Pre-Register

Join Agilent for breakfast on Sunday, January 21 and meet a few of our Mass Spectrometry Experts. We will be covering the following material:

MassHunter Software Overview: Review by Exception and PDF Reporting.

New Innovations and New Synthetic Opioids. Introducing the Agilent Ultivo Miniature Tandem LC/Mass Spectrometer with clinical research application to Toxicological analytes of interest.

Jet Steam Proteomics with Automated Sample Prep for High-Throughput Peptide Quantitation in Clinical Research.

We hope to see you there!

Biompatible Solid Phase Microextraction Coupled to MS for Improved Analysis of Biological Fluids

Microextraction using newly developed biocompatible solid phase microextraction (BioSPME) devices can be used to directly sample from complex biological matrices without significant co-extraction of interferences. BioSPME extractions may be coupled with a mass spectrometer directly or analyzed via a standard LC/MS workflow. This sample preparation methodology has evolved into a useful tool for clinical applications. Performing direct MS analysis eliminates time-consuming and costly steps specific to LC and GC separations. This rapid detection technique facilitates fast screening methods and, due to analyte concentration as well as extraction from matrix interferences, often provides highly quantitative results. This workshop will provide an overview of the technique including method development and optimization schemes. Applications including analysis of drugs of abuse, steroids and hormones from a variety of biological matrices including plasma, urine and saliva, will be explored and contrasted to conventional approaches.

It's all about the Base: How much Simpler, Cleaner and Faster can Mixed Mode Ion Exchange SPE Methods get?

Kim Haynes, Principal Product Marketing Manager, Chemistry Technology Center

Mixed-mode ion exchange solid phase extraction (SPE) is an extremely powerful sample cleanup tool when higher degrees of analyte specificity and sample cleanliness are required. However, these methods are often associated with extra method development time and complicated processes.
In this seminar we will explore the compromise scientists have had to make between analyte specificity, sample cleanliness and simple workflows. We will then introduce an easy-to-implement solution to this problem using a new solid phase extraction product recently developed by scientists at Waters Corporation. Finally, we will demonstrate how this new product simplifies workflows, reduces method development and processing time, while improving sample cleanliness in applications.

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Discover a new era of mass spectrometry effectiveness - revealing the power hidden in your existing MS data!

Transform your existing mass spectral data sets and subsequent analyses to unexpected new levels of quality and effectiveness. Discover how to employ fully-automated PeakInvestigator® advanced post-processing software to open a new era of effective life sciences problem solving with the introduction of statistically-valid MS peak determinations, including error bars on every mass and abundance call.

Learn how PeakInvestigator can transform your existing MS results into more powerful and complete data sets by deconvolving overlapped peaks, extracting remarkably improved sensitivity with noise rejection, and providing higher precision in peak determinations. These remarkable improvements extracted from your existing MS data outputs enable you to open a new era of effectiveness in subsequent data analysis, discoveries and confirmations.

Join the Veritomyx team and renowned guest speakers for presentations and Q&A including:
“Fully-Automated, Advanced Mass Spectral Data Analysis”
“Increased Quantity & Quality Of Proteomics Identifications"
“Transformation in Metabolic Biomarkers Blind Discovery Effectiveness”

Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) are unique biomarkers of alcohol use. EtG and EtS analysis offers many advantages for abstinence monitoring including the detection window, stability in stored specimens, and specificity. EtG and EtS are both polar, making them difficult to retain via reversed-phase chromatography. Both compounds are also very sensitive to matrix interferences which can result in being unable to achieve low limits of detection and can also make quantitation impossible. In this study, a simple dilute and shoot method was developed and validated for the analysis of EtG and EtS in human urine by LC-MS/MS.

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The Patient & Lab Perspective: Capillary vs. Venous Monitoring of Immunosuppressants

Dr. Paul Jannetto, Mayo Clinic, Director, Clinical Mass Spectrometry Lab, Clinical and Forensic Toxicology Lab, and Metals Lab

This session will provide a brief summary of a clinical pilot study where 100 patients were enrolled to compare the analytical results and patient satisfaction from a traditional venous whole blood draw versus a capillary collected whole blood sample using the Mitra microsampling collection device. In addition, the operational and analytical validation of the new automated Mitra workflow will be discussed.

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Endocrine Applications requiring high sensitivity: performance of the new SCIEX Citrine™ Mass Spectrometry System for measuring Thyroglobulin and 1,25 dihydroxyvitamin D
Dr. Daniel T. Holmes, MD; FRCPC Division Head, Clinical Chemistry,
St. Paul's Hospital Department of Pathology and Laboratory Medicine Vancouver, BC, Canada

SCIEX is very pleased to invite you to attend the unveiling of the Citrine™ MS/MS system, our fastest, most sensitive IVD mass spectrometer. The Citrine MS/MS system provides the clinical lab with the performance and robustness to address the most challenging applications. In this session, data will be presented to highlight the performance of the Citrine MS/MS system for (i) the measurement of 1,25-dihydroxyvitamin D, and (ii) the measurement of thyroglobulin, using the SISCAPA workflow.

Measurement of Eicosanoids and their Urinary Metabolites using Mass Spectrometry

Ginger L. Milne, PhD, Research Associate Professor, Director, Eicosanoid & Neurochemistry Core Laboratories, School of Medicine, Vanderbilt University, TN

Eicosanoids are important signaling molecules central to many critical physiological processes such as inflammation, pregnancy and childbirth, and cardiovascular function. Dysregulation of eicosanoid production has been implicated in a number of diseases such as oncology, metabolic syndrome, and cardiovascular disease. Derived by the enzymatic or non-enzymatic oxidation of arachidonic acid or other 20 carbon length polyunsaturated fatty acids (PUFAs), eicosanoids are challenging to quantitatively measure due to their inherent structural and chemical similarities. This workshop will demonstrate how targeted mass spectrometry workflows are key to accurate and precise measurement of eicosanoids for clinical research and why they are required to further biomedical research of these important class of biochemicals.

For Research Use Only. Not for use in Diagnostic Procedures.

The Batch and Beyond - LCMS Result Automation Strategies and Analytics

Jim Edwards

The utilization of self-aware peak processing algorithms, a comprehensive quality architecture, and a streamlined, exception-based data/result review process have proven to be a successful strategy for improving both quality and throughput of LCMS analysis. The positive impacts of these batch-oriented optimizations can be significantly magnified by an additional layer of analytics and visualization which provide comprehensive information across instruments, assays, and batches over time. Please join us for a discussion on how these analytics are used to diagnose and prevent issues, target quality improvement efforts where they will be most effective, improve the quality and speed of automated result release, and align both the business and science aspects of the laboratory for an elevation in the efficiency and effectiveness of both.

Innovative Filtration Method to Rapidly Remove Protein from Biological Matrices Prior to LC/MS/MS Analyses

Daniel B. Kassel, Ph.D., Founder & CEO, SciAnalytical Strategies, Inc., La Jolla, CA; Kaylee R. Mastrianni, Ph.D., Applications Chemist, DPX Technologies, LLC,
Columbia, SC

Conventional protein precipitation methods require centrifugation and oftentimes offline sample handling prior to LC/MS/MS analyses. We introduce a rapid and readily automated patent pending method for protein precipitation with automated filtration. The method utilizes Tip-On-Tip (ToT) technology for the streamlined analysis of urine, whole blood, and serum/plasma. We will discuss numerous applications such as filtration of hydrolyzed urine samples, comprehensive drug testing in whole blood, and steroid analysis in serum. We will also present a validated method for the analysis of total testosterone in serum, and show detailed patient results obtained from a collaborative clinical laboratory. Using this ToT technology, up to 96 serum samples were processed simultaneously in less than 10 minutes using a Hamilton Nimbus96, providing clean extracts immediately ready for injection into LC/MS instrumentation.

Mass Spectrometry Approaches to the Opioid Epidemic

Marilyn Huestis, Retired Chief, Chemistry and Drug Metabolism, NIDA, Huestis & Smith Toxicology, LLC, USA

The opioid epidemic began when pain became the 6th vital sign. More than 100 million US citizens report chronic pain that requires treatment. Physicians rapidly moved to potent opioid analgesics rather than other non-steroidal anti-inflammatory drugs, leading to opioid dependence. Prescription opioid abuse is estimated to cost $72.5 B annually in health-care costs. The Drug Enforcement Agency's increased controls on health care providers and clandestine laboratories offerings of designer opioids and synthetic fentanyls resulted in opioid-dependent users moving to these new potent opioid drugs. These developments challenge laboratories to identify and quantify a wide variety of prescription opioids, heroin, and novel psychoactive opioids. Laboratories need analytical solutions to address the opioid epidemic. Liquid chromatography tandem mass spectrometry (LC-MS/MS) offers the power of multi-opioid analysis and rapid quantification of numerous analgesics. To determine the utility of high resolution accurate mass spectrometry (HRAM) to enable broad spectrum screening for prescription, illicit and clandestine laboratory opioids in clinical research will be discussed.

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Implementation of a fully integrated automated sample preparation system for routine clinical LC-MS/MS analysis

Lorin Bachmann, PhD, DABCC, Associate Professor of Pathology, Co-Director of Clinical Chemistry, Virginia Commonwealth University

Lack of availability of a fully automated LC-MS/MS system has been one of the largest barriers to meaningful adoption of mass spectrometry in the routine clinical laboratory. Our laboratory evaluated the workflow attributes and analytical performance characteristics of the Clinical Laboratory Automation Module 2000 (CLAM-2000) integrated with the Prominence LCMS-8050 platform for routine analysis of total 25-OH Vitamin D (25-OHD). This configuration enabled complete integration of automated sample preparation with LCMS analysis during the validation study. The method validation included patient samples obtained from our academic medical center and was performed according to Clinical and Laboratory Standards Institute (CLSI) guidelines. The CLAM-2000 Prominence LCMS-8050 method was linear from 2ng/mL- 150 ng/mL for 25-OH D3, 3-epi 25-OH D3 and 25-OH D2. Precision was excellent with coefficients of variation < 6%. The method agreed with our validated manual LCMS method, however the CLAM-2000 Prominence LCMS-8050 system had the additional advantage of resolving the 3-epimer of 25-OH Vitamin D3. Trueness was confirmed using NIST 972a Vitamin D reference materials.

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Despite a few decades of proteomics research and the apparent discovery of multiple protein biomarkers to support the diagnosis and treatment of patients, the number of protein biomarkers that have been developed to the stage of being used routinely is disappointingly low. So, it's clear that whilst there’s huge interest in the field of research for development of new protein biomarkers and major drivers for this to happen: including the pharmaceutical industry’s need to better stratify patients for effective treatment, as yet biomarker development and delivery is proving very challenging. Why is this?

By enabling rapid assay development and evaluation, SRM/MRM on triple quadrupole mass spectrometers holds huge potential as a platform for the development of specific and sensitive 'biomarker signatures' comprising multiple proteins. However, once such prototype signatures are developed can they be clinically validated and then delivered to a clinical test environment? Addressing this current bottleneck may be dependent on the implementation of robust and reliable workflows with methods that are easy, quick and inexpensive and may be automated.

For Research Use Only. Not for use in diagnostic procedures.

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Next-Generation Proteomics Technology to Increase Depth of Coverage and Data Reproducibility In Clinical Proteomics

Recent major advancements in label free mass spectrometry based proteomics have enabled deeper and more reproducible quantification of thousands of proteins in a single measurement. This next generation proteomics technology is based on data independent acquisition (DIA) which overcomes the technical limitation of sampling speed of mass spectrometers by isolating broad ranges of peptide ions in parallel and utilizing powerful data deconvolution algorithms. DIA technology is only limited by the sensitivity of the detector, and not the sequential speed of the instrument. Researchers can now carry out deeper analysis of proteins in clinical samples and with new chromatographic set-ups the studies can be extended to hundreds of samples without any loss in depth, coverage and reproducibility.
During the lunch symposium proteomics experts from Biognosys will present the latest improvements in data acquisition, analysis and interpretation. Attendees will learn how to identify more than 8`000 protein groups in single shot DIA with almost no missing values across technical replicates.
Further we will present an optimized capillary flow system coupled to the Thermo Fisher Orbitrap Fusion Lumos. This system was used to analyse over 1500 human plasma samples.

Sample Preparation for Meaningful LC-MS

Mass spectrometry-based analysis is playing an increasingly vital role in basic research and more significantly, clinical applications. Sample preparation is an integral, but often overlooked, component of a successful LC-MS experiment. However, given the highly manual nature of the process, dearth of efficient standardized methods, and the wide variability in sample content, sample processing is the predominant source of errors and reporting bias. Due to the nature of the workflow, sample prep errors remain undetected until the final data analysis step; such issues are particularly costly in clinical settings where samples are precious or access is limited.
This workshop will offer simple tips and tricks to expedite sample preparation while ensuring sample integrity is maintained. Aspects of sample preparation to be covered in the workshop include:

- Quick guidance to filtration membrane selection allowing efficient and contamination (extractables) free sample cleanup
- Importance of plate selection for high throughput removal of matrix components while retaining desired analyte(s)
- Filter Aided Sample Preparation (FASP) and attempts on quantitative analysis
- Quick ZipTip based sample pre-treatment to enhance LC-MS quality

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Achieving Low Level Detection of Clinical Samples Prior to LC-MS/MS Analysis through efficient Sample Prep

Dr. Lee Williams, Biotage GB Limited, UK

The use of LC/MS analysis in the clinical lab has increased exponentially over the last 10 years. Modern mass spectrometers are extremely sensitive allowing low level detection of many target analytes. However, this sensitivity can come at a price, in that levels of contamination not previous detected with less sensitive instruments can now have larger impact on analysis. The complexity of common matrices such as plasma/serum and urine while presenting different challenges can have a marked influence on method performance. As a result sample preparation is an extremely important part of the process in order to provide robust methods. This seminar will focus on some of the method development challenges our lab faced when looking at two clinical assays; Endogenous steroid hormone extraction from serum, and catecholamine extraction from plasma and urine. Particular emphasis will be placed on the various sample preparation options we looked at for the extraction of these analytes. Optimization of the extraction process we investigated included recovery, co-extractable matrix components, HPLC column degradation, calibration curve performance and limits of quantitation.

Comparison of Sample Purification Methods for Therapeutic Monoclonal Antibody Quantitation in Human Serum

Mohsin el Amrani, University Medical Center, University of Utrecht, The Netherlands

In recent years, there has been growing interest in quantifying biopharmaceuticals such as monoclonal antibodies (mAbs) with liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) in biological matrices for clinical research and drug monitoring research. LC-MS/MS possesses notable advantages over several other technologies with capabilities that ensure faster method development, wider linear dynamic range, and most importantly, higher selectivity. However, it can be challenging to select an appropriate and feasible sample purification method for absolute quantification of the target mAb with LC-MS/MS. In this study, a comparison between various sample purification methods for the quantification of total mAbs, including fast, economical and easy pre-analytical sample work-up will be shown. Furthermore, optimized workflow enabling the use of a stable isotopically labelled (SIL) peptide instead of SIL proteins which are commercially unavailable for most mAbs and a successful validation of quantitation assays of mAbs following EMA guidelines using the therapeutic mAbs infliximab and dinutuximab will be discussed.

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The Vitamin D 200M Assay for the Topaz™ System as a Model for LC-MS-based Diagnostics

Jason Cournoyer, Ph.D. Senior Development Scientist, SCIEX R&D

The SCIEX Vitamin D 200M Assay for the Topaz™ System is the first FDA-cleared LC-MS/MS assay for Vitamin D. It represents an evolution towards simple, turnkey solutions that enable rapid adoption of this powerful technology in a standard clinical diagnostic lab setting. This workshop will review the development and performance characteristics and advantages of this novel assay, and it's streamlined utilization on the intuitive ClearCore™ MD software platform.

Automation and Integration of LC/MS/MS Assays into the Workflow of a Clinical Laboratory

Dr. Emma Walker, Charing Cross Hospital, London, UK

LC-MS/MS has been utilized in the clinical laboratory for approximately two decades and offers increased specificity over more traditional immunoassay based techniques. Widespread adoption of this technique has been hindered as a result of the high capital cost of the equipment, need for highly trained laboratory personnel and the often labor intensive sample preparation required. Automation of sample preparation and interfacing of the LC-MS/MS system to the laboratory information system has the potential to reduce staff time and increase sample throughput. The options available to improve automation and to integrate LC-MS/MS into the workflow of the clinical laboratory will be discussed, including the steps that we have taken within the laboratory at Charing Cross hospital.

Introducing the Thermo Scientific Cascadion SM Clinical Analyzer

Peter Cooke, Market Development Specialist, Thermo Fisher Scientific

The Thermo Scientific Cascadion SM Clinical Analyzer will be the first all-in-one LC-MS/MS solution designed to meet the needs of clinical laboratories. Our fresh vision for fully automated liquid chromatography-tandem mass spectrometry (LC-MS/MS) testing is cultivated by listening to our customers. You asked for a complete solution that was accurate, easy-to-use, and designed for the clinical laboratory. The Cascadion Clinical Analyzer is designed as a turnkey solution to enable clinical labs to easily adopt the power and capabilities of LC-MS/MS as the gold standard in diagnostic testing. The Cascadion system will combine assays, software, accessories, consumables and support/service in a standalone system designed to meet the regulatory requirements for routine and specialized clinical testing. This presentation will showcase the Cascadion solution.
Product under development, not CE/IVD marked nor FDA cleared yet.

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Simultaneous analysis of multiple steroid hormones by LC-MS/MS

David Erikson, PhD, Director of the Endocrine Technologies Support Core at OHSU

Measurement of steroid hormones has been traditionally performed by radioimmunoassay (RIA) or automatic immunoassay (AI). Recently, liquid chromatography-tandem mass spectrometry (LC-MS/MS) has emerged as the "gold standard" for steroid analysis in the clinical laboratory, as this method offers dramatic improvements in sensitivity, specificity, and automation of serum steroid measurements over immunoassay.

Our laboratory has focused on simultaneous, sensitive measurement of multiple steroid hormones in nonhuman primate and human samples for basic and clinical research using a Shimadzu Nexera-LCMS-8050 platform. Using this technology we are often able to quantify as low as 10 pg/ml using as little as 200 ul of serum from a single sample. The purpose of this presentation is to describe methodology for quantitation of endogenous steroid hormones in serum samples, as well as methods for quantitation of synthetic hormones used for contraception and therapeutic reasons.

We will discuss application of an analytical method for quantitating synthetic hormone levels in women for the purpose of monitoring systemic exposure to determine drug interactions, nonadherence, misreporting, and proper dosing.