IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1)

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1 0843 IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1) Cat. No. IA2638 / IA2633 Lot No. 978EC Size: 10 x 5 ml / 12 x 5 ml Expiry: INTENDED USE This product is intended for in vitro diagnostic use in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of Immunoassays. 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. Health and Safety Data Sheets are available on request. STORAGE AND STABILITY OPENED: Store refrigerated (+2 C to +8 C). 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. 25-OH Vitamin D is stable for 5 days at +2 C to +8 C. C-Peptide is stable for 1 day at +2 C to +8 C. Parathyroid hormone (PTH) and 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 The Immunoassay Control is supplied lyophilised. 1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml of distilled water at +15 C to +25 C. Close 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 Control - Level 1: 10 x 5ml Tri Level: 12 x 5ml MATERIALS REQUIRED BUT NOT PROVIDED Volumetric pipette VALUE ASSIGNMENT Each batch of Immunoassay Control is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories, using a unique statistical analysis. With each batch, a control range is provided for individual parameters and each parameter method. The control range is equivalent to the assigned mean ±2 S.D. This results in extremely accurate values, which may be confidently used by laboratories to ensure the accuracy of their methods. Aldosterone, ACTH and Estriol are present in the control, but values may not be provided for all levels. Free Testosterone and 1,25(OH)2 Vitamin D are present in the Immunoassay Controls, but no values are provided or claims made on their stability. If a method is unavailable, contact Randox Laboratories - Technical Support, Northern Ireland, tel: +44 (0) or 21 Dec 12 ne PAGE 1 OF 16

2 17-OH-Progesterone nmol/l Siemens Coat-a-Count ng/ml OH Vitamin D nmol/l Diasorin Liaison nmol/l Roche Elecsys Alphafoetoprotein KIU/l = lu/ml Abbott AXSYM ng/ml KIU/l = lu/ml BioMerieux Vidas ng/ml KIU/l = lu/ml Siemens Immulite 1000 ng/ml KIU/l = lu/ml Roche Elecsys ng/ml KIU/l = lu/ml Beckman Access ng/ml KIU/l = lu/ml Vitros ECi ng/ml KIU/l = lu/ml Siemens Advia Centaur ng/ml KIU/l = lu/ml Siemens Immulite 2000/2500 ng/ml KIU/l = lu/ml Abbott Architect ng/ml KIU/l = lu/ml Diasorin RIA ng/ml KIU/l = lu/ml Roche Modular E170 ng/ml KIU/l = lu/ml Beckman DxI800 ng/ml KIU/l = lu/ml Roche Cobas 6000/8000 ng/ml KIU/l = lu/ml Roche Cobas E411 ng/ml Amikacin µmol/l Gravimetric µg/ml Beta-2-microglobulin µg/ml = mg/l Siemens Immulite 1000 µg/ml = mg/l BioMerieux Vidas µg/ml = mg/l Roche Tinaquant µg/ml = mg/l Abbott AXSYM µg/ml = mg/l Siemens Immulite 2000/2500 µg/ml = mg/l Abbott Architect µg/ml = mg/l Roche Cobas 6000/8000 C-Peptide nmol/l Diasorin Liaison ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 2 OF 16

3 C-Peptide nmol/l Roche Modular E170 ng/ml Carbamazepine µmol/l Vitros µg/ml µmol/l Abbott AXSYM µg/ml µmol/l Siemens Advia Centaur µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l Roche Integra µg/ml µmol/l Siemens Dimension µg/ml µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml Carcinoembryonic ng/ml = µg/l Abbott AXSYM Antigen (CEA) ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Siemens Immulite 1000 ng/ml = µg/l Roche Elecsys ng/ml = µg/l Vitros ECi ng/ml = µg/l Beckman Access ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Abbott Architect ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Roche Cobas E411 Cortisol nmol/l Abbott AXSYM µg/dl nmol/l BioMerieux Vidas µg/dl nmol/l Siemens Immulite 1000 µg/dl nmol/l Roche Elecsys µg/dl nmol/l Beckman Access µg/dl nmol/l Siemens Advia Centaur µg/dl RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 3 OF 16

4 Cortisol nmol/l Siemens Immulite 2000/2500 µg/dl nmol/l Vitros ECi µg/dl nmol/l Abbott Architect µg/dl nmol/l Diasorin Liaison µg/dl nmol/l Roche Modular E170 µg/dl nmol/l Beckman DxI800 µg/dl nmol/l Roche Cobas 6000/8000 µg/dl nmol/l Roche Cobas E411 µg/dl DHEA-S µmol/l Siemens Immulite 1000 µmol/l Siemens Immulite 2000/2500 µmol/l Roche Elecsys µmol/l Roche Modular E170 µmol/l Abbott Architect µmol/l Beckman DxI800 µmol/l Roche Cobas 6000/8000 Digoxin nmol/l Beckman Access ng/ml nmol/l Abbott AXSYM ng/ml nmol/l Vitros ng/ml nmol/l Siemens Immulite 1000 ng/ml nmol/l BioMerieux Vidas ng/ml nmol/l Roche Elecsys ng/ml nmol/l Roche Integra ng/ml nmol/l Siemens Advia Centaur ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Siemens Dimension ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 4 OF 16

5 Digoxin nmol/l Gravimetric ng/ml Ethosuximide µmol/l Gravimetric µg/ml Ferritin ng/ml = µg/l Abbott AXSYM ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Siemens Immulite 1000 ng/ml = µg/l Roche Elecsys ng/ml = µg/l Beckman Access ng/ml = µg/l Vitros ECi ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Abbott Architect ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 Folate nmol/l Abbott AXSYM ng/ml nmol/l Beckman Access ng/ml nmol/l Roche Elecsys ng/ml nmol/l Siemens Immulite 2000 ng/ml nmol/l Vitros ECi ng/ml nmol/l Abbott Architect ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Siemens ADVIA Centaur (enhanced kit) ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Siemens Immulite 2500 ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Abbott Architect restandardised ng/ml Free T3 pmol/l Tosoh AIA360 ng/dl pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 5 OF 16

6 Free T3 pmol/l Abbott AXSYM ng/dl pg/ml pmol/l BioMerieux Vidas ng/dl pg/ml pmol/l Roche Elecsys ng/dl pg/ml pmol/l Beckman Access ng/dl pg/ml pmol/l Siemens Immulite 1000 ng/dl pg/ml pmol/l Vitros ECi ng/dl pg/ml pmol/l Siemens Advia Centaur ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml pmol/l Abbott Architect ng/dl pg/ml pmol/l Roche Modular E170 ng/dl pg/ml pmol/l Beckman DxI800 ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml pmol/l Roche Cobas 6000/8000 ng/dl pg/ml Free T4 pmol/l Abbott AXSYM ng/dl pg/ml pmol/l BioMerieux Vidas ng/dl pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 6 OF 16

7 Free T4 pmol/l Siemens Immulite 1000 ng/dl pg/ml pmol/l Roche Elecsys ng/dl pg/ml pmol/l Beckman Access ng/dl pg/ml pmol/l Vitros ECi ng/dl pg/ml pmol/l Siemens Advia Centaur ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml pmol/l Abbott Architect ng/dl pg/ml pmol/l Roche Modular E170 ng/dl pg/ml pmol/l Beckman DxI800 ng/dl pg/ml pmol/l Roche Cobas 6000/8000 ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml FSH mu/ml Tosoh AIA360 mu/ml Siemens Immulite 1000 mu/ml BioMerieux Vidas mu/ml Abbott AXSYM mu/ml Beckman Access mu/ml Roche/BM Elecsys mu/ml Vitros ECi mu/ml Siemens Advia Centaur mu/ml Siemens Immulite 2000/2500 mu/ml Abbott Architect mu/ml Roche Modular E170 mu/ml Beckman DxI800 mu/ml Roche Cobas E411 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 7 OF 16

8 FSH mu/ml Roche Cobas 6000/8000 Gentamicin µmol/l Gravimetric µg/ml Growth Hormone (GH) µu/ml Siemens Immulite 1000 ng/ml µu/ml Siemens Immulite 2000/2500 ng/ml Immunoglobulin E KIU/l = IU/ml Siemens Immulite 1000 KIU/l = IU/ml BioMerieux Vidas KIU/l = IU/ml Beckman Access KIU/l = IU/ml Pharmacia Unicap KIU/l = IU/ml Roche Elecsys KIU/l = IU/ml Siemens Advia Centaur KIU/l = IU/ml Siemens Immulite 2000/2500 KIU/l = IU/ml Roche Modular E170 KIU/l = IU/ml Roche Cobas E411 KIU/l = IU/ml Roche Cobas 6000/8000 Insulin mu/l Siemens Advia Centaur mu/l Abbott AXSYM mu/l Roche Modular E170 mu/l Siemens Immulite 2000 mu/l Roche Cobas 6000/8000 mu/l Beckman DxI800 Luteinising Hormone mu/ml Abbott AXSYM (LH) mu/ml Beckman Access mu/ml BioMerieux Vidas mu/ml Siemens Immulite 1000 mu/ml Tosoh AIA360 mu/ml Roche Elecsys mu/ml Siemens Advia Centaur mu/ml Siemens Immulite 2000 mu/ml Abbott Architect mu/ml Roche Modular E170 mu/ml Beckman DxI800 mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 Oestradiol pmol/l BioMerieux Vidas pg/ml pmol/l Roche Elecsys pg/ml pmol/l Beckman Access pg/ml pmol/l Siemens Advia Centaur pg/ml pmol/l Siemens Immulite 2000/2500 pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 8 OF 16

9 Oestradiol pmol/l Abbott Architect pg/ml pmol/l Roche Modular E170 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml pmol/l Roche Cobas E411 pg/ml Paracetamol mmol/l Abbott AXSYM mg/l mmol/l Abbott Architect mg/l mmol/l Gravimetric mg/l Parathyroid Hormone pmol/l Siemens Immulite 2000 (PTH) pg/ml pmol/l Roche Elecsys pg/ml pmol/l Roche Modular E170 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml Phenobarbital µmol/l Gravimetric µg/ml Phenytoin µmol/l Siemens Advia Centaur µg/ml µmol/l Abbott AXSYM µg/ml µmol/l Vitros µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l Roche Integra µg/ml µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml Primidone µmol/l Gravimetric µg/ml Progesterone nmol/l Beckman Access ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 9 OF 16

10 Progesterone nmol/l Abbott AXSYM ng/ml nmol/l BioMerieux Vidas ng/ml nmol/l Roche Elecsys ng/ml nmol/l Vitros ECi ng/ml nmol/l Siemens Advia Centaur ng/ml nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Abbott Architect ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml Prolactin µu/ml Beckman Access µu/ml Abbott AXSYM µu/ml BioMerieux Vidas µu/ml Siemens Immulite 1000 µu/ml Roche Elecsys µu/ml Vitros ECi µu/ml Siemens Advia Centaur µu/ml Siemens Immulite 2000/2500 µu/ml Abbott Architect µu/ml Roche Modular E170 µu/ml Beckman DxI800 µu/ml Roche Modular E170 2nd Gen prolactin II µu/ml Roche Elecsys 2nd Gen. prolactin II µu/ml Roche Cobas E411 µu/ml Roche Cobas 6000/8000 PSA Free ng/ml = µg/l Siemens Immulite 1000 ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Abbott Axsym - monoclonal ng/ml = µg/l Roche Elecsys ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman Access ng/ml = µg/l Beckman Access (Hybritech) ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Diasorin Liaison RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 10 OF 16

11 PSA Free ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 PSA Total ng/ml = µg/l Abbott Axsym - monoclonal ng/ml = µg/l Siemens Immulite st generation ng/ml = µg/l Roche Elecsys ng/ml = µg/l Tosoh AIA360 ng/ml = µg/l Beckman Access-non-standardised results ng/ml = µg/l Siemens ADVIA Centaur (equimolar) ng/ml = µg/l biomerieux VIDAS TPSA ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Siemens Immulite 2000/2500 1st generation ng/ml = µg/l Abbott Architect ng/ml = µg/l Siemens Immulite 2000/2500 3rd generation ng/ml = µg/l Vitros ECi ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Beckman Access standardised to IRP96/670 ng/ml = µg/l Beckman DxI800 non-standardised ng/ml = µg/l Beckman DxI800 standardised to IRP96/670 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 Salicylic Acid mmol/l Gravimetric mg/dl SHBG nmol/l Siemens Immulite 1000 nmol/l Siemens Immulite 2000/2500 nmol/l Roche Elecsys nmol/l Roche Modular E170 nmol/l Roche Cobas E411 nmol/l Roche Cobas 6000/8000 T Uptake %U Siemens Immulite 2000 Testosterone nmol/l Siemens Immulite 1000 ng/ml ng/dl nmol/l Roche Elecsys ng/ml ng/dl nmol/l Vitros ECi ng/ml ng/dl nmol/l Siemens Advia Centaur ng/ml ng/dl nmol/l Siemens Immulite 2000/2500 ng/ml ng/dl RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 11 OF 16

12 Testosterone nmol/l Abbott Architect ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Roche Modular E170 ng/ml ng/dl nmol/l Beckman DxI800 ng/ml ng/dl nmol/l Roche Cobas E411 ng/ml ng/dl nmol/l Roche Cobas 6000/8000 ng/ml ng/dl Theophylline µmol/l Abbott AXSYM µg/ml µmol/l Roche Integra µg/ml µmol/l Siemens Dimension µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml Thyroglobulin ng/ml Siemens Immulite 1000 ng/ml Roche Elecsys ng/ml Roche Modular E170 ng/ml Beckman DxI800 ng/ml Roche Cobas 6000/8000 Thyroid Stimulating µu/ml = mlu/l Abbott Axsym Ultrasensitive htsh II Hormone µu/ml = mlu/l biomerieux VIDAS TSH µu/ml = mlu/l Siemens Immulite 1000 µu/ml = mlu/l Roche Elecsys µu/ml = mlu/l Beckman Access hypertsh 3rd Generation µu/ml = mlu/l Siemens Advia Centaur µu/ml = mlu/l Siemens Immulite 2000/2500 µu/ml = mlu/l Abbott Architect Ultrasensitive htsh II µu/ml = mlu/l Abbott Axsym 3rd generation µu/ml = mlu/l Diasorin Liaison RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 12 OF 16

13 Thyroid Stimulating µu/ml = mlu/l Roche Modular E170 Hormone µu/ml = mlu/l biomerieux VIDAS TSH3 Ultrasensitive µu/ml = mlu/l Beckman DxI800 µu/ml = mlu/l Beckman DxI800 Fast TSH µu/ml = mlu/l Siemens ADVIA Centaur 3rd Generation µu/ml = mlu/l Roche Cobas E411 µu/ml = mlu/l Roche Cobas 6000/8000 µu/ml = mlu/l Beckman DxI800 Hyper TSH Tobramycin µmol/l Gravimetric µg/ml Total Beta hcg mu/ml=iu/l Abbott AXSYM IU/ml mu/ml=iu/l BioMerieux Vidas IU/ml mu/ml=iu/l Siemens Immulite 1000 IU/ml mu/ml=iu/l Roche Elecsys HCG + Beta IU/ml mu/ml=iu/l Beckman Access IU/ml mu/ml=iu/l Vitros ECi IU/ml mu/ml=iu/l Siemens Advia Centaur IU/ml mu/ml=iu/l Siemens Immulite 2000 IU/ml mu/ml=iu/l Abbott Architect IU/ml mu/ml=iu/l Roche Modular E170 IU/ml mu/ml=iu/l Siemens Dimension IU/ml mu/ml=iu/l Beckman DxI800 IU/ml mu/ml=iu/l Roche Elecsys HCG STAT Intact IU/ml mu/ml=iu/l Roche Cobas E411 IU/ml mu/ml=iu/l Roche Cobas 6000/8000 IU/ml Total T3 nmol/l Abbott AXSYM ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 13 OF 16

14 Total T3 nmol/l Roche Elecsys ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Tosoh AIA360 ng/ml ng/dl nmol/l Siemens Advia Centaur ng/ml ng/dl nmol/l Siemens Immulite 2000/2500 ng/ml ng/dl nmol/l Abbott Architect ng/ml ng/dl nmol/l Vitros ECi ng/ml ng/dl nmol/l Roche Modular E170 ng/ml ng/dl nmol/l Beckman DxI800 ng/ml ng/dl nmol/l Roche Cobas E411 ng/ml ng/dl nmol/l Roche Cobas 6000/8000 ng/ml ng/dl Total T4 nmol/l Vitros ECi µg/dl ng/ml nmol/l Abbott AXSYM µg/dl ng/ml nmol/l BioMerieux Vidas µg/dl ng/ml nmol/l Siemens Immulite 1000 µg/dl ng/ml nmol/l Roche Elecsys µg/dl ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 14 OF 16

15 Total T4 nmol/l Beckman Access µg/dl ng/ml nmol/l Siemens Advia Centaur µg/dl ng/ml nmol/l Siemens Immulite 2000/2500 µg/dl ng/ml nmol/l Abbott Architect µg/dl ng/ml nmol/l Roche Modular E170 µg/dl ng/ml nmol/l Roche Cobas E411 µg/dl ng/ml nmol/l Roche Cobas 6000/8000 µg/dl ng/ml Valproic Acid µmol/l Abbott AXSYM µg/ml µmol/l Siemens Immulite 1000 µg/ml µmol/l Roche Integra µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Siemens Advia Centaur µg/ml µmol/l Siemens Dimension µg/ml µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml Vancomycin µmol/l Gravimetric µg/ml Vitamin B12 pmol/l Roche Elecsys pg/ml pmol/l Beckman Access pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 15 OF 16

16 Vitamin B12 pmol/l Siemens Immulite 1000 pg/ml pmol/l Siemens Advia Centaur pg/ml pmol/l Siemens Immulite 2000 pg/ml pmol/l Abbott Architect pg/ml pmol/l Vitros ECi pg/ml pmol/l Roche Modular E170 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Siemens Immulite 2500 pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 16 OF 16

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