IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)

Transcription

1 0086 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) CT. NO. I3110 GTIN: SIZE: 12 x 5 ml CT. NO. I3112 GTIN: SIZE: 4 x 5 ml LOT NO. 1727EC 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. SFETY PRECUTIONS ND WRNINGS 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 ntigen (Hbsg), and Hepatitis C Virus (HCV) antibody and found to be NON- RECTIVE. FD 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 bbott rchitect C19-9 assay utilises an antibody/antigen system based on the 1116-N-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-N-19-9 reactive determinants. Health and Safety Data Sheets are available on request. STORGE ND STBILITY 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. CTH should be tested immediately after the 30-minute reconstitution period. No frozen stability claim is made for CTH, ldosterone and C-Peptide. Only the required amount of product should be removed. fter 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. PREPRTION 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. void 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. MTERILS PROVIDED Immunoassay Premium Plus - Level 2: 12 x 5 ml Tri-Level: 4 x 5 ml MTERIL REQUIRED BUT NOT PROVIDED Volumetric pipette VLUE SSIGNMENT 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. verage 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. ldosterone 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. 03 Oct 17 ne PGE 1 OF 25

2 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods 17-OH-Progesterone nmol/l Immunotech RI ng/ml nmol/l DRG ELIS ng/ml nmol/l DIsource RI ng/ml nmol/l DiaMetra ELIS ng/ml nmol/l IBL ELIS ng/ml OH Vitamin D nmol/l Diasorin Liaison nmol/l Siemens Centaur XP/XPT/Classic nmol/l Roche Vitamin D Total nmol/l HPLC nmol/l bbott rchitect nmol/l IDS isys nmol/l Vitros ECi nmol/l Tosoh I360 nmol/l BioMerieux Vidas nmol/l Beckman DxI 600/800 nmol/l Fujirebio Lumipulse G Series nmol/l Beckman ccess 25 OH Vitamin D Total CTH pmol/l Siemens Immulite 2000/2500 pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml pmol/l Siemens Immulite 1000 pg/ml ldosterone pmol/l CIS RI pg/ml pmol/l ELIS pg/ml pmol/l IDS isys pg/ml pmol/l Diasorin Liaison pg/ml lphafoetoprotein KIU/l = lu/ml bbott rchitect ng/ml KIU/l = lu/ml BioMerieux Vidas ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 2 OF 25

3 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods lphafoetoprotein KIU/l = lu/ml Siemens Centaur XP/XPT/Classic ng/ml KIU/l = lu/ml Siemens Immulite 2000/2500 ng/ml 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 ccess ng/ml KIU/l = lu/ml Tosoh I360 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 IRM ng/ml KIU/l = lu/ml Roche Cobas E411 ng/ml KIU/l = lu/ml Fujirebio Lumipulse G Series ng/ml KIU/l = lu/ml Siemens Dimension ng/ml KIU/l = lu/ml Siemens Centaur CP ng/ml mikacin µmol/l Roche Integra µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml ndrostenedione nmol/l Siemens Immulite 2000 ng/ml Beta-2-microglobulin µg/ml = mg/l bbott rchitect 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 Siemens Immulite 1000 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 3 OF 25

4 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Beta-2-microglobulin µg/ml = mg/l Diasorin Liaison µg/ml = mg/l Roche Cobas E411 µg/ml = mg/l Roche Cobas 6000/8000 µg/ml = mg/l Roche Modular E170 µg/ml = mg/l Siemens DVI 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 bbott rchitect ng/ml nmol/l Siemens Centaur XP/XPT/Classic ng/ml nmol/l Tosoh I360 ng/ml C 15-3 U/ml bbott rchitect U/ml BioMerieux Vidas U/ml Siemens Centaur XP/XPT/Classic U/ml Siemens Immulite 2000/2500 U/ml Siemens Immulite 1000 U/ml Beckman DxI800 U/ml Roche Elecsys U/ml Diasorin Liaison U/ml Roche Modular E170 U/ml Beckman ccess U/ml Tosoh I360 U/ml Vitros ECi U/ml Roche Cobas 6000/8000 U/ml Roche Cobas E411 U/ml Fujirebio Lumipulse G Series U/ml Siemens Centaur CP C 19-9 U/ml bbott rchitect U/ml BioMerieux Vidas U/ml Siemens Centaur XP/XPT/Classic U/ml Siemens Immulite 2000/2500 U/ml Beckman DxI800 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 4 OF 25

5 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5ml / 4 x 5 ml Expiry: nalyte unit Target low high methods C 19-9 U/ml Roche Elecsys U/ml Diasorin Liaison U/ml Roche Modular E170 U/ml Beckman ccess U/ml Tosoh I360 U/ml Vitros ECi U/ml bbott rchitect XR/XR2 kit U/ml Roche Cobas 6000/8000 U/ml Roche Cobas E411 U/ml Fujirebio Lumipulse G Series U/ml Siemens Centaur CP C125 U/ml bbott rchitect U/ml BioMerieux Vidas U/ml Siemens Centaur XP/XPT/Classic OV Kit U/ml Siemens Centaur XP/XPT/Classic C125 II kit U/ml Siemens Immulite 2000/2500 U/ml Siemens Immulite 1000 U/ml Beckman DxI800 U/ml Roche Elecsys U/ml Diasorin Liaison U/ml Roche Modular E170 U/ml Beckman ccess U/ml Tosoh I360 U/ml Vitros ECi U/ml Roche Cobas E411 U/ml Roche Cobas 6000/8000 U/ml Fujirebio Lumipulse G Series U/ml Siemens Centaur CP C125 II kit Carbamazepine µmol/l bbott rchitect 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 Roche Integra µg/ml µmol/l Vitros µg/ml µmol/l Roche Cobas E411 µg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 5 OF 25

6 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Carbamazepine µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Beckman U400/600/640/2700/5400 µg/ml µmol/l Siemens DVI 1200/1650/1800/2400 µg/ml µmol/l Gravimetric µg/ml Carcinoembryonic ng/ml = µg/l bbott rchitect ntigen (CE) ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Siemens Centaur XP/XPT/Classic ng/ml = µg/l CIS RI 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 ccess ng/ml = µg/l Tosoh I360 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 Fujirebio Lumipulse G Series ng/ml = µg/l Siemens Centaur CP Cortisol nmol/l bbott rchitect µg/dl nmol/l BioMerieux Vidas µg/dl nmol/l Siemens Centaur XP/XPT/Classic µg/dl nmol/l CIS RI 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 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 6 OF 25

7 IMMUNOSSY PREMIUM PLUS LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Cortisol nmol/l Beckman ccess µg/dl nmol/l Tosoh I360 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 DHE-S µmol/l bbott rchitect 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 ccess 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 Siemens DVI 1200/1650/1800/2400 ng/ml nmol/l Roche Cobas 4000/E411 ng/ml nmol/l Siemens Centaur CP ng/ml nmol/l bbott rchitect 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 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 7 OF 25

8 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Digoxin nmol/l Siemens Immulite 1000 ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Roche Elecsys ng/ml 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 U400/600/640/2700/5400 ng/ml nmol/l Gravimetric ng/ml Ethosuximide µmol/l Gravimetric µg/ml Ferritin ng/ml = µg/l bbott rchitect 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 ccess ng/ml = µg/l Tosoh I360 ng/ml = µg/l Vitros ECi ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Beckman U400/600/640/2700/5400 ng/ml = µg/l Fujirebio Lumipulse G Series ng/ml = µg/l Siemens Centaur CP Folate nmol/l bbott rchitect ng/ml nmol/l Siemens Centaur XP/XPT/Classic (enhanced kit) ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 8 OF 25

9 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Folate 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 ccess ng/ml nmol/l Tosoh I360 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 Siemens Dimension ng/ml nmol/l Siemens Centaur CP (enhanced kit) ng/ml nmol/l Roche Cobas 6000/8000 Folate III ng/ml nmol/l Roche Cobas 4000/e411 Folate III ng/ml nmol/l Roche Modular E170 Folate III ng/ml Free T3 pmol/l bbott rchitect 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 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 9 OF 25

10 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Free T3 pmol/l Roche Elecsys ng/dl pg/ml pmol/l Diasorin Liaison ng/dl pg/ml pmol/l Roche Modular E170 ng/dl pg/ml pmol/l Beckman ccess ng/dl pg/ml pmol/l Tosoh I360 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 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 bbott rchitect ng/dl pg/ml pmol/l Siemens Centaur XP/XPT/Classic ng/dl pg/ml pmol/l CIS RI Coated tube ng/dl pg/ml pmol/l Siemens Dimension ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 10 OF 25

11 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Free T4 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 pmol/l Roche Modular E170 ng/dl pg/ml pmol/l Beckman ccess ng/dl pg/ml pmol/l Tosoh I360 ng/dl pg/ml pmol/l Vitros ECi ng/dl pg/ml pmol/l Roche Cobas 6000/8000 ng/dl pg/ml pmol/l Immunotech IRM ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml pmol/l Monobind Inc. ELIS / CLI 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 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 11 OF 25

12 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods FSH mu/ml bbott rchitect 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 mu/ml Beckman ccess mu/ml Tosoh I360 mu/ml Vitros ECi mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 mu/ml Fujirebio Lumipulse G Series 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 Roche Cobas 6000/8000 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 Beckman ccess 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 bbott rchitect Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 12 OF 25

13 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Immunoglobulin E 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 KIU/l = IU/ml Roche Modular E170 KIU/l = IU/ml Tosoh I360 KIU/l = IU/ml Roche Cobas E411 KIU/l = IU/ml Roche Cobas 6000/8000 KIU/l = IU/ml Fujirebio Lumipulse G Series 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 Roche Elecsys pmol/l mu/l Beckman ccess pmol/l mu/l bbott rchitect pmol/l mu/l Tosoh I360 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 Fujirebio Lumipulse G Series pmol/l mu/l Siemens Centaur CP pmol/l mu/l Ortho Vitros ECi pmol/l Luteinising Hormone mu/ml bbott rchitect (LH) mu/ml BioMerieux Vidas mu/ml Siemens Centaur XP/XPT/Classic mu/ml Siemens Immulite 2000 mu/ml Siemens Immulite 1000 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 13 OF 25

14 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Luteinising Hormone mu/ml Beckman DxI800 (LH) mu/ml Roche Elecsys mu/ml Diasorin Liaison mu/ml Roche Modular E170 mu/ml Beckman ccess mu/ml Tosoh I360 mu/ml Vitros ECi mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 mu/ml Fujirebio Lumipulse G Series mu/ml Siemens Centaur CP Oestradiol pmol/l bbott rchitect 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 ccess 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 Siemens Centaur CP pg/ml pmol/l Siemens Centaur CP Enhanced (ee2) pg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 14 OF 25

15 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Oestradiol 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 pmol/l Roche Modular E170 (Estradiol III) pg/ml Paracetamol mmol/l Roche Integra mg/l mmol/l Vitros mg/l mmol/l bbott rchitect mg/l mmol/l Roche Cobas 6000/8000 mg/l mmol/l Gravimetric mg/l Phenobarbital µmol/l bbott rchitect µg/ml µmol/l Siemens DVI 1200/1650/1800/2400 µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Beckman U400/600/640/2700/5400 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 Gravimetric µg/ml Phenytoin µmol/l bbott rchitect 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 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 15 OF 25

16 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods 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 bbott rchitect 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 (Prog. II) ng/ml nmol/l Roche Modular E170 (Prog. II) ng/ml nmol/l Beckman ccess Prog Cal ng/ml nmol/l Tosoh I360 ng/ml nmol/l Vitros ECi ng/ml nmol/l Roche Cobas 4000/e411 (Prog. II) ng/ml nmol/l Roche Cobas 6000/8000 (Prog. II) ng/ml nmol/l Diasorin Liaison ng/ml nmol/l Beckman DxI Prog DE Cal ng/ml nmol/l Beckman ccess Prog DE Cal ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 16 OF 25

17 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Progesterone nmol/l Siemens Centaur CP ng/ml nmol/l Roche Cobas 6000/8000 (Prog. III) ng/ml nmol/l Roche Elecsys (Prog. III) ng/ml nmol/l Roche Cobas 4000/e411 (Prog. III) ng/ml nmol/l Roche Modular E170 (Prog. III) ng/ml Prolactin µu/ml bbott rchitect 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 ccess µu/ml Tosoh I360 µu/ml Vitros ECi µu/ml Roche Elecsys/E170/Cobas 6000/8000 PRLII µu/ml Immunotech IRM µu/ml Roche Cobas E411 µu/ml Roche Cobas 6000/8000 µu/ml Fujirebio Lumipulse G Series µu/ml bbott rchitect restandardised µu/ml Siemens Centaur CP PS Free ng/ml = µg/l bbott rchitect 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 ccess standardised to Hybritech ng/ml = µg/l Tosoh I360 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 Beckman ccess standardised to WHO IRP96/670 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 17 OF 25

18 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods PS Free ng/ml = µg/l Ortho Vitros 3600/5600/ECi PS II ng/ml = µg/l Fujirebio Lumipulse G Series PS Total ng/ml = µg/l bbott rchitect ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l biomerieux VIDS TPS 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 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 ccess standardised to Hybritech ng/ml = µg/l Beckman ccess standardised to WHO IRP96/670 ng/ml = µg/l Tosoh I360 ng/ml = µg/l Vitros ECi ng/ml = µg/l CIS RI 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 PS II ng/ml = µg/l Siemens Centaur CP Salicylic cid mmol/l bbott rchitect 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 bbott rchitect nmol/l Roche Cobas E411 nmol/l Roche Cobas 6000/8000 nmol/l Beckman DxI800 T Uptake %U Siemens Immulite 2000 Testosterone nmol/l bbott rchitect ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 18 OF 25

19 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Testosterone nmol/l Siemens Centaur XP/XPT/Classic ng/ml ng/dl nmol/l CIS RI Coated tube 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 Beckman ccess ng/ml ng/dl nmol/l Tosoh I360 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 bbott rchitect 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 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 19 OF 25

20 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Theophylline µmol/l Siemens Centaur XP/XPT/Classic µg/ml µmol/l Siemens Dimension µg/ml µmol/l Roche Integra µg/ml µmol/l Vitros µg/ml µmol/l bbott rchitect µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Beckman U400/600/640/2700/5400 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 Roche Cobas 6000/8000 ng/ml Beckman ccess ng/ml Tosoh I360 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 bbott rchitect Hormone µu/ml = mlu/l biomerieux VIDS TSH µu/ml = mlu/l biomerieux VIDS TSH3 Ultrasensitive µu/ml = mlu/l Siemens Centaur XP/XPT/Classic µu/ml = mlu/l CIS IRM 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 ccess Fast TSH Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 20 OF 25

21 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Thyroid Stimulating µu/ml = mlu/l Beckman ccess hypertsh 3rd Generation Hormone µu/ml = mlu/l Tosoh I360 µu/ml = mlu/l Vitros ECi 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 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 µu/ml = mlu/l Beckman DxI 600/800 ccess (3rd IS) Tobramycin µmol/l Gravimetric µg/ml Total Beta hcg mu/ml=iu/l bbott rchitect 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 EI IU/ml mu/ml=iu/l Beckman ccess IU/ml mu/ml=iu/l Tosoh I360 IU/ml mu/ml=iu/l Vitros ECi IU/ml mu/ml=iu/l Roche STT (Intact) IU/ml mu/ml=iu/l Roche hcg+beta IU/ml mu/ml=iu/l Fujirebio Lumipulse G Series IU/ml mu/ml=iu/l Radiometer QT90 Flex IU/ml mu/ml=iu/l Beckman ccess Total BhCG (5th IS) IU/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 21 OF 25

22 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Total Beta hcg mu/ml=iu/l Beckman DxI Total BhCG (5th IS) IU/ml mu/ml=iu/l Siemens Centaur CP IU/ml Total T3 nmol/l bbott rchitect 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 ccess ng/ml ng/dl nmol/l Tosoh I360 ng/ml ng/dl nmol/l Vitros ECi ng/ml ng/dl nmol/l CIS RI Coated tube ng/ml ng/dl nmol/l Roche Cobas E411 ng/ml ng/dl Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 22 OF 25

23 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Total T3 nmol/l Roche Cobas 6000/8000 ng/ml ng/dl nmol/l Monobind Inc. ELIS / CLI ng/ml ng/dl nmol/l Siemens Centaur CP ng/ml ng/dl Total T4 nmol/l bbott rchitect 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 ccess µg/dl ng/ml nmol/l Tosoh I360 µg/dl ng/ml nmol/l Vitros ECi µg/dl ng/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 23 OF 25

24 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Total T4 nmol/l CIS RI 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 IRM µg/dl ng/ml nmol/l Siemens Centaur CP µg/dl ng/ml Valproic cid µmol/l bbott rchitect 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 Cobas E411 µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Beckman DxC µg/ml µmol/l Beckman U400/600/640/2700/5400 µg/ml µmol/l Siemens DVI 1200/1650/1800/2400 µg/ml µmol/l Siemens Centaur CP µg/ml µmol/l Gravimetric µg/ml Vancomycin µmol/l Roche Integra µg/ml µmol/l Ortho Vitros Microslide Systems µg/ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County ntrim, BT29 4QY, United Kingdom PGE 24 OF 25

25 IMMUNOSSY PREMIUM PLUS - LEVEL 2 (I PREMIUM PLUS 2) Cat. No. I3110 / I3112 Lot No. 1727EC Size: 12 x 5 ml / 4 x 5 ml Expiry: nalyte unit Target low high methods Vancomycin µmol/l bbott rchitect 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 bbott rchitect 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 ccess pg/ml pmol/l Tosoh I360 pg/ml pmol/l Vitros ECi 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 ntrim, BT29 4QY, United Kingdom PGE 25 OF 25