Waters solution in clinical laboratory Waters Corporation 1

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1 Waters solution in clinical laboratory 2015 Waters Corporation 1

2 Systems Solution for clinical laboratory Liquid Chromatography Systems: Alliance HPLC HPLC with quaternary pump Acquity UPLC core UPLC with binary pump with an high pressure gradient mixing solution (CE-IVD) Acquity UPLC H-Class UPLC with a quaternary pump, versatile Acquity UPLC I-Class UPLC with binary pump an high pressure gradient mixing solution, with dead volume (<100 µl) and band spread ( 6 µl) very low (CE-IVD). Mass Spectrometry Systems (Triple Quad): TQD (CE-IVD) Xevo TQD (CE-IVD) Xevo TQ-S micro (CE-IVD) Xevo TQ-S (CE-IVD) 2015 Waters Corporation 2

3 Why the CE-IVD mark is important? CE-IVD Mark means: Controlled production with technical and electrical specifications suitable for the clinical market Analytical Performances of the instruments certified with documented tests Application notes and technical brief produced by Waters are controlled by external company before the final release Higher level of quality control in production Protocols of investigation of the different problems verified in the customers laboratories (AUDIT) Technical Service with technicians learned foth the GLP for the clinical laboratories 2015 Waters Corporation 3

4 Ideal Waters Clinical Solutions Data receiving from LIS Automation of the sample prep Analysis in LC-MS/MS Results exported to LIS 2015 Waters Corporation 4

5 Data receiving from LIS Automation of the sample prep Bi-directional interface with the most common LIS thanks to our HL-7 SW Collaboration with Tecan and Hamilton Collaboration with Siemens and Abbott Analysis in LC-MS/MS Results exported to LIS TQD Xevo TQD Xevo TQ-S micro Bi-directional interface with the most common LIS thanks to our HL-7 SW 2015 Waters Corporation 5

Analysis in LC-MS/MS TQD Xevo TQD Xevo TQ-S micro TDM Therapeutic Drug Monitoring Immunosuppressants Mycophenolic acid Antiretroviral Neuroleptics ed

Metil Malonic Acids Homocysteine Hepcidine Aminoacids Toxicology and Forensic DOA in urine Ethylglucorinide in urine All the parameters performed on TQD

(steroids) MMA, Hcy and propionic acid Lysosomial disorders oxisterols, sphingolipids All the parameters performed on Xevo TQD plus: Steroids at pediatric

6 Analysis in LC-MS/MS TQD Xevo TQD Xevo TQ-S micro TDM Therapeutic Drug Monitoring Immunosuppressants Mycophenolic acid Antiretroviral Neuroleptics ed Antidepressants Antiepileptics Antibiotics Anticoagulants Antifungals Antitumorals Clinical Biochemistry Steroids (not all) 25-OH-vitamin D2 e D3 + epimer Metil Malonic Acids Homocysteine Hepcidine Aminoacids Toxicology and Forensic DOA in urine Ethylglucorinide in urine All the parameters performed on TQD plus: All steroids Ethylglucorinide in hair DOA in whole blood and hair Newborn Screening Panel: Newborn Screening Second tier test in DBS: CAH hyperplasia (steroids) MMA, Hcy and propionic acid Lysosomial disorders oxisterols, sphingolipids All the parameters performed on Xevo TQD plus: Steroids at pediatric levels (estradiol/aldosterone) 1,25 (OH)2 Vitamin D3/D2 Ethylglucorinide on hair DOA in hair All of these analysis are performed with one source: ESCI 2015 Waters Corporation 6

7 Waters Application notes list: More than 4000 clinical application notes! 3988 Pichini S et al Journal of Pharmaceutical and Biomedical Analysis 118 (2016) 9 16 antidepressant and anxiolytic drugs Toyo oka T & Kikura Hanajirib R Chem. Pharm. Bull. 63, (2015) Synthetic Canabinoids 3990 Liang S-H Restek Apps Note Nicotine and Related Compounds 3991 Hodson L et al J Am Heart Assoc. 2015;4:e Cortisol, DHEA, ASD 3992 Slominski AT et al doi: /exd Vitamin D3 metabolites 3993 Johnson JS et al en (October 2015) Thyroglobulin 3994 Li Y et al Journal of Chromatography A, 1409 (2015) Metabolome, Lipidome 3995 Schlittenbauer L et al Journal of Chromatography A, 1415 (2015) Matrix effects in human urine analysis 3996 Zhou Y et al Journal of Chromatography B, (2015) remimazolam and its metabolite 3997 Nye LC et al Bioanalysis (2015) 7(6), metabolite of tenofovir disoproxil fumarate 3998 Leonart LP et al Bioanalysis (2015) 7(12), metabolite id 3999 Meng X et al Anal. Methods, 2015, 7, fluoroquinolone antibiotics 4000 Meijerink J et al British Journal of Pharmacology (2015) Eicosanoids 4001 Wang X et al Forensic Toxicol DOI /s GHB and GHB glucuronide 4002 Shintani-Ishida K et al Forensic Toxicol (2015) 33: MeOPBP 4003 Wang C-H et al Heart Vessels DOI /s p-cresyl sulfate 4004 Cháfer-Pericás C et al Analytica Chimica Acta 886 (2015) lipid peroxidation biomarkers 4005 Choi JY et al Additives & Contaminants: Part A, 32:7, , DOI: / narcotic adulterants 4006 Masubuchi N et al Oxidative stress markers, secondary bile acids and sulfated bile acids 4007 Andersson M et al Forensic Science International 252 (2015) Opioids 4008 Pechlivanis A et al DOI: /acs.jproteome.5b00470 Human Urinary Metabolome 4009 Wang X et al J. Proteome Res. 2015, 14, Metabolic Profiling of Age-Related Mitochondrial Dysfunction 4010 Bolechová M et al Chem. Listy 109, (2015) (Czech) Isoprostanes 4011 Bashaw S et al SOFT 2015 (Atlanta GA) Basic, Acid, and Neutral Drugs 4012 Chindarkar NS et al doi: /jat/bkv057 Tof vs tandem 4013 Henderson CM et al doi: /clinchem Vitamin D Binding Protein 4014 James L et al PLOS ONE DOI: /journal.pone Bile Acids 4015 Xie G et al J. Proteome Res. 2015, 14, Bile Acids 4016 Belul N Thesis (June 2015) Oxytocin 4017 Bronsema KJ et al Bioanalysis (2015) 7(1), Nanobody 4018 Linder C et al Bioanalysis (2015) 7(16), carbamazepine, lamotrigine and valproic acid 4019 Kozlovich S et al DOI: /acs.chemrestox.5b00278 Tobacco-Specific Nitrosamine, NNAL 4020 Ehling S & Reddy TM J. Agric. Food Chem. 2015, 63, leucine and metabolites 4021 Boccard J et al Bioanalysis (2014) 6(19), Steroid metabolites 4022 Abbassi-Ghadi N et al DOI: /s Lipidomic Profiling of h cancer tissue 4023 Burch TC et al PLOS ONE DOI: /journal.pone Metabolomic and Lipidomic Analysis 4024 Lang LM & Linnet K Cortisol 4025 Daan NMP et al doi: /humrep/dev195 Androgens 2015 Waters Corporation 7

Analysis of Testosterone, Androstenedione, and Dehydroepiandrosterone Sulfate in Serum for Clinical Research

Analysis of Testosterone, Androstenedione, and Dehydroepiandrosterone Sulfate in Serum for Clinical Research Dominic Foley, Michelle Wills, and Lisa Calton Waters Corporation, Wilmslow, UK APPLICATION