Be Sure Presentation_V11_updated.pptffgx
- 2. 2
- 3. 3 Components that are Legally Marketed for Clinical Use (FDA Class I Devices) Liquid Chromatography Systems Intended Use: The Vanquish MD HPLC (high performance liquid chromatograph), Prelude MD HPLC, and Prelude LX-4 MD HPLC are general purpose laboratory instruments intended to separate drugs or compounds in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. Indications for Use: The Vanquish MD HPLC, Prelude MD HPLC, and Prelude LX-4 MD HPLC will be used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow. Contraindications of Use: For in vitro diagnostic applications only. The Vanquish MD HPLC, Prelude MD HPLC, and Prelude LX-4 MD HPLC are to be operated only with hardware or software approved for in vitro diagnostic application. Limitations of Use: The Vanquish MD HPLC, Prelude MD HPLC, and Prelude LX-4 MD HPLC are compatible with the following Thermo Fisher Scientific instruments: TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers. Mass Spectrometers Intended Use: The TSQ Altis MD Series and the TSQ Quantis MD Series mass spectrometers are intended to identify and quantify inorganic and organic compound in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. Indications for Use: The TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers will be used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow. Contraindications of Use: For in vitro diagnostic applications only. The TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers are to be operated only with hardware or software labeled for in vitro diagnostic use. Limitations of Use: The TSQ Altis MD Series and the TSQ Quantis MD Series mass spectrometers are compatible with the following Thermo Fisher Scientific instruments: Vanquish MD HPLC, Prelude MD HPLC, and Prelude LX-4 MD HPLC. As a component of an LDT method or workflow, validation of the LDT method or workflow is the responsibility of the clinical laboratory.
- 4. 4 P E A C E PRODUCTIVITY EFFICIENCY ACCURACY COST/SAMPLEEASE OF USE Addressing throughput goals for every analyte Achieving better results in shorter time Sensitive, robust, selective, and specific results for every analyte Reducing cost/sample to address profitability goals High quality results for every analyte regardless of complexity and user expertise Critical Challenges
- 5. 5 COMPREHENSIVE PORTFOLIO Offering a range of options in productivity (throughput) and sensitivity LDTs to Biomedical research FUTURE PROOFING INVESTMENT Address complexity of working with human specimens Address analyte complexity – small to large OUTSTANDING PERFORMANCE Platform solution comprises ideal performing instruments Ease-of-use in implementation, maintenance, and management Be Sure – Why Bother with any other options?
- 6. 6 Addressing in vitro Diagnostic Requirements Protecting today’s investment for tomorrow’s testing • Increase efficiency, throughput, and cost savings with LC-MS • Compared to traditional assays, achieve better selectivity and specificity while addressing sensitivity requirements • Customize throughput requirements to address organizational goals • Robust instruments enabling easy development and optimization of LDTs regardless of analyte, matrix complexity or user expertise • Ease, efficiency, and flexibility for LDTs • Flexible options to meet sensitivity and throughput needs • HPLC options • VanquishTM MD HPLC system • Prelude MDTM HPLC system • Prelude LX-4 MDTM HPLC system • Mass Spectrometer options • TSQ QuantisTM MD Series • TSQ AltisTM MD Series
- 7. 7 Vanquish MD HPLC System Sample injection for the highest confidence in peak identification and quantification The Vanquish MD HPLC system combines maximum injection precision with huge sample capacity and high- throughput capabilities. The fully biocompatible fluidics are consequently optimized for the highest ruggedness and uptime, even under the toughest system pressure and eluent conditions. • Reliable results • Ensure data integrity • Ease of use
- 8. 8 Prelude MD HPLC System and Prelude LX-4 MD HPLC System Confidence in results with ease and efficiency Designed to quickly and cost-effectively deliver accurate, reproducible patient test results you can count on day after day. With automated sample clean-up and two channels of HPLC separation, achieve higher productivity and certainty in LC-MS test results. Run more samples with ease Four automated HPLC channels deliver up to four different separations to a single mass spectrometer, streamlining LC-MS workflows and reducing idle time. Achieve ultimate productivity by maximizing the potential of your LC-MS instruments, laboratory space, and technical staff.
- 9. 9 TSQ Quantis MD Series Mass Spectrometer Robust, Sensitive Results, Every Day Offers the sensitivity needed for routine quantitative analyses together with remarkable speed and robustness. The TSQ Quantis MD Series mass spectrometer will be used by clinical diagnostic laboratories to meet their routine requirements for laboratory developed tests. With AIM+ technology, the TSQ Quantis MD Series delivers confident quantitation for routine analyses of human specimens. • High quality results • Confidence Every Day, Every Sample • Ease of use
- 10. 10 TSQ Altis MD Series Mass Spectrometer Ultimate Sensitivity, Robustness, Reliability for Every Sample Offers ultimate sensitivity needed for quantitative analyses together with remarkable speed and robustness. With AIM+ technology, the TSQ Altis MD series delivers ultimate performance in human specimens and low levels of analyte • High sensitivity results • Every analyte, matrix type • Ease of use
- 11. 11 Complete Software Suite Bi-Directional LIS Connection The .CSV input and output of MS do not conform to the requirements of typical laboratory information system resulting in challenges such as, downloading test requests to the MS and uploading test reports to LIS. B-Link LIS/LIMS Connector resolves critical data management issues by converting data to the appropriate format and providing bi-directional communication • Between LIS/LIMS and B-Link • Between B-Link and TraceFinder LDT software
- 12. 12
- 13. 13
- 14. 14 IVD-CE MARKED DIAGNOSTICS KITS BY HPLC & LC-MS/MS Provide Mobile Phase Analytical Column Calibrators & Quality Controls
- 15. 15 Five reasons to implement LC-MS platforms for your laboratory developed tests 1. Specificity, selectivity, sensitivity 2. Speed and high throughput capability for increased productivity 3. Comprehensive and flexible platform options 4. Connectivity : LIS & LIMS 5. Eliminating costs/increasing productivity
- 16. 16 Clinical and Toxicology Analysis Application Compendium
- 17. 17
- 18. 18
- 19. 19 Drug Of Abuse Cobas LC-MS/MS Amphetamines 1450 Compound; with 16 min run time Barbiturates Benzodiazepines Cannabinoids Cocain Metabolite Ethanol Methadone Methaqualone Opiates Phencyclidine Propoxyphene LSD TDM, medication monitoring Cobas LC-MS/MS Acetaminophen 36- Benzodiazepines Analysis (7.5 min) Amikacin Carbamazepine 27-Antiepileptic Drugs 5 min run time Cyclosporine Digitoxin 1-Mycophenolic Acid 3 min run time Digoxin Gentamicin 13-Tricyclic antidepressants Analysis: 3.8 min Lidocaine Lithium 37-Antidepressants 5 min Run Time MPA NAPA 11-antimycotics Drugs Analysis: 3.5 min Phenobarbital Phenytoin 28-neuroleptics Analysis (7.5 min) Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic Acid Vancomycin Setroid Hormons Cobas LC-MS/MS ACTH Cortisol Cortisol DHEAS DHEA-S 21-Deoxycortisol Estradiol 11-Deoxycortisol FSH Testosteron HCG+β Androstendion HCG STAT 21-OH-Progesteron LH 17-OH-Progesteron PAPP-A Progesterone Analysis (6 min) Prolactin SHBG Testosterone Amino Acid LC-MS/MS 48 - Amino acid Newborn Screening Test Panel ( Cobas Analyzer VS LC-MS/MS)
- 20. 20
- 21. 21