2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 1

(IA PREMIUM PLUS 1)
CAT. NO. IA3109 GTIN: 05055273207255 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 2179EC EXPIRY: 2025-06-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes
listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS

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

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

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

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY

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

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

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

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

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

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

MATERIAL REQUIRED BUT NOT PROVIDED

Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium Plus is submitted to a number of external laboratories. Values are assigned from a consensus of results
obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for analytes in the
instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory technique. Therefore,
the range produced herein should only be considered as a reference and it is recommended that each laboratory establish its own mean and
acceptable ranges. 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
[email protected].

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

Rev. 24 Apr '23 me

PAGE 1 OF 27
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 2.79 2.09 3.49 Immunotech RIA
ng/ml 0.923 0.692 1.15
nmol/l 2.49 1.87 3.11 DRG ELISA
ng/ml 0.824 0.619 1.03
nmol/l 4.58 3.44 5.73 DIAsource RIA
ng/ml 1.52 1.14 1.90
25-OH Vitamin D nmol/l 49.0 36.8 61.3 Diasorin Liaison
nmol/l 24.5 18.4 30.6 Siemens Centaur XP/XPT/Classic
nmol/l 26.2 19.7 32.8 Abbott Architect (3L52)
nmol/l 115 86.3 144 Vitros ECi
nmol/l 26.1 19.6 32.6 Tosoh Series
nmol/l 39.6 29.7 49.5 BioMerieux Vidas
nmol/l 47.9 35.9 59.9 Beckman DxI 600/800
nmol/l 23.8 17.9 29.8 Fujirebio Lumipulse G Series
nmol/l 50.7 38.0 63.4 Beckman Access 25 OH Vitamin D Total
nmol/l 26.3 19.7 32.9 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 51.5 38.6 64.4 Diasorin Liaison XL
nmol/l 26.1 19.6 32.6 Abbott Alinity i
nmol/l 21.1 15.8 26.4 Siemens Atellica IM
nmol/l 22.5 16.9 28.1 Roche Vitamin D Total II e801
ACTH pmol/l 1.10 0.825 1.38 Siemens Immulite 2000/2500
pg/ml 5.00 3.75 6.25
pmol/l 1.56 1.17 1.95 Roche Cobas 4000/E411
pg/ml 7.09 5.32 8.86
pmol/l 1.60 1.20 2.00 Roche Cobas e601/602
pg/ml 7.27 5.45 9.09
pmol/l 2.20 1.65 2.75 Siemens Immulite 1000
pg/ml 10.0 7.50 12.5
pmol/l 1.60 1.20 2.00 Roche Elecsys
pg/ml 7.27 5.45 9.09
pmol/l 1.83 1.37 2.29 Roche Cobas e402/e801
pg/ml 8.32 6.23 10.4
Aldosterone pmol/l 105 78.8 131 Immunotech RIA
pg/ml 37.9 28.4 47.4
Alphafoetoprotein KIU/l = lU/ml 7.59 6.07 9.11 Abbott Architect
ng/ml 9.18 7.34 11.0
KIU/l = lU/ml 7.67 6.14 9.20 BioMerieux Vidas
ng/ml 9.28 7.43 11.1
KIU/l = lU/ml 8.92 7.14 10.7 Siemens Centaur XP/XPT/Classic
ng/ml 10.8 8.64 13.0
KIU/l = lU/ml 8.11 6.49 9.73 Siemens Immulite 2000/2500
ng/ml 9.81 7.85 11.8

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Alphafoetoprotein KIU/l = lU/ml 7.86 6.29 9.43 Beckman DxI800
ng/ml 9.51 7.61 11.4
KIU/l = lU/ml 8.64 6.91 10.4 Roche Elecsys
ng/ml 10.5 8.36 12.6
KIU/l = lU/ml 7.80 6.24 9.36 Beckman Access
ng/ml 9.44 7.55 11.3
KIU/l = lU/ml 8.47 6.78 10.2 Tosoh Series
ng/ml 10.2 8.20 12.2
KIU/l = lU/ml 8.61 6.89 10.3 Vitros ECi
ng/ml 8.95 7.16 10.7
KIU/l = lU/ml 8.80 7.04 10.6 Roche Cobas e601/602
ng/ml 10.6 8.52 12.7
KIU/l = lU/ml 8.52 6.82 10.2 Roche Cobas 4000/E411
ng/ml 10.3 8.25 12.4
KIU/l = lU/ml 8.42 6.74 10.1 Fujirebio Lumipulse G Series
ng/ml 10.2 8.16 12.2
KIU/l = lU/ml 8.46 6.77 10.2 Siemens Dimension
ng/ml 10.2 8.19 12.2
KIU/l = lU/ml 8.74 6.99 10.5 Siemens Centaur CP
ng/ml 10.6 8.46 12.7
KIU/l = lU/ml 9.11 7.29 10.9 Immunotech IRMA
ng/ml 11.0 8.82 13.2
KIU/l = lU/ml 8.07 6.46 9.68 Sysmex HISCL Series
ng/ml 9.76 7.82 11.7
KIU/l = lU/ml 7.94 6.35 9.53 Mindray CL Series
ng/ml 9.61 7.68 11.5
KIU/l = lU/ml 9.46 7.57 11.4 Diasorin Liaison XL
ng/ml 11.4 9.16 13.6
KIU/l = lU/ml 9.16 7.33 11.0 Siemens Atellica IM
ng/ml 11.1 8.87 13.3
KIU/l = lU/ml 7.56 6.05 9.07 Abbott Alinity i
ng/ml 9.15 7.32 11.0
KIU/l = lU/ml 9.25 7.40 11.1 Roche Cobas e402/e801
ng/ml 11.2 8.95 13.5
KIU/l = lU/ml 7.46 5.97 8.95 Tosoh AIA-CL Series
ng/ml 9.03 7.22 10.8
Amikacin µmol/l 6.18 4.94 7.42 Roche Cobas 6000/8000
µg/ml 3.62 2.89 4.35
µmol/l 6.11 4.89 7.33 Abbott Architect
µg/ml 3.58 2.86 4.30
µmol/l 6.53 5.22 7.84 Thermo Scientific QMS Amikacin
µg/ml 3.82 3.06 4.58
µmol/l 6.39 5.11 7.67 Abbott Alinity
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

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Androstenedione nmol/l 1.98 1.49 2.48 Beckman Coulter RIA
ng/ml 0.568 0.428 0.708
nmol/l 4.03 3.02 5.04 Diasorin Liaison XL
ng/ml 1.16 0.867 1.45
Beta-2-microglobulin µg/ml = mg/l 0.609 0.487 0.731 Abbott Architect
µg/ml = mg/l 0.678 0.542 0.814 BioMerieux Vidas
µg/ml = mg/l 0.560 0.448 0.672 Behring Nephelometer
µg/ml = mg/l 0.650 0.520 0.780 Siemens Immulite 2000/2500
µg/ml = mg/l 0.660 0.528 0.792 Roche Cobas 6000/8000
µg/ml = mg/l 0.450 0.360 0.540 Diasorin Liaison XL
µg/ml = mg/l 0.530 0.424 0.636 Siemens Atellica CH
µg/ml = mg/l 0.630 0.504 0.756 Abbott Alinity
C-Peptide nmol/l 0.474 0.356 0.593 Siemens Immulite 2000/2500
ng/ml 1.43 1.07 1.79
nmol/l 0.634 0.476 0.793 Roche Elecsys
ng/ml 1.91 1.44 2.38
nmol/l 0.644 0.483 0.805 Roche Cobas e601/602
ng/ml 1.94 1.46 2.42
nmol/l 0.434 0.326 0.543 Siemens Immulite 1000
ng/ml 1.31 0.984 1.64
nmol/l 0.658 0.494 0.823 Diasorin Liaison
ng/ml 1.99 1.49 2.49
nmol/l 0.661 0.496 0.826 Roche Cobas 4000/E411
ng/ml 2.00 1.50 2.50
nmol/l 0.568 0.426 0.710 Abbott Architect
ng/ml 1.71 1.29 2.13
nmol/l 0.417 0.313 0.521 Siemens Centaur XP/XPT/Classic
ng/ml 1.26 0.945 1.58
nmol/l 0.582 0.437 0.728 Tosoh Series
ng/ml 1.76 1.32 2.20
nmol/l 0.657 0.493 0.821 Diasorin Liaison XL
ng/ml 1.98 1.49 2.47
nmol/l 0.630 0.473 0.788 Roche Cobas e402/e801
ng/ml 1.90 1.43 2.37
nmol/l 0.394 0.296 0.493 Siemens Atellica IM
ng/ml 1.19 0.894 1.49
nmol/l 0.601 0.451 0.751 Vitros ECi
ng/ml 1.81 1.36 2.26
nmol/l 0.629 0.472 0.786 Tosoh AIA-CL Series
ng/ml 1.90 1.42 2.38
nmol/l 0.551 0.413 0.689 Abbott Alinity i
ng/ml 1.66 1.25 2.07
CA 15-3 U/ml 22.8 18.2 27.4 Abbott Architect
U/ml 22.3 17.8 26.8 BioMerieux Vidas
U/ml 22.1 17.7 26.5 Siemens Centaur XP/XPT/Classic
U/ml 21.1 16.9 25.3 Siemens Immulite 2000/2500

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
CA 15-3 U/ml 10.3 8.24 12.4 Beckman DxI800
U/ml 22.6 18.1 27.1 Roche Elecsys
U/ml 10.1 8.08 12.1 Beckman Access
U/ml 24.4 19.5 29.3 Tosoh Series
U/ml 18.4 14.7 22.1 Vitros ECi
U/ml 23.3 18.6 28.0 Roche Cobas e601/602
U/ml 21.6 17.3 25.9 Immunotech IRMA
U/ml 22.9 18.3 27.5 Roche Cobas 4000/E411
U/ml 27.0 21.6 32.4 Fujirebio Lumipulse G Series
U/ml 23.0 18.4 27.6 Siemens Centaur CP
U/ml 11.3 9.04 13.6 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
U/ml 21.7 17.4 26.0 Diasorin Liaison XL
U/ml 23.5 18.8 28.2 Siemens Atellica IM
U/ml 22.0 17.6 26.4 Roche Cobas e402/e801
U/ml 23.1 18.5 27.7 Abbott Alinity i
CA 19-9 U/ml 30.2 24.2 36.2 BioMerieux Vidas
U/ml 37.3 29.8 44.8 Siemens Centaur XP/XPT/Classic
U/ml 34.2 27.4 41.0 Siemens Immulite 2000/2500
U/ml 42.8 34.2 51.4 Beckman DxI800
U/ml 20.6 16.5 24.7 Roche Elecsys
U/ml 47.5 38.0 57.0 Beckman Access
U/ml 23.4 18.7 28.1 Tosoh Series
U/ml 40.1 32.1 48.1 Vitros ECi
U/ml 63.6 50.9 76.3 Abbott Architect XR/XR2/XRL
U/ml 20.8 16.6 25.0 Roche Cobas e601/602
U/ml 20.7 16.6 24.8 Roche Cobas 4000/E411
U/ml 43.4 34.7 52.1 Fujirebio Lumipulse G Series
U/ml 26.4 21.1 31.7 Izotop RIA
U/ml 36.4 29.1 43.7 Siemens Centaur CP
U/ml 12.8 10.2 15.4 Immunotech IRMA
U/ml 16.4 13.1 19.7 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
U/ml 38.8 31.0 46.6 Diasorin Liaison XL
U/ml 40.9 32.7 49.1 Siemens Atellica IM
U/ml 23.0 18.4 27.6 Roche Cobas e402/e801
U/ml 66.4 53.1 79.7 Abbott Alinity XR/XR2/XRL
CA125 U/ml 27.8 22.2 33.4 Abbott Architect
U/ml 19.3 15.4 23.2 BioMerieux Vidas
U/ml 21.3 17.0 25.6 Siemens Centaur XP/XPT/Classic OV Kit
U/ml 21.9 17.5 26.3 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 16.2 13.0 19.4 Siemens Immulite 2000/2500
U/ml 16.3 13.0 19.6 Siemens Immulite 1000
U/ml 15.5 12.4 18.6 Beckman DxI800
U/ml 17.8 14.2 21.4 Roche Elecsys
U/ml 15.7 12.6 18.8 Beckman Access
U/ml 35.4 28.3 42.5 Tosoh Series
U/ml 16.7 13.4 20.0 Vitros ECi

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
CA125 U/ml 18.9 15.1 22.7 Roche Cobas 4000/E411
U/ml 19.0 15.2 22.8 Roche Cobas e601/602
U/ml 9.27 7.42 11.1 Immunotech IRMA
U/ml 16.9 13.5 20.3 Fujirebio Lumipulse G Series
U/ml 22.2 17.8 26.6 Siemens Centaur CP CA125 II kit
U/ml 33.1 26.5 39.7 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
U/ml 22.5 18.0 27.0 Diasorin Liaison XL
U/ml 24.6 19.7 29.5 Siemens Atellica IM
U/ml 18.3 14.6 22.0 Roche Cobas e402/e801
U/ml 28.0 22.4 33.6 Abbott Alinity i
Carbamazepine µmol/l 15.9 12.7 19.1 Abbott Architect (CMIA)
µg/ml 3.76 3.00 4.52
µmol/l 17.8 14.2 21.4 Siemens Centaur XP/XPT/Classic
µg/ml 4.21 3.36 5.06
µmol/l 13.6 10.9 16.3 Siemens Dimension
µg/ml 3.22 2.58 3.86
µmol/l 12.4 9.92 14.9 Siemens Immulite 2000/2500
µg/ml 2.93 2.35 3.51
µmol/l 16.0 12.8 19.2 Roche Integra
µg/ml 3.78 3.03 4.53
µmol/l 14.4 11.5 17.3 Roche Cobas 6000/8000
µg/ml 3.40 2.72 4.08
µmol/l 15.6 12.5 18.7 Beckman AU400/600/640/2700/5400
µg/ml 3.69 2.96 4.42
µmol/l 13.8 11.0 16.6 Abbott Architect (PETINA)
µg/ml 3.26 2.60 3.92
µmol/l 16.9 13.5 20.3 EMIT
µg/ml 4.00 3.19 4.81
µmol/l 14.5 11.6 17.4 Siemens Atellica CH
µg/ml 3.43 2.74 4.12
µmol/l 13.5 10.8 16.2 Abbott Alinity (PETINA)
µg/ml 3.19 2.55 3.83
µmol/l 15.4 12.3 18.5 Gravimetric
µg/ml 3.64 2.91 4.37
Carcinoembryonic ng/ml = µg/l 4.35 3.48 5.22 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 3.85 3.08 4.62 BioMerieux Vidas
ng/ml = µg/l 4.22 3.38 5.06 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 5.13 4.10 6.16 Siemens Immulite 2000/2500
ng/ml = µg/l 4.61 3.69 5.53 Siemens Immulite 1000
ng/ml = µg/l 3.90 3.12 4.68 Beckman DxI800
ng/ml = µg/l 4.04 3.23 4.85 Roche Elecsys
ng/ml = µg/l 3.94 3.15 4.73 Beckman Access
ng/ml = µg/l 6.28 5.02 7.54 Tosoh Series
ng/ml = µg/l 4.31 3.45 5.17 Vitros ECi
ng/ml = µg/l 4.08 3.26 4.90 Roche Cobas e601/602
ng/ml = µg/l 3.98 3.18 4.78 Immunotech IRMA

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Carcinoembryonic ng/ml = µg/l 4.15 3.32 4.98 Roche Cobas 4000/E411
Antigen (CEA)
ng/ml = µg/l 5.97 4.78 7.16 Fujirebio Lumipulse G Series
ng/ml = µg/l 4.59 3.67 5.51 Siemens Centaur CP
ng/ml = µg/l 4.36 3.49 5.23 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/ml = µg/l 4.19 3.35 5.03 Diasorin Liaison XL
ng/ml = µg/l 4.20 3.36 5.04 Siemens Atellica IM
ng/ml = µg/l 3.94 3.15 4.73 Roche Cobas e402/e801
ng/ml = µg/l 4.25 3.40 5.10 Abbott Alinity i
Cortisol nmol/l 230 173 288 Abbott Architect
µg/dl 8.28 6.23 10.3
nmol/l 157 118 196 BioMerieux Vidas
µg/dl 5.65 4.25 7.05
nmol/l 207 155 259 Siemens Centaur XP/XPT/Classic
µg/dl 7.45 5.58 9.32
nmol/l 192 144 240 Siemens Immulite 2000/2500
µg/dl 6.91 5.18 8.64
nmol/l 215 161 269 Siemens Immulite 1000
µg/dl 7.74 5.80 9.68
nmol/l 225 169 281 Beckman DxI800
µg/dl 8.10 6.08 10.1
nmol/l 198 149 248 Roche Elecsys
µg/dl 7.13 5.36 8.90
nmol/l 231 173 289 Beckman Access
µg/dl 8.32 6.23 10.4
nmol/l 201 151 251 Tosoh Series
µg/dl 7.24 5.44 9.04
nmol/l 156 117 195 Vitros ECi
µg/dl 5.62 4.21 7.03
nmol/l 205 154 256 Roche Cobas e601/602
µg/dl 7.38 5.54 9.22
nmol/l 214 161 268 Roche Cobas 4000/E411
µg/dl 7.70 5.80 9.60
nmol/l 385 289 481 Immunotech RIA
µg/dl 13.9 10.4 17.4
nmol/l 210 158 263 Roche Cobas 4000/e411 Gen II
µg/dl 7.56 5.69 9.43
nmol/l 201 151 251 Roche Cobas e601/602 Gen II
µg/dl 7.24 5.44 9.04
nmol/l 205 154 256 Roche Elecsys Gen II
µg/dl 7.38 5.54 9.22
nmol/l 258 194 323 Diasorin Liaison XL
µg/dl 9.29 6.98 11.6
nmol/l 226 170 283 Siemens Atellica IM
µg/dl 8.14 6.12 10.2
nmol/l 196 147 245 Roche Cobas e402/e801
µg/dl 7.06 5.29 8.83

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 216 162 270 Tosoh AIA-CL Series
µg/dl 7.78 5.83 9.73
nmol/l 228 171 285 Abbott Alinity i
µg/dl 8.21 6.16 10.3
DHEA-S µmol/l 2.11 1.69 2.53 Abbott Architect
µmol/l 1.72 1.38 2.06 Siemens Immulite 2000/2500
µmol/l 1.78 1.42 2.14 Siemens Immulite 1000
µmol/l 1.98 1.58 2.38 Beckman DxI800
µmol/l 3.05 2.44 3.66 Roche Elecsys
µmol/l 2.28 1.82 2.74 Beckman Access
µmol/l 2.14 1.71 2.57 Siemens Centaur XP/XPT/Classic
µmol/l 2.68 2.14 3.22 Roche Cobas 4000/E411
µmol/l 2.68 2.14 3.22 Roche Cobas e601/602
µmol/l 1.87 1.50 2.24 Diasorin Liaison XL
µmol/l 2.09 1.67 2.51 Siemens Atellica IM
µmol/l 2.62 2.10 3.14 Roche Cobas e402/e801
µmol/l 2.06 1.65 2.47 Abbott Alinity i
Digoxin nmol/l 0.572 0.458 0.686 Abbott Architect (CMIA)
ng/ml 0.447 0.358 0.536
nmol/l 0.633 0.506 0.760 BioMerieux Vidas
ng/ml 0.494 0.395 0.593
nmol/l 1.00 0.800 1.20 Siemens Centaur XP/XPT/Classic
ng/ml 0.781 0.625 0.937
nmol/l 0.716 0.573 0.859 Siemens Dimension
ng/ml 0.559 0.448 0.670
nmol/l 0.754 0.603 0.905 Beckman DxI800
ng/ml 0.589 0.471 0.707
nmol/l 0.825 0.660 0.990 Roche Cobas e601/602
ng/ml 0.644 0.515 0.773
nmol/l 0.801 0.641 0.961 Beckman AU400/600/640/2700/5400
ng/ml 0.626 0.501 0.751
nmol/l 0.877 0.702 1.05 Roche Cobas 4000/E411
ng/ml 0.685 0.548 0.822
nmol/l 0.842 0.674 1.01 Roche Cobas e402/e801
ng/ml 0.658 0.526 0.790
nmol/l 1.00 0.800 1.20 Siemens Atellica IM
ng/ml 0.781 0.625 0.937
nmol/l 0.569 0.455 0.683 Siemens Atellica CH
ng/ml 0.444 0.355 0.533
nmol/l 0.757 0.606 0.908 Abbott Alinity (CMIA)
ng/ml 0.591 0.473 0.709
nmol/l 0.839 0.671 1.01 Abbott Alinity (PETINA)
ng/ml 0.655 0.524 0.786
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

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 19.3 15.4 23.2 Abbott Architect
ng/ml = µg/l 14.4 11.5 17.3 BioMerieux Vidas
ng/ml = µg/l 14.3 11.4 17.2 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 16.7 13.4 20.0 Siemens Immulite 2000/2500
ng/ml = µg/l 15.6 12.5 18.7 Siemens Immulite 1000
ng/ml = µg/l 12.5 10.0 15.0 Beckman DxI800
ng/ml = µg/l 19.7 15.8 23.6 Roche Elecsys/Cobas e411
ng/ml = µg/l 19.8 15.8 23.8 Roche Modular E170 / Roche Cobas e601/602
ng/ml = µg/l 12.2 9.76 14.6 Beckman Access
ng/ml = µg/l 12.2 9.76 14.6 Tosoh Series
ng/ml = µg/l 13.9 11.1 16.7 Vitros ECi
ng/ml = µg/l 20.2 16.2 24.2 Roche Cobas 4000/c311
ng/ml = µg/l 21.5 17.2 25.8 Roche Cobas c501/502/503/701/702
ng/ml = µg/l 13.5 10.8 16.2 Siemens Centaur CP
ng/ml = µg/l 16.1 12.9 19.3 Diasorin Liaison XL
ng/ml = µg/l 20.5 16.4 24.6 Abbott Alinity i
ng/ml = µg/l 13.6 10.9 16.3 Siemens Atellica IM
ng/ml = µg/l 20.0 16.0 24.0 Roche Cobas e402/e801
Folate nmol/l 7.19 5.46 8.92 Abbott Architect
ng/ml 3.17 2.41 3.93
nmol/l 20.0 15.2 24.8 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 8.82 6.70 10.9
nmol/l 5.64 4.29 6.99 Siemens Immulite 2000
ng/ml 2.49 1.89 3.09
nmol/l 6.69 5.08 8.30 Beckman DxI 600 / 800 - A14208
ng/ml 2.95 2.24 3.66
nmol/l 7.38 5.61 9.15 Beckman Access
ng/ml 3.25 2.47 4.03
nmol/l 5.77 4.39 7.15 Vitros ECi
ng/ml 2.54 1.94 3.14
nmol/l 3.07 2.33 3.81 Siemens Dimension
ng/ml 1.35 1.03 1.67
nmol/l 6.94 5.27 8.61 Beckman DxI 600 / 800 - A98032
ng/ml 3.06 2.32 3.80
nmol/l 6.75 5.13 8.37 Roche Folate III - 04476433
ng/ml 2.98 2.26 3.70
nmol/l 6.50 4.94 8.06 Roche Folate III - 07559992
ng/ml 2.87 2.18 3.56
nmol/l 24.9 18.9 30.9 Siemens Atellica IM
ng/ml 11.0 8.33 13.7
nmol/l 7.45 5.66 9.24 Abbott Alinity i
ng/ml 3.29 2.50 4.08
nmol/l 5.77 4.39 7.15 Roche Folate 07027290 e801
ng/ml 2.54 1.94 3.14
Free T3 pmol/l 3.43 2.57 4.29 Abbott Architect, 2 point calibration
ng/dl 0.223 0.167 0.279
pg/ml 2.23 1.67 2.79

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 3.79 2.84 4.74 BioMerieux Vidas
ng/dl 0.246 0.185 0.307
pg/ml 2.47 1.85 3.09
pmol/l 4.91 3.68 6.14 Siemens Centaur XP/XPT/Classic
ng/dl 0.319 0.239 0.399
pg/ml 3.20 2.40 4.00
pmol/l 3.76 2.82 4.70 Siemens Immulite 2000/2500
ng/dl 0.244 0.183 0.305
pg/ml 2.45 1.84 3.06
pmol/l 4.09 3.07 5.11 Beckman DxI800
ng/dl 0.266 0.200 0.332
pg/ml 2.66 2.00 3.32
pmol/l 5.02 3.77 6.28 Roche Elecsys
ng/dl 0.326 0.245 0.407
pg/ml 3.27 2.45 4.09
pmol/l 3.52 2.64 4.40 Diasorin Liaison
ng/dl 0.229 0.172 0.286
pg/ml 2.29 1.72 2.86
pmol/l 4.09 3.07 5.11 Beckman Access
ng/dl 0.266 0.200 0.332
pg/ml 2.66 2.00 3.32
pmol/l 3.53 2.65 4.41 Tosoh Series
ng/dl 0.229 0.172 0.286
pg/ml 2.30 1.73 2.87
pmol/l 7.70 5.78 9.63 Vitros ECi
ng/dl 0.501 0.376 0.626
pg/ml 5.01 3.76 6.26
pmol/l 5.19 3.89 6.49 Roche Cobas 4000/E411
ng/dl 0.337 0.253 0.421
pg/ml 3.38 2.53 4.23
pmol/l 4.96 3.72 6.20 Roche Cobas e601/602
ng/dl 0.322 0.242 0.402
pg/ml 3.23 2.42 4.04
pmol/l 4.13 3.10 5.16 Fujirebio Lumipulse G Series
ng/dl 0.268 0.202 0.334
pg/ml 2.69 2.02 3.36
pmol/l 5.09 3.82 6.36 Siemens Centaur CP
ng/dl 0.331 0.248 0.414
pg/ml 3.31 2.49 4.13
pmol/l 4.34 3.26 5.43 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/dl 0.282 0.212 0.352
pg/ml 2.83 2.12 3.54
pmol/l 3.52 2.64 4.40 Sysmex HISCL Series
ng/dl 0.229 0.172 0.286
pg/ml 2.29 1.72 2.86

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T3 pmol/l 3.46 2.60 4.33 Diasorin Liaison XL
ng/dl 0.225 0.169 0.281
pg/ml 2.25 1.69 2.81
pmol/l 5.40 4.05 6.75 Siemens Atellica IM
ng/dl 0.351 0.263 0.439
pg/ml 3.52 2.64 4.40
pmol/l 3.57 2.68 4.46 Abbott Alinity, 2 point cal
ng/dl 0.232 0.174 0.290
pg/ml 2.32 1.74 2.90
pmol/l 3.41 2.56 4.26 Abbott Architect, 6 point calibration
ng/dl 0.222 0.166 0.278
pg/ml 2.22 1.67 2.77
pmol/l 4.91 3.68 6.14 Roche Cobas e402/e801
ng/dl 0.319 0.239 0.399
pg/ml 3.20 2.40 4.00
pmol/l 2.86 2.15 3.58 Tosoh AIA-CL Series
ng/dl 0.186 0.140 0.232
pg/ml 1.86 1.40 2.32
pmol/l 3.59 2.69 4.49 Abbott Alinity, 6 point cal
ng/dl 0.233 0.175 0.291
pg/ml 2.34 1.75 2.93
Free T4 pmol/l 9.49 7.12 11.9 Abbott Architect
ng/dl 0.740 0.555 0.925
pg/ml 7.40 5.55 9.25
pmol/l 8.60 6.45 10.8 Siemens Centaur XP/XPT/Classic
ng/dl 0.671 0.503 0.839
pg/ml 6.71 5.03 8.39
pmol/l 13.8 10.4 17.3 Siemens Immulite 2000/2500
ng/dl 1.08 0.811 1.35
pg/ml 10.8 8.11 13.5
pmol/l 13.2 9.90 16.5 Siemens Immulite 1000
ng/dl 1.03 0.772 1.29
pg/ml 10.3 7.72 12.9
pmol/l 10.3 7.73 12.9 Beckman DxI800
ng/dl 0.803 0.603 1.00
pg/ml 8.03 6.03 10.0
pmol/l 14.1 10.6 17.6 Roche Elecsys
ng/dl 1.10 0.827 1.37
pg/ml 11.0 8.27 13.7
pmol/l 12.2 9.15 15.3 Diasorin Liaison
ng/dl 0.952 0.714 1.19
pg/ml 9.52 7.14 11.9
pmol/l 10.6 7.95 13.3 Beckman Access
ng/dl 0.827 0.620 1.03
pg/ml 8.27 6.20 10.3

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 9.43 7.07 11.8 Tosoh Series
ng/dl 0.736 0.551 0.921
pg/ml 7.36 5.51 9.21
pmol/l 15.0 11.3 18.8 Vitros ECi
ng/dl 1.17 0.881 1.46
pg/ml 11.7 8.81 14.6
pmol/l 12.2 9.15 15.3 BioMerieux Vidas
ng/dl 0.952 0.714 1.19
pg/ml 9.52 7.14 11.9
pmol/l 13.6 10.2 17.0 Roche Cobas e601/602
ng/dl 1.06 0.796 1.32
pg/ml 10.6 7.96 13.2
pmol/l 13.7 10.3 17.1 Roche Cobas 4000/E411
ng/dl 1.07 0.803 1.34
pg/ml 10.7 8.03 13.4
pmol/l 11.4 8.55 14.3 Biomerieux Vidas FT4N Kit
ng/dl 0.889 0.667 1.11
pg/ml 8.89 6.67 11.1
pmol/l 10.8 8.10 13.5 Immunotech RIA
ng/dl 0.842 0.632 1.05
pg/ml 8.42 6.32 10.5
pmol/l 8.08 6.06 10.1 Fujirebio Lumipulse G Series
ng/dl 0.630 0.473 0.787
pg/ml 6.30 4.73 7.87
pmol/l 8.21 6.16 10.3 Siemens Dimension ExI LOCI
ng/dl 0.640 0.480 0.800
pg/ml 6.40 4.80 8.00
pmol/l 9.27 6.95 11.6 Siemens Centaur CP
ng/dl 0.723 0.542 0.904
pg/ml 7.23 5.42 9.04
pmol/l 12.0 9.00 15.0 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/dl 0.936 0.702 1.17
pg/ml 9.36 7.02 11.7
pmol/l 9.88 7.41 12.4 Sysmex HISCL Series
ng/dl 0.771 0.578 0.964
pg/ml 7.71 5.78 9.64
pmol/l 12.2 9.15 15.3 Diasorin Liaison XL
ng/dl 0.952 0.714 1.19
pg/ml 9.52 7.14 11.9
pmol/l 9.53 7.15 11.9 Siemens Atellica IM
ng/dl 0.743 0.558 0.928
pg/ml 7.43 5.58 9.28
pmol/l 9.42 7.07 11.8 Abbott Alinity i
ng/dl 0.735 0.551 0.919
pg/ml 7.35 5.51 9.19
pmol/l 13.1 9.83 16.4 Roche Cobas e402/e801
ng/dl 1.02 0.767 1.27
pg/ml 10.2 7.67 12.7

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 11.2 8.40 14.0 Tosoh AIA-CL Series
ng/dl 0.874 0.655 1.09
pg/ml 8.74 6.55 10.9
FSH mU/ml 5.84 4.67 7.01 Abbott Architect
mU/ml 6.26 5.01 7.51 BioMerieux Vidas
mU/ml 8.69 6.95 10.4 Siemens Centaur XP/XPT/Classic
mU/ml 6.53 5.22 7.84 Siemens Immulite 2000/2500
mU/ml 6.77 5.42 8.12 Siemens Immulite 1000
mU/ml 6.84 5.47 8.21 Beckman DxI800
mU/ml 6.37 5.10 7.64 Roche/BM Elecsys
mU/ml 6.80 5.44 8.16 Beckman Access
mU/ml 7.78 6.22 9.34 Tosoh Series
mU/ml 5.34 4.27 6.41 Vitros ECi
mU/ml 6.74 5.39 8.09 Roche Cobas 4000/E411
mU/ml 6.03 4.82 7.24 Roche Cobas e601/602
mU/ml 6.85 5.48 8.22 Siemens Centaur CP
mU/ml 7.62 6.10 9.14 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
mU/ml 8.92 7.14 10.7 Diasorin Liaison XL
mU/ml 7.30 5.84 8.76 Siemens Atellica IM
mU/ml 6.13 4.90 7.36 Abbott Alinity i
mU/ml 6.38 5.10 7.66 Roche Cobas e402/e801
Gentamicin µmol/l 4.48 3.58 5.38 Roche Integra
µg/ml 2.14 1.71 2.57
µmol/l 4.69 3.75 5.63 Siemens Centaur XP/XPT/Classic
µg/ml 2.24 1.79 2.69
µmol/l 4.61 3.69 5.53 Abbott Architect (CMIA)
µg/ml 2.20 1.76 2.64
µmol/l 3.43 2.74 4.12 Roche Cobas 6000/8000 Online KIMS
µg/ml 1.64 1.31 1.97
µmol/l 4.32 3.46 5.18 Roche Cobas 6000/8000 CEDIA
µg/ml 2.06 1.65 2.47
µmol/l 4.62 3.70 5.54 Siemens Atellica CH
µg/ml 2.21 1.77 2.65
µmol/l 5.13 4.10 6.16 Abbott Alinity (PETINA)
µg/ml 2.45 1.96 2.94
µmol/l 4.85 3.88 5.82 Gravimetric
µg/ml 2.32 1.85 2.78
Growth Hormone (GH) µU/ml 4.26 3.41 5.11 Siemens Immulite 2000/2500
ng/ml 1.42 1.14 1.70
µU/ml 4.09 3.27 4.91 Siemens Immulite 1000
ng/ml 1.36 1.09 1.63
µU/ml 2.84 2.27 3.41 Beckman DxI800
ng/ml 0.946 0.756 1.14
µU/ml 2.80 2.24 3.36 Beckman Access
ng/ml 0.932 0.746 1.12

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Growth Hormone (GH) µU/ml 3.98 3.18 4.78 Tosoh Series
ng/ml 1.33 1.06 1.60
µU/ml 2.87 2.30 3.44 Diasorin Liaison
ng/ml 0.956 0.766 1.15
µU/ml 4.37 3.50 5.24 Roche Cobas 4000/E411
ng/ml 1.46 1.17 1.75
µU/ml 4.35 3.48 5.22 Roche Cobas e601/602
ng/ml 1.45 1.16 1.74
µU/ml 2.81 2.25 3.37 Diasorin Liaison XL
ng/ml 0.936 0.749 1.12
µU/ml 4.42 3.54 5.30 Roche Cobas e402/e801
ng/ml 1.47 1.18 1.76
µU/ml 3.06 2.45 3.67 Tosoh AIA-CL Series
ng/ml 1.02 0.816 1.22
Immunoglobulin E KIU/l = IU/ml 219 175 263 Abbott Architect
KIU/l = IU/ml 204 163 245 BioMerieux Vidas
KIU/l = IU/ml 233 186 280 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 252 202 302 Siemens Immulite 2000/2500
KIU/l = IU/ml 263 210 316 Siemens Immulite 1000
KIU/l = IU/ml 230 184 276 Roche Elecsys
KIU/l = IU/ml 222 178 266 Pharmacia Unicap
KIU/l = IU/ml 213 170 256 Tosoh Series
KIU/l = IU/ml 233 186 280 Roche Cobas 4000/E411
KIU/l = IU/ml 230 184 276 Roche Cobas e601/602
KIU/l = IU/ml 284 227 341 Agappe Mispa i2
KIU/l = IU/ml 232 186 278 Siemens Atellica IM
KIU/l = IU/ml 237 190 284 Roche Cobas e402/e801
KIU/l = IU/ml 220 176 264 Abbott Alinity
Insulin mU/l 1.40 1.05 1.75 Siemens Centaur XP/XPT/Classic
µU/ml 1.40 1.05 1.75
mU/l 7.97 5.98 9.96 Siemens Immulite 2000
µU/ml 7.97 5.98 9.96
mU/l 0.814 0.611 1.02 Beckman Access
µU/ml 0.814 0.611 1.02
mU/l 0.950 0.713 1.19 Abbott Architect
µU/ml 0.950 0.713 1.19
mU/l 0.773 0.580 0.966 Beckman DxI 600/800
µU/ml 0.773 0.580 0.966
mU/l 1.25 0.938 1.56 Mindray CL Series
µU/ml 1.25 0.938 1.56
mU/l 0.812 0.609 1.02 Diasorin Liaison XL
µU/ml 0.812 0.609 1.02
mU/l 1.19 0.893 1.49 Siemens Atellica IM
µU/ml 1.19 0.893 1.49
mU/l 1.20 0.900 1.50 Tosoh AIA-CL Series
µU/ml 1.20 0.900 1.50

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Luteinising Hormone (LH) mU/ml 2.13 1.70 2.56 Abbott Architect
mU/ml 2.75 2.20 3.30 BioMerieux Vidas
mU/ml 2.96 2.37 3.55 Siemens Centaur XP/XPT/Classic
mU/ml 5.00 4.00 6.00 Siemens Immulite 2000
mU/ml 5.18 4.14 6.22 Siemens Immulite 1000
mU/ml 2.16 1.73 2.59 Beckman DxI800
mU/ml 3.94 3.15 4.73 Roche Elecsys
mU/ml 2.23 1.78 2.68 Beckman Access
mU/ml 2.54 2.03 3.05 Tosoh Series
mU/ml 6.43 5.14 7.72 Vitros ECi
mU/ml 3.93 3.14 4.72 Roche Cobas 4000/E411
mU/ml 3.93 3.14 4.72 Roche Cobas e601/602
mU/ml 2.80 2.24 3.36 Siemens Centaur CP
mU/ml 3.61 2.89 4.33 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
mU/ml 3.71 2.97 4.45 Diasorin Liaison XL
mU/ml 2.74 2.19 3.29 Siemens Atellica IM
mU/ml 2.17 1.74 2.60 Abbott Alinity i
mU/ml 3.91 3.13 4.69 Roche Cobas e402/e801
Oestradiol pmol/l 175 140 210 Abbott Architect
pg/ml 47.6 38.1 57.1
pmol/l 320 256 384 BioMerieux Vidas
pg/ml 87.0 69.6 104
pmol/l 147 118 176 Siemens Centaur XP/XPT/Classic
pg/ml 40.0 32.1 47.9
pmol/l 130 104 156 Beckman DxI800
pg/ml 35.4 28.3 42.5
pmol/l 193 154 232 Roche Elecsys (Estradiol II)
pg/ml 52.5 41.9 63.1
pmol/l 133 106 160 Beckman Access
pg/ml 36.2 28.8 43.6
pmol/l 138 110 166 Tosoh (E2)
pg/ml 37.5 29.9 45.1
pmol/l 89.5 71.6 107 Vitros ECi
pg/ml 24.3 19.5 29.1
pmol/l 194 155 233 Roche Cobas e601/602 (Estradiol II)
pg/ml 52.8 42.2 63.4
pmol/l 192 154 230 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 52.2 41.9 62.5
pmol/l 164 131 197 Siemens Centaur CP
pg/ml 44.6 35.6 53.6
pmol/l 138 110 166 Siemens Centaur CP Enhanced (eE2)
pg/ml 37.5 29.9 45.1
pmol/l 198 158 238 Roche Cobas e601/602 (Estradiol III)
pg/ml 53.9 43.0 64.8
pmol/l 184 147 221 Roche Elecsys (Estradiol III)
pg/ml 50.0 40.0 60.0

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 191 153 229 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 52.0 41.6 62.4
pmol/l 154 123 185 Mindray CL Series
pg/ml 41.9 33.5 50.3
pmol/l 95.2 76.2 114 Diasorin Liaison XL
pg/ml 25.9 20.7 31.1
pmol/l 131 105 157 Beckman Access / Access 2 Sensitive B84493
pg/ml 35.6 28.6 42.6
pmol/l 122 97.6 146 Beckman DxI600/800 Sensitive B84493
pg/ml 33.2 26.5 39.9
pmol/l 163 130 196 Siemens Atellica IM
pg/ml 44.3 35.4 53.2
pmol/l 161 129 193 Abbott Alinity i
pg/ml 43.8 35.1 52.5
pmol/l 194 155 233 Roche Cobas e801 (Estradiol III)
pg/ml 52.8 42.2 63.4
pmol/l 78.6 62.9 94.3 Tosoh AIA-CL Series
pg/ml 21.4 17.1 25.7
Paracetamol mmol/l 0.153 0.122 0.184 Roche Cobas c501/502/503/701/702
mg/l 23.1 18.5 27.7
mmol/l 0.164 0.131 0.197 Beckman AU Instruments
mg/l 24.8 19.8 29.8
mmol/l 0.164 0.131 0.197 Abbott Alinity
mg/l 24.8 19.8 29.8
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 (CMIA)
µg/ml 8.24 6.59 9.89
µmol/l 32.1 25.7 38.5 Roche Cobas e601/602/801
µg/ml 7.45 5.96 8.94
µmol/l 32.9 26.3 39.5 Beckman AU400/600/640/2700/5400
µg/ml 7.63 6.10 9.16
µmol/l 50.1 40.1 60.1 Siemens Centaur XP/XPT/Classic
µg/ml 11.6 9.30 13.9
µmol/l 34.0 27.2 40.8 Roche Integra
µg/ml 7.89 6.31 9.47
µmol/l 33.3 26.6 40.0 Roche Cobas C303/501/502/503/701
µg/ml 7.73 6.17 9.29
µmol/l 32.4 25.9 38.9 Abbott Architect (PETINA)
µg/ml 7.52 6.01 9.03
µmol/l 29.3 23.4 35.2 Abbott Alinity (PETINA)
µg/ml 6.80 5.43 8.17
µmol/l 34.5 27.6 41.4 Gravimetric
µg/ml 8.00 6.40 9.60
Phenytoin µmol/l 19.5 15.6 23.4 Abbott Architect
µg/ml 4.92 3.94 5.90

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Phenytoin µmol/l 18.9 15.1 22.7 Siemens Centaur XP/XPT/Classic
µg/ml 4.77 3.81 5.73
µmol/l 17.2 13.8 20.6 Siemens Dimension
µg/ml 4.34 3.48 5.20
µmol/l 19.5 15.6 23.4 Roche Integra
µg/ml 4.92 3.94 5.90
µmol/l 18.8 15.0 22.6 Roche Cobas 6000/8000
µg/ml 4.75 3.79 5.71
µmol/l 19.1 15.3 22.9 Beckman AU Instruments
µg/ml 4.82 3.86 5.78
µmol/l 19.8 15.8 23.8 EMIT
µg/ml 5.00 3.99 6.01
µmol/l 17.8 14.2 21.4 Siemens Atellica CH
µg/ml 4.49 3.59 5.39
µmol/l 19.5 15.6 23.4 Abbott Alinity
µg/ml 4.92 3.94 5.90
µmol/l 20.2 16.2 24.2 Gravimetric
µg/ml 5.10 4.09 6.11
Primidone µmol/l 12.3 9.84 14.8 Gravimetric
µg/ml 2.69 2.15 3.23
Progesterone nmol/l 3.14 2.51 3.77 Abbott Architect
ng/ml 0.983 0.786 1.18
nmol/l 4.49 3.59 5.39 BioMerieux Vidas
ng/ml 1.41 1.12 1.70
nmol/l 2.59 2.07 3.11 Siemens Centaur XP/XPT/Classic
ng/ml 0.811 0.648 0.974
nmol/l 2.88 2.30 3.46 Siemens Immulite 2000/2500
ng/ml 0.901 0.720 1.08
nmol/l 3.24 2.59 3.89 Roche Elecsys (Prog. II)
ng/ml 1.01 0.811 1.21
nmol/l 2.14 1.71 2.57 Tosoh Series
ng/ml 0.670 0.535 0.805
nmol/l 2.17 1.74 2.60 Vitros ECi
ng/ml 0.679 0.545 0.813
nmol/l 3.37 2.70 4.04 Roche Cobas 4000/e411 (Prog. II)
ng/ml 1.05 0.845 1.26
nmol/l 3.48 2.78 4.18 Roche Cobas e601/602 (Prog. II)
ng/ml 1.09 0.870 1.31
nmol/l 2.46 1.97 2.95 Beckman Access Prog DE Cal A80773
ng/ml 0.770 0.617 0.923
nmol/l 2.58 2.06 3.10 Siemens Centaur CP
ng/ml 0.808 0.645 0.971
nmol/l 2.61 2.09 3.13 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/ml 0.817 0.654 0.980
nmol/l 3.49 2.79 4.19 Roche Cobas e601/602 (Prog. III)
ng/ml 1.09 0.873 1.31

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 3.24 2.59 3.89 Roche Elecsys (Prog. III)
ng/ml 1.01 0.811 1.21
nmol/l 3.41 2.73 4.09 Roche Cobas 4000/e411 (Prog. III)
ng/ml 1.07 0.854 1.29
nmol/l 2.66 2.13 3.19 Abbott Alinity i
ng/ml 0.833 0.667 0.999
nmol/l 2.89 2.31 3.47 Siemens Atellica IM
ng/ml 0.905 0.723 1.09
nmol/l 3.27 2.62 3.92 Roche Cobas e801 (Prog. III)
ng/ml 1.02 0.820 1.22
nmol/l 3.58 2.86 4.30 Tosoh AIA-CL Series
ng/ml 1.12 0.895 1.35
Prolactin µU/ml 161 129 193 Abbott Architect
µU/ml 125 100 150 BioMerieux Vidas
µU/ml 139 111 167 Siemens Centaur XP/XPT/Classic
µU/ml 137 110 164 Siemens Immulite 2000/2500
µU/ml 150 120 180 Siemens Immulite 1000
µU/ml 140 112 168 Beckman DxI800
µU/ml 171 137 205 Roche Elecsys
µU/ml 148 118 178 Beckman Access
µU/ml 149 119 179 Tosoh Series
µU/ml 169 135 203 Vitros ECi
µU/ml 175 140 210 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 188 150 226 Immunotech IRMA
µU/ml 179 143 215 Roche Cobas 4000/E411
µU/ml 173 138 208 Roche Cobas e601/602
µU/ml 132 106 158 Siemens Centaur CP
µU/ml 190 152 228 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
µU/ml 175 140 210 Diasorin Liaison XL
µU/ml 138 110 166 Siemens Atellica IM
µU/ml 163 130 196 Abbott Alinity i
µU/ml 173 138 208 Roche Cobas e801 PRL II
PSA Free ng/ml = µg/l 1.42 1.07 1.78 Abbott Architect
ng/ml = µg/l 1.93 1.45 2.41 BioMerieux Vidas
ng/ml = µg/l 1.29 0.968 1.61 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.16 0.870 1.45 Siemens Immulite 2000/2500
ng/ml = µg/l 1.04 0.780 1.30 Siemens Immulite 1000
ng/ml = µg/l 1.73 1.30 2.16 Beckman DXI standardised to Hybritech
ng/ml = µg/l 1.19 0.893 1.49 Roche Elecsys
ng/ml = µg/l 1.74 1.31 2.18 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.18 0.885 1.48 Tosoh Series
ng/ml = µg/l 1.16 0.870 1.45 Roche Cobas 4000/E411
ng/ml = µg/l 1.19 0.893 1.49 Roche Cobas e601/602
ng/ml = µg/l 1.05 0.788 1.31 Siemens Dimension Vista
ng/ml = µg/l 1.44 1.08 1.80 Beckman DxI800 standardised to WHO IRP96/670

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
PSA Free ng/ml = µg/l 1.69 1.27 2.11 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 1.06 0.795 1.33 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 1.47 1.10 1.84 Diasorin Liaison XL
ng/ml = µg/l 1.37 1.03 1.71 Siemens Atellica IM
ng/ml = µg/l 1.48 1.11 1.85 Abbott Alinity i
ng/ml = µg/l 1.17 0.878 1.46 Roche Cobas e402/e801
PSA Total ng/ml = µg/l 1.24 0.930 1.55 Abbott Architect
ng/ml = µg/l 1.63 1.22 2.04 BioMerieux Vidas
ng/ml = µg/l 1.60 1.20 2.00 bioMerieux VIDAS TPSA
ng/ml = µg/l 1.56 1.17 1.95 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 1.36 1.02 1.70 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 1.50 1.13 1.88 Siemens Immulite 1000 1st generation
ng/ml = µg/l 1.66 1.25 2.08 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 1.41 1.06 1.76 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 1.54 1.16 1.93 Roche Elecsys
ng/ml = µg/l 1.72 1.29 2.15 Beckman Access standardised to Hybritech
ng/ml = µg/l 1.73 1.30 2.16 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 1.17 0.878 1.46 Tosoh Series
ng/ml = µg/l 1.55 1.16 1.94 Vitros ECi
ng/ml = µg/l 1.25 0.938 1.56 Immunotech IRMA
ng/ml = µg/l 1.58 1.19 1.98 Roche Cobas 4000/E411
ng/ml = µg/l 1.63 1.22 2.04 Roche Cobas e601/602
ng/ml = µg/l 1.11 0.833 1.39 Fujirebio Lumipulse G Series
ng/ml = µg/l 1.57 1.18 1.96 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 1.42 1.07 1.78 Siemens Centaur CP
ng/ml = µg/l 1.44 1.08 1.80 Diasorin Liaison XL
ng/ml = µg/l 1.52 1.14 1.90 Siemens Atellica IM
ng/ml = µg/l 1.30 0.975 1.63 Abbott Alinity i
ng/ml = µg/l 1.60 1.20 2.00 Roche Cobas e402/e801
Salicylic Acid mmol/l 0.268 0.214 0.322 Roche Cobas c501/502/503
mg/dl 3.70 2.96 4.44
mmol/l 0.293 0.234 0.352 EMIT
mg/dl 4.05 3.23 4.87
mmol/l 0.286 0.230 0.340 Gravimetric
mg/dl 3.95 3.18 4.70
SHBG nmol/l 10.3 8.24 12.4 Siemens Immulite 2000/2500
nmol/l 10.1 8.08 12.1 Abbott Architect
nmol/l 10.1 8.08 12.1 Beckman DxI800
nmol/l 8.63 6.90 10.4 Siemens Atellica IM
nmol/l 9.70 7.76 11.6 Roche analysers - 413417/15
nmol/l 9.77 7.82 11.7 Roche Cobas e801 - 413429
nmol/l 10.0 8.00 12.0 Abbott Alinity i
T Uptake %U 31.3 25.7 36.9 Siemens Immulite 2000
Testosterone nmol/l 2.69 2.15 3.23 Abbott Architect
ng/ml 0.775 0.619 0.931
ng/dl 77.5 61.9 93.1

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 1.39 1.11 1.67 BioMerieux Vidas
ng/ml 0.400 0.320 0.480
ng/dl 40.0 32.0 48.0
nmol/l 1.99 1.59 2.39 Siemens Centaur XP/XPT/Classic
ng/ml 0.573 0.458 0.688
ng/dl 57.3 45.8 68.8
nmol/l 1.20 0.960 1.44 Siemens Immulite 1000
ng/ml 0.346 0.276 0.416
ng/dl 34.6 27.6 41.6
nmol/l 1.90 1.52 2.28 Beckman DxI800
ng/ml 0.547 0.438 0.656
ng/dl 54.7 43.8 65.6
nmol/l 2.08 1.66 2.50 Beckman Access
ng/ml 0.599 0.478 0.720
ng/dl 59.9 47.8 72.0
nmol/l 1.14 0.912 1.37 Vitros ECi
ng/ml 0.328 0.263 0.393
ng/dl 32.8 26.3 39.3
nmol/l 2.35 1.88 2.82 Roche Cobas e601/602 Test II
ng/ml 0.677 0.541 0.813
ng/dl 67.7 54.1 81.3
nmol/l 2.32 1.86 2.78 Roche Elecsys Test II
ng/ml 0.668 0.536 0.800
ng/dl 66.8 53.6 80.0
nmol/l 2.43 1.94 2.92 Roche Cobas 4000/e411 Test II
ng/ml 0.700 0.559 0.841
ng/dl 70.0 55.9 84.1
nmol/l 2.68 2.14 3.22 Abbott Architect 2nd Generation
ng/ml 0.772 0.616 0.928
ng/dl 77.2 61.6 92.8
nmol/l 1.44 1.15 1.73 BioMerieux Vidas Testosterone II
ng/ml 0.415 0.331 0.499
ng/dl 41.5 33.1 49.9
nmol/l 1.76 1.41 2.11 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
ng/ml 0.507 0.406 0.608
ng/dl 50.7 40.6 60.8
nmol/l 2.03 1.62 2.44 Siemens Centaur TST II
ng/ml 0.585 0.467 0.703
ng/dl 58.5 46.7 70.3
nmol/l 1.77 1.42 2.12 Siemens Atellica IM
ng/ml 0.510 0.409 0.611
ng/dl 51.0 40.9 61.1
nmol/l 2.51 2.01 3.01 Roche Cobas e801 Test II
ng/ml 0.723 0.579 0.867
ng/dl 72.3 57.9 86.7
nmol/l 2.36 1.89 2.83 Tosoh AIA-CL Series
ng/ml 0.680 0.544 0.816
ng/dl 68.0 54.4 81.6

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 2.64 2.11 3.17 Abbott Alinity i
ng/ml 0.760 0.608 0.912
ng/dl 76.0 60.8 91.2
Theophylline µmol/l 28.0 22.4 33.6 Roche Integra
µg/ml 5.05 4.04 6.06
µmol/l 24.8 19.8 29.8 Abbott Architect (CMIA)
µg/ml 4.47 3.57 5.37
µmol/l 27.0 21.6 32.4 Roche Cobas 6000/8000
µg/ml 4.87 3.89 5.85
µmol/l 25.6 20.5 30.7 Beckman AU400/600/640/2700/5400
µg/ml 4.61 3.69 5.53
µmol/l 25.7 20.6 30.8 Abbott Alinity Enzyme-Immu
µg/ml 4.63 3.71 5.55
µmol/l 28.3 22.6 34.0 Gravimetric
µg/ml 5.10 4.07 6.13
Thyroglobulin ng/ml 1.84 1.38 2.30 Roche Elecsys
ng/ml 1.27 0.953 1.59 Beckman DxI800
ng/ml 1.96 1.47 2.45 Roche Cobas 4000/E411
ng/ml 1.90 1.43 2.38 Roche Cobas e601/602
ng/ml 1.37 1.03 1.71 Beckman Access
ng/ml 1.74 1.31 2.18 Abbott Architect 2000i
ng/ml 2.00 1.50 2.50 Tosoh Series
ng/ml 1.89 1.42 2.36 Roche Cobas e601/602 Tg II
ng/ml 1.91 1.43 2.39 Roche Elecsys TGII
ng/ml 1.92 1.44 2.40 Roche Cobas 4000/E411 TGII
ng/ml 0.660 0.495 0.825 Diasorin Liaison XL
ng/ml 1.86 1.40 2.33 Roche Cobas e801 Tg II
ng/ml 0.660 0.495 0.825 DiaSorin Liaison TG II Gen
ng/ml 0.730 0.548 0.913 DiaSorin Liaison XL TG II Gen
ng/ml 1.72 1.29 2.15 Abbott Alinity i
Thyroid Stimulating µU/ml = mlU/l 0.087 0.070 0.104 Abbott Architect
Hormone
µU/ml = mlU/l 0.076 0.061 0.091 bioMerieux VIDAS TSH
µU/ml = mlU/l 0.067 0.054 0.080 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 0.099 0.079 0.119 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 0.100 0.080 0.120 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 0.089 0.071 0.107 Siemens Immulite 2000/2500
µU/ml = mlU/l 0.079 0.063 0.095 Beckman DxI800
µU/ml = mlU/l 0.134 0.107 0.161 Roche Elecsys
µU/ml = mlU/l 0.136 0.109 0.163 Diasorin Liaison
µU/ml = mlU/l 0.077 0.062 0.092 Beckman Access Fast TSH
µU/ml = mlU/l 0.077 0.062 0.092 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 0.360 0.288 0.432 Tosoh Series
µU/ml = mlU/l 0.139 0.111 0.167 Roche Cobas 4000/E411
µU/ml = mlU/l 0.136 0.109 0.163 Roche Cobas e601/602

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 0.077 0.062 0.092 Beckman DxI800 Hyper TSH
Hormone
µU/ml = mlU/l 0.102 0.082 0.122 Siemens Dimension Vista LOCI
µU/ml = mlU/l 0.098 0.078 0.118 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 0.095 0.076 0.114 Siemens Centaur CP
µU/ml = mlU/l 0.092 0.074 0.110 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 0.160 0.128 0.192 Mindray CL 8000i / 6000i / 2000i / 1200i / 1000i
µU/ml = mlU/l 0.079 0.063 0.095 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 0.144 0.115 0.173 Diasorin Liaison XL
µU/ml = mlU/l 0.095 0.076 0.114 Siemens Atellica IM
µU/ml = mlU/l 0.093 0.074 0.112 Abbott Alinity i
µU/ml = mlU/l 0.128 0.102 0.154 Roche Cobas e402/e801
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 11.6 9.28 13.9 Abbott Architect
IU/ml 0.012 0.009 0.015
mU/ml=IU/l 14.7 11.8 17.6 BioMerieux Vidas
IU/ml 0.015 0.012 0.018
mU/ml=IU/l 13.6 10.9 16.3 Siemens Centaur XP/XPT/Classic
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 16.5 13.2 19.8 Siemens Dimension
IU/ml 0.017 0.013 0.021
mU/ml=IU/l 19.8 15.8 23.8 Siemens Immulite 2000
IU/ml 0.020 0.016 0.024
mU/ml=IU/l 20.4 16.3 24.5 Siemens Immulite 1000
IU/ml 0.020 0.016 0.024
mU/ml=IU/l 13.2 10.6 15.8 Beckman DxI800
IU/ml 0.013 0.011 0.015
mU/ml=IU/l 11.4 9.12 13.7 Roche Cobas Core EIA
IU/ml 0.011 0.009 0.013
mU/ml=IU/l 12.8 10.2 15.4 Beckman Access
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 15.9 12.7 19.1 Tosoh Series
IU/ml 0.016 0.013 0.019
mU/ml=IU/l 17.4 13.9 20.9 Vitros ECi
IU/ml 0.017 0.014 0.020
mU/ml=IU/l 10.1 8.08 12.1 Roche hCG STAT (Intact)
IU/ml 0.010 0.008 0.012
mU/ml=IU/l 11.4 9.12 13.7 Roche hCG+Beta
IU/ml 0.011 0.009 0.013
mU/ml=IU/l 12.9 10.3 15.5 Beckman Access Total BhCG (5th IS)
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 13.3 10.6 16.0 Beckman DxI Total BhCG (5th IS)
IU/ml 0.013 0.011 0.015
mU/ml=IU/l 12.6 10.1 15.1 Siemens Centaur CP
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 9.89 7.91 11.9 Mindray CL Series
IU/ml 0.010 0.008 0.012

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 11.5 9.20 13.8 Diasorin Liaison XL
IU/ml 0.012 0.009 0.015
mU/ml=IU/l 12.8 10.2 15.4 Siemens Atellica IM
IU/ml 0.013 0.010 0.016
mU/ml=IU/l 12.0 9.60 14.4 Abbott Alinity i
IU/ml 0.012 0.010 0.014
mU/ml=IU/l 11.5 9.20 13.8 Roche hCG+Beta e801
IU/ml 0.012 0.009 0.015
mU/ml=IU/l 19.3 15.4 23.2 Tosoh AIA-CL Series
IU/ml 0.019 0.015 0.023
Total T3 nmol/l 0.893 0.670 1.12 Abbott Architect
ng/ml 0.581 0.436 0.726
ng/dl 58.1 43.6 72.6
nmol/l 0.713 0.535 0.891 BioMerieux Vidas
ng/ml 0.464 0.348 0.580
ng/dl 46.4 34.8 58.0
nmol/l 0.815 0.611 1.02 Siemens Centaur XP/XPT/Classic
ng/ml 0.531 0.398 0.664
ng/dl 53.1 39.8 66.4
nmol/l 0.642 0.482 0.803 Siemens Immulite 2000/2500
ng/ml 0.418 0.314 0.522
ng/dl 41.8 31.4 52.2
nmol/l 0.664 0.498 0.830 Siemens Immulite 1000
ng/ml 0.432 0.324 0.540
ng/dl 43.2 32.4 54.0
nmol/l 1.19 0.893 1.49 Beckman DxI800
ng/ml 0.775 0.581 0.969
ng/dl 77.5 58.1 96.9
nmol/l 1.39 1.04 1.74 Roche Elecsys
ng/ml 0.905 0.677 1.13
ng/dl 90.5 67.7 113
nmol/l 1.27 0.953 1.59 Beckman Access
ng/ml 0.827 0.620 1.03
ng/dl 82.7 62.0 103
nmol/l 0.759 0.569 0.949 Tosoh Series
ng/ml 0.494 0.370 0.618
ng/dl 49.4 37.0 61.8
nmol/l 1.02 0.765 1.28 Vitros ECi
ng/ml 0.664 0.498 0.830
ng/dl 66.4 49.8 83.0
nmol/l 1.42 1.07 1.78 Roche Cobas 4000/E411
ng/ml 0.924 0.697 1.15
ng/dl 92.4 69.7 115
nmol/l 0.781 0.586 0.976 Immunotech RIA
ng/ml 0.508 0.381 0.635
ng/dl 50.8 38.1 63.5

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 1.35 1.01 1.69 Roche Cobas e601/602
ng/ml 0.879 0.658 1.10
ng/dl 87.9 65.8 110
nmol/l 0.852 0.639 1.07 Mindray CL Series
ng/ml 0.555 0.416 0.694
ng/dl 55.5 41.6 69.4
nmol/l 0.910 0.683 1.14 Diasorin Liaison XL
ng/ml 0.592 0.445 0.739
ng/dl 59.2 44.5 73.9
nmol/l 0.895 0.671 1.12 Abbott Alinity i
ng/ml 0.583 0.437 0.729
ng/dl 58.3 43.7 72.9
nmol/l 0.846 0.635 1.06 Siemens Atellica IM
ng/ml 0.551 0.413 0.689
ng/dl 55.1 41.3 68.9
nmol/l 1.32 0.990 1.65 Roche Cobas e402/e801
ng/ml 0.859 0.644 1.07
ng/dl 85.9 64.4 107
nmol/l 0.795 0.596 0.994 Tosoh AIA-CL Series
ng/ml 0.518 0.388 0.648
ng/dl 51.8 38.8 64.8
Total T4 nmol/l 34.0 25.5 42.5 Abbott Architect
µg/dl 2.65 1.99 3.31
ng/ml 26.5 19.9 33.1
nmol/l 33.6 25.2 42.0 BioMerieux Vidas
µg/dl 2.62 1.97 3.27
ng/ml 26.2 19.7 32.7
nmol/l 23.0 17.3 28.8 Siemens Centaur XP/XPT/Classic
µg/dl 1.79 1.35 2.23
ng/ml 17.9 13.5 22.3
nmol/l 25.3 19.0 31.6 Siemens Immulite 2000/2500
µg/dl 1.97 1.48 2.46
ng/ml 19.7 14.8 24.6
nmol/l 22.1 16.6 27.6 Beckman DxI800
µg/dl 1.72 1.29 2.15
ng/ml 17.2 12.9 21.5
nmol/l 40.5 30.4 50.6 Roche Elecsys
µg/dl 3.16 2.37 3.95
ng/ml 31.6 23.7 39.5
nmol/l 24.8 18.6 31.0 Beckman Access
µg/dl 1.93 1.45 2.41
ng/ml 19.3 14.5 24.1
nmol/l 25.5 19.1 31.9 Tosoh Series
µg/dl 1.99 1.49 2.49
ng/ml 19.9 14.9 24.9

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 29.2 21.9 36.5 Vitros ECi
µg/dl 2.28 1.71 2.85
ng/ml 22.8 17.1 28.5
nmol/l 39.5 29.6 49.4 Roche Cobas 4000/E411
µg/dl 3.08 2.31 3.85
ng/ml 30.8 23.1 38.5
nmol/l 37.6 28.2 47.0 Roche Cobas e601/602
µg/dl 2.93 2.20 3.66
ng/ml 29.3 22.0 36.6
nmol/l 32.5 24.4 40.6 Immunotech IRMA
µg/dl 2.54 1.90 3.18
ng/ml 25.4 19.0 31.8
nmol/l 27.3 20.5 34.1 Mindray CL Series
µg/dl 2.13 1.60 2.66
ng/ml 21.3 16.0 26.6
nmol/l 39.6 29.7 49.5 Diasorin Liaison XL
µg/dl 3.09 2.32 3.86
ng/ml 30.9 23.2 38.6
nmol/l 33.2 24.9 41.5 Abbott Alinity i
µg/dl 2.59 1.94 3.24
ng/ml 25.9 19.4 32.4
nmol/l 29.3 22.0 36.6 Siemens Atellica IM
µg/dl 2.29 1.72 2.86
ng/ml 22.9 17.2 28.6
nmol/l 34.7 26.0 43.4 Roche Cobas e402/e801
µg/dl 2.71 2.03 3.39
ng/ml 27.1 20.3 33.9
nmol/l 35.5 26.6 44.4 Tosoh AIA-CL Series
µg/dl 2.77 2.07 3.47
ng/ml 27.7 20.7 34.7
Valproic Acid µmol/l 160 128 192 Abbott Architect (CMIA)
µg/ml 23.1 18.5 27.7
µmol/l 213 170 256 Siemens Centaur XP/XPT/Classic
µg/ml 30.7 24.5 36.9
µmol/l 199 159 239 Siemens Dimension
µg/ml 28.7 22.9 34.5
µmol/l 191 153 229 Siemens Immulite 2000/2500
µg/ml 27.6 22.1 33.1
µmol/l 202 162 242 Roche Integra
µg/ml 29.1 23.4 34.8
µmol/l 201 161 241 Roche Cobas 4000/c311
µg/ml 29.0 23.2 34.8
µmol/l 198 158 238 Roche Cobas 6000/8000
µg/ml 28.6 22.8 34.4
µmol/l 212 170 254 Beckman AU400/600/640/2700/5400
µg/ml 30.6 24.5 36.7

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 25 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 167 134 200 Abbott Architect (PETINA)
µg/ml 24.1 19.3 28.9
µmol/l 212 170 254 EMIT
µg/ml 30.6 24.5 36.7
µmol/l 202 162 242 Siemens Atellica CH
µg/ml 29.1 23.4 34.8
µmol/l 167 134 200 Abbott Alinity (CMIA)
µg/ml 24.1 19.3 28.9
µmol/l 174 139 209 Abbott Alinity (PETINA)
µg/ml 25.1 20.1 30.1
µmol/l 243 194 292 Gravimetric
µg/ml 35.1 28.0 42.1
Vancomycin µmol/l 3.58 2.86 4.30 Roche Integra
µg/ml 5.32 4.25 6.39
µmol/l 3.44 2.75 4.13 Ortho Vitros Microslide Systems
µg/ml 5.11 4.09 6.13
µmol/l 3.62 2.90 4.34 Abbott Architect (CMIA)
µg/ml 5.38 4.31 6.45
µmol/l 2.67 2.14 3.20 Siemens Centaur XP/XPT/Classic
µg/ml 3.97 3.18 4.76
µmol/l 3.47 2.78 4.16 Roche Cobas 6000/8000
µg/ml 5.16 4.13 6.19
µmol/l 3.14 2.51 3.77 Thermo Scientific QMS Vancomycin
µg/ml 4.67 3.73 5.61
µmol/l 3.63 2.90 4.36 Abbott Architect (PETINA)
µg/ml 5.39 4.31 6.47
µmol/l 3.50 2.80 4.20 EMIT
µg/ml 5.20 4.16 6.24
µmol/l 3.56 2.85 4.27 Siemens Atellica CH
µg/ml 5.29 4.23 6.35
µmol/l 3.81 3.05 4.57 Abbott Alinity (CMIA)
µg/ml 5.66 4.53 6.79
µmol/l 3.70 2.96 4.44 Abbott Alinity (PETINA)
µg/ml 5.50 4.40 6.60
µmol/l 3.43 2.74 4.12 Gravimetric
µg/ml 5.10 4.07 6.12
Vitamin B12 pmol/l 137 110 164 Abbott Architect
pg/ml 186 149 223
pmol/l 130 104 156 Siemens Centaur XP/XPT/Classic
pg/ml 176 141 211
pmol/l 114 91.2 137 Siemens Immulite 2000
pg/ml 154 124 184
pmol/l 85.0 68.0 102 Beckman DxI800
pg/ml 115 92.1 138
pmol/l 161 129 193 Roche Elecsys
pg/ml 218 175 261

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 26 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot. No. 2179EC Size 12 x 5ml / 4 x 5ml Expiry 2025-06-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 90.2 72.2 108 Beckman Access
pg/ml 122 97.8 146
pmol/l 131 105 157 Tosoh Series
pg/ml 178 142 214
pmol/l 141 113 169 Vitros ECi
pg/ml 191 153 229
pmol/l 118 94.4 142 Siemens Dimension
pg/ml 160 128 192
pmol/l 167 134 200 Roche Cobas 4000/e411 Gen II
pg/ml 226 182 270
pmol/l 154 123 185 Roche Cobas e601/602 Gen II
pg/ml 209 167 251
pmol/l 160 128 192 Mindray CL Series
pg/ml 217 173 261
pmol/l 149 119 179 Siemens Atellica IM
pg/ml 202 161 243
pmol/l 196 157 235 Abbott Alinity i
pg/ml 266 213 319
pmol/l 136 109 163 Roche Cobas e801 Gen II
pg/ml 184 148 220

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 27 OF 27
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
 2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 1

(IA PREMIUM PLUS 1)
CAT. NO. IA3109 GTIN: 05055273207255 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 2179EC EXPIRY: 2025-06-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes
listed in the package insert.

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS

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

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

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

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY

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

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

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

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

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

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

MATERIAL REQUIRED BUT NOT PROVIDED

Volumetric pipette

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

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

(S). 27 Mar ’23 me

PAGE 1 OF 4
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 2179EC Size: 12 x 5ml / 4 x 5ml Expiry: 2025-06-28
Range
Analyte unit Target low high methods
Alpha-fetoprotein KIU/l = lU/ml 7.80 6.24 9.36 Beckman Access / Access 2
ng/ml 9.44 7.55 11.3
KIU/l = lU/ml 7.86 6.29 9.43 Beckman DxI600/800
ng/ml 9.51 7.61 11.4
CA 15-3 U/ml 10.1 8.08 12.1 Beckman Access / Access 2
U/ml 10.3 8.24 12.4 Beckman DxI600/800
CA 19-9 U/ml 47.5 38.0 57.0 Beckman Access / Access 2
U/ml 42.8 34.2 51.4 Beckman DxI600/800
CA125 U/ml 15.7 12.6 18.8 Beckman Access / Access 2
U/ml 15.5 12.4 18.6 Beckman DxI600/800
Carcinoembryonic ng/ml = µg/l 3.94 3.15 4.73 Beckman Access / Access 2
Antigen (CEA) ng/ml = µg/l 3.90 3.12 4.68 Beckman DxI600/800
Cortisol nmol/l 231 173 289 Beckman Access / Access 2
µg/dl 8.32 6.23 10.4
nmol/l 225 169 281 Beckman DxI600/800
µg/dl 8.10 6.08 10.1
DHEA-S µmol/l 2.28 1.82 2.74 Beckman Access / Access 2
µg/dl 84.0 67.2 101
µmol/l 1.98 1.58 2.38 Beckman DxI600/800
µg/dl 73.0 58.4 87.6
Digoxin nmol/l 0.768 0.614 0.922 Beckman Access / Access 2
ng/ml 0.600 0.480 0.720
nmol/l 0.754 0.603 0.905 Beckman DxI600/800
ng/ml 0.589 0.471 0.707
Ferritin ng/ml = µg/l 12.2 9.76 14.6 Beckman Access / Access 2
ng/ml = µg/l 12.5 10.0 15.0 Beckman DxI600/800
Folate nmol/l 7.38 5.61 9.15 Beckman Access / Access 2
ng/ml 3.25 2.47 4.03
nmol/l 6.94 5.27 8.61 Beckman DxI600/800 - A98032
ng/ml 3.06 2.32 3.80
nmol/l 6.69 5.08 8.30 Beckman DxI600/800 - A14208
ng/ml 2.95 2.24 3.66
Free T3 pmol/l 4.09 3.07 5.11 Beckman Access / Access 2
ng/dl 0.266 0.200 0.332
pg/ml 2.66 2.00 3.32
pmol/l 4.09 3.07 5.11 Beckman DxI600/800
ng/dl 0.266 0.200 0.332
pg/ml 2.66 2.00 3.32
Free T4 pmol/l 10.6 7.95 13.3 Beckman Access / Access 2
ng/dl 0.827 0.620 1.03
pg/ml 8.27 6.20 10.3
pmol/l 10.3 7.73 12.9 Beckman DxI600/800
ng/dl 0.803 0.603 1.00
pg/ml 8.03 6.03 10.0
FSH mU/ml 6.80 5.44 8.16 Beckman Access / Access 2
mU/ml 6.84 5.47 8.21 Beckman DxI600/800
Growth Hormone (GH) µU/ml 2.80 2.24 3.36 Beckman Access / Access 2
ng/ml 0.932 0.746 1.12
µU/ml 2.84 2.27 3.41 Beckman DxI600/800
ng/ml 0.946 0.756 1.14
Insulin mU/l 0.814 0.611 1.02 Beckman Access / Access 2
mU/l 0.773 0.580 0.966 Beckman DxI600/800
Luteinising Hormone (LH) mU/ml 2.23 1.78 2.68 Beckman Access / Access 2
mU/ml 2.16 1.73 2.59 Beckman DxI600/800

PAGE 2 OF 4
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 2179EC Size: 12 x 5ml / 4 x 5ml Expiry: 2025-06-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 133 106 160 Beckman Access / Access 2
pg/ml 36.2 28.8 43.6
pmol/l 131 105 157 Beckman Access / Access 2 Sensitive B84493
pg/ml 35.6 28.6 42.6
pmol/l 130 104 156 Beckman DxI600/800
pg/ml 35.4 28.3 42.5
pmol/l 122 97.6 146 Beckman DxI600/800 Sensitive B84493
pg/ml 33.2 26.5 39.9
Progesterone nmol/l 2.46 1.97 2.95 Beckman Access / Access 2 Prog Cal 33555
ng/ml 0.770 0.616 0.923
nmol/l 2.46 1.97 2.95 Beckman Access / Access 2 Prog DE Cal A80773
ng/ml 0.770 0.616 0.924
nmol/l 1.92 1.54 2.30 Beckman DxI600/800 Prog Cal 33555
ng/ml 0.601 0.481 0.721
Prolactin µU/ml 148 118 178 Beckman Access / Access 2
µg/l 6.99 5.59 8.39
µU/ml 140 112 168 Beckman DxI600/800
µg/l 6.61 5.29 7.93
PSA Free Beckman Access / Access 2 standardised to
ng/ml = µg/l 1.74 1.31 2.18
Hybritech
Beckman Access / Access 2 standardised to WHO
ng/ml = µg/l 1.69 1.27 2.11
IRP96/670
Beckman DxI600/800 standardised to Hybritech
ng/ml = µg/l 1.73 1.30 2.16

Beckman DxI600/800 standardised to WHO

ng/ml = µg/l 1.44 1.08 1.80
IRP96/670
PSA Total Beckman Access / Access 2 standardised to
ng/ml = µg/l 1.72 1.29 2.15
Hybritech
Beckman Access / Access 2 standardised to WHO
ng/ml = µg/l 1.73 1.30 2.16
IRP96/670
Beckman DxI600/800 standardised to Hybritech
ng/ml = µg/l 1.66 1.25 2.08

Beckman DxI600/800 standardised to WHO

ng/ml = µg/l 1.41 1.06 1.76
IRP96/670
SHBG nmol/l 10.7 8.56 12.8 Beckman Access / Access 2
nmol/l 10.1 8.08 12.1 Beckman DxI600/800
Testosterone nmol/l 2.08 1.66 2.50 Beckman Access / Access 2
ng/ml 0.599 0.478 0.720
ng/dl 59.9 47.8 72.0
nmol/l 1.90 1.52 2.28 Beckman DxI600/800
ng/ml 0.547 0.438 0.656
ng/dl 54.7 43.8 65.6
Thyroglobulin ng/ml 1.37 1.03 1.71 Beckman Access / Access 2
ng/ml 1.27 0.953 1.59 Beckman DxI600/800
Thyroid Stimulating Hormone µU/ml = mlU/l 0.077 0.062 0.092 Beckman Access / Access 2 Fast TSH
Beckman Access / Access 2 hyperTSH 3rd
µU/ml = mlU/l 0.077 0.062 0.092
Generation
µU/ml = mlU/l 0.079 0.063 0.095 Beckman DxI600/800
µU/ml = mlU/l 0.078 0.062 0.094 Beckman DxI600/800 Fast TSH
µU/ml = mlU/l 0.077 0.062 0.092 Beckman DxI600/800 Hyper TSH
µU/ml = mlU/l 0.079 0.063 0.095 Beckman DxI600/800 Access (3rd IS)

PAGE 3 OF 4
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No. 2179EC Size: 12 x 5ml / 4 x 5ml Expiry: 2025-06-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml = lU/l 12.8 10.2 15.4 Beckman Access / Access 2
IU/ml 0.013 0.010 0.016
mU/ml = lU/l 12.9 10.3 15.5 Beckman Access / Access 2 Total BhCG (5th IS)
IU/ml 0.013 0.010 0.016
mU/ml = lU/l 13.2 10.6 15.8 Beckman DxI600/800
IU/ml 0.013 0.011 0.015
mU/ml = lU/l 13.3 10.6 16.0 Beckman DxI600/800 Total BhCG (5th IS)
IU/ml 0.013 0.011 0.015
Total T3 nmol/l 1.27 0.953 1.59 Beckman Access / Access 2
ng/ml 0.827 0.620 1.03
ng/dl 82.7 62.0 103
nmol/l 1.19 0.893 1.49 Beckman DxI600/800
ng/ml 0.775 0.581 0.969
ng/dl 77.5 58.1 96.9
Total T4 nmol/l 24.8 18.6 31.0 Beckman Access / Access 2
µg/dl 1.93 1.45 2.41
ng/ml 19.3 14.5 24.1
nmol/l 22.1 16.6 27.6 Beckman DxI600/800
µg/dl 1.72 1.29 2.15
ng/ml 17.2 12.9 21.5
Vitamin B12 pmol/l 90.2 72.2 108 Beckman Access / Access 2
pg/ml 122 97.8 146
pmol/l 85.0 68.0 102 Beckman DxI600/800
pg/ml 115 92.1 138

PAGE 4 OF 4
 2797

ADDITIONAL VALUES FOR

IMMUNOASSAY PREMIUM PLUS - LEVEL 1
(IA PREMIUM PLUS 1)
Cat No. IA3109 / IA3112
Lot No. 2179EC
GTIN: 05055273207255 / 05055273207286

COMPONENTS UNITS TARGET RANGE METHOD

Androstenedione nmol/l 3.72 2.79 – 4.65 Roche Elecsys

ng/ml 1.07 0.803 – 1.34

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

05 Mar ’24 me

PAGE 1 OF 1
 2797

ADDITIONAL VALUES FOR

IMMUNOASSAY PREMIUM PLUS - LEVEL 1
(IA PREMIUM PLUS 1)
Cat No. IA3109 / IA3112
Lot No. 2179EC
GTIN: 05055273207255 / 05055273207286
COMPONENT UNITS TARGET RANGE METHOD

17-OH Progesterone nmol/l 2.50 1.75 - 3.24 SNIBE Maglumi Analysers

ng/ml 0.826 0.580 - 1.07
25-OH Vitamin D nmol/l 53.9 37.7 - 70.1 SNIBE Maglumi Analysers
ng/ml 21.6 15.1 - 28.1
25-OH Vitamin D nmol/l 46.2 32.3 - 60.1 SNIBE Maglumi Analysers II
ng/ml 18.5 13.0 - 24.0
Alpha-foetoprotein KIU/l = lU/ml 10.0 7.00 - 13.0 SNIBE Maglumi Analysers
ng/ml 12.1 8.47 - 15.7
Androstenedione nmol/l 3.97 2.78 - 5.16 SNIBE Maglumi Analysers
ng/ml 1.14 0.798 - 1.48
Beta-2-microglobulin µg/ml = mg/l 0.492 0.344 - 0.640 SNIBE Maglumi Analysers
C-Peptide nmol/l 0.722 0.505 - 0.939 SNIBE Maglumi Analysers
ng/ml 2.18 1.53 - 2.83
CA 15-3 U/ml 26.7 18.7 – 34.7 SNIBE Maglumi Analysers
CA 19-9 U/ml 19.6 13.7 – 25.5 SNIBE Maglumi Analysers
CA125 U/ml 20.8 14.6 – 27.0 SNIBE Maglumi Analysers
Carcinoembryonic Antigen (CEA) ng/ml = µg/l 5.61 3.93 – 7.29 SNIBE Maglumi Analysers
Cortisol nmol/l 311 218 - 404 SNIBE Maglumi Analysers
µg/dl 11.2 7.84 - 14.56
DHEA-S µmol/l 1.50 1.05 - 1.94 SNIBE Maglumi Analysers
µg/dl 55.1 38.6 - 71.6
Digoxin nmol/l 0.443 0.310 - 0.576 SNIBE Maglumi Analysers
ng/ml 0.346 0.242 - 0.450
Ferritin ng/ml = µg/l 18.5 13.0 - 24.0 SNIBE Maglumi Analysers
Folate nmol/l 4.49 3.14 - 5.84 SNIBE Maglumi Analysers
ng/ml 1.98 1.39 - 2.57
Free T3 pmol/l 2.81 1.97 - 3.65 SNIBE Maglumi Analysers
ng/dl 0.183 0.128 - 0.238
pg/ml 1.83 1.28 - 2.38

PAGE 1 OF 2
 LOT NO. 2179EC 2797

COMPONENT UNITS TARGET RANGE METHOD

Free T4 pmol/l 11.6 8.11 - 15.1 SNIBE Maglumi Analysers
ng/dl 0.904 0.633 - 1.18
pg/ml 9.04 6.33 - 11.8
FSH mU/ml 6.74 4.72 - 8.76 SNIBE Maglumi Analysers
Growth Hormone (GH) µU/ml 5.62 3.93 - 7.31 SNIBE Maglumi Analysers
ng/ml 1.87 1.31 - 2.43
Immunoglobulin E KIU/l = IU/ml 201 141 - 261 SNIBE Maglumi Analysers
Luteinising Hormone (LH) mU/ml 5.21 3.65 - 6.77 SNIBE Maglumi Analysers
Oestradiol pmol/l 169 119 - 220 SNIBE Maglumi Analysers
pg/ml 46.1 32.3 - 59.9
Progesterone nmol/l 1.62 0.972 - 2.27 SNIBE Maglumi Analysers
ng/ml 0.507 0.304 - 0.710
Prolactin µU/ml 160 112 - 208 SNIBE Maglumi Analysers
PSA Free ng/ml = µg/l 0.967 0.677 - 1.26 SNIBE Maglumi Analysers
PSA Total ng/ml = µg/l 1.39 0.973 - 1.81 SNIBE Maglumi Analysers
SHBG nmol/l 13.3 9.31 - 17.3 SNIBE Maglumi Analysers
Testosterone nmol/l 1.83 1.28 - 2.38 SNIBE Maglumi Analysers
ng/ml 0.527 0.369 - 0.685
ng/dl 52.7 36.9 - 68.5
Thyroid Stimulating Hormone µU/ml = mIU/l 0.125 0.088 - 0.162 SNIBE Maglumi Analysers
Total Beta hCG mU/ml=IU/l 16.5 11.6 - 21.4 SNIBE Maglumi Analysers
IU/ml 0.017 0.012 - 0.022
Total T3 nmol/l 0.427 0.299 - 0.555 SNIBE Maglumi Analysers
ng/ml 0.278 0.195 - 0.361
ng/dl 27.8 19.5 - 36.1
Total T4 nmol/l 36.5 25.6 - 47.4 SNIBE Maglumi Analysers
µg/dl 2.85 2.00 - 3.70
ng/ml 28.5 20.0 - 37.0
Vitamin B12 pmol/l 90.0 63.0 - 117 SNIBE Maglumi Analysers
pg/ml 122 85.4 - 159

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

23 Jan ‘23 me

PAGE 2 OF 2
 2797

ADDITIONAL VALUES FOR

IMMUNOASSAY PREMIUM PLUS - LEVEL 1
(IA PREMIUM PLUS 1)
Cat No. IA3109 / IA3112
Lot No. 2179EC
GTIN: 05055273207255 / 05055273207286
COMPONENT UNITS TARGET RANGE METHOD

Alphafoetoprotein KIU/l = lU/ml 9.26 7.41-11.1 Diasorin Liaison Series

ng/ml 11.2 8.97-13.4

Cortisol nmol/l 253 190-316 Diasorin Liaison Series

µg/dl 9.11 6.84-11.4

Ferritin ng/ml = µg/l 16.1 12.9-19.3 Diasorin Liaison Series

FSH mU/ml 9.01 7.21-10.8 Diasorin Liaison Series

Insulin mU/l 0.860 0.865-1.08 Diasorin Liaison Series

µU/ml 0.860 0.865-1.08

Luteinising mU/m 3.70 2.96-4.44 Diasorin Liaison Series

Hormone (LH)

Prolactin µU/ml 172 138-206 Diasorin Liaison Series

PSA Free ng/ml = µg/l 1.41 1.06-1.76 Diasorin Liaison Series

PSA Total ng/ml = µg/l 1.42 1.07-1.78 Diasorin Liaison Series

Total Beta hCG mU/ml=IU/l 11.6 9.28-13.9 Diasorin Liaison Series

IU/ml 0.012 0.001-0.014

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland
Rev. 11 May ’23 me

PAGE 1 OF 1
 2797

ADDITIONAL VALUES FOR

IMMUNOASSAY PREMIUM PLUS - LEVEL 1
(IA PREMIUM PLUS 1)
Cat No. IA3109 / IA3112
Lot No. 2179EC
GTIN: 05055273207255 / 05055273207286
COMPONENT UNITS TARGET RANGE METHOD

25-OH Vitamin D nmol/l 19.6 12.7 – 25.5 Roche Vitamin D Total III
Roche Cobas e601/e602

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

Rev. 17 Apr ’23 me

PAGE 1 OF 1
 2797

ADDITIONAL VALUES FOR

IMMUNOASSAY PREMIUM PLUS - LEVEL 1
(IA PREMIUM PLUS 1)
Cat No. IA3109 / IA3112
Lot No. 2179EC
GTIN: 05055273207255 / 05055273207286
COMPONENT UNITS TARGET RANGE METHOD

Insulin mU/l 0.922 0.692 – 1.15 Roche Cobas 6000/8000

µU/ml 0.922 0.692 – 1.15

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

Rev. 06 Jun ’23 me

PAGE 1 OF 1
 2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 1

(IA PREMIUM PLUS 1)
CAT. NO. IA3109 GTIN: 05055273207255 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 2179EC EXPIRY: 2025-06-28
INTENDED USE
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes
listed in the package insert.

This device is for prescription use only.

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

Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency Virus
(HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE. FDA
approved methods have been used to conduct these tests.

However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be
handled as though capable of transmitting infectious diseases and disposed of accordingly.

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

Health and Safety Data Sheets are available on request.

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

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

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

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial contamination is
suspected, the vial should be discarded and a fresh vial reconstituted.
PREPARATION
Immunoassay Premium Plus is supplied lyophilized.
1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of foam. Do
not shake.
2. Refer to the Control section of the individual analyser application.
3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.
MATERIALS PROVIDED
Immunoassay Premium Plus - Level 1: 12 x 5 ml Tri-Level: 4 x 5 ml
MATERIAL REQUIRED BUT NOT PROVIDED
Volumetric pipette
VALUE ASSIGNMENT
Each batch of Immunoassay Premium Plus is submitted to a number of external laboratories. Values are assigned from a consensus of results
obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for analytes in the
instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory technique. Therefore,
the range produced herein should only be considered as a reference and it is recommended that each laboratory establish its own mean and
acceptable ranges. 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
[email protected].

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

(S). 05 Nov ’24 me

PAGE 1 OF 3
 2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)

Cat. No. IA3109 / IA3112 Lot No.2179EC Size: 12 x 5ml / 4 x 5ml Expiry: 2025-06-28
Range
Analyte unit Target low high methods
9.69 6.30 13.1 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Alphafoetoprotein ng/ml
10.2 6.65 13.8 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
11.4 7.44 15.4 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
CA 15-3 U/ml
11.2 7.29 15.1 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
16.5 10.7 22.3 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
CA 19-9 U/ml
17.7 11.5 23.9 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
29.5 19.2 39.9 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
CA125 U/ml
27.9 18.2 37.7 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
Carcinoembryonic 4.43 2.88 5.98 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
ng/ml
Antigen (CEA) 4.38 2.84 5.91 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
1.53 1.12 1.94 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
C-Peptide ng/mL
1.47 1.07 1.86 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
7.75 5.03 10.5 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Cortisol μg/dL
7.59 4.94 10.3 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
72.2 52.7 91.7 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
DHEA-S µg/dl
76.6 55.9 97.2 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
45.3 33.1 57.5 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i <= Lot 230501
42.3 30.9 53.7 Wiener Lab CLIA Series & Mindray CL 900i <= Lot 230501
Oestradiol pg/mL
84.4 57.4 111 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i >= Lot 231001
84.4 57.4 111 Wiener Lab CLIA Series & Mindray CL 900i >= Lot 231001
16.4 12.0 20.9 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Ferritin ng/ml
16.6 12.1 21.1 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
8.03 5.86 10.2 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Folate ng/ml
8.16 5.95 10.4 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
7.67 5.60 9.74 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i <= Lot 231101
7.72 5.63 9.80 Wiener Lab CLIA Series & Mindray CL 900i <= Lot 231101
FSH mIU/mL
5.89 3.52 8.26 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i >= Lot 240401
5.89 3.52 8.26 Wiener Lab CLIA Series & Mindray CL 900i >= Lot 240401
1.23 0.796 1.65 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Insulin μIU/ml
1.18 0.769 1.60 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
3.63 2.65 4.61 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Luteinising Hormone (LH) mIU/ml
3.60 2.63 4.57 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
9.04 6.60 11.5 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Prolactin ng/ml
8.78 6.41 11.1 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
1.47 1.07 1.87 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
PSA Free ng/ml
1.42 1.04 1.81 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
1.72 1.25 2.18 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
PSA Total ng/ml
1.70 1.24 2.15 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i

PAGE 2 OF 3
 2797
IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1)
Cat. No. IA3109 / IA3112 Lot No.2179EC Size: 12 x 5ml / 4 x 5ml Expiry: 2025-06-28
Range
Analyte unit Target low high methods
0.491 0.319 0.663 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref: TESTO 11X
0.513 0.334 0.693 Wiener Lab CLIA Series & Mindray CL 900i Ref: TESTO 11X
0.210 0.126 0.294 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref 105-0025XX-00
Testosterone ng/mL
0.208 0.125 0.292 Wiener Lab CLIA Series & Mindray CL 900i Ref 105-0025XX-00
0.609 0.414 0.804 Wiener Lab CLIA Series & Mindray TESTO II CL 8/6/2/12/1000i
0.609 0.414 0.804 Wiener Lab CLIA Series & Mindray TESTO II CL 900i
18.5 11.1 25.9 Wiener Lab CLIA Series & Mindray hCG2 8000/6000/2000/1200/1000i
18.5 11.1 25.9 Wiener Lab CLIA Series & Mindray hCG2 CL 900i
Total Beta hCG mIU/mL
11.1 7.20 15.0 Wiener Lab CLIA Series & Mindray hCG 8000/6000/2000/1200/1000i
11.8 7.65 15.9 Wiener Lab CLIA Series & Mindray hCG CL 900i/920i/960i/980i
213 155 270 Wiener Lab CLIA Series & Mindray CL 8000i/6000i/2000i/1200i/1000i
Vitamin B12 pg/mL
205 149 260 Wiener Lab CLIA Series & Mindray CL 900i/920i/960i/980i
0.172 0.125 0.218 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref: TSH 11X
Thyroid Stimulating 0.177 0.129 0.225 Wiener Lab CLIA Series & Mindray CL 900i Ref: TSH 11X
μIU/mL
Hormone 0.085 0.058 0.112 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i TSH105-0042XX-00
0.085 0.058 0.112 Wiener Lab CLIA Series & Mindray CL 900i TSH 105-0042XX-00
2.63 1.92 3.34 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref: FT3 11X
2.68 1.95 3.40 Wiener Lab CLIA Series & Mindray CL 900i Ref: FT3 11X
Free T3 pg/mL
2.63 1.92 3.34 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i FT3 105-0042XX-00
2.68 1.95 3.40 Wiener Lab CLIA Series & Mindray CL 900i FT3 105-0042XX-00
0.864 0.631 1.10 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref: FT4 11X
0.861 0.628 1.09 Wiener Lab CLIA Series & Mindray CL 900i Ref: FT4 11X
Free T4 ng/dL
1.17 0.851 1.48 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i FT4 105-0042XX-00
1.20 0.879 1.53 Wiener Lab CLIA Series & Mindray CL 900i FT4 105-0042XX-00
0.547 0.400 0.695 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref: T3 11X
0.561 0.409 0.712 Wiener Lab CLIA Series & Mindray CL 900i Ref: T3 11X
Total T3 ng/mL
0.547 0.400 0.695 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i T3 105-0042XX-00
0.561 0.409 0.712 Wiener Lab CLIA Series & Mindray CL 900i T3 105-0042XX-00
1.96 1.43 2.49 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i Ref: T4 11X
1.99 1.45 2.53 Wiener Lab CLIA Series & Mindray CL 900i Ref: T4 11X
Total T4 μg/dL
2.46 1.79 3.12 Wiener Lab CLIA Series & Mindray CL 8/6/2/12/1000i T4 105-0042XX-00
2.41 1.76 3.06 Wiener Lab CLIA Series & Mindray CL 900i T4 105-0042XX-00
0.680 0.462 0.897 Wiener Lab CLIA Series & Mindray PROG II CL 8000i/6000i/2000i/1200i/1000i
Progesterone ng/mL
0.680 0.462 0.897 Wiener Lab CLIA Series & Mindray PROG II CL 900i

PAGE 3 OF 3
Method Immunoassay Premium Plus - Level 1 (IA PREMIUM PLUS 1)
Lot. No: 2179EC Cat. No: IA3109 / IA3112 Expiry: 2025-06-28
Size: 12 x 5 ml / 4 x 5 ml / 3 x 4 x 5 ml Range
Analyte Unit Target Low High 1SD 2SD Method
C-Peptide ng/ml 1.26 0.945 1.58 0.160 0.320 Beckman Access/LXi725
nmol/l 0.418 0.314 0.522 0.052 0.104

Page 1 of 1 2025/01/23

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: [email protected] Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated