IMMUNOASSAY PREMIUM PLUS LEVEL 3 (IA PREMIUM PLUS 3)

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1 0843 IMMUNOASSAY PREMIUM PLUS LEVEL 3 (IA PREMIUM PLUS 3) Cat. No.: IA3111 / IA3112 Lot No.: 1130EC Size.: 12 x 5ml / 12 x 5ml 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. No frozen stability claim is made for ACTH, Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial. UNOPENED: Store refrigerated (+2 C to +8 C). Stable to expiration date printed on individual vials. Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial contamination is suspected, the vial should be discarded and a fresh vial reconstituted. PREPARATION Immunoassay Premium Plus is supplied lyophilised. 1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml of distilled water at +15 C to +25 C. Close bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of foam. Do not shake. 2. Refer to the control section of the individual analyser application. 3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly. MATERIALS PROVIDED Immunoassay Premium Plus - Level 3: 12 x 5ml Tri-Level: 12 x 5ml MATERIAL REQUIRED BUT NOT PROVIDED Volumetric Pipette VALUE ASSIGNMENT Each batch of Immunoassay Premium Plus 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, 1,25 OH Vitamin D, ACTH and Estriol are present in the control, but values are not provided for all levels. If a method is unavailable, contact Randox Laboratories - Technical Support, Northern Ireland, tel: +44 (0) or Revised 22 Jun 12 pl PAGE 1 OF 19

2 17-OH-Progesterone nmol/l Siemens Coat-a-Count ng/ml OH Vitamin D nmol/l Diasorin Liaison nmol/l Roche Elecsys nmol/l Roche Cobas E411 nmol/l Roche Modular E170 nmol/l Abbott Architect ACTH pmol/l Siemens Immulite 1000 pg/ml Aldosterone pmol/l Siemens Coat-a-Count pg/ml 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 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 Roche Modular E170 ng/ml KIU/l = lu/ml Beckman DxI800 ng/ml KIU/l = lu/ml Roche Cobas 6000 ng/ml KIU/l = lu/ml Roche Cobas E411 ng/ml KIU/l = lu/ml Pishtaz Teb- ELISA ng/ml Amikacin µmol/l Gravimetric µg/ml Beta-2-microglobulin µg/ml = mg/l BioMerieux Vidas µg/ml = mg/l Roche Tinaquant µg/ml = mg/l Behring Nephelometer RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 2 OF 19

3 Beta-2-microglobulin 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 C-Peptide nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Siemens Advia Centaur ng/ml CA 15-3 U/ml Roche Elecsys U/ml BioMerieux Vidas U/ml Siemens Advia Centaur U/ml Abbott Architect U/ml Siemens Immulite 2000/2500 U/ml Abbott AXSYM U/ml Vitros ECi U/ml Diasorin Liaison U/ml Roche Modular E170 U/ml Beckman Access U/ml Beckman DxI800 U/ml Roche Cobas 6000 U/ml Roche Cobas E411 CA 19-9 U/ml Abbott AXSYM U/ml BioMerieux Vidas U/ml Roche Elecsys U/ml Siemens Advia Centaur U/ml Siemens Immulite 2000/2500 U/ml Abbott Architect U/ml Vitros ECi U/ml Roche Modular E170 U/ml Beckman DxI800 U/ml Abbott Architect XR kit U/ml Roche Cobas 6000 U/ml Roche Cobas E411 CA125 U/ml Abbott AXSYM U/ml Siemens Immulite 1000 U/ml BioMerieux Vidas U/ml Roche Elecsys U/ml Siemens Immulite 2000/2500 U/ml Vitros ECi U/ml Roche Modular E170 U/ml Abbott Architect U/ml Siemens ADVIA Centaur CA125 II kit U/ml Beckman Access U/ml Beckman DxI800 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 3 OF 19

4 CA125 U/ml Roche Cobas E411 U/ml Roche Cobas 6000 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 Roche Modular E170 µg/ml µmol/l Abbott Architect µg/ml µmol/l Roche Cobas E411 µg/ml µmol/l Roche Cobas 6000 µg/ml µmol/l Roche Modular 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 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Pishtaz Teb- ELISA Cortisol nmol/l Abbott AXSYM µg/dl nmol/l BioMerieux Vidas µg/dl nmol/l Siemens Immulite 1000 µg/dl nmol/l Siemens Coat-a-Count µg/dl RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 4 OF 19

5 Cortisol nmol/l Roche Elecsys µg/dl nmol/l Beckman Access µg/dl nmol/l Siemens Advia Centaur µg/dl 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 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 Modular E170 µmol/l Abbott Architect µmol/l Beckman DxI800 µmol/l Roche Cobas 6000 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 Roche Elecsys ng/ml nmol/l Siemens Advia Centaur ng/ml nmol/l Vitros ECi ng/ml nmol/l Roche Modular E170 ng/ml nmol/l Abbott Architect ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 5 OF 19

6 Digoxin nmol/l Beckman DxI800 ng/ml nmol/l Roche Cobas 6000 ng/ml 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 Siemens Dimension ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000 ng/ml = µg/l Pishtaz Teb- ELISA Folate nmol/l Abbott AXSYM ng/ml nmol/l Beckman Access ng/ml nmol/l Siemens Immulite 1000 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 Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000 ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 6 OF 19

7 Folate nmol/l Abbott Architect restandardised ng/ml 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 ng/dl pg/ml pmol/l Pishtaz Teb- ELISA ng/dl pg/ml Free T4 pmol/l Abbott AXSYM ng/dl pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 7 OF 19

8 Free T4 pmol/l BioMerieux Vidas ng/dl pg/ml 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 Tosoh AIA360 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 Diasorin Liaison 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 ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml pmol/l Monobind Inc. ELISA ng/dl pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 8 OF 19

9 Free T4 pmol/l Pishtaz Teb- ELISA ng/dl pg/ml Free Testosterone pmol/l Siemens Coat-a-Count 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 Diasorin Liaison mu/ml Roche Modular E170 mu/ml Beckman DxI800 mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000 mu/ml Human Elisys UNO mu/ml Pishtaz Teb- ELISA Gentamicin µmol/l Gravimetric µg/ml Growth Hormone (GH) µu/ml Siemens Immulite 1000 ng/ml µu/ml Siemens Immulite 2000/2500 ng/ml µu/ml Beckman DxI800 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 Beckman DxI800 KIU/l = IU/ml Abbott Architect KIU/l = IU/ml Roche Cobas E411 KIU/l = IU/ml Roche Cobas 6000 KIU/l = IU/ml Pishtaz Teb- ELISA Insulin mu/l Siemens Advia Centaur mu/l Abbott AXSYM RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 9 OF 19

10 Insulin mu/l Siemens Immulite 1000 mu/l Roche Modular E170 mu/l Roche Elecsys mu/l Abbott Architect mu/l Roche Cobas E411 mu/l Roche Cobas 6000 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 Vitros ECi mu/ml Siemens Advia Centaur mu/ml Siemens Immulite 2000 mu/ml Abbott Architect mu/ml Diasorin Liaison mu/ml Roche Modular E170 mu/ml Beckman DxI800 mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000 mu/ml Human Elisys UNO mu/ml Pishtaz Teb- ELISA Oestradiol pmol/l Abbott AXSYM pg/ml pmol/l BioMerieux Vidas pg/ml pmol/l Siemens Immulite 1000 pg/ml pmol/l Roche Elecsys pg/ml pmol/l Vitros ECi pg/ml pmol/l Siemens Immulite 2000/2500 pg/ml pmol/l Abbott Architect pg/ml pmol/l Roche Modular E170 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Roche Cobas 6000 pg/ml pmol/l Roche Cobas E411 pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 10 OF 19

11 Oestradiol pmol/l Siemens Advia Centaur E26 III pg/ml Paracetamol mmol/l Roche Modular E170 mg/l mmol/l Roche Integra mg/l mmol/l Siemens Advia Centaur mg/l mmol/l Gravimetric mg/l Parathyroid Hormone pmol/l Siemens Advia Centaur (PTH) pg/ml pmol/l Siemens Immulite 1000 pg/ml pmol/l Siemens Immulite 2000 pg/ml pmol/l Roche Elecsys pg/ml pmol/l Roche Modular E170 pg/ml pmol/l Abbott Architect pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000 pg/ml pmol/l Beckman DxI800 pg/ml Phenobarbital µmol/l Gravimetric µg/ml Phenytoin µmol/l Behring Emit 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 Modular P-D µg/ml µmol/l Roche Cobas 6000 µg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 11 OF 19

12 Phenytoin µmol/l Gravimetric µg/ml Primidone µmol/l Gravimetric µg/ml Progesterone nmol/l Beckman Access ng/ml nmol/l Abbott AXSYM ng/ml nmol/l Siemens Immulite 1000 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 ng/ml Prolactin µu/ml Beckman Access µu/ml Abbott AXSYM µu/ml BioMerieux Vidas µu/ml Siemens Immulite 1000 µu/ml Tosoh AIA360 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 Diasorin Liaison 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 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 12 OF 19

13 Prolactin µu/ml Roche Cobas 6000 µu/ml Pishtaz Teb- ELISA 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 (Hybritech) ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Diasorin Liaison 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 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 rd generation ng/ml = µg/l Siemens Immulite 2000/2500 3rd generation ng/ml = µg/l Vitros ECi ng/ml = µg/l Diasorin Liaison ng/ml = µg/l Roche Modular E170 ng/ml = µg/l Siemens Dimension equimolar 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 ng/ml = µg/l Pishtaz Teb- ELISA Salicylic Acid mmol/l Vitros mg/dl mmol/l Gravimetric mg/dl SHBG 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 nmol/l Beckman DxI800 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 13 OF 19

14 T Uptake %U Siemens Immulite 2000 %U Pishtaz Teb- ELISA Testosterone nmol/l Abbott AXSYM ng/ml ng/dl nmol/l Siemens Immulite 1000 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 nmol/l Abbott Architect ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Roche Modular E170 Test II ng/ml ng/dl nmol/l Roche Cobas 6000 Test 2 ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Roche Elecsys Test II ng/ml ng/dl nmol/l Roche Cobas 4000/e411 Test II ng/ml ng/dl nmol/l Beckman DxI800 ng/ml ng/dl Theophylline µmol/l Abbott AXSYM µg/ml µmol/l Roche Integra µg/ml µmol/l Siemens Advia Centaur µg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 14 OF 19

15 Theophylline µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000 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 Roche Cobas 6000 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 Tosoh AIA360 µu/ml = mlu/l Vitros ECi 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 Diasorin Liaison µu/ml = mlu/l Roche Modular E170 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 µu/ml = mlu/l Beckman DxI800 Hyper TSH µu/ml = mlu/l Monobind Inc. ELISA µu/ml = mlu/l Pishtaz Teb- ELISA 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 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 15 OF 19

16 Total Beta hcg 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 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 IU/ml mu/ml=iu/l Pishtaz Teb- ELISA IU/ml Total T3 nmol/l Abbott AXSYM ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Siemens Immulite 1000 ng/ml ng/dl nmol/l Roche Elecsys ng/ml ng/dl nmol/l Beckman Access 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 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 16 OF 19

17 Total T3 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 ng/ml ng/dl nmol/l Pishtaz Teb- ELISA 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 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 Beckman DxI800 µg/dl ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 17 OF 19

18 Total T4 nmol/l Roche Cobas E411 µg/dl ng/ml nmol/l Roche Cobas 6000 µg/dl ng/ml nmol/l Pishtaz Teb- ELISA 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 Vitros µg/ml µmol/l Siemens Dimension µg/ml µmol/l Abbott Architect µg/ml µmol/l Roche Cobas 6000 µg/ml µmol/l Gravimetric µg/ml Vancomycin µmol/l Ortho Vitros Microslide Systems µg/ml µmol/l Abbott Architect µg/ml µmol/l Gravimetric µg/ml Vitamin B12 pmol/l Abbott AXSYM pg/ml pmol/l Roche Elecsys pg/ml pmol/l Beckman Access pg/ml pmol/l Siemens Immulite 1000 pg/ml pmol/l Siemens Advia Centaur pg/ml pmol/l Siemens Immulite 2000 pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 18 OF 19

19 Vitamin B12 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 Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000 pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 19 OF 19

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