IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3)

Transcription

1 0086 IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3) CAT. NO. IA2640 GTIN: SIZE: 12 x 5 ml CAT. NO. IA2633 GTIN: SIZE: 4 x 5 ml LOT NO. 1627EC EXPIRY: 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 assayed within 4 hours of reconstitution, when stored at +2 C to +8 C. 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 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 - 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 is submitted to a number of external laboratories. Values are assigned from a consensus of results obtained by these laboratories, using a unique statistical analysis. Average values should normally fall within the listed ranges for analytes in the instruments specified in this product insert. However, variations may be caused by instrument reagents and laboratory technique. Therefore, the range produced herein should only be considered as a reference and it is recommended that each laboratory establish its own mean and acceptable ranges. Aldosterone is present in control levels 2 and level 3 only. Parathyroid Hormone (PTH) is present in the control, but no claim is made for the expected value or stability of this analyte. If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) or Technical.Services@randox.com. 01 Nov 16 ne PAGE 1 OF 24

2 17-OH-Progesterone nmol/l Immunotech RIA ng/ml nmol/l DRG ELISA ng/ml nmol/l DIAsource RIA ng/ml nmol/l IBL ELISA ng/ml nmol/l MP Biomedicals RIA ng/ml OH Vitamin D nmol/l Diasorin Liaison nmol/l Siemens Centaur XP/XPT/Classic nmol/l Roche Vitamin D Total nmol/l Abbott Architect nmol/l IDS isys nmol/l Vitros ECi nmol/l Tosoh AIA360 nmol/l BioMerieux Vidas nmol/l Beckman DxI 600/800 nmol/l Fujirebio Lumipulse G Series nmol/l Beckman Access 25 OH Vitamin D Total ACTH pmol/l Siemens Immulite 2000/2500 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml pmol/l Siemens Immulite 1000 pg/ml pmol/l Roche Modular E170 pg/ml Aldosterone pmol/l DRG ELISA pg/ml pmol/l Immunotech RIA pg/ml pmol/l Diasorin Liaison pg/ml Alphafoetoprotein KIU/l = lu/ml Abbott Architect ng/ml KIU/l = lu/ml BioMerieux Vidas ng/ml KIU/l = lu/ml Siemens Centaur XP/XPT/Classic ng/ml KIU/l = lu/ml Siemens Immulite 2000/2500 ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 24

3 Alphafoetoprotein KIU/l = lu/ml Siemens Immulite 1000 ng/ml KIU/l = lu/ml Beckman DxI800 ng/ml KIU/l = lu/ml Roche Elecsys ng/ml KIU/l = lu/ml Diasorin Liaison ng/ml KIU/l = lu/ml Roche Modular E170 ng/ml KIU/l = lu/ml Beckman Access ng/ml KIU/l = lu/ml Tosoh AIA360 ng/ml KIU/l = lu/ml Vitros ECi ng/ml KIU/l = lu/ml Roche Cobas 6000/8000 ng/ml KIU/l = lu/ml CIS IRMA ng/ml KIU/l = lu/ml Roche Cobas E411 ng/ml KIU/l = lu/ml Siemens Dimension ng/ml KIU/l = lu/ml Siemens Centaur CP ng/ml Amikacin µmol/l EMIT µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml Androstenedione nmol/l Siemens Immulite 2000 ng/ml Beta-2-microglobulin µg/ml = mg/l Abbott AXSYM µg/ml = mg/l Abbott Architect µg/ml = mg/l Beckman Immage µg/ml = mg/l BioMerieux Vidas µg/ml = mg/l Behring Nephelometer µg/ml = mg/l Roche Tinaquant µg/ml = mg/l Siemens Immulite 2000/2500 µg/ml = mg/l Diasorin Liaison µg/ml = mg/l Tosoh AIA360 µg/ml = mg/l Roche Cobas E411 µg/ml = mg/l Roche Cobas 6000/8000 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 24

4 Beta-2-microglobulin µg/ml = mg/l Roche Modular E170 µg/ml = mg/l Siemens Dimension µg/ml = mg/l Siemens ADVIA 1200/1650/1800/2400 C-Peptide nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Roche Elecsys ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Siemens Immulite 1000 ng/ml nmol/l Diasorin Liaison ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Abbott Architect ng/ml nmol/l Siemens Centaur XP/XPT/Classic ng/ml nmol/l Tosoh AIA360 ng/ml Carbamazepine µmol/l Abbott Architect µg/ml µmol/l Behring Emit µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l HPLC µg/ml µmol/l Roche Integra µg/ml µmol/l Vitros µg/ml µmol/l Roche Cobas E411 µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 24

5 Carbamazepine µmol/l Beckman AU400/600/640/2700/5400 µg/ml µmol/l Siemens ADVIA 1200/1650/1800/2400 µg/ml µmol/l Gravimetric µg/ml Carcinoembryonic ng/ml = µg/l Abbott Architect Antigen (CEA) ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Siemens Centaur XP/XPT/Classic ng/ml = µg/l CIS RIA Coated tube ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Siemens Immulite 1000 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Roche Elecsys ng/ml = µg/l Diasorin Liaison ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman Access ng/ml = µg/l Tosoh AIA360 ng/ml = µg/l Vitros ECi ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Boditech Med Inc i-chroma ng/ml = µg/l Siemens Centaur CP Cortisol nmol/l Abbott Architect µg/dl nmol/l BioMerieux Vidas µg/dl nmol/l Siemens Centaur XP/XPT/Classic µg/dl nmol/l CIS RIA µg/dl nmol/l Siemens Immulite 2000/2500 µg/dl nmol/l Siemens Immulite 1000 µg/dl nmol/l Beckman DxI800 µg/dl nmol/l Roche Elecsys µg/dl nmol/l Diasorin Liaison µg/dl nmol/l Roche Modular E170 µg/dl nmol/l Beckman Access µg/dl Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 24

6 Cortisol nmol/l Tosoh AIA360 µg/dl nmol/l Vitros ECi µg/dl nmol/l Roche Cobas 6000/8000 µg/dl nmol/l Roche Cobas E411 µg/dl nmol/l Siemens Centaur CP µg/dl nmol/l Roche Modular E170 Gen II µg/dl nmol/l Roche Cobas 4000/e411 Gen II µg/dl nmol/l Roche Cobas 6000/8000 Gen II µg/dl nmol/l Roche Elecsys Gen II µg/dl DHEA-S µmol/l Abbott Architect µmol/l Siemens Immulite 2000/2500 µmol/l Siemens Immulite 1000 µmol/l Beckman DxI800 µmol/l Roche Elecsys µmol/l Roche Modular E170 µmol/l Beckman Access µmol/l Diasorin Liaison µmol/l Siemens Centaur XP/XPT/Classic µmol/l Roche Cobas E411 µmol/l Roche Cobas 6000/8000 Digoxin nmol/l Abbott AXSYM ng/ml nmol/l Abbott Architect ng/ml nmol/l BioMerieux Vidas ng/ml nmol/l Siemens Centaur XP/XPT/Classic ng/ml nmol/l Siemens Dimension ng/ml nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Siemens Immulite 1000 ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Roche Elecsys ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 24

7 Digoxin nmol/l Roche Integra ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Vitros ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Beckman DxC ng/ml nmol/l Beckman AU400/600/640/2700/5400 ng/ml nmol/l Siemens ADVIA 1200/1650/1800/2400 ng/ml nmol/l Microgenics DRI assay ng/ml nmol/l Roche Cobas 4000/E411 ng/ml nmol/l Gravimetric ng/ml Ethosuximide µmol/l Gravimetric µg/ml Ferritin ng/ml = µg/l Abbott Architect ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Roche Tinaquant ng/ml = µg/l Siemens Centaur XP/XPT/Classic ng/ml = µg/l Siemens Dimension ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Siemens Immulite 1000 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Roche Elecsys ng/ml = µg/l Diasorin Liaison ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman Access ng/ml = µg/l Tosoh AIA360 ng/ml = µg/l Vitros ECi ng/ml = µg/l Immunotech IRMA ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Siemens/Dade Behring Nephelometer ng/ml = µg/l Beckman AU400/600/640/2700/5400 ng/ml = µg/l Siemens Centaur CP Folate nmol/l Abbott Architect ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 24

8 Folate nmol/l Siemens Centaur XP/XPT/Classic (enhanced kit) ng/ml nmol/l Siemens Immulite 2000 ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Roche Elecsys ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Beckman Access ng/ml nmol/l Tosoh AIA360 ng/ml nmol/l Vitros ECi ng/ml nmol/l MP Biomedicals RIA ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Siemens Dimension ng/ml Free T3 pmol/l Abbott Architect ng/dl pg/ml pmol/l BioMerieux Vidas ng/dl pg/ml pmol/l Siemens Centaur XP/XPT/Classic ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml pmol/l Siemens Immulite 1000 ng/dl pg/ml pmol/l Beckman DxI800 ng/dl pg/ml pmol/l Roche Elecsys ng/dl pg/ml pmol/l Diasorin Liaison ng/dl pg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 24

9 Free T3 pmol/l Roche Modular E170 ng/dl pg/ml pmol/l Beckman Access ng/dl pg/ml pmol/l Tosoh AIA360 ng/dl pg/ml pmol/l Vitros ECi ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml pmol/l Roche Cobas 6000/8000 ng/dl pg/ml pmol/l Siemens Dimension Vista LOCI ng/dl pg/ml pmol/l Siemens Centaur CP ng/dl pg/ml Free T4 pmol/l Abbott Architect ng/dl pg/ml pmol/l Siemens Centaur XP/XPT/Classic ng/dl pg/ml pmol/l CIS RIA Coated tube ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml pmol/l Siemens Immulite 1000 ng/dl pg/ml pmol/l Beckman DxI800 ng/dl pg/ml pmol/l Roche Elecsys ng/dl pg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 24

10 Free T4 pmol/l Diasorin Liaison ng/dl pg/ml pmol/l Roche Modular E170 ng/dl pg/ml pmol/l Beckman Access ng/dl pg/ml pmol/l Tosoh AIA360 ng/dl pg/ml pmol/l Roche Cobas 6000/8000 ng/dl pg/ml pmol/l Immunotech IRMA ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml pmol/l Brahms RIA ng/dl pg/ml pmol/l Monobind Inc. ELISA / CLIA ng/dl pg/ml pmol/l Siemens Dimension Vista LOCI ng/dl pg/ml pmol/l Biomerieux Vidas FT4N Kit ng/dl pg/ml pmol/l Siemens Centaur CP ng/dl pg/ml FSH mu/ml Abbott Architect mu/ml BioMerieux Vidas mu/ml Siemens Centaur XP/XPT/Classic mu/ml Siemens Immulite 2000/2500 mu/ml Siemens Immulite 1000 mu/ml Beckman DxI800 mu/ml Roche/BM Elecsys mu/ml Diasorin Liaison mu/ml Roche Modular E170 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 24

11 FSH mu/ml Beckman Access mu/ml Tosoh AIA360 mu/ml Vitros ECi mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 mu/ml Immunotech IRMA mu/ml Siemens Centaur CP Gentamicin µmol/l Roche Integra µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension Vista µg/ml µmol/l Beckman DxC µg/ml µmol/l Gravimetric µg/ml Growth Hormone (GH) µu/ml Siemens Immulite 2000/2500 ng/ml µu/ml Siemens Immulite 1000 ng/ml µu/ml Beckman DxI800 ng/ml µu/ml Roche Modular E170 ng/ml µu/ml Beckman Access ng/ml µu/ml Tosoh AIA360 ng/ml µu/ml Diasorin Liaison ng/ml µu/ml Roche Cobas E411 ng/ml µu/ml Roche Cobas 6000/8000 ng/ml µu/ml IDS isys ng/ml Immunoglobulin E KIU/l = IU/ml Abbott Architect KIU/l = IU/ml Beckman Immage KIU/l = IU/ml BioMerieux Vidas KIU/l = IU/ml Siemens Centaur XP/XPT/Classic KIU/l = IU/ml Siemens Immulite 2000/2500 KIU/l = IU/ml Siemens Immulite 1000 KIU/l = IU/ml Beckman DxI800 KIU/l = IU/ml Roche Elecsys KIU/l = IU/ml Pharmacia Unicap Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 24

12 Immunoglobulin E KIU/l = IU/ml Roche Modular E170 KIU/l = IU/ml Beckman Access KIU/l = IU/ml Tosoh AIA360 KIU/l = IU/ml Roche Cobas E411 KIU/l = IU/ml Roche Cobas 6000/8000 KIU/l = IU/ml Siemens Centaur CP Insulin mu/l Siemens Centaur XP/XPT/Classic pmol/l mu/l Siemens Immulite 1000 pmol/l mu/l Roche Modular E170 pmol/l mu/l Siemens Immulite 2000 pmol/l mu/l Roche Elecsys pmol/l mu/l Beckman Access pmol/l mu/l Abbott Architect pmol/l mu/l Tosoh AIA360 pmol/l mu/l Roche Cobas E411 pmol/l mu/l Beckman DxI 600/800 pmol/l mu/l Diasorin Liaison pmol/l mu/l Roche Cobas 6000/8000 pmol/l mu/l Siemens Centaur CP pmol/l Luteinising Hormone mu/ml Abbott Architect (LH) mu/ml BioMerieux Vidas mu/ml Siemens Centaur XP/XPT/Classic mu/ml Siemens Immulite 2000 mu/ml Siemens Immulite 1000 mu/ml Beckman DxI800 mu/ml Roche Elecsys mu/ml Diasorin Liaison mu/ml Roche Modular E170 mu/ml Beckman Access mu/ml Tosoh AIA360 mu/ml Vitros ECi mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 24

13 Luteinising Hormone mu/ml Siemens Centaur CP Oestradiol pmol/l Abbott Architect pg/ml pmol/l BioMerieux Vidas pg/ml pmol/l Siemens Centaur XP/XPT/Classic pg/ml pmol/l Siemens Immulite 2000/2500 pg/ml pmol/l Siemens Immulite 1000 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Roche Elecsys (Estradiol II) pg/ml pmol/l Roche Modular E170 (Estradiol II) pg/ml pmol/l Beckman Access pg/ml pmol/l Tosoh (E2) pg/ml pmol/l Vitros ECi pg/ml pmol/l Roche Cobas 6000/8000 (Estradiol II) pg/ml pmol/l Roche Cobas 4000/E411 (Estradiol II) pg/ml pmol/l Siemens Centaur XP/XPT/Classic Enhanced (ee2) pg/ml pmol/l Siemens Centaur XP/XPT/Classic E26 III pg/ml pmol/l Tosoh (ie2-hse2) pg/ml pmol/l Immunotech RIA Ultra-sensitive pg/ml pmol/l Siemens Centaur CP pg/ml pmol/l Siemens Centaur CP Enhanced (ee2) pg/ml pmol/l Fujirebio Lumipulse G Series pg/ml pmol/l Roche Cobas 6000/8000 (Estradiol III) pg/ml pmol/l Roche Elecsys (Estradiol III) pg/ml pmol/l Roche Cobas 4000/E411 (Estradiol III) pg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 24

14 Oestradiol pmol/l Roche Modular E170 (Estradiol III) pg/ml Paracetamol mmol/l Roche Integra mg/l mmol/l Abbott Architect mg/l mmol/l Roche Cobas 6000/8000 mg/l mmol/l Gravimetric mg/l Phenobarbital µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Beckman AU400/600/640/2700/5400 µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Roche Integra µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l Roche Cobas E411 µg/ml µmol/l Beckman DxC µg/ml µmol/l HPLC µg/ml µmol/l Gravimetric µg/ml Phenytoin µmol/l Abbott AXSYM µg/ml µmol/l Abbott Architect µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l HPLC µg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 24

15 Phenytoin µmol/l Roche Integra µg/ml µmol/l Vitros µg/ml µmol/l Roche Cobas E411 µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Gravimetric µg/ml Primidone µmol/l Gravimetric µg/ml Progesterone nmol/l Abbott Architect ng/ml nmol/l BioMerieux Vidas ng/ml nmol/l Siemens Centaur XP/XPT/Classic ng/ml nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Siemens Immulite 1000 ng/ml nmol/l Beckman DxI Prog Cal ng/ml nmol/l Roche Elecsys ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Beckman Access Prog Cal ng/ml nmol/l Tosoh AIA360 ng/ml nmol/l Vitros ECi ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Diasorin Liaison ng/ml nmol/l Immunotech RIA ng/ml nmol/l Beckman DxI Prog DE Cal A80773 ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 24

16 Progesterone nmol/l Siemens Centaur CP ng/ml Prolactin µu/ml Abbott Architect µu/ml BioMerieux Vidas µu/ml Siemens Centaur XP/XPT/Classic µu/ml Siemens Immulite 2000/2500 µu/ml Siemens Immulite 1000 µu/ml Beckman DxI800 µu/ml Roche Elecsys µu/ml Diasorin Liaison µu/ml Roche Modular E170 µu/ml Beckman Access µu/ml Tosoh AIA360 µu/ml Vitros ECi µu/ml Roche Elecsys/E170/Cobas 6000/8000 PRLII µu/ml Immunotech IRMA µu/ml Roche Cobas E411 µu/ml Roche Cobas 6000/8000 µu/ml Abbott Architect restandardised µu/ml Siemens Centaur CP PSA Free ng/ml = µg/l Abbott Architect ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Siemens Centaur XP/XPT/Classic ng/ml = µg/l Siemens Dimension ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Siemens Immulite 1000 ng/ml = µg/l Beckman DXI standardised to Hybritech ng/ml = µg/l Roche Elecsys ng/ml = µg/l Diasorin Liaison ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman Access standardised to Hybritech ng/ml = µg/l Tosoh AIA360 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Beckman DxI800 standardised to WHO IRP96/670 ng/ml = µg/l Ortho Vitros 3600/5600/ECi PSA II ng/ml = µg/l Fujirebio Lumipulse G Series PSA Total ng/ml = µg/l Abbott Architect ng/ml = µg/l biomerieux VIDAS TPSA ng/ml = µg/l Siemens Centaur XP/XPT/Classic ng/ml = µg/l Siemens Immulite 2000/2500 1st generation ng/ml = µg/l Siemens Immulite rd generation ng/ml = µg/l Siemens Immulite 2000/2500 3rd generation ng/ml = µg/l Siemens Immulite st generation ng/ml = µg/l Beckman DxI standardisd to Hybritech Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 24

17 PSA Total ng/ml = µg/l Beckman DxI800 standardised to WHO IRP96/670 ng/ml = µg/l Roche Elecsys ng/ml = µg/l Diasorin Liaison ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman Access standardised to Hybritech ng/ml = µg/l Beckman Access standardised to WHO IRP96/670 ng/ml = µg/l Tosoh AIA360 ng/ml = µg/l Vitros ECi ng/ml = µg/l CIS RIA Coated tube ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Fujirebio Lumipulse G Series ng/ml = µg/l Ortho Vitros 3600/5600/ECi PSA II ng/ml = µg/l Siemens Centaur CP Salicylic Acid mmol/l Roche Integra mg/dl mmol/l Abbott Architect mg/dl mmol/l Beckman DxC mg/dl mmol/l Gravimetric mg/dl SHBG nmol/l Siemens Centaur XP/XPT/Classic nmol/l Siemens Immulite 1000 nmol/l Siemens Immulite 2000/2500 nmol/l Roche Elecsys nmol/l Roche Modular E170 nmol/l Abbott Architect nmol/l Roche Cobas E411 nmol/l Roche Cobas 6000/8000 nmol/l Beckman Access nmol/l Beckman DxI800 T Uptake %U Siemens Immulite 2000 Testosterone nmol/l Abbott Architect ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Siemens Centaur XP/XPT/Classic ng/ml ng/dl nmol/l CIS RIA Coated tube ng/ml ng/dl nmol/l Siemens Immulite 2000/2500 ng/ml ng/dl Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 24

18 Testosterone nmol/l Siemens Immulite 1000 ng/ml ng/dl nmol/l Beckman DxI800 ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Tosoh AIA360 ng/ml ng/dl nmol/l Vitros ECi ng/ml ng/dl nmol/l Roche Cobas 6000 Test 2 ng/ml ng/dl nmol/l Roche Elecsys Test II ng/ml ng/dl nmol/l Roche Modular E170 Test II ng/ml ng/dl nmol/l Roche Cobas 4000/e411 Test II ng/ml ng/dl nmol/l Abbott Architect 2nd Generation ng/ml ng/dl nmol/l Siemens Centaur CP ng/ml ng/dl nmol/l BioMerieux Vidas Testosterone II ng/ml ng/dl Theophylline µmol/l Abbott AXSYM µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 24

19 Theophylline µmol/l Roche Integra µg/ml µmol/l Vitros µg/ml µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Beckman AU400/600/640/2700/5400 µg/ml µmol/l Gravimetric µg/ml Thyroglobulin ng/ml Siemens Immulite 1000 ng/ml Siemens Immulite 2000 ng/ml Roche Elecsys ng/ml Roche Modular E170 ng/ml Beckman DxI800 ng/ml Roche Cobas E411 ng/ml Diesse Chorus ng/ml Roche Cobas 6000/8000 ng/ml Beckman Access ng/ml Tosoh AIA360 ng/ml Roche Cobas 6000 TGII ng/ml Roche Elecsys TGII ng/ml Roche Cobas 4000/E411 TGII ng/ml Roche Modular E170 TGII Thyroid Stimulating µu/ml = mlu/l Abbott Architect Hormone µu/ml = mlu/l biomerieux VIDAS TSH µu/ml = mlu/l biomerieux VIDAS TSH3 Ultrasensitive µu/ml = mlu/l Siemens Centaur XP/XPT/Classic µu/ml = mlu/l CIS IRMA µu/ml = mlu/l Siemens Centaur XP/XPT/Classic 3rd Generation µu/ml = mlu/l Siemens Dimension µu/ml = mlu/l Siemens Immulite 2000/2500 µu/ml = mlu/l Siemens Immulite 1000 µu/ml = mlu/l Beckman DxI800 Fast TSH µu/ml = mlu/l Beckman DxI800 µu/ml = mlu/l Roche Elecsys µu/ml = mlu/l Diasorin Liaison µu/ml = mlu/l Roche Modular E170 µu/ml = mlu/l Beckman Access Fast TSH µu/ml = mlu/l Beckman Access hypertsh 3rd Generation µu/ml = mlu/l Tosoh AIA360 µu/ml = mlu/l Vitros ECi Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 19 OF 24

20 Thyroid Stimulating µu/ml = mlu/l Immunotech IRMA Hormone µu/ml = mlu/l Roche Cobas E411 µu/ml = mlu/l Roche Cobas 6000/8000 µu/ml = mlu/l Beckman DxI800 Hyper TSH µu/ml = mlu/l Monobind Inc. ELISA / CLIA µu/ml = mlu/l Siemens Dimension Vista LOCI µu/ml = mlu/l Siemens Centaur XP/XPT/Classic TSH3-Ultra µu/ml = mlu/l Siemens Centaur CP µu/ml = mlu/l Siemens Centaur CP TSH3-Ultra Tobramycin µmol/l Gravimetric µg/ml Total Beta hcg mu/ml=iu/l Abbott Architect IU/ml mu/ml=iu/l BioMerieux Vidas IU/ml mu/ml=iu/l Siemens Centaur XP/XPT/Classic IU/ml mu/ml=iu/l Siemens Dimension IU/ml mu/ml=iu/l Siemens Immulite 2000 IU/ml mu/ml=iu/l Siemens Immulite 1000 IU/ml mu/ml=iu/l Beckman DxI800 IU/ml mu/ml=iu/l Diasorin Liaison IU/ml mu/ml=iu/l Roche Cobas Core EIA IU/ml mu/ml=iu/l Beckman Access IU/ml mu/ml=iu/l Tosoh AIA360 IU/ml mu/ml=iu/l Vitros ECi IU/ml mu/ml=iu/l Roche STAT (Intact) IU/ml mu/ml=iu/l Roche hcg+beta IU/ml mu/ml=iu/l Brahms Kryptor IU/ml mu/ml=iu/l Radiometer AQT90 Flex IU/ml mu/ml=iu/l Beckman Access Total BhCG (5th IS) IU/ml mu/ml=iu/l Beckman DxI Total BhCG (5th IS) IU/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 20 OF 24

21 Total Beta hcg mu/ml=iu/l Siemens Centaur CP IU/ml Total T3 nmol/l Abbott Architect ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Siemens Centaur XP/XPT/Classic ng/ml ng/dl nmol/l Siemens Immulite 2000/2500 ng/ml ng/dl nmol/l Siemens Immulite 1000 ng/ml ng/dl nmol/l Beckman DxI800 ng/ml ng/dl nmol/l Roche Elecsys ng/ml ng/dl nmol/l Diasorin Liaison ng/ml ng/dl nmol/l Roche Modular E170 ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Tosoh AIA360 ng/ml ng/dl nmol/l Vitros ECi ng/ml ng/dl nmol/l CIS RIA Coated tube ng/ml ng/dl nmol/l Roche Cobas E411 ng/ml ng/dl nmol/l Roche Cobas 6000/8000 ng/ml ng/dl Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 21 OF 24

22 Total T3 nmol/l Monobind Inc. ELISA / CLIA ng/ml ng/dl nmol/l Siemens Centaur CP ng/ml ng/dl Total T4 nmol/l Abbott Architect µg/dl ng/ml nmol/l BioMerieux Vidas µg/dl ng/ml nmol/l Siemens Centaur XP/XPT/Classic µg/dl ng/ml nmol/l Siemens Immulite 2000/2500 µg/dl ng/ml nmol/l Siemens Immulite 1000 µg/dl ng/ml nmol/l Beckman DxI800 µg/dl ng/ml nmol/l Roche Elecsys µg/dl ng/ml nmol/l Diasorin Liaison µg/dl ng/ml nmol/l Roche Modular E170 µg/dl ng/ml nmol/l Beckman Access µg/dl ng/ml nmol/l Tosoh AIA360 µg/dl ng/ml nmol/l Vitros ECi µg/dl ng/ml nmol/l MP Biomedicals RIA µg/dl ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 22 OF 24

23 Total T4 nmol/l CIS RIA Coated tube µg/dl ng/ml nmol/l Roche Cobas E411 µg/dl ng/ml nmol/l Roche Cobas 6000/8000 µg/dl ng/ml nmol/l Immunotech IRMA µg/dl ng/ml nmol/l Siemens Centaur CP µg/dl ng/ml Valproic Acid µmol/l Abbott Architect µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l Roche Integra µg/ml µmol/l Vitros µg/ml µmol/l Roche Modular P-D µg/ml µmol/l Roche Cobas E411 µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Beckman AU400/600/640/2700/5400 µg/ml µmol/l Siemens ADVIA 1200/1650/1800/2400 µg/ml µmol/l Gravimetric µg/ml Vancomycin µmol/l Roche Integra µg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 23 OF 24

24 Vancomycin µmol/l Ortho Vitros Microslide Systems µg/ml µmol/l Abbott Architect µg/ml µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Gravimetric µg/ml Vitamin B12 pmol/l Abbott AXSYM pg/ml pmol/l Abbott Architect pg/ml pmol/l Siemens Centaur XP/XPT/Classic pg/ml pmol/l Siemens Immulite 2000 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Roche Elecsys pg/ml pmol/l Roche Modular E170 pg/ml pmol/l Beckman Access pg/ml pmol/l Tosoh AIA360 pg/ml pmol/l Vitros ECi pg/ml pmol/l MP Biomedicals RIA pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml pmol/l Siemens Dimension pg/ml pmol/l Siemens Centaur CP pg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 24 OF 24