2797

IMMUNOASSAY PREMIUM PLUS - LEVEL 3

(IA PREMIUM PLUS 3)
CAT. NO. IA3111 GTIN: 05055273207279 SIZE: 12 x 5 ml
CAT. NO. IA3112 GTIN: 05055273207286 SIZE: 4 x 5 ml
LOT NO. 2079EC EXPIRY: 2024-10-28

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

This device is for prescription use only.

SAFETY PRECAUTIONS AND WARNINGS

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

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

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

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY

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

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

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

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

MATERIAL REQUIRED BUT NOT PROVIDED

Volumetric pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium Plus is submitted to a number of external laboratories. Values are assigned from a consensus of
results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for
analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory
technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory
establish its own mean and acceptable ranges. 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
11 Jan ‘22 me

PAGE 1 OF 28
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
17-OH-Progesterone nmol/l 30.4 22.8 38.0 ELISA
ng/ml 10.1 7.55 12.7
nmol/l 22.8 17.1 28.5 DIAsource RIA
ng/ml 7.55 5.66 9.44
25-OH Vitamin D nmol/l 100 75.0 125 Diasorin Liaison
nmol/l 126 94.5 158 Siemens Centaur XP/XPT/Classic
nmol/l 85.3 64.0 107 Roche Vitamin D Total
nmol/l 98.9 74.2 124 Abbott Architect (3L52)
nmol/l 113 84.8 141 Vitros ECi
nmol/l 83.8 62.9 105 Tosoh Series
nmol/l 92.6 69.5 116 BioMerieux Vidas
nmol/l 80.9 60.7 101 Beckman DxI 600/800
nmol/l 111 83.3 139 Fujirebio Lumipulse G Series
nmol/l 81.1 60.8 101 Beckman Access 25 OH Vitamin D Total
nmol/l 112 84.0 140 LC/MS
nmol/l 98.5 73.9 123 Abbott Architect (5P02)/ Alinity (8P45)
nmol/l 102 76.5 128 Diasorin Liaison XL
nmol/l 103 77.3 129 Roche Vitamin D Total II
nmol/l 104 78.0 130 Abbott Alinity i
nmol/l 131 98.3 164 Siemens Atellica IM
nmol/l 99.0 74.3 124 Roche Vitamin D Total II e801
ACTH pmol/l 55.6 41.7 69.5 Siemens Immulite 2000/2500
pg/ml 253 190 316
pmol/l 43.9 32.9 54.9 Roche Cobas 4000/E411
pg/ml 200 150 250
pmol/l 43.2 32.4 54.0 Roche Cobas e601/602
pg/ml 196 147 245
pmol/l 102 76.5 128 CIS IRMA
pg/ml 464 348 580
pmol/l 56.1 42.1 70.1 Diasorin Liaison
pg/ml 255 191 319
pmol/l 70.6 53.0 88.3 Diasorin Liaison XL
pg/ml 321 241 401
pmol/l 46.3 34.7 57.9 Roche Cobas e402/e801
pg/ml 210 158 262
Aldosterone pmol/l 363 272 454 CIS RIA
pg/ml 131 98.1 164
pmol/l 1087 815 1359 Immunotech RIA
pg/ml 392 294 490
pmol/l 758 569 948 Diasorin Liaison
pg/ml 273 205 341
pmol/l 793 595 991 Diasorin Liaison XL
pg/ml 286 215 357

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Alphafoetoprotein KIU/l = lU/ml 170 136 204 Abbott Architect
ng/ml 206 165 247
KIU/l = lU/ml 191 153 229 BioMerieux Vidas
ng/ml 231 185 277
KIU/l = lU/ml 192 154 230 Siemens Centaur XP/XPT/Classic
ng/ml 232 186 278
KIU/l = lU/ml 173 138 208 Siemens Immulite 2000/2500
ng/ml 209 167 251
KIU/l = lU/ml 184 147 221 Siemens Immulite 1000
ng/ml 223 178 268
KIU/l = lU/ml 163 130 196 Beckman DxI800
ng/ml 197 157 237
KIU/l = lU/ml 185 148 222 Roche Elecsys
ng/ml 224 179 269
KIU/l = lU/ml 183 146 220 Diasorin Liaison
ng/ml 221 177 265
KIU/l = lU/ml 172 138 206 Beckman Access
ng/ml 208 167 249
KIU/l = lU/ml 162 130 194 Tosoh Series
ng/ml 196 157 235
KIU/l = lU/ml 191 153 229 Vitros ECi
ng/ml 199 159 239
KIU/l = lU/ml 191 153 229 Roche Cobas e601/602
ng/ml 231 185 277
KIU/l = lU/ml 303 242 364 CIS IRMA
ng/ml 367 293 441
KIU/l = lU/ml 194 155 233 Roche Cobas 4000/E411
ng/ml 235 188 282
KIU/l = lU/ml 184 147 221 Fujirebio Lumipulse G Series
ng/ml 223 178 268
KIU/l = lU/ml 189 151 227 Siemens Dimension
ng/ml 229 183 275
KIU/l = lU/ml 191 153 229 Siemens Centaur CP
ng/ml 231 185 277
KIU/l = lU/ml 192 154 230 Diasorin Liaison XL
ng/ml 232 186 278
KIU/l = lU/ml 190 152 228 Siemens Atellica IM
ng/ml 230 184 276
KIU/l = lU/ml 169 135 203 Abbott Alinity i
ng/ml 204 163 245
KIU/l = lU/ml 186 149 223 Roche Cobas e402/e801
ng/ml 225 180 270
Amikacin µmol/l 23.1 18.5 27.7 Roche Cobas 6000/8000
µg/ml 13.5 10.8 16.2
µmol/l 24.8 19.8 29.8 Abbott Architect
µg/ml 14.5 11.6 17.4

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Amikacin µmol/l 24.3 19.4 29.2 Thermo Scientific QMS Amikacin
µg/ml 14.2 11.4 17.0
µmol/l 24.5 19.6 29.4 Abbott Alinity
µg/ml 14.3 11.5 17.1
µmol/l 24.1 19.3 28.9 Gravimetric
µg/ml 14.1 11.3 16.9
Androstenedione nmol/l 16.9 12.7 21.1 Beckman Coulter RIA
ng/ml 4.85 3.64 6.06
nmol/l 33.8 25.4 42.3 Siemens Immulite 2000
ng/ml 9.70 7.29 12.1
nmol/l 28.7 21.5 35.9 Siemens Immulite 1000
ng/ml 8.24 6.17 10.3
nmol/l 24.4 18.3 30.5 Diasorin Liaison XL
ng/ml 7.00 5.25 8.75
Beta-2-microglobulin µg/ml = mg/l 6.59 5.27 7.91 Abbott Architect
µg/ml = mg/l 7.09 5.67 8.51 BioMerieux Vidas
µg/ml = mg/l 6.39 5.11 7.67 Behring Nephelometer
µg/ml = mg/l 5.43 4.34 6.52 Siemens Immulite 2000/2500
µg/ml = mg/l 7.22 5.78 8.66 Tosoh Series
µg/ml = mg/l 6.33 5.06 7.60 Roche Cobas 6000/8000
µg/ml = mg/l 6.81 5.45 8.17 Siemens Dimension
µg/ml = mg/l 5.20 4.16 6.24 Fujirebio Lumipulse G Series
µg/ml = mg/l 5.76 4.61 6.91 Diasorin Liaison XL
µg/ml = mg/l 7.40 5.92 8.88 Siemens Atellica CH
µg/ml = mg/l 6.66 5.33 7.99 Abbott Alinity
C-Peptide nmol/l 3.570 2.680 4.460 Siemens Immulite 2000/2500
ng/ml 10.8 8.09 13.5
nmol/l 3.570 2.680 4.460 Roche Elecsys
ng/ml 10.8 8.09 13.5
nmol/l 3.590 2.690 4.490 Roche Cobas e601/602
ng/ml 10.8 8.12 13.5
nmol/l 3.570 2.680 4.460 Diasorin Liaison
ng/ml 10.8 8.09 13.5
nmol/l 3.580 2.690 4.480 Roche Cobas 4000/E411
ng/ml 10.8 8.12 13.5
nmol/l 3.250 2.440 4.060 Abbott Architect
ng/ml 9.81 7.37 12.3
nmol/l 2.590 1.940 3.240 Siemens Centaur XP/XPT/Classic
ng/ml 7.82 5.86 9.78
nmol/l 3.300 2.480 4.130 Tosoh Series
ng/ml 9.96 7.49 12.4
nmol/l 4.070 3.050 5.090 Diasorin Liaison XL
ng/ml 12.3 9.21 15.4
nmol/l 3.440 2.580 4.300 Roche Cobas e402/e801
ng/ml 10.4 7.79 13.0

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
C-Peptide nmol/l 2.500 1.880 3.130 Siemens Atellica IM
ng/ml 7.55 5.68 9.42
nmol/l 3.170 2.380 3.960 Abbott Alinity i
ng/ml 9.57 7.19 12.0
nmol/l 3.260 2.445 4.075 Vitros ECi
ng/ml 9.84 7.38 12.3
CA 15-3 U/ml 96.1 76.9 115 Abbott Architect
U/ml 65.9 52.7 79.1 BioMerieux Vidas
U/ml 72.0 57.6 86.4 Siemens Centaur XP/XPT/Classic
U/ml 78.5 62.8 94.2 Siemens Immulite 2000/2500
U/ml 87.1 69.7 105 Siemens Immulite 1000
U/ml 32.9 26.3 39.5 Beckman DxI800
U/ml 80.1 64.1 96.1 Roche Elecsys
U/ml 32.6 26.1 39.1 Beckman Access
U/ml 84.3 67.4 101 Tosoh Series
U/ml 70.5 56.4 84.6 Vitros ECi
U/ml 81.7 65.4 98.0 Roche Cobas e601/602
U/ml 81.0 64.8 97.2 Roche Cobas 4000/E411
U/ml 87.3 69.8 105 Fujirebio Lumipulse G Series
U/ml 71.2 57.0 85.4 Siemens Centaur CP
U/ml 79.4 63.5 95.3 Diasorin Liaison XL
U/ml 78.0 62.4 93.6 Siemens Atellica IM
U/ml 75.5 60.4 90.6 Roche Cobas e402/e801
U/ml 91.3 73.0 110 Abbott Alinity i
CA 19-9 U/ml 185 148 222 BioMerieux Vidas
U/ml 228 182 274 Siemens Centaur XP/XPT/Classic
U/ml 632 506 758 Siemens Immulite 2000/2500
U/ml 790 632 948 Siemens Immulite 1000
U/ml 560 448 672 Beckman DxI800
U/ml 169 135 203 Roche Elecsys
U/ml 276 221 331 Diasorin Liaison
U/ml 630 504 756 Beckman Access
U/ml 127 102 152 Tosoh Series
U/ml 325 260 390 Vitros ECi
U/ml 349 279 419 Abbott Architect XR/XR2/XRL
U/ml 168 134 202 Roche Cobas e601/602
U/ml 170 136 204 Roche Cobas 4000/E411
U/ml 316 253 379 Fujirebio Lumipulse G Series
U/ml 208 166 250 Siemens Centaur CP
U/ml 292 234 350 Diasorin Liaison XL
U/ml 223 178 268 Siemens Atellica IM
U/ml 164 131 197 Roche Cobas e402/e801
U/ml 352 282 422 Abbott Alinity XR/XR2/XRL
CA125 U/ml 255 204 306 Abbott Architect
U/ml 200 160 240 BioMerieux Vidas
U/ml 206 165 247 Siemens Centaur XP/XPT/Classic OV Kit

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
CA125 U/ml 210 168 252 Siemens Centaur XP/XPT/Classic CA125 II kit
U/ml 173 138 208 Siemens Immulite 2000/2500
U/ml 196 157 235 Siemens Immulite 1000
U/ml 167 134 200 Beckman DxI800
U/ml 183 146 220 Roche Elecsys
U/ml 169 135 203 Beckman Access
U/ml 310 248 372 Tosoh Series
U/ml 196 157 235 Vitros ECi
U/ml 189 151 227 Roche Cobas 4000/E411
U/ml 187 150 224 Roche Cobas e601/602
U/ml 170 136 204 Fujirebio Lumipulse G Series
U/ml 207 166 248 Siemens Centaur CP CA125 II kit
U/ml 262 210 314 Diasorin Liaison XL
U/ml 242 194 290 Siemens Atellica IM
U/ml 179 143 215 Roche Cobas e402/e801
U/ml 265 212 318 Abbott Alinity i
Carbamazepine µmol/l 72.0 57.6 86.4 Abbott Architect (CMIA)
µg/ml 17.0 13.6 20.4
µmol/l 71.7 57.4 86.0 Siemens Centaur XP/XPT/Classic
µg/ml 16.9 13.6 20.2
µmol/l 65.8 52.6 79.0 Siemens Dimension
µg/ml 15.6 12.4 18.8
µmol/l 63.2 50.6 75.8 Siemens Immulite 2000/2500
µg/ml 14.9 12.0 17.8
µmol/l 60.6 48.5 72.7 Siemens Immulite 1000
µg/ml 14.3 11.5 17.1
µmol/l 80.6 64.5 96.7 Roche Integra
µg/ml 19.1 15.2 23.0
µmol/l 71.2 57.0 85.4 Roche Cobas 6000/8000
µg/ml 16.8 13.5 20.1
µmol/l 70.7 56.6 84.8 Beckman AU400/600/640/2700/5400
µg/ml 16.7 13.4 20.0
µmol/l 56.8 45.4 68.2 Abbott Architect (PETINA)
µg/ml 13.4 10.7 16.1
µmol/l 70.7 56.6 84.8 EMIT
µg/ml 16.7 13.4 20.0
µmol/l 67.9 54.3 81.5 Siemens Atellica CH
µg/ml 16.1 12.8 19.4
µmol/l 59.1 47.3 70.9 Abbott Alinity (PETINA)
µg/ml 14.0 11.2 16.8
µmol/l 72.2 57.8 86.6 Gravimetric
µg/ml 17.1 13.7 20.5
Carcinoembryonic ng/ml = µg/l 73.0 58.4 87.6 Abbott Architect
Antigen (CEA)
ng/ml = µg/l 63.2 50.6 75.8 BioMerieux Vidas
ng/ml = µg/l 63.0 50.4 75.6 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 49.9 39.9 59.9 CIS RIA Coated tube

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Carcinoembryonic ng/ml = µg/l 83.6 66.9 100 Siemens Immulite 2000/2500
Antigen (CEA)
ng/ml = µg/l 77.5 62.0 93.0 Siemens Immulite 1000
ng/ml = µg/l 57.1 45.7 68.5 Beckman DxI800
ng/ml = µg/l 51.4 41.1 61.7 Roche Elecsys
ng/ml = µg/l 60.8 48.6 73.0 Diasorin Liaison
ng/ml = µg/l 59.8 47.8 71.8 Beckman Access
ng/ml = µg/l 81.6 65.3 97.9 Tosoh Series
ng/ml = µg/l 69.6 55.7 83.5 Vitros ECi
ng/ml = µg/l 52.2 41.8 62.6 Roche Cobas e601/602
ng/ml = µg/l 53.4 42.7 64.1 Roche Cobas 4000/E411
ng/ml = µg/l 79.3 63.4 95.2 Fujirebio Lumipulse G Series
ng/ml = µg/l 69.6 55.7 83.5 Boditech Med Inc i-CHROMA
ng/ml = µg/l 63.6 50.9 76.3 Siemens Centaur CP
ng/ml = µg/l 61.6 49.3 73.9 Diasorin Liaison XL
ng/ml = µg/l 61.5 49.2 73.8 Siemens Atellica IM
ng/ml = µg/l 52.9 42.3 63.5 Roche Cobas e402/e801
ng/ml = µg/l 72.5 58.0 87.0 Abbott Alinity i
Cortisol nmol/l 911 683 1139 Abbott Architect
µg/dl 32.8 24.6 41.0
nmol/l 1020 765 1275 BioMerieux Vidas
µg/dl 36.7 27.5 45.9
nmol/l 1126 845 1408 Siemens Centaur XP/XPT/Classic
µg/dl 40.5 30.4 50.6
nmol/l 832 624 1040 CIS RIA
µg/dl 30.0 22.5 37.5
nmol/l 926 695 1158 Siemens Immulite 2000/2500
µg/dl 33.3 25.0 41.6
nmol/l 1021 766 1276 Siemens Immulite 1000
µg/dl 36.8 27.6 46.0
nmol/l 1041 781 1301 Beckman DxI800
µg/dl 37.5 28.1 46.9
nmol/l 1019 764 1274 Roche Elecsys
µg/dl 36.7 27.5 45.9
nmol/l 1116 837 1395 Beckman Access
µg/dl 40.2 30.1 50.3
nmol/l 1087 815 1359 Tosoh Series
µg/dl 39.1 29.3 48.9
nmol/l 924 693 1155 Vitros ECi
µg/dl 33.3 24.9 41.7
nmol/l 964 723 1205 Roche Cobas e601/602
µg/dl 34.7 26.0 43.4
nmol/l 1038 779 1298 Roche Cobas 4000/E411
µg/dl 37.4 28.0 46.8
nmol/l 1239 929 1549 Siemens Centaur CP
µg/dl 44.6 33.4 55.8
nmol/l 1032 774 1290 Roche Cobas 4000/e411 Gen II
µg/dl 37.2 27.9 46.5

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Cortisol nmol/l 975 731 1219 Roche Cobas e601/602 Gen II
µg/dl 35.1 26.3 43.9
nmol/l 1012 759 1265 Roche Elecsys Gen II
µg/dl 36.4 27.3 45.5
nmol/l 1013 760 1266 Diasorin Liaison XL
µg/dl 36.5 27.4 45.6
nmol/l 1229 922 1536 Siemens Atellica IM
µg/dl 44.2 33.2 55.2
nmol/l 981 736 1226 Roche Cobas e402/e801
µg/dl 35.3 26.5 44.1
nmol/l 898 674 1123 Abbott Alinity i
µg/dl 32.3 24.3 40.3
DHEA-S µmol/l 21.8 17.4 26.2 Abbott Architect
µmol/l 18.1 14.5 21.7 Siemens Immulite 2000/2500
µmol/l 17.0 13.6 20.4 Siemens Immulite 1000
µmol/l 17.1 13.7 20.5 Beckman DxI800
µmol/l 27.2 21.8 32.6 Roche Elecsys
µmol/l 18.1 14.5 21.7 Beckman Access
µmol/l 14.7 11.8 17.6 Diasorin Liaison
µmol/l 16.8 13.4 20.2 Siemens Centaur XP/XPT/Classic
µmol/l 25.9 20.7 31.1 Roche Cobas 4000/E411
µmol/l 26.3 21.0 31.6 Roche Cobas e601/602
µmol/l 13.6 10.9 16.3 Diasorin Liaison XL
µmol/l 17.1 13.7 20.5 Siemens Atellica IM
µmol/l 25.2 20.2 30.2 Roche Cobas e402/e801
µmol/l 22.3 17.8 26.8 Abbott Alinity i
Digoxin nmol/l 4.04 3.23 4.85 Abbott Architect (CMIA)
ng/ml 3.16 2.52 3.80
nmol/l 4.32 3.46 5.18 BioMerieux Vidas
ng/ml 3.37 2.70 4.04
nmol/l 5.30 4.24 6.36 Siemens Centaur XP/XPT/Classic
ng/ml 4.14 3.31 4.97
nmol/l 4.60 3.68 5.52 Siemens Dimension
ng/ml 3.59 2.87 4.31
nmol/l 4.80 3.84 5.76 Beckman DxI800
ng/ml 3.75 3.00 4.50
nmol/l 4.66 3.73 5.59 Roche Integra
ng/ml 3.64 2.91 4.37
nmol/l 4.73 3.78 5.68 Roche Cobas e601/602
ng/ml 3.69 2.95 4.43
nmol/l 5.05 4.04 6.06 Beckman AU400/600/640/2700/5400
ng/ml 3.94 3.16 4.72
nmol/l 4.78 3.82 5.74 Roche Cobas 4000/E411
ng/ml 3.73 2.98 4.48
nmol/l 4.64 3.71 5.57 Roche Cobas e402/e801
ng/ml 3.62 2.90 4.34

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Digoxin nmol/l 5.95 4.76 7.14 Siemens Atellica IM
ng/ml 4.65 3.72 5.58
nmol/l 4.38 3.50 5.26 Siemens Atellica CH
ng/ml 3.42 2.73 4.11
nmol/l 4.47 3.58 5.36 Abbott Alinity (CMIA)
ng/ml 3.49 2.80 4.18
nmol/l 4.40 3.52 5.28 Abbott Alinity (PETINA)
ng/ml 3.44 2.75 4.13
nmol/l 5.12 4.10 6.14 Gravimetric
ng/ml 4.00 3.20 4.80
Ethosuximide µmol/l 493 394 592 Gravimetric
µg/ml 69.9 55.9 83.9
Ferritin ng/ml = µg/l 325 260 390 Abbott Architect
ng/ml = µg/l 233 186 280 BioMerieux Vidas
ng/ml = µg/l 227 182 272 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 270 216 324 Siemens Dimension
ng/ml = µg/l 257 206 308 Siemens Immulite 2000/2500
ng/ml = µg/l 206 165 247 Siemens Immulite 1000
ng/ml = µg/l 204 163 245 Beckman DxI800
ng/ml = µg/l 306 245 367 Roche Elecsys/Cobas e411
ng/ml = µg/l 274 219 329 Diasorin Liaison
ng/ml = µg/l 300 240 360 Roche Modular E170 / Roche Cobas e601/602
ng/ml = µg/l 208 166 250 Beckman Access
ng/ml = µg/l 204 163 245 Tosoh Series
ng/ml = µg/l 186 149 223 Vitros ECi
ng/ml = µg/l 289 231 347 Roche Cobas 4000/c311
ng/ml = µg/l 241 193 289 Beckman AU400/600/640/2700/5400
ng/ml = µg/l 281 225 337 Roche Cobas c501/502/503/701/702
ng/ml = µg/l 227 182 272 Siemens Centaur CP
ng/ml = µg/l 308 246 370 Diasorin Liaison XL
ng/ml = µg/l 333 266 400 Abbott Alinity i
ng/ml = µg/l 215 172 258 Siemens Atellica IM
ng/ml = µg/l 296 237 355 Roche Cobas e402/e801
Folate nmol/l 17.7 13.5 21.9 Abbott Architect
ng/ml 7.81 5.95 9.67
nmol/l 39.6 30.1 49.1 Siemens Centaur XP/XPT/Classic (enhanced kit)
ng/ml 17.5 13.3 21.7
nmol/l 15.6 11.9 19.3 Siemens Immulite 2000
ng/ml 6.88 5.25 8.51
nmol/l 21.7 16.5 26.9 Beckman DxI 600 / 800 - A14208
ng/ml 9.57 7.28 11.9
nmol/l 21.6 16.4 26.8 Beckman Access
ng/ml 9.53 7.23 11.8
nmol/l 33.4 25.4 41.4 Tosoh Series
ng/ml 14.7 11.2 18.2

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Folate nmol/l 12.9 9.80 16.0 Vitros ECi
ng/ml 5.69 4.32 7.06
nmol/l 12.8 9.73 15.9 Siemens Dimension
ng/ml 5.64 4.29 6.99
nmol/l 21.4 16.3 26.5 Beckman DxI 600 / 800 - A98032
ng/ml 9.44 7.19 11.7
nmol/l 23.1 17.6 28.6 Roche Folate III - 04476433
ng/ml 10.2 7.76 12.6
nmol/l 21.2 16.1 26.3 Roche Elecsys Folate
ng/ml 9.35 7.10 11.6
nmol/l 22.6 17.2 28.0 Roche Folate III - 07559992
ng/ml 9.97 7.59 12.4
nmol/l 35.6 27.1 44.1 Siemens Atellica IM
ng/ml 15.7 12.0 19.4
nmol/l 18.5 14.1 22.9 Abbott Alinity i
ng/ml 8.16 6.22 10.1
nmol/l 22.9 17.4 28.4 Roche Folate 07027290 e801
ng/ml 10.1 7.67 12.5
Free T3 pmol/l 25.4 19.1 31.8 Abbott Architect, 2 point calibration
ng/dl 1.65 1.24 2.06
pg/ml 16.5 12.4 20.6
pmol/l 23.9 17.9 29.9 BioMerieux Vidas
ng/dl 1.55 1.16 1.94
pg/ml 15.6 11.7 19.5
pmol/l 24.4 18.3 30.5 Siemens Centaur XP/XPT/Classic
ng/dl 1.59 1.19 1.99
pg/ml 15.9 11.9 19.9
pmol/l 15.1 11.3 18.9 Siemens Immulite 2000/2500
ng/dl 0.982 0.735 1.23
pg/ml 9.83 7.36 12.3
pmol/l 14.8 11.1 18.5 Siemens Immulite 1000
ng/dl 0.962 0.722 1.20
pg/ml 9.63 7.23 12.0
pmol/l 17.5 13.1 21.9 Beckman DxI800
ng/dl 1.14 0.852 1.43
pg/ml 11.4 8.53 14.3
pmol/l 30.3 22.7 37.9 Roche Elecsys
ng/dl 1.97 1.48 2.46
pg/ml 19.7 14.8 24.6
pmol/l 32.7 24.5 40.9 Diasorin Liaison
ng/dl 2.13 1.59 2.67
pg/ml 21.3 15.9 26.7
pmol/l 19.0 14.3 23.8 Beckman Access
ng/dl 1.24 0.930 1.55
pg/ml 12.4 9.31 15.5
pmol/l 36.9 27.7 46.1 Tosoh Series
ng/dl 2.40 1.80 3.00
pg/ml 24.0 18.0 30.0

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Free T3 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 30.0 22.5 37.5 Roche Cobas 4000/E411
ng/dl 1.95 1.46 2.44
pg/ml 19.5 14.6 24.4
pmol/l 30.3 22.7 37.9 Roche Cobas e601/602
ng/dl 1.97 1.48 2.46
pg/ml 19.7 14.8 24.6
pmol/l 30.7 23.0 38.4 Siemens Dimension
ng/dl 2.00 1.50 2.50
pg/ml 20.0 15.0 25.0
pmol/l 31.1 23.3 38.9 Siemens Dimension Vista LOCI
ng/dl 2.02 1.51 2.53
pg/ml 20.2 15.2 25.2
pmol/l 25.1 18.8 31.4 Siemens Centaur CP
ng/dl 1.63 1.22 2.04
pg/ml 16.3 12.2 20.4
pmol/l 36.5 27.4 45.6 Diasorin Liaison XL
ng/dl 2.37 1.78 2.96
pg/ml 23.8 17.8 29.8
pmol/l 25.9 19.4 32.4 Siemens Atellica IM
ng/dl 1.68 1.26 2.10
pg/ml 16.9 12.6 21.2
pmol/l 25.6 19.2 32.0 Abbott Alinity, 2 point cal
ng/dl 1.66 1.25 2.07
pg/ml 16.7 12.5 20.9
pmol/l 25.2 18.9 31.5 Abbott Architect, 6 point calibration
ng/dl 1.64 1.23 2.05
pg/ml 16.4 12.3 20.5
pmol/l 29.8 22.4 37.3 Roche Cobas e402/e801
ng/dl 1.94 1.46 2.42
pg/ml 19.4 14.6 24.2
pmol/l 25.7 19.3 32.1 Abbott Alinity, 6 point cal
ng/dl 1.67 1.25 2.09
pg/ml 16.7 12.6 20.8
Free T4 pmol/l 47.8 35.9 59.8 Abbott Architect
ng/dl 3.73 2.80 4.66
pg/ml 37.3 28.0 46.6
pmol/l 48.7 36.5 60.9 Siemens Centaur XP/XPT/Classic
ng/dl 3.80 2.85 4.75
pg/ml 38.0 28.5 47.5
pmol/l 56.0 42.0 70.0 CIS RIA Coated tube
ng/dl 4.37 3.28 5.46
pg/ml 43.7 32.8 54.6

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 71.6 53.7 89.5 Siemens Dimension
ng/dl 5.58 4.19 6.97
pg/ml 55.8 41.9 69.7
pmol/l 72.5 54.4 90.6 Siemens Immulite 2000/2500
ng/dl 5.66 4.24 7.08
pg/ml 56.6 42.4 70.8
pmol/l 74.4 55.8 93.0 Siemens Immulite 1000
ng/dl 5.80 4.35 7.25
pg/ml 58.0 43.5 72.5
pmol/l 55.7 41.8 69.6 Beckman DxI800
ng/dl 4.34 3.26 5.42
pg/ml 43.4 32.6 54.2
pmol/l 68.8 51.6 86.0 Roche Elecsys
ng/dl 5.37 4.02 6.72
pg/ml 53.7 40.2 67.2
pmol/l 94.3 70.7 118 Diasorin Liaison
ng/dl 7.36 5.51 9.21
pg/ml 73.6 55.1 92.1
pmol/l 51.9 38.9 64.9 Beckman Access
ng/dl 4.05 3.03 5.07
pg/ml 40.5 30.3 50.7
pmol/l 69.8 52.4 87.3 Tosoh Series
ng/dl 5.44 4.09 6.79
pg/ml 54.4 40.9 67.9
pmol/l 89.7 67.3 112 Vitros ECi
ng/dl 7.00 5.25 8.75
pg/ml 70.0 52.5 87.5
pmol/l 71.0 53.3 88.8 Roche Cobas e601/602
ng/dl 5.54 4.16 6.92
pg/ml 55.4 41.6 69.2
pmol/l 45.7 34.3 57.1 Immunotech IRMA
ng/dl 3.56 2.68 4.44
pg/ml 35.6 26.8 44.4
pmol/l 68.6 51.5 85.8 Roche Cobas 4000/E411
ng/dl 5.35 4.02 6.68
pg/ml 53.5 40.2 66.8
pmol/l 74.0 55.5 92.5 Siemens Dimension Vista LOCI
ng/dl 5.77 4.33 7.21
pg/ml 57.7 43.3 72.1
pmol/l 71.4 53.6 89.3 Biomerieux Vidas FT4N Kit
ng/dl 5.57 4.18 6.96
pg/ml 55.7 41.8 69.6
pmol/l 80.6 60.5 101 Siemens Dimension ExI LOCI
ng/dl 6.29 4.72 7.86
pg/ml 62.9 47.2 78.6

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
A
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Free T4 pmol/l 53.1 39.8 66.4 Siemens Centaur CP
ng/dl 4.14 3.10 5.18
pg/ml 41.4 31.0 51.8
pmol/l 112 84.0 140 Diasorin Liaison XL
ng/dl 8.74 6.55 10.9
pg/ml 87.4 65.5 109
pmol/l 53.6 40.2 67.0 Siemens Atellica IM
ng/dl 4.18 3.14 5.22
pg/ml 41.8 31.4 52.2
pmol/l 44.0 33.0 55.0 Abbott Alinity i
ng/dl 3.43 2.57 4.29
pg/ml 34.3 25.7 42.9
pmol/l 72.3 54.2 90.4 Roche Cobas e402/e801
ng/dl 5.64 4.23 7.05
pg/ml 56.4 42.3 70.5
FSH mU/ml 52.4 41.9 62.9 Abbott Architect
mU/ml 69.3 55.4 83.2 BioMerieux Vidas
mU/ml 77.5 62.0 93.0 Siemens Centaur XP/XPT/Classic
mU/ml 59.9 47.9 71.9 Siemens Immulite 2000/2500
mU/ml 60.6 48.5 72.7 Siemens Immulite 1000
mU/ml 64.0 51.2 76.8 Beckman DxI800
mU/ml 57.6 46.1 69.1 Roche/BM Elecsys
mU/ml 68.0 54.4 81.6 Diasorin Liaison
mU/ml 65.1 52.1 78.1 Beckman Access
mU/ml 63.3 50.6 76.0 Tosoh Series
mU/ml 51.8 41.4 62.2 Vitros ECi
mU/ml 59.6 47.7 71.5 Roche Cobas 4000/E411
mU/ml 55.3 44.2 66.4 Roche Cobas e601/602
mU/ml 49.4 39.5 59.3 Fujirebio Lumipulse G Series
mU/ml 70.3 56.2 84.4 Siemens Centaur CP
mU/ml 92.1 73.7 111 Diasorin Liaison XL
mU/ml 78.0 62.4 93.6 Siemens Atellica IM
mU/ml 52.2 41.8 62.6 Abbott Alinity i
mU/ml 55.5 44.4 66.6 Roche Cobas e402/e801
Gentamicin µmol/l 17.9 14.3 21.5 Siemens Centaur XP/XPT/Classic
µg/ml 8.56 6.84 10.3
µmol/l 14.3 11.4 17.2 Abbott Architect (CMIA)
µg/ml 6.84 5.45 8.23
µmol/l 10.3 8.24 12.4 Roche Cobas 6000/8000 Online KIMS
µg/ml 4.92 3.94 5.90
µmol/l 11.7 9.36 14.0 Roche Cobas 6000/8000 CEDIA
µg/ml 5.59 4.47 6.71
µmol/l 14.3 11.4 17.2 Siemens Atellica CH
µg/ml 6.84 5.45 8.23
µmol/l 14.5 11.6 17.4 Abbott Alinity (PETINA)
µg/ml 6.93 5.54 8.32

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Gentamicin µmol/l 11.7 9.36 14.0 Gravimetric
µg/ml 5.59 4.47 6.69
Growth Hormone (GH) µU/ml 43.2 34.6 51.8 Siemens Immulite 2000/2500
ng/ml 14.4 11.5 17.3
µU/ml 40.7 32.6 48.8 Siemens Immulite 1000
ng/ml 13.6 10.9 16.3
µU/ml 32.6 26.1 39.1 Beckman DxI800
ng/ml 10.9 8.69 13.1
µU/ml 35.8 28.6 43.0 Beckman Access
ng/ml 11.9 9.52 14.3
µU/ml 44.3 35.4 53.2 Tosoh Series
ng/ml 14.8 11.8 17.8
µU/ml 35.2 28.2 42.2 Diasorin Liaison
ng/ml 11.7 9.39 14.0
µU/ml 37.3 29.8 44.8 Roche Cobas 4000/E411
ng/ml 12.4 9.92 14.9
µU/ml 38.6 30.9 46.3 Roche Cobas e601/602
ng/ml 12.9 10.3 15.5
µU/ml 36.3 29.0 43.6 Diasorin Liaison XL
ng/ml 12.1 9.66 14.5
µU/ml 39.1 31.3 46.9 Roche Cobas e402/e801
ng/ml 13.0 10.4 15.6
Immunoglobulin E KIU/l = IU/ml 484 387 581 Abbott Architect
KIU/l = IU/ml 505 404 606 Beckman Immage
KIU/l = IU/ml 494 395 593 BioMerieux Vidas
KIU/l = IU/ml 550 440 660 Siemens Centaur XP/XPT/Classic
KIU/l = IU/ml 535 428 642 Siemens Immulite 2000/2500
KIU/l = IU/ml 544 435 653 Siemens Immulite 1000
KIU/l = IU/ml 602 482 722 Roche Elecsys
KIU/l = IU/ml 499 399 599 Pharmacia Unicap
KIU/l = IU/ml 491 393 589 Tosoh Series
KIU/l = IU/ml 578 462 694 Roche Cobas 4000/E411
KIU/l = IU/ml 561 449 673 Roche Cobas e601/602
KIU/l = IU/ml 505 404 606 Siemens Centaur CP
KIU/l = IU/ml 575 460 690 Siemens Atellica IM
KIU/l = IU/ml 562 450 674 Roche Cobas e402/e801
KIU/l = IU/ml 480 384 576 Abbott Alinity
Insulin mU/l 18.3 13.7 22.9 Siemens Centaur XP/XPT/Classic
µU/ml 18.3 13.7 22.9
mU/l 8.74 6.56 10.9 Siemens Immulite 2000
µU/ml 8.74 6.56 10.9
mU/l 26.7 20.0 33.4 Roche Elecsys
µU/ml 26.7 20.0 33.4
mU/l 19.1 14.3 23.9 Beckman Access
µU/ml 19.1 14.3 23.9
mU/l 18.0 13.5 22.5 Abbott Architect
µU/ml 18.0 13.5 22.5

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Insulin mU/l 31.7 23.8 39.6 Tosoh Series
µU/ml 31.7 23.8 39.6
mU/l 26.8 20.1 33.5 Roche Cobas 4000/E411
µU/ml 26.8 20.1 33.5
mU/l 17.9 13.4 22.4 Beckman DxI 600/800
µU/ml 17.9 13.4 22.4
mU/l 26.7 20.0 33.4 Diasorin Liaison
µU/ml 26.7 20.0 33.4
mU/l 26.4 19.8 33.0 Roche Cobas 6000/8000
µU/ml 26.4 19.8 33.0
mU/l 22.4 16.8 28.0 Fujirebio Lumipulse G Series
µU/ml 22.4 16.8 28.0
mU/l 28.7 21.5 35.9 Diasorin Liaison XL
µU/ml 28.7 21.5 35.9
mU/l 18.9 14.2 23.6 Siemens Atellica IM
µU/ml 18.9 14.2 23.6
mU/l 16.7 12.5 20.9 Abbott Alinity i
µU/ml 16.7 12.5 20.9
Luteinising Hormone (LH) mU/ml 41.0 32.8 49.2 Abbott Architect
mU/ml 50.4 40.3 60.5 BioMerieux Vidas
mU/ml 49.3 39.4 59.2 Siemens Centaur XP/XPT/Classic
mU/ml 69.7 55.8 83.6 Siemens Immulite 2000
mU/ml 76.1 60.9 91.3 Siemens Immulite 1000
mU/ml 41.0 32.8 49.2 Beckman DxI800
mU/ml 53.9 43.1 64.7 Roche Elecsys
mU/ml 66.6 53.3 79.9 Diasorin Liaison
mU/ml 40.8 32.6 49.0 Beckman Access
mU/ml 48.1 38.5 57.7 Tosoh Series
mU/ml 58.7 47.0 70.4 Vitros ECi
mU/ml 54.6 43.7 65.5 Roche Cobas 4000/E411
mU/ml 54.7 43.8 65.6 Roche Cobas e601/602
mU/ml 47.8 38.2 57.4 Fujirebio Lumipulse G Series
mU/ml 47.8 38.2 57.4 Siemens Centaur CP
mU/ml 66.2 53.0 79.4 Diasorin Liaison XL
mU/ml 50.6 40.5 60.7 Siemens Atellica IM
mU/ml 40.1 32.1 48.1 Abbott Alinity i
mU/ml 54.8 43.8 65.8 Roche Cobas e402/e801
Oestradiol pmol/l 1285 1028 1542 Abbott Architect
pg/ml 350 280 420
pmol/l 2937 2350 3524 BioMerieux Vidas
pg/ml 799 639 959
pmol/l 2402 1922 2882 Siemens Centaur XP/XPT/Classic
pg/ml 653 523 783
pmol/l 2209 1767 2651 Siemens Immulite 2000/2500
pg/ml 601 481 721

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Oestradiol pmol/l 2154 1723 2585 Siemens Immulite 1000
pg/ml 586 469 703
pmol/l 1469 1175 1763 Beckman DxI800
pg/ml 400 320 480
pmol/l 1419 1135 1703 Roche Elecsys (Estradiol II)
pg/ml 386 309 463
pmol/l 1619 1295 1943 Tosoh (E2)
pg/ml 440 352 528
pmol/l 2527 2022 3032 Vitros ECi
pg/ml 687 550 824
pmol/l 1040 832 1248 Diasorin Liaison
pg/ml 283 226 340
pmol/l 1460 1168 1752 Roche Cobas e601/602 (Estradiol II)
pg/ml 397 318 476
pmol/l 1449 1159 1739 Roche Cobas 4000/E411 (Estradiol II)
pg/ml 394 315 473
pmol/l 2383 1906 2860 Siemens Centaur XP/XPT/Classic Enhanced (eE2)
pg/ml 648 518 778
pmol/l 1791 1433 2149 Tosoh (iE2-hsE2)
pg/ml 487 390 584
pmol/l 1457 1166 1748 Roche Cobas e601/602 (Estradiol III)
pg/ml 396 317 475
pmol/l 1421 1137 1705 Roche Elecsys (Estradiol III)
pg/ml 387 309 465
pmol/l 1455 1164 1746 Roche Cobas 4000/E411 (Estradiol III)
pg/ml 396 317 475
pmol/l 1049 839 1259 Diasorin Liaison XL
pg/ml 285 228 342
pmol/l 1637 1310 1964 Beckman Access / Access 2 Sensitive B84493
pg/ml 445 356 534
pmol/l 1438 1150 1726 Beckman DxI600/800 Sensitive B84493
pg/ml 391 313 469
pmol/l 2572 2058 3086 Siemens Atellica IM
pg/ml 700 560 840
pmol/l 1257 1006 1508 Abbott Alinity i
pg/ml 342 274 410
pmol/l 1449 1159 1739 Roche Cobas e801 (Estradiol III)
pg/ml 394 315 473
Paracetamol mmol/l 0.503 0.402 0.604 Abbott Architect
mg/l 76.1 60.8 91.4
mmol/l 0.483 0.386 0.580 Roche Cobas c501/502/503/701/702
mg/l 73.1 58.4 87.8
mmol/l 0.508 0.406 0.610 Beckman AU Instruments
mg/l 76.9 61.4 92.4
mmol/l 0.518 0.414 0.622 EMIT
mg/l 78.4 62.6 94.2

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Paracetamol mmol/l 0.513 0.410 0.616 Abbott Alinity
mg/l 77.6 62.0 93.2
mmol/l 0.529 0.420 0.630 Gravimetric
mg/l 80.0 63.5 95.3
Phenobarbital µmol/l 124 99.0 149 Abbott Architect (CMIA)
µg/ml 28.8 23.0 34.6
µmol/l 118 94.4 142 Roche Cobas e601/602/801
µg/ml 27.4 21.9 32.9
µmol/l 113 90.4 136 Beckman AU400/600/640/2700/5400
µg/ml 26.2 21.0 31.4
µmol/l 162 130 194 Siemens Centaur XP/XPT/Classic
µg/ml 37.6 30.2 45.0
µmol/l 118 94.4 142 Roche Integra
µg/ml 27.4 21.9 32.9
µmol/l 125 100 150 Siemens Atellica CH
µg/ml 29.0 23.2 34.8
µmol/l 106 84.8 127 Abbott Alinity (PETINA)
µg/ml 24.6 19.7 29.5
µmol/l 121 96.8 145 Gravimetric
µg/ml 28.1 22.5 33.6
µmol/l 117 93.6 140 Roche Cobas C303/501/502/503/701
µg/ml 27.1 21.7 32.5
Phenytoin µmol/l 94.9 75.9 114 Abbott Architect
µg/ml 24.0 19.2 28.8
µmol/l 130 104 156 Siemens Centaur XP/XPT/Classic
µg/ml 32.8 26.3 39.3
µmol/l 102 81.6 122 Siemens Dimension
µg/ml 25.8 20.6 31.0
µmol/l 97.1 77.7 117 Siemens Immulite 2000/2500
µg/ml 24.5 19.6 29.4
µmol/l 92.5 74.0 111 Roche Integra
µg/ml 23.4 18.7 28.1
µmol/l 96.1 76.9 115 Vitros
µg/ml 24.3 19.4 29.2
µmol/l 95.2 76.2 114 Roche Cobas 6000/8000
µg/ml 24.0 19.2 28.8
µmol/l 103 82.4 124 EMIT
µg/ml 26.0 20.8 31.2
µmol/l 102 81.6 122 Siemens Atellica CH
µg/ml 25.8 20.6 31.0
µmol/l 102 81.6 122 Abbott Alinity
µg/ml 25.8 20.6 31.0
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

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Progesterone nmol/l 92.9 74.3 111 Abbott Architect
ng/ml 29.1 23.3 34.9
nmol/l 145 116 174 BioMerieux Vidas
ng/ml 45.4 36.3 54.5
nmol/l 74.3 59.4 89.2 Siemens Centaur XP/XPT/Classic
ng/ml 23.3 18.6 28.0
nmol/l 77.0 61.6 92.4 Siemens Immulite 2000/2500
ng/ml 24.1 19.3 28.9
nmol/l 78.0 62.4 93.6 Siemens Immulite 1000
ng/ml 24.4 19.5 29.3
nmol/l 92.8 74.2 111 Beckman DxI Prog Cal 33555
ng/ml 29.0 23.2 34.8
nmol/l 100 80.0 120 Roche Elecsys (Prog. II)
ng/ml 31.3 25.0 37.6
nmol/l 92.3 73.8 111 Beckman Access Prog Cal 33555
ng/ml 28.9 23.1 34.7
nmol/l 108 86.4 130 Tosoh Series
ng/ml 33.8 27.0 40.6
nmol/l 101 80.8 121 Vitros ECi
ng/ml 31.6 25.3 37.9
nmol/l 101 80.8 121 Roche Cobas 4000/e411 (Prog. II)
ng/ml 31.6 25.3 37.9
nmol/l 101 80.8 121 Roche Cobas e601/602 (Prog. II)
ng/ml 31.6 25.3 37.9
nmol/l 83.6 66.9 100 Diasorin Liaison
ng/ml 26.2 20.9 31.5
nmol/l 87.6 70.1 105 Beckman DxI Prog DE Cal A80773
ng/ml 27.4 21.9 32.9
nmol/l 85.3 68.2 102 Beckman Access Prog DE Cal A80773
ng/ml 26.7 21.3 32.1
nmol/l 73.1 58.5 87.7 Siemens Centaur CP
ng/ml 22.9 18.3 27.5
nmol/l 100 80.0 120 Roche Cobas e601/602 (Prog. III)
ng/ml 31.3 25.0 37.6
nmol/l 101 80.8 121 Roche Elecsys (Prog. III)
ng/ml 31.6 25.3 37.9
nmol/l 101 80.8 121 Roche Cobas 4000/e411 (Prog. III)
ng/ml 31.6 25.3 37.9
nmol/l 89.5 71.6 107 Diasorin Liaison XL
ng/ml 28.0 22.4 33.6
nmol/l 87.1 69.7 105 Abbott Alinity i
ng/ml 27.3 21.8 32.8
nmol/l 102 81.6 122 Roche Cobas e801 (Prog. III)
ng/ml 31.9 25.5 38.3
Prolactin µU/ml 950 760 1140 Abbott Architect
µU/ml 1013 810 1216 BioMerieux Vidas

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Prolactin µU/ml 794 635 953 Siemens Centaur XP/XPT/Classic
µU/ml 832 666 998 Siemens Immulite 2000/2500
µU/ml 942 754 1130 Siemens Immulite 1000
µU/ml 769 615 923 Beckman DxI800
µU/ml 1033 826 1240 Roche Elecsys
µU/ml 1036 829 1243 Diasorin Liaison
µU/ml 807 646 968 Beckman Access
µU/ml 864 691 1037 Tosoh Series
µU/ml 818 654 982 Vitros ECi
µU/ml 989 791 1187 Roche Elecsys/E170/Cobas 6000/8000 PRLII
µU/ml 944 755 1133 Immunotech IRMA
µU/ml 1041 833 1249 Roche Cobas 4000/E411
µU/ml 993 794 1192 Roche Cobas e601/602
µU/ml 1042 834 1250 Fujirebio Lumipulse G Series
µU/ml 760 608 912 Siemens Centaur CP
µU/ml 1019 815 1223 Diasorin Liaison XL
µU/ml 779 623 935 Siemens Atellica IM
µU/ml 991 793 1189 Abbott Alinity i
µU/ml 992 794 1190 Roche Cobas e801 PRL II
PSA Free ng/ml = µg/l 22.7 17.0 28.4 Abbott Architect
ng/ml = µg/l 22.1 16.6 27.6 BioMerieux Vidas
ng/ml = µg/l 17.9 13.4 22.4 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 14.8 11.1 18.5 Siemens Immulite 2000/2500
ng/ml = µg/l 14.3 10.7 17.9 Siemens Immulite 1000
ng/ml = µg/l 23.2 17.4 29.0 Beckman DXI standardised to Hybritech
ng/ml = µg/l 17.9 13.4 22.4 Roche Elecsys
ng/ml = µg/l 22.6 17.0 28.3 Beckman Access standardised to Hybritech
ng/ml = µg/l 18.0 13.5 22.5 Tosoh Series
ng/ml = µg/l 18.0 13.5 22.5 Roche Cobas 4000/E411
ng/ml = µg/l 17.6 13.2 22.0 Roche Cobas e601/602
ng/ml = µg/l 16.7 12.5 20.9 Siemens Dimension Vista
ng/ml = µg/l 20.7 15.5 25.9 Beckman DxI800 standardised to WHO IRP96/670
ng/ml = µg/l 17.4 13.1 21.8 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 14.5 10.9 18.1 Fujirebio Lumipulse G Series
ng/ml = µg/l 16.8 12.6 21.0 Diasorin Liaison XL
ng/ml = µg/l 19.3 14.5 24.1 Siemens Atellica IM
ng/ml = µg/l 21.0 15.8 26.3 Abbott Alinity i
ng/ml = µg/l 16.9 12.7 21.1 Roche Cobas e402/e801
PSA Total ng/ml = µg/l 17.9 13.4 22.4 Abbott Architect
ng/ml = µg/l 21.3 16.0 26.6 BioMerieux Vidas
ng/ml = µg/l 21.6 16.2 27.0 bioMerieux VIDAS TPSA
ng/ml = µg/l 21.4 16.1 26.8 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 18.0 13.5 22.5 Siemens Immulite 2000/2500 1st generation
ng/ml = µg/l 19.5 14.6 24.4 Siemens Immulite 1000 1st generation
ng/ml = µg/l 22.1 16.6 27.6 Beckman DxI standardisd to Hybritech
ng/ml = µg/l 17.4 13.1 21.8 Beckman DxI800 standardised to WHO IRP96/670

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
PSA Total ng/ml = µg/l 22.6 17.0 28.3 Roche Elecsys
ng/ml = µg/l 21.5 16.1 26.9 Diasorin Liaison
ng/ml = µg/l 22.6 17.0 28.3 Beckman Access standardised to Hybritech
ng/ml = µg/l 23.1 17.3 28.9 Beckman Access standardised to WHO IRP96/670
ng/ml = µg/l 16.7 12.5 20.9 Tosoh Series
ng/ml = µg/l 23.0 17.3 28.8 Vitros ECi
ng/ml = µg/l 24.8 18.6 31.0 CIS RIA Coated tube
ng/ml = µg/l 23.4 17.6 29.3 Roche Cobas 4000/E411
ng/ml = µg/l 22.9 17.2 28.6 Roche Cobas e601/602
ng/ml = µg/l 16.2 12.2 20.3 Fujirebio Lumipulse G Series
ng/ml = µg/l 23.0 17.3 28.8 Ortho Vitros 3600/5600/ECi PSA II
ng/ml = µg/l 21.3 16.0 26.6 Siemens Centaur CP
ng/ml = µg/l 22.1 16.6 27.6 Diasorin Liaison XL
ng/ml = µg/l 22.8 17.1 28.5 Siemens Atellica IM
ng/ml = µg/l 17.7 13.3 22.1 Abbott Alinity i
ng/ml = µg/l 22.0 16.5 27.5 Roche Cobas e402/e801
Salicylic Acid mmol/l 2.97 2.38 3.56 Abbott Architect
mg/dl 41.0 32.9 49.1
mmol/l 2.89 2.31 3.47 Roche Cobas c501/502/503
mg/dl 39.9 31.9 47.9
mmol/l 2.97 2.38 3.56 EMIT
mg/dl 41.0 32.9 49.1
mmol/l 2.88 2.30 3.46 Gravimetric
mg/dl 39.8 31.8 47.8
SHBG nmol/l 38.6 30.9 46.3 Siemens Immulite 2000/2500
nmol/l 42.9 34.3 51.5 Abbott Architect
nmol/l 41.8 33.4 50.2 Beckman Access
nmol/l 39.6 31.7 47.5 Beckman DxI800
nmol/l 39.5 31.6 47.4 Siemens Atellica IM
nmol/l 38.5 30.8 46.2 Roche analysers - 413417/15
nmol/l 37.0 29.6 44.4 Roche Cobas e801 - 413429
nmol/l 41.4 33.1 49.7 Abbott Alinity i
T Uptake %U 37.6 30.8 44.4 Siemens Immulite 2000
Testosterone nmol/l 28.5 22.8 34.2 Abbott Architect
ng/ml 8.21 6.57 9.85
ng/dl 821 657 985
nmol/l 26.2 21.0 31.4 BioMerieux Vidas
ng/ml 7.55 6.05 9.05
ng/dl 755 605 905
nmol/l 25.4 20.3 30.5 Siemens Centaur XP/XPT/Classic
ng/ml 7.32 5.85 8.79
ng/dl 732 585 879
nmol/l 28.1 22.5 33.7 CIS RIA Coated tube
ng/ml 8.09 6.48 9.70
ng/dl 809 648 970
nmol/l 33.0 26.4 39.6 Siemens Immulite 2000/2500
ng/ml 9.50 7.60 11.4
ng/dl 950 760 1140

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Testosterone nmol/l 40.7 32.6 48.8 Siemens Immulite 1000
ng/ml 11.7 9.39 14.0
ng/dl 1172 939 1405
nmol/l 24.0 19.2 28.8 Beckman DxI800
ng/ml 6.91 5.53 8.29
ng/dl 691 553 829
nmol/l 26.3 21.0 31.6 Beckman Access
ng/ml 7.57 6.05 9.09
ng/dl 757 605 909
nmol/l 38.5 30.8 46.2 Tosoh Series
ng/ml 11.1 8.87 13.3
ng/dl 1109 887 1331
nmol/l 38.8 31.0 46.6 Vitros ECi
ng/ml 11.2 8.93 13.5
ng/dl 1117 893 1341
nmol/l 28.7 23.0 34.4 Roche Cobas e601/602 Test II
ng/ml 8.27 6.62 9.92
ng/dl 827 662 992
nmol/l 29.1 23.3 34.9 Roche Elecsys Test II
ng/ml 8.38 6.71 10.1
ng/dl 838 671 1005
nmol/l 28.6 22.9 34.3 Roche Cobas 4000/e411 Test II
ng/ml 8.24 6.60 9.88
ng/dl 824 660 988
nmol/l 28.3 22.6 34.0 Abbott Architect 2nd Generation
ng/ml 8.15 6.51 9.79
ng/dl 815 651 979
nmol/l 26.8 21.4 32.2 BioMerieux Vidas Testosterone II
ng/ml 7.72 6.16 9.28
ng/dl 772 616 928
nmol/l 26.0 20.8 31.2 Siemens Centaur TST II
ng/ml 7.49 5.99 8.99
ng/dl 749 599 899
nmol/l 26.3 21.0 31.6 Siemens Atellica IM
ng/ml 7.57 6.05 9.09
ng/dl 757 605 909
nmol/l 28.6 22.9 34.3 Roche Cobas e801 Test II
ng/ml 8.24 6.60 9.88
ng/dl 824 660 988
nmol/l 29.0 23.2 34.8 Abbott Alinity i
ng/ml 8.35 6.68 10.0
ng/dl 835 668 1002
Theophylline µmol/l 156 125 187 Siemens Centaur XP/XPT/Classic
µg/ml 28.1 22.5 33.7

_________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Theophylline µmol/l 155 124 186 Siemens Dimension
µg/ml 27.9 22.3 33.5
µmol/l 168 134 202 Roche Integra
µg/ml 30.3 24.1 36.5
µmol/l 154 123 185 Abbott Architect (CMIA)
µg/ml 27.8 22.2 33.4
µmol/l 166 133 199 Roche Cobas 6000/8000
µg/ml 29.9 24.0 35.8
µmol/l 157 126 188 Abbott Alinity Enzyme-Immu
µg/ml 28.3 22.7 33.9
µmol/l 166 133 199 Gravimetric
µg/ml 29.9 24.0 35.9
Thyroglobulin ng/ml 40.2 30.2 50.3 Siemens Immulite 1000
ng/ml 36.7 27.5 45.9 Siemens Immulite 2000
ng/ml 65.2 48.9 81.5 Roche Elecsys
ng/ml 61.7 46.3 77.1 Beckman DxI800
ng/ml 68.6 51.5 85.8 Roche Cobas 4000/E411
ng/ml 57.6 43.2 72.0 Diesse Chorus
ng/ml 65.7 49.3 82.1 Roche Cobas e601/602
ng/ml 62.7 47.0 78.4 Beckman Access
ng/ml 76.1 57.1 95.1 Abbott Architect 2000i
ng/ml 70.1 52.6 87.6 Tosoh Series
ng/ml 66.3 49.7 82.9 Roche Cobas e601/602 Tg II
ng/ml 69.9 52.4 87.4 Roche Elecsys TGII
ng/ml 67.1 50.3 83.9 Roche Cobas 4000/E411 TGII
ng/ml 68.2 51.2 85.3 Roche Cobas e801 Tg II
ng/ml 64.1 48.1 80.1 DiaSorin Liaison TG II Gen
ng/ml 65.8 49.4 82.3 DiaSorin Liaison XL TG II Gen
ng/ml 74.3 55.7 92.9 Abbott Alinity i
Thyroid Stimulating µU/ml = mlU/l 17.8 14.2 21.4 Abbott Architect
Hormone
µU/ml = mlU/l 21.5 17.2 25.8 bioMerieux VIDAS TSH
µU/ml = mlU/l 19.5 15.6 23.4 bioMerieux VIDAS TSH3 Ultrasensitive
µU/ml = mlU/l 21.4 17.1 25.7 Siemens Centaur XP/XPT/Classic
µU/ml = mlU/l 22.3 17.8 26.8 CIS IRMA
µU/ml = mlU/l 21.6 17.3 25.9 Siemens Centaur XP/XPT/Classic 3rd Generation
µU/ml = mlU/l 20.9 16.7 25.1 Siemens Immulite 2000/2500
µU/ml = mlU/l 21.1 16.9 25.3 Siemens Immulite 1000
µU/ml = mlU/l 18.8 15.0 22.6 Beckman DxI800 Fast TSH
µU/ml = mlU/l 19.2 15.4 23.0 Beckman DxI800
µU/ml = mlU/l 20.2 16.2 24.2 Roche Elecsys
µU/ml = mlU/l 24.7 19.8 29.6 Diasorin Liaison
µU/ml = mlU/l 19.9 15.9 23.9 Beckman Access Fast TSH
µU/ml = mlU/l 19.3 15.4 23.2 Beckman Access hyperTSH 3rd Generation
µU/ml = mlU/l 22.3 17.8 26.8 Tosoh Series
µU/ml = mlU/l 25.9 20.7 31.1 Vitros ECi
µU/ml = mlU/l 20.7 16.6 24.8 Roche Cobas 4000/E411

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Thyroid Stimulating µU/ml = mlU/l 20.7 16.6 24.8 Roche Cobas e601/602
Hormone
µU/ml = mlU/l 19.5 15.6 23.4 Beckman DxI800 Hyper TSH
µU/ml = mlU/l 19.8 15.8 23.8 Siemens Dimension Vista LOCI
µU/ml = mlU/l 22.4 17.9 26.9 Siemens Centaur XP/XPT/Classic TSH3-Ultra
µU/ml = mlU/l 20.7 16.6 24.8 Siemens Centaur CP
µU/ml = mlU/l 21.6 17.3 25.9 Siemens Centaur CP TSH3-Ultra
µU/ml = mlU/l 19.2 15.4 23.0 Beckman DxI 600/800 Access (3rd IS)
µU/ml = mlU/l 25.0 20.0 30.0 Diasorin Liaison XL
µU/ml = mlU/l 21.6 17.3 25.9 Siemens Atellica IM
µU/ml = mlU/l 17.7 14.2 21.2 Abbott Alinity i
µU/ml = mlU/l 19.9 15.9 23.9 Roche Cobas e402/e801
Tobramycin µmol/l 10.3 8.24 12.4 Gravimetric
µg/ml 4.82 3.86 5.80
Total Beta hCG mU/ml=IU/l 264 211 317 Abbott Architect
IU/ml 0.264 0.211 0.317
mU/ml=IU/l 486 389 583 BioMerieux Vidas
IU/ml 0.486 0.389 0.583
mU/ml=IU/l 231 185 277 Siemens Centaur XP/XPT/Classic
IU/ml 0.231 0.185 0.277
mU/ml=IU/l 484 387 581 Siemens Dimension
IU/ml 0.484 0.387 0.581
mU/ml=IU/l 562 450 674 Siemens Immulite 2000
IU/ml 0.562 0.450 0.674
mU/ml=IU/l 587 470 704 Siemens Immulite 1000
IU/ml 0.587 0.470 0.704
mU/ml=IU/l 269 215 323 Beckman DxI800
IU/ml 0.269 0.215 0.323
mU/ml=IU/l 234 187 281 Diasorin Liaison
IU/ml 0.234 0.187 0.281
mU/ml=IU/l 332 266 398 Roche Cobas Core EIA
IU/ml 0.332 0.266 0.398
mU/ml=IU/l 259 207 311 Beckman Access
IU/ml 0.259 0.207 0.311
mU/ml=IU/l 491 393 589 Tosoh Series
IU/ml 0.491 0.393 0.589
mU/ml=IU/l 490 392 588 Vitros ECi
IU/ml 0.490 0.392 0.588
mU/ml=IU/l 235 188 282 Roche hCG STAT (Intact)
IU/ml 0.235 0.188 0.282
mU/ml=IU/l 325 260 390 Roche hCG+Beta
IU/ml 0.325 0.260 0.390
mU/ml=IU/l 257 206 308 Beckman Access Total BhCG (5th IS)
IU/ml 0.257 0.206 0.308
mU/ml=IU/l 267 214 320 Beckman DxI Total BhCG (5th IS)
IU/ml 0.267 0.214 0.320
mU/ml=IU/l 224 179 269 Siemens Centaur CP
IU/ml 0.224 0.179 0.269

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Total Beta hCG mU/ml=IU/l 255 204 306 Diasorin Liaison XL
IU/ml 0.255 0.204 0.306
mU/ml=IU/l 247 198 296 Siemens Atellica IM
IU/ml 0.247 0.198 0.296
mU/ml=IU/l 269 215 323 Abbott Alinity i
IU/ml 0.269 0.215 0.323
mU/ml=IU/l 304 243 365 Roche hCG+Beta e801
IU/ml 0.304 0.243 0.365
Total T3 nmol/l 5.27 3.95 6.59 Abbott Architect
ng/ml 3.43 2.57 4.29
ng/dl 343 257 429
nmol/l 5.92 4.44 7.40 BioMerieux Vidas
ng/ml 3.85 2.89 4.81
ng/dl 385 289 481
nmol/l 7.00 5.25 8.75 Siemens Centaur XP/XPT/Classic
ng/ml 4.56 3.42 5.70
ng/dl 456 342 570
nmol/l 6.27 4.70 7.84 Siemens Immulite 2000/2500
ng/ml 4.08 3.06 5.10
ng/dl 408 306 510
nmol/l 6.04 4.53 7.55 Siemens Immulite 1000
ng/ml 3.93 2.95 4.91
ng/dl 393 295 491
nmol/l 6.06 4.55 7.58 Beckman DxI800
ng/ml 3.95 2.96 4.94
ng/dl 395 296 494
nmol/l 5.83 4.37 7.29 Roche Elecsys
ng/ml 3.80 2.84 4.76
ng/dl 380 284 476
nmol/l 6.08 4.56 7.60 Beckman Access
ng/ml 3.96 2.97 4.95
ng/dl 396 297 495
nmol/l 5.88 4.41 7.35 Tosoh Series
ng/ml 3.83 2.87 4.79
ng/dl 383 287 479
nmol/l 7.64 5.73 9.55 Vitros ECi
ng/ml 4.97 3.73 6.21
ng/dl 497 373 621
nmol/l 5.51 4.13 6.89 CIS RIA Coated tube
ng/ml 3.59 2.69 4.49
ng/dl 359 269 449
nmol/l 6.17 4.63 7.71 Roche Cobas 4000/E411
ng/ml 4.02 3.01 5.03
ng/dl 402 301 503
nmol/l 6.05 4.54 7.56 Roche Cobas e601/602
ng/ml 3.94 2.96 4.92
ng/dl 394 296 492

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Total T3 nmol/l 7.61 5.71 9.51 Siemens Centaur CP
ng/ml 4.95 3.72 6.18
ng/dl 495 372 618
nmol/l 5.20 3.90 6.50 Diasorin Liaison XL
ng/ml 3.39 2.54 4.24
ng/dl 339 254 424
nmol/l 5.29 3.97 6.61 Abbott Alinity i
ng/ml 3.44 2.58 4.30
ng/dl 344 258 430
nmol/l 6.84 5.13 8.55 Siemens Atellica IM
ng/ml 4.45 3.34 5.56
ng/dl 445 334 556
nmol/l 6.42 4.82 8.03 Roche Cobas e402/e801
ng/ml 4.18 3.14 5.22
ng/dl 418 314 522
Total T4 nmol/l 201 151 251 Abbott Architect
µg/dl 15.7 11.8 19.6
ng/ml 157 118 196
nmol/l 210 158 263 BioMerieux Vidas
µg/dl 16.4 12.3 20.5
ng/ml 164 123 205
nmol/l 215 161 269 Siemens Centaur XP/XPT/Classic
µg/dl 16.8 12.6 21.0
ng/ml 168 126 210
nmol/l 200 150 250 Siemens Immulite 2000/2500
µg/dl 15.6 11.7 19.5
ng/ml 156 117 195
nmol/l 186 140 233 Siemens Immulite 1000
µg/dl 14.5 10.9 18.1
ng/ml 145 109 181
nmol/l 218 164 273 Beckman DxI800
µg/dl 17.0 12.8 21.2
ng/ml 170 128 212
nmol/l 176 132 220 Roche Elecsys
µg/dl 13.7 10.3 17.1
ng/ml 137 103 171
nmol/l 206 155 258 Beckman Access
µg/dl 16.1 12.1 20.1
ng/ml 161 121 201
nmol/l 194 146 243 Tosoh Series
µg/dl 15.1 11.4 18.8
ng/ml 151 114 188
nmol/l 220 165 275 Vitros ECi
µg/dl 17.2 12.9 21.5
ng/ml 172 129 215

__________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 25 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Total T4 nmol/l 262 197 328 CIS RIA Coated tube
µg/dl 20.4 15.4 25.4
ng/ml 204 154 254
nmol/l 179 134 224 Roche Cobas 4000/E411
µg/dl 14.0 10.5 17.5
ng/ml 140 105 175
nmol/l 179 134 224 Roche Cobas e601/602
µg/dl 14.0 10.5 17.5
ng/ml 140 105 175
nmol/l 159 119 199 Immunotech IRMA
µg/dl 12.4 9.28 15.5
ng/ml 124 92.8 155
nmol/l 224 168 280 Siemens Centaur CP
µg/dl 17.5 13.1 21.9
ng/ml 175 131 219
nmol/l 195 146 244 Diasorin Liaison XL
µg/dl 15.2 11.4 19.0
ng/ml 152 114 190
nmol/l 196 147 245 Abbott Alinity i
µg/dl 15.3 11.5 19.1
ng/ml 153 115 191
nmol/l 230 173 288 Siemens Atellica IM
µg/dl 17.9 13.5 22.3
ng/ml 179 135 223
nmol/l 178 134 223 Roche Cobas e402/e801
µg/dl 13.9 10.5 17.3
ng/ml 139 105 173
Valproic Acid µmol/l 913 730 1096 Abbott Architect (CMIA)
µg/ml 132 105 159
µmol/l 974 779 1169 Siemens Centaur XP/XPT/Classic
µg/ml 141 112 170
µmol/l 919 735 1103 Siemens Dimension
µg/ml 133 106 160
µmol/l 989 791 1187 Siemens Immulite 2000/2500
µg/ml 143 114 172
µmol/l 975 780 1170 Siemens Immulite 1000
µg/ml 141 113 169
µmol/l 920 736 1104 Roche Integra
µg/ml 133 106 160
µmol/l 920 736 1104 Vitros
µg/ml 133 106 160
µmol/l 911 729 1093 Roche Cobas 6000/8000
µg/ml 131 105 157
µmol/l 964 771 1157 Beckman DxC
µg/ml 139 111 167

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 26 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Valproic Acid µmol/l 960 768 1152 Beckman AU400/600/640/2700/5400
µg/ml 139 111 167
µmol/l 907 726 1088 Abbott Architect (PETINA)
µg/ml 131 105 157
µmol/l 968 774 1162 EMIT
µg/ml 140 112 168
µmol/l 908 726 1090 Siemens Atellica CH
µg/ml 131 105 157
µmol/l 926 741 1111 Abbott Alinity (CMIA)
µg/ml 134 107 161
µmol/l 893 714 1072 Abbott Alinity (PETINA)
µg/ml 129 103 155
µmol/l 1116 893 1339 Gravimetric
µg/ml 161 129 193
Vancomycin µmol/l 12.1 9.68 14.5 Roche Integra
µg/ml 18.0 14.4 21.6
µmol/l 9.50 7.60 11.4 Ortho Vitros Microslide Systems
µg/ml 14.1 11.3 16.9
µmol/l 12.6 10.1 15.1 Abbott Architect (CMIA)
µg/ml 18.7 15.0 22.4
µmol/l 10.2 8.16 12.2 Siemens Centaur XP/XPT/Classic
µg/ml 15.2 12.1 18.3
µmol/l 11.6 9.28 13.9 Siemens Dimension
µg/ml 17.2 13.8 20.6
µmol/l 11.3 9.04 13.6 Roche Cobas 6000/8000
µg/ml 16.8 13.4 20.2
µmol/l 11.6 9.28 13.9 Thermo Scientific QMS Vancomycin
µg/ml 17.2 13.8 20.6
µmol/l 11.1 8.88 13.3 Siemens Atellica CH
µg/ml 16.5 13.2 19.8
µmol/l 11.0 8.80 13.2 Abbott Alinity (PETINA)
µg/ml 16.3 13.1 19.5
µmol/l 10.8 8.64 13.0 Gravimetric
µg/ml 16.0 12.8 19.3
Vitamin B12 pmol/l 509 407 611 Abbott Architect
pg/ml 690 551 829
pmol/l 681 545 817 Siemens Centaur XP/XPT/Classic
pg/ml 923 738 1108
pmol/l 638 510 766 Siemens Immulite 2000
pg/ml 864 691 1037
pmol/l 526 421 631 Beckman DxI800
pg/ml 713 570 856
pmol/l 638 510 766 Roche Elecsys
pg/ml 864 691 1037
pmol/l 540 432 648 Beckman Access
pg/ml 732 585 879

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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 27 OF 28
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: [email protected] Website: www.randox.com
a
IMMUNOASSAY PREMIUM PLUS - LEVEL 3 (IA PREMIUM PLUS 3)
Cat. No. IA3111 / IA3112 Lot. No. 2079EC Size 12 x 5ml / 4 x 5ml Expiry 2024-10-28
Range
Analyte unit Target low high methods
Vitamin B12 pmol/l 810 648 972 Tosoh Series
pg/ml 1098 878 1318
pmol/l 627 502 752 Vitros ECi
pg/ml 850 680 1020
pmol/l 585 468 702 Siemens Dimension
pg/ml 793 634 952
pmol/l 788 630 946 Siemens Centaur CP
pg/ml 1068 854 1282
pmol/l 636 509 763 Roche Cobas 4000/e411 Gen II
pg/ml 862 690 1034
pmol/l 655 524 786 Roche Cobas e601/602 Gen II
pg/ml 888 710 1066
pmol/l 563 450 676 Diasorin Liaison XL
pg/ml 763 610 916
pmol/l 746 597 895 Siemens Atellica IM
pg/ml 1011 809 1213
pmol/l 428 342 514 Abbott Alinity i
pg/ml 580 463 697
pmol/l 665 532 798 Roche Cobas e801 Gen II
pg/ml 901 721 1081

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