.0
µmol/l 503 402 604 Abbott Architect
µg/ml 72.6 58.0 87.2
µmol/l 524 419 629 Roche Cobas 6000/8000
µg/ml 75.6 60.5 90.7
µmol/l 638 510 765 Gravimetric
µg/ml 92.0 73.6 110
Vancomycin µmol/l 7.42 5.94 8.90 Abbott Architect
µg/ml 11.0 8.83 13.2
µmol/l 6.89 5.51 8.27 Roche Cobas 6000/8000
µg/ml 10.2 8.19 12.2
µmol/l 7.10 5.68 8.52 Gravimetric
µg/ml 10.5 8.44 12.7

___________________________________________________________________________________________________

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

IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
Cat. No. IA3110 / IA3112 Lot No. 1877EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 421 337 505 Beckman Access
pg/ml 570 457 683
pmol/l 499 374 624 Siemens Centaur XP/XPT/Classic
pg/ml 676 507 845
pmol/l 449 359 539 Siemens Immulite 2000
pg/ml 608 486 730
pmol/l 443 354 532 Abbott Architect
pg/ml 600 480 720
pmol/l 449 359 539 Vitros ECi
pg/ml 608 486 730
pmol/l 395 316 474 Beckman DxI800
pg/ml 535 428 642
pmol/l 489 391 587 Roche Cobas E411
pg/ml 663 530 796
pmol/l 487 390 584 Roche Cobas 6000/8000
pg/ml 660 528 792
pmol/l 519 415 623 Siemens Atellica IM
pg/ml 704 562 844

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 3


(IA PREMIUM PLUS 3)
CAT. NO. IA3111 GTIN: 05055273207279 SIZE: 12 x 5ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5ml
LOT NO. 1867EC EXPIRY: 2021-11-28

INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of
analytes listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS


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

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

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

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY


OPENED: Store refrigerated (+2ºC to +8ºC). Reconstituted serum is stable for 7 days at +2°C to +8°C, if kept capped in original
container and free from contamination, or 4 weeks frozen once at –20°C. 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 5ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of
foam. Do not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

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

MATERIAL REQUIRED BUT NOT PROVIDED


Volumetric pipette

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

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

27 May ’19 ne

PAGE 1 OF 15
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 28.4 21.3 35.5 Immunotech RIA
ng/ml 9.40 7.05 11.8
25-OH Vitamin D nmol/l 138 104 173 Siemens Centaur XP/XPT/Classic
nmol/l 78.4 58.8 98.0 Roche Vitamin D Total
nmol/l 88.3 66.2 110 Abbott Architect
nmol/l 107 80.3 134 Vitros ECi
nmol/l 82.8 62.1 104 BioMerieux Vidas
nmol/l 85.6 64.2 107 Beckman DxI 600/800
nmol/l 102 76.5 128 Roche Vitamin D Total II
nmol/l 109 81.8 136 Diasorin Liaison XL
nmol/l 125 93.5 156 Siemens Atellica IM
ACTH pmol/l 35.1 26.3 43.9 Siemens Immulite 2000/2500
pg/ml 160 120 200
pmol/l 24.2 18.2 30.3 Roche Cobas E411
pg/ml 110 82.7 137
pmol/l 27.3 20.5 34.1 Roche Cobas 6000/8000
pg/ml 124 93.2 155
pmol/l 34.2 25.7 42.8 Siemens Immulite 1000
pg/ml 155 117 193
pmol/l 50.2 37.7 62.8 Diasorin Liaison XL
pg/ml 228 171 285
Aldosterone pmol/l 631 473 789 Diasorin Liaison XL
pg/ml 228 171 285
Alpha-fetoprotein KIU/l = lU/ml 210 168 252 BioMerieux Vidas
ng/ml 254 203 305
KIU/l = lU/ml 199 159 239 Vitros ECi
ng/ml 207 166 248
KIU/l = lU/ml 223 176 270 Siemens Centaur XP/XPT/Classic
ng/ml 270 213 327
KIU/l = lU/ml 187 150 224 Siemens Immulite 2000/2500
ng/ml 226 182 270
KIU/l = lU/ml 183 146 220 Abbott Architect
ng/ml 221 177 265
KIU/l = lU/ml 174 139 209 Beckman DxI800
ng/ml 211 168 254
KIU/l = lU/ml 210 168 252 Roche Cobas 6000/8000
ng/ml 254 203 305
KIU/l = lU/ml 209 167 251 Roche Cobas E411
ng/ml 253 202 304
KIU/l = lU/ml 210 168 252 Siemens Atellica IM
ng/ml 254 203 305
Amikacin µmol/l 24.1 19.3 28.9 Gravimetric
µg/ml 14.1 11.3 16.9

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Androstenedione nmol/l 34.0 25.5 42.5 Siemens Immulite 2000
ng/ml 9.76 7.32 12.2
Beta-2-microglobulin µg/ml = mg/l 6.27 5.02 7.52 Siemens Immulite 2000/2500
µg/ml = mg/l 7.17 5.74 8.60 Abbott Architect
µg/ml = mg/l 6.94 5.55 8.33 Roche Cobas 6000/8000
C-Peptide nmol/l 3.390 2.540 4.240 Siemens Immulite 2000/2500
ng/ml 10.2 7.67 12.7
nmol/l 3.240 2.430 4.050 Roche Cobas 6000/8000
ng/ml 9.78 7.34 12.2
nmol/l 2.950 2.210 3.690 Abbott Architect
ng/ml 8.91 6.67 11.2
CA 15-3 U/ml 79.9 55.1 105 Siemens Centaur XP/XPT/Classic
U/ml 85.7 68.6 103 Abbott Architect
U/ml 72.7 58.2 87.2 Siemens Immulite 2000/2500
U/ml 67.4 53.9 80.9 Vitros ECi
U/ml 27.6 22.1 33.1 Beckman DxI800
U/ml 80.9 64.7 97.1 Roche Cobas 6000/8000
U/ml 79.5 63.6 95.4 Roche Cobas E411
U/ml 80.2 64.2 96.3 Siemens Atellica IM
CA 19-9 U/ml 478 382 574 BioMerieux Vidas
U/ml 615 424 806 Siemens Centaur XP/XPT/Classic
U/ml 244 195 293 Siemens Immulite 2000/2500
U/ml 385 308 462 Vitros ECi
U/ml 226 181 271 Beckman DxI800
U/ml 1931 1545 2317 Abbott Architect XR/XR2 kit
U/ml 128 102 154 Roche Cobas 6000/8000
U/ml 133 106 160 Roche Cobas E411
U/ml 588 470 706 Siemens Atellica IM
CA125 U/ml 217 174 260 BioMerieux Vidas
U/ml 189 151 227 Siemens Immulite 2000/2500
U/ml 197 158 236 Vitros ECi
U/ml 269 215 323 Abbott Architect
U/ml 202 139 265 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 177 142 212 Beckman DxI800
U/ml 205 164 246 Roche Cobas E411
U/ml 202 162 242 Roche Cobas 6000/8000
U/ml 233 187 280 Siemens Atellica IM
Carbamazepine µmol/l 68.4 42.4 94.4 Siemens Centaur XP/XPT/Classic
µg/ml 16.2 10.0 22.4
µmol/l 69.0 55.2 82.8 Abbott Architect
µg/ml 16.3 13.0 19.6
µmol/l 69.2 55.4 83.0 Roche Cobas 6000/8000
µg/ml 16.4 13.1 19.7
µmol/l 72.2 57.8 86.6 Gravimetric
µg/ml 17.1 13.7 20.5

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Carcinoembryonic ng/ml = µg/l 62.3 49.8 74.8 BioMerieux Vidas
Antigen (CEA)
ng/ml = µg/l 82.0 65.6 98.4 Siemens Immulite 1000
ng/ml = µg/l 63.1 50.5 75.7 Vitros ECi
ng/ml = µg/l 64.1 51.3 76.9 Beckman Access
ng/ml = µg/l 64.1 44.2 84.0 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 84.3 67.4 101 Siemens Immulite 2000/2500
ng/ml = µg/l 72.1 57.7 86.5 Abbott Architect
ng/ml = µg/l 57.9 46.3 69.5 Beckman DxI800
ng/ml = µg/l 50.5 40.4 60.6 Roche Cobas 6000/8000
ng/ml = µg/l 51.0 40.8 61.2 Roche Cobas E411
ng/ml = µg/l 61.1 48.9 73.3 Siemens Atellica IM
Cortisol nmol/l 913 685 1141 Siemens Immulite 1000
µg/dl 32.9 24.7 41.1
nmol/l 1069 802 1336 Roche Elecsys
µg/dl 38.5 28.9 48.1
nmol/l 1082 747 1417 Siemens Centaur XP/XPT/Classic
µg/dl 39.0 26.9 51.1
nmol/l 877 658 1096 Siemens Immulite 2000/2500
µg/dl 31.6 23.7 39.5
nmol/l 869 652 1086 Vitros ECi
µg/dl 31.3 23.5 39.1
nmol/l 818 614 1023 Abbott Architect
µg/dl 29.4 22.1 36.7
nmol/l 922 692 1153 Beckman DxI800
µg/dl 33.2 24.9 41.5
nmol/l 1105 829 1381 Roche Cobas 6000/8000
µg/dl 39.8 29.8 49.8
nmol/l 1000 750 1250 Roche Cobas E411
µg/dl 36.0 27.0 45.0
nmol/l 954 716 1193 Roche Cobas 4000/e411 Gen II
µg/dl 34.3 25.8 42.8
nmol/l 906 680 1133 Roche Cobas 6000/8000 Gen II
µg/dl 32.6 24.5 40.7
nmol/l 1171 878 1464 Siemens Atellica IM
µg/dl 42.2 31.6 52.7
DHEA-S µmol/l 17.6 14.1 21.1 Siemens Immulite 2000/2500
µmol/l 26.2 21.0 31.4 Roche Elecsys
µmol/l 19.2 15.4 23.0 Abbott Architect
µmol/l 15.9 9.54 22.3 Siemens Centaur XP/XPT/Classic
µmol/l 24.9 19.9 29.9 Roche Cobas E411
µmol/l 25.0 20.0 30.0 Roche Cobas 6000/8000
µmol/l 16.7 13.3 20.0 Siemens Atellica IM
Digoxin nmol/l 5.53 4.42 6.64 Siemens Immulite 2000/2500
ng/ml 4.32 3.45 5.19
nmol/l 4.39 3.51 5.27 Abbott Architect
ng/ml 3.43 2.74 4.12

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 4.88 3.90 5.86 Beckman DxI800
ng/ml 3.81 3.05 4.57
nmol/l 4.98 3.98 5.98 Roche Cobas 6000/8000
ng/ml 3.89 3.11 4.67
nmol/l 5.12 4.10 6.14 Gravimetric
ng/ml 4.00 3.20 4.80
Ethosuximide µmol/l 493 395 592 Gravimetric
µg/ml 70.0 56.0 83.9
Ferritin ng/ml = µg/l 281 225 337 BioMerieux Vidas
ng/ml = µg/l 350 280 420 Roche Elecsys
ng/ml = µg/l 237 190 284 Beckman Access
ng/ml = µg/l 212 170 254 Vitros ECi
ng/ml = µg/l 323 252 394 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 293 234 352 Siemens Immulite 2000/2500
ng/ml = µg/l 375 300 450 Abbott Architect
ng/ml = µg/l 339 271 407 Roche Modular E170
ng/ml = µg/l 237 190 284 Beckman DxI800
ng/ml = µg/l 320 256 384 Siemens Atellica IM
Folate nmol/l 23.5 17.9 29.1 Beckman Access
ng/ml 10.4 7.89 12.9
nmol/l 17.4 13.2 21.6 Siemens Immulite 2000
ng/ml 7.67 5.82 9.52
nmol/l 14.5 11.0 18.0 Vitros ECi
ng/ml 6.39 4.85 7.93
nmol/l 20.2 15.4 25.0 Abbott Architect
ng/ml 8.91 6.79 11.0
nmol/l 44.8 26.9 62.7 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 19.8 11.9 27.7
nmol/l 23.5 17.9 29.1 Beckman DxI800
ng/ml 10.4 7.89 12.9
nmol/l 23.8 18.1 29.5 Roche Cobas 6000/8000 Folate III
ng/ml 10.5 7.98 13.0
nmol/l 37.4 28.4 46.4 Siemens Atellica IM
ng/ml 16.5 12.5 20.5
Free T3 pmol/l 29.8 22.4 37.3 Roche Elecsys
ng/dl 1.94 1.46 2.42
pg/ml 19.4 14.6 24.2
pmol/l 19.3 14.5 24.1 Beckman Access
ng/dl 1.25 0.943 1.56
pg/ml 12.6 9.44 15.8
pmol/l 35.0 26.3 43.8 Vitros ECi
ng/dl 2.28 1.71 2.85
pg/ml 22.8 17.1 28.5
pmol/l 25.1 15.1 35.1 Siemens Centaur XP/XPT/Classic
ng/dl 1.63 0.978 2.28
pg/ml 16.3 9.78 22.8

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 14.4 10.8 18.0 Siemens Immulite 2000/2500
ng/dl 0.936 0.702 1.17
pg/ml 9.37 7.03 11.7
pmol/l 23.5 17.6 29.4 Abbott Architect
ng/dl 1.53 1.14 1.92
pg/ml 15.3 11.5 19.1
pmol/l 18.6 14.0 23.3 Beckman DxI800
ng/dl 1.21 0.910 1.51
pg/ml 12.1 9.11 15.1
pmol/l 30.1 22.6 37.6 Roche Cobas E411
ng/dl 1.96 1.47 2.45
pg/ml 19.6 14.7 24.5
pmol/l 30.5 22.9 38.1 Roche Cobas 6000/8000
ng/dl 1.98 1.49 2.47
pg/ml 19.9 14.9 24.9
pmol/l 27.3 20.5 34.1 Siemens Atellica IM
ng/dl 1.77 1.33 2.22
pg/ml 17.8 13.3 22.2
Free T4 pmol/l 77.1 57.8 96.4 Siemens Immulite 1000
ng/dl 6.01 4.51 7.51
pg/ml 60.1 45.1 75.1
pmol/l 76.8 57.6 96.0 Roche Elecsys
ng/dl 5.99 4.49 7.49
pg/ml 59.9 44.9 74.9
pmol/l 54.3 40.7 67.9 Beckman Access
ng/dl 4.24 3.17 5.31
pg/ml 42.4 31.7 53.1
pmol/l 89.8 67.4 112 Vitros ECi
ng/dl 7.00 5.26 8.74
pg/ml 70.0 52.6 87.4
pmol/l 54.6 41.0 68.3 Siemens Centaur XP/XPT/Classic
ng/dl 4.26 3.20 5.32
pg/ml 42.6 32.0 53.2
pmol/l 76.8 57.6 96.0 Siemens Immulite 2000/2500
ng/dl 5.99 4.49 7.49
pg/ml 59.9 44.9 74.9
pmol/l 49.8 37.4 62.3 Abbott Architect
ng/dl 3.88 2.92 4.84
pg/ml 38.8 29.2 48.4
pmol/l 101 75.8 126 Diasorin Liaison
ng/dl 7.88 5.91 9.85
pg/ml 78.8 59.1 98.5
pmol/l 59.4 44.6 74.3 Beckman DxI800
ng/dl 4.63 3.48 5.78
pg/ml 46.3 34.8 57.8
pmol/l 76.8 57.6 96.0 Roche Cobas 6000/8000
ng/dl 5.99 4.49 7.49
pg/ml 59.9 44.9 74.9

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 77.2 57.9 96.5 Roche Cobas E411
ng/dl 6.02 4.52 7.52
pg/ml 60.2 45.2 75.2
pmol/l 83.9 62.9 105 Biomerieux Vidas FT4N Kit
ng/dl 6.54 4.91 8.17
pg/ml 65.4 49.1 81.7
pmol/l 59.1 44.3 73.9 Siemens Centaur CP
ng/dl 4.61 3.46 5.76
pg/ml 46.1 34.6 57.6
pmol/l 60.4 45.3 75.5 Siemens Atellica IM
ng/dl 4.71 3.53 5.89
pg/ml 47.1 35.3 58.9
FSH mU/ml 61.3 49.0 73.6 Siemens Immulite 1000
mU/ml 78.4 62.7 94.1 BioMerieux Vidas
mU/ml 61.9 49.5 74.3 Beckman Access
mU/ml 56.8 45.4 68.2 Roche/BM Elecsys
mU/ml 43.5 34.8 52.2 Vitros ECi
mU/ml 80.0 62.4 97.6 Siemens Centaur XP/XPT/Classic
mU/ml 59.5 47.6 71.4 Siemens Immulite 2000/2500
mU/ml 51.4 41.1 61.7 Abbott Architect
mU/ml 62.5 50.0 75.0 Beckman DxI800
mU/ml 58.9 47.1 70.7 Roche Cobas E411
mU/ml 55.6 44.5 66.7 Roche Cobas 6000/8000
mU/ml 82.6 66.1 99.1 Siemens Atellica IM
Gentamicin µmol/l 11.7 9.38 14.1 Gravimetric
µg/ml 5.60 4.48 6.74
Growth Hormone (GH) µU/ml 45.5 36.4 54.6 Siemens Immulite 1000
ng/ml 15.2 12.1 18.3
µU/ml 49.3 39.4 59.2 Siemens Immulite 2000/2500
ng/ml 16.4 13.1 19.7
µU/ml 41.2 33.0 49.4 Beckman DxI800
ng/ml 13.7 11.0 16.4
µU/ml 45.9 36.7 55.1 Roche Cobas 6000/8000
ng/ml 15.3 12.2 18.4
Immunoglobulin E KIU/l = IU/ml 509 407 611 Siemens Immulite 1000
KIU/l = IU/ml 482 386 578 Pharmacia Unicap
KIU/l = IU/ml 505 303 707 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 547 438 656 Siemens Immulite 2000/2500
KIU/l = IU/ml 539 431 647 Abbott Architect
KIU/l = IU/ml 541 433 649 Roche Cobas E411
KIU/l = IU/ml 524 419 629 Roche Cobas 6000/8000
KIU/l = IU/ml 522 417 626 Siemens Atellica IM
Insulin mU/l 28.7 21.5 35.9 Siemens Centaur XP/XPT/Classic
µU/ml 28.7 21.5 35.9

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Insulin mU/l 25.3 19.0 31.6 Abbott Architect
µU/ml 25.3 19.0 31.6
mU/l 33.1 24.8 41.4 Roche Cobas E411
µU/ml 33.1 24.8 41.4
mU/l 32.3 24.2 40.4 Roche Cobas 6000/8000
µU/ml 32.3 24.2 40.4
mU/l 25.5 19.1 31.9 Beckman DxI 600/800
µU/ml 25.5 19.1 31.9
mU/l 28.9 21.7 36.1 Siemens Atellica IM
µU/ml 28.9 21.7 36.1
Luteinising Hormone mU/ml 35.7 28.6 42.8 Beckman Access
(LH)
mU/ml 50.9 40.7 61.1 BioMerieux Vidas
mU/ml 76.3 61.0 91.6 Siemens Immulite 1000
mU/ml 58.8 47.0 70.6 Vitros ECi
mU/ml 50.1 38.6 61.6 Siemens Centaur XP/XPT/Classic
mU/ml 69.2 55.4 83.0 Siemens Immulite 2000
mU/ml 42.1 33.7 50.5 Abbott Architect
mU/ml 35.0 28.0 42.0 Beckman DxI800
mU/ml 53.8 43.0 64.6 Roche Cobas E411
mU/ml 55.4 44.3 66.5 Roche Cobas 6000/8000
mU/ml 50.9 40.7 61.1 Siemens Atellica IM
Oestradiol pmol/l 3181 2545 3817 BioMerieux Vidas
pg/ml 865 692 1038
pmol/l 2657 2126 3188 Vitros ECi
pg/ml 723 578 868
pmol/l 2646 2117 3175 Beckman Access
pg/ml 720 576 864
pmol/l 2549 2039 3059 Siemens Immulite 2000/2500
pg/ml 693 555 831
pmol/l 1477 1182 1772 Abbott Architect
pg/ml 402 322 482
pmol/l 2399 1919 2879 Beckman DxI800
pg/ml 653 522 784
pmol/l 1749 1399 2099 Roche Cobas 6000/8000 (Estradiol II)
pg/ml 476 381 571
pmol/l 1738 1390 2086 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 473 378 568
pmol/l 2835 1758 3912 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 771 478 1064
pmol/l 1744 1395 2093 Roche Cobas 6000/8000 (Estradiol III)
pg/ml 474 379 569
pmol/l 1755 1404 2106 Roche Elecsys (Estradiol III)
pg/ml 477 382 572
pmol/l 1727 1382 2072 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 470 376 564
pmol/l 2941 2353 3529 Siemens Atellica IM
pg/ml 800 640 960

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Paracetamol mmol/l 0.484 0.387 0.581 Roche Cobas 6000/8000
mg/l 73.2 58.6 87.8
mmol/l 0.529 0.420 0.630 Gravimetric
mg/l 80.0 63.5 95.3
Phenobarbital µmol/l 121 96.8 145 Abbott Architect
µg/ml 28.1 22.5 33.7
µmol/l 120 96.0 144 Siemens Immulite 2000/2500
µg/ml 27.8 22.3 33.3
µmol/l 122 97.6 146 Beckman AU400/600/640/2700/5400
µg/ml 28.3 22.6 34.0
µmol/l 121 96.6 145 Gravimetric
µg/ml 28.0 22.4 33.6
Phenytoin µmol/l 92.8 74.2 111 Abbott Architect
µg/ml 23.4 18.7 28.1
µmol/l 88.3 70.6 106 Beckman DxC
µg/ml 22.3 17.8 26.8
µmol/l 93.1 74.5 112 Roche Cobas 6000/8000
µg/ml 23.5 18.8 28.2
µmol/l 99.8 79.8 120 Gravimetric
µg/ml 25.2 20.1 30.3
Primidone µmol/l 32.7 26.2 39.2 Gravimetric
µg/ml 7.14 5.72 8.56
Progesterone nmol/l 97.9 78.3 117 Beckman Access Prog Cal 33555
ng/ml 30.6 24.5 36.7
nmol/l 77.2 61.8 92.6 Siemens Immulite 1000
ng/ml 24.2 19.3 29.1
nmol/l 160 128 192 BioMerieux Vidas
ng/ml 50.1 40.1 60.1
nmol/l 109 87.2 131 Roche Elecsys (Prog. II)
ng/ml 34.1 27.3 40.9
nmol/l 102 81.6 122 Vitros ECi
ng/ml 31.9 25.5 38.3
nmol/l 71.9 51.0 92.8 Siemens Centaur XP/XPT/Classic
ng/ml 22.5 16.0 29.0
nmol/l 61.7 49.4 74.0 Siemens Immulite 2000/2500
ng/ml 19.3 15.5 23.1
nmol/l 90.3 72.2 108 Abbott Architect
ng/ml 28.3 22.6 34.0
nmol/l 107 85.6 128 Beckman DxI Prog Cal 33555
ng/ml 33.5 26.8 40.2
nmol/l 102 81.6 122 Roche Cobas 4000/e411 (Prog. II)
ng/ml 31.9 25.5 38.3
nmol/l 103 82.4 124 Roche Cobas 6000/8000 (Prog. II)
ng/ml 32.2 25.8 38.6
nmol/l 85.9 68.7 103 Beckman DxI Prog DE Cal A80773
ng/ml 26.9 21.5 32.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 100 80.0 120 Roche Cobas 6000/8000 (Prog. III)
ng/ml 31.3 25.0 37.6
nmol/l 102 81.6 122 Roche Cobas 4000/e411 (Prog. III)
ng/ml 31.9 25.5 38.3
nmol/l 80.6 64.5 96.7 Siemens Atellica IM
ng/ml 25.2 20.2 30.3
Prolactin µU/ml 870 696 1044 Beckman Access
µU/ml 1399 1119 1679 BioMerieux Vidas
µU/ml 1032 826 1238 Siemens Immulite 1000
µU/ml 919 735 1103 Vitros ECi
µU/ml 926 695 1157 Siemens Centaur XP/XPT/Classic
µU/ml 936 749 1123 Siemens Immulite 2000/2500
µU/ml 1083 866 1300 Abbott Architect
µU/ml 874 699 1049 Beckman DxI800
µU/ml 1033 826 1240 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 1074 859 1289 Roche Cobas E411
µU/ml 1022 818 1226 Roche Cobas 6000/8000
µU/ml 1054 843 1265 Abbott Architect restandardised
µU/ml 923 738 1107 Siemens Atellica IM
PSA Free ng/ml = µg/l 19.5 14.6 24.4 Siemens Immulite 2000/2500
ng/ml = µg/l 25.3 19.0 31.6 Abbott Architect
ng/ml = µg/l 18.6 14.0 23.3 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 25.2 18.9 31.5 Beckman DXI standardised to Hybritech
ng/ml = µg/l 16.9 12.7 21.1 Roche Cobas E411
ng/ml = µg/l 16.6 12.5 20.8 Roche Cobas 6000/8000
ng/ml = µg/l 20.5 15.4 25.6 Siemens Atellica IM
PSA Total ng/ml = µg/l 14.5 10.9 18.1 Siemens Immulite 1000 1st generation
ng/ml = µg/l 29.0 21.8 36.3 Roche Elecsys
ng/ml = µg/l 34.8 26.1 43.5 Beckman Access standardised to Hybritech
ng/ml = µg/l 26.6 20.0 33.3 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 29.3 22.0 36.6 bioMerieux VIDAS TPSA
ng/ml = µg/l 14.8 11.1 18.5 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 22.0 16.5 27.5 Abbott Architect
ng/ml = µg/l 29.7 22.3 37.1 Vitros ECi
ng/ml = µg/l 33.4 25.1 41.8 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 26.6 20.0 33.3 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 32.4 24.3 40.5 Roche Cobas E411
ng/ml = µg/l 30.8 23.1 38.5 Roche Cobas 6000/8000
ng/ml = µg/l 29.5 22.1 36.9 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 27.7 20.8 34.6 Siemens Centaur CP
ng/ml = µg/l 28.0 21.0 34.9 Siemens Atellica IM
Salicylate mmol/l 2.88 2.30 3.46 Gravimetric
mg/dl 39.7 31.7 47.7
SHBG nmol/l 35.8 28.6 43.0 Siemens Immulite 2000/2500
nmol/l 32.0 25.6 38.4 Abbott Architect

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
SHBG nmol/l 37.1 29.7 44.5 Roche Cobas E411
nmol/l 35.9 28.7 43.1 Roche Cobas 6000/8000
nmol/l 32.7 26.2 39.2 Beckman DxI800
nmol/l 34.5 27.6 41.3 Siemens Atellica IM
T Uptake %U 41.4 33.9 48.9 Siemens Immulite 2000
Testosterone nmol/l 46.8 37.4 56.2 Vitros ECi
ng/ml 13.5 10.8 16.2
ng/dl 1348 1077 1619
nmol/l 25.2 18.4 32.0 Siemens Centaur XP/XPT/Classic
ng/ml 7.26 5.30 9.22
ng/dl 726 530 922
nmol/l 37.2 29.8 44.6 Siemens Immulite 2000/2500
ng/ml 10.7 8.58 12.8
ng/dl 1071 858 1284
nmol/l 30.2 24.2 36.2 Abbott Architect
ng/ml 8.70 6.97 10.4
ng/dl 870 697 1043
nmol/l 28.7 23.0 34.4 Beckman Access
ng/ml 8.27 6.62 9.92
ng/dl 827 662 992
nmol/l 25.1 20.1 30.1 Beckman DxI800
ng/ml 7.23 5.79 8.67
ng/dl 723 579 867
nmol/l 32.3 25.8 38.8 Roche Elecsys Test II
ng/ml 9.30 7.43 11.2
ng/dl 930 743 1117
nmol/l 31.5 25.2 37.8 Roche Cobas 4000/e411 Test II
ng/ml 9.07 7.26 10.9
ng/dl 907 726 1088
nmol/l 31.5 25.2 37.8 Roche Cobas 6000 Test 2
ng/ml 9.07 7.26 10.9
ng/dl 907 726 1088
nmol/l 30.7 24.6 36.8 Abbott Architect 2nd Generation
ng/ml 8.84 7.08 10.6
ng/dl 884 708 1060
nmol/l 28.1 22.5 33.7 BioMerieux Vidas Testosterone II
ng/ml 8.09 6.48 9.70
ng/dl 809 648 970
nmol/l 25.9 18.9 32.9 Siemens Centaur TST II
ng/ml 7.46 5.45 9.47
ng/dl 746 545 947
nmol/l 25.1 20.1 30.1 Siemens Atellica IM
ng/ml 7.23 5.79 8.67
ng/dl 723 579 867
Theophylline µmol/l 158 126 190 Beckman DxC
µg/ml 28.5 22.7 34.3

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Theophylline µmol/l 153 122 184 Roche Cobas 6000/8000
µg/ml 27.6 22.0 33.2
µmol/l 166 133 200 Gravimetric
µg/ml 30.0 24.0 36.0
Thyroglobulin ng/ml 36.5 27.4 45.6 Siemens Immulite 2000
ng/ml 59.6 44.7 74.5 Beckman Access
ng/ml 64.0 48.0 80.0 Roche Cobas E411
ng/ml 62.6 47.0 78.3 Roche Cobas 6000/8000
ng/ml 60.9 45.7 76.1 Roche Cobas 6000 TGII
Thyroid Stimulating µU/ml = mlU/l 21.9 17.5 26.3 bioMerieux VIDAS TSH
Hormone
µU/ml = mlU/l 21.5 17.2 25.8 Siemens Immulite 1000
µU/ml = mlU/l 22.6 18.1 27.1 Roche Elecsys
µU/ml = mlU/l 21.4 17.1 25.7 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 31.4 25.1 37.7 Vitros ECi
µU/ml = mlU/l 24.5 16.7 32.3 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 22.7 18.2 27.2 Siemens Immulite 2000/2500
µU/ml = mlU/l 19.4 15.5 23.3 Abbott Architect
µU/ml = mlU/l 22.0 17.6 26.4 Beckman Access Fast TSH
µU/ml = mlU/l 22.6 18.1 27.1 Roche Cobas E411
µU/ml = mlU/l 22.8 18.2 27.4 Roche Cobas 6000/8000
µU/ml = mlU/l 21.0 16.8 25.2 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 24.6 16.7 32.5 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 20.7 16.6 24.8 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 22.9 18.3 27.5 Siemens Atellica IM
Tobramycin µmol/l 10.3 8.21 12.3 Gravimetric
µg/ml 4.80 3.84 5.76
Total Beta hCG mU/ml=IU/l 541 433 649 BioMerieux Vidas
IU/ml 0.541 0.433 0.649
mU/ml=IU/l 619 495 743 Siemens Immulite 1000
IU/ml 0.619 0.495 0.743
mU/ml=IU/l 385 308 462 Roche Cobas Core EIA
IU/ml 0.385 0.308 0.462
mU/ml=IU/l 335 268 402 Beckman Access
IU/ml 0.335 0.268 0.402
mU/ml=IU/l 532 426 638 Vitros ECi
IU/ml 0.532 0.426 0.638
mU/ml=IU/l 313 188 438 Siemens Centaur XP/XPT/Classic
IU/ml 0.313 0.188 0.438
mU/ml=IU/l 611 489 733 Siemens Immulite 2000
IU/ml 0.611 0.489 0.733
mU/ml=IU/l 328 262 394 Abbott Architect
IU/ml 0.328 0.262 0.394
mU/ml=IU/l 557 446 668 Siemens Dimension
IU/ml 0.557 0.446 0.668
mU/ml=IU/l 347 278 416 Beckman DxI800
IU/ml 0.347 0.278 0.416

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 299 239 359 Roche STAT (Intact)
IU/ml 0.299 0.239 0.359
mU/ml=IU/l 388 310 466 Roche hCG+Beta
IU/ml 0.388 0.310 0.466
mU/ml=IU/l 330 264 396 Radiometer AQT90 Flex
IU/ml 0.330 0.264 0.396
mU/ml=IU/l 340 272 408 Beckman Access Total BhCG (5th IS)
IU/ml 0.340 0.272 0.408
mU/ml=IU/l 349 279 419 Beckman DxI Total BhCG (5th IS)
IU/ml 0.349 0.279 0.419
mU/ml=IU/l 317 254 380 Siemens Atellica IM
IU/ml 0.317 0.254 0.380
Total T3 nmol/l 5.94 4.46 7.43 BioMerieux Vidas
ng/ml 3.87 2.90 4.84
ng/dl 387 290 484
nmol/l 5.44 4.08 6.80 Beckman Access
ng/ml 3.54 2.66 4.42
ng/dl 354 266 442
nmol/l 7.52 5.64 9.40 Siemens Centaur XP/XPT/Classic
ng/ml 4.90 3.67 6.13
ng/dl 490 367 613
nmol/l 6.46 4.85 8.08 Siemens Immulite 2000/2500
ng/ml 4.21 3.16 5.26
ng/dl 421 316 526
nmol/l 5.22 3.92 6.53 Abbott Architect
ng/ml 3.40 2.55 4.25
ng/dl 340 255 425
nmol/l 7.84 5.88 9.80 Vitros ECi
ng/ml 5.10 3.83 6.37
ng/dl 510 383 637
nmol/l 6.68 5.01 8.35 Roche Cobas E411
ng/ml 4.35 3.26 5.44
ng/dl 435 326 544
nmol/l 6.54 4.91 8.18 Roche Cobas 6000/8000
ng/ml 4.26 3.20 5.32
ng/dl 426 320 532
Total T4 nmol/l 209 157 261 Vitros ECi
µg/dl 16.3 12.2 20.4
ng/ml 163 122 204
nmol/l 238 179 298 BioMerieux Vidas
µg/dl 18.6 14.0 23.2
ng/ml 186 140 232
nmol/l 204 153 255 Siemens Immulite 1000
µg/dl 15.9 11.9 19.9
ng/ml 159 119 199
nmol/l 210 147 273 Siemens Centaur XP/XPT/Classic
µg/dl 16.4 11.5 21.3
ng/ml 164 115 213

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 198 149 248 Siemens Immulite 2000/2500
µg/dl 15.4 11.6 19.2
ng/ml 154 116 192
nmol/l 194 146 243 Abbott Architect
µg/dl 15.1 11.4 18.8
ng/ml 151 114 188
nmol/l 218 164 273 Beckman DxI800
µg/dl 17.0 12.8 21.2
ng/ml 170 128 212
nmol/l 184 138 230 Roche Cobas E411
µg/dl 14.4 10.8 18.0
ng/ml 144 108 180
nmol/l 174 131 218 Roche Cobas 6000/8000
µg/dl 13.6 10.2 17.0
ng/ml 136 102 170
Valproic Acid µmol/l 960 768 1152 Siemens Immulite 2000/2500
µg/ml 139 111 167
µmol/l 955 764 1146 Siemens Centaur XP/XPT/Classic
µg/ml 138 110 166
µmol/l 893 714 1072 Abbott Architect
µg/ml 129 103 155
µmol/l 952 762 1142 Roche Cobas 6000/8000
µg/ml 137 110 164
µmol/l 1116 893 1339 Gravimetric
µg/ml 161 129 193
µmol/l 915 732 1098 Siemens Atellica CH
µg/ml 132 106 158
Vancomycin µmol/l 10.8 8.64 13.0 Abbott Architect
µg/ml 16.0 12.8 19.2
µmol/l 9.54 7.63 11.4 Roche Cobas 6000/8000
µg/ml 14.2 11.3 17.1
µmol/l 10.2 8.16 12.2 Beckman DxC
µg/ml 15.2 12.1 18.3
µmol/l 10.8 8.62 12.9 Gravimetric
µg/ml 16.0 12.8 19.2
Vitamin B12 pmol/l 739 591 887 Beckman Access
pg/ml 1001 801 1201
pmol/l 842 632 1052 Siemens Centaur XP/XPT/Classic
pg/ml 1141 856 1426
pmol/l 642 514 770 Siemens Immulite 2000
pg/ml 870 696 1044
pmol/l 768 614 922 Abbott Architect
pg/ml 1041 832 1250
pmol/l 654 523 785 Vitros ECi
pg/ml 886 709 1063

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 15
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111/IA3112 Lot No. 1867EC Size: 12 x 5ml / 4 x 5ml Expiry: 2021-11-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 739 591 887 Beckman DxI800
pg/ml 1001 801 1201
pmol/l 905 724 1086 Siemens Atellica IM
pg/ml 1226 981 1472

___________________________________________________________________________________________________

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

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