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©2015 Waters Corporation 1
Waters’ clinical solutions
Automating and Integrating Sample
Preparation with LC/MS
and
Software connection to the LIMS
Dr. Simone Donzelli
Health Sciences Business Development Manager
Southern Europe
©2015 Waters Corporation 2
Outline
Sample Preparation Needs and Strategies
Product Portfolio for Integration of Sample Prep and LC/MS
– Offline Sample Preparation
o Offline Automated Sample Preparation System (OASPS)
• Product Features
• Applications
Example of the Effects of Automated Sample Preparation
©2015 Waters Corporation 3
Sample Preparation for LC/MS
Prevailing attitude in many laboratories is to do as little sample prep as possible because sample prep is seen as: – Costly, labor intensive and inefficient
– Delivering inconsistent results
– Requires slow and difficult method development
– Uses “expensive” sample prep consumables
If sample prep is needed many labs deploy “good enough” techniques – Dilute and Shoot
– LLE/ILE
– Protein Crash and Shoot
Try to solve assay issues with LC/MS and avoid sample prep – Increased instrument downtime and service requirements
– Increased column consumption
– Solvent exposure and disposal
– Compromised assay results
©2015 Waters Corporation 4
Many LC/MS assays require or can greatly benefit from sample prep
– Low level analytes
– Poorly ionizing analytes
– Complex matrices (Blood, Plasma, Saliva, Urine, Hair)
When using LC/MS, most laboratories inevitably reach a sample prep bottleneck
– More efficient sample prep processes needed for assays
– More throughput needed
– Better cost/test needed
– Better integration between sample prep and LC/MS
– Fewer errors in sample processing requiring retests
To resolve their sample prep issues, labs turn to automation
Sample Preparation for LC/MS
©2015 Waters Corporation 5
Offline Automated Sample Preparation System (OASPS)
Semi-Automated SPE
– Offline sample preparation
– Automation of many SPE steps
– Interface to LC/MS
Moving Seamlessly from Sample to Answer: Automated Sample Preparation Products
Lab Productivity
Cost Benefit Method
Development Lab productivity: Sample prep completely automated Creation of Worklist via barcode
Cost benefit: Reasonable price/test Diagnostic kits CE_IVD at same price of the manual ones
Method development Extraction’s Methods created and validated from Waters
©2015 Waters Corporation 6
Offline Automated Sample Preparation
System
(OASPS)
Automation of the
sample prep Collaboration with Tecan and Hamilton Collaboration with Siemens and Abbott
©2015 Waters Corporation 7
Freedom EVO100 Robotic
Workstation
Offline Automated Sample Prep System
ACQUITY UPLC with TQD or
XEVO Series of Mass Specs
Dedicated System for SPE Sample Preparation and
LC/MS Analysis
©2015 Waters Corporation 8
Offline Automated Sample Preparation Automation System Features
4-Tip independent liquid handling arm equipped with liquid level detection Robotic gripper arm for Oasis ® µElution SPE plates Two position vacuum manifold Single position plate shaker Barcode scanner for tubes Reagent trays for solvents and wash solutions
________________________________
Pre-loaded SPE pipetting script(s) File Converter to automatically generate sample list for LC/MS
©2015 Waters Corporation 9
Uncapped Tubes are Loaded onto Freedom EVO100 Deck
Tube Barcodes Read Automatically
Samples aliquoted into Plates for Protein Precipitation
Organic Solvent Added and Plates Shaken
Operator transfers Plate to Centrifuge to Pellet Proteins
Operator Puts Plate back on Freedom EVO100 Deck
SPE Plates Conditioned
Samples loaded onto SPE Plates
SPE Plates Washed as Needed
Samples eluted from SPE Plates into Collection Plate
Collection plate transferred by operator to ACQUITY Sample Manager
Sample list generated by Freedom EVO for import to MassLynx
Samples analyzed by ACQUITY System
Operating Script available for Oasis 96 µElution SPE Plates
Automation offline Tecan
©2015 Waters Corporation 10
Benefits of Offline Automated Sample Preparation System
Automation of liquid handling and plate manipulation
Minimized manual intervention
Flexibility to prepare multiple types of analytes easily
Can perform protein precipitation, SPE, derivatisation
Convenient interface with LC/MS
Small footprint
Robust and easy to use System
©2015 Waters Corporation 11
Comparison of Automated vs. Manual SPE Methods
Manual SPE Method
Automated Sample Preparation
Processing Time
2-4+ Hours/96 Samples
<2 hrs/96 Samples
Analyst Intervention Requirement
100% Involvement
10% Involvement
Reported Assay Precision
Typically 2-5%
Typically <1.5%
Exposure to Biological and Chemical Hazards
Repeated and Constant
Minimized with Automation
Opportunity for Sample Processing Errors
Multiple Points of Potential Error
Minimal
©2015 Waters Corporation 12
Application Examples
©2015 Waters Corporation 13
Application Examples
Vitamin D and Metabolites
Biogenic Amines
– Metanephrines
Drugs of Abuse
– Opiates
– Benzodiazopenes
– Canabinoids
o Metabolites
o Synthetic
For research use only. Not intended for use in clinical diagnostics.
©2015 Waters Corporation 14
The MassLynx Clinical LIMS Interface
Data receiving from LIS
Bi-directional interface with the most common LIS thanks to our HL-7 SW
Results exported
to LIS
Bi-directional interface with the most common LIS thanks to our HL-7 SW
©2015 Waters Corporation 15
LIMS Interfacing: What was previously possible ?
.xls,.doc,
.txt,.xml
•Import sample information in txt or Excel file •Export results in txt file or XML file
Procedure not allowed!
©2015 Waters Corporation 16
What is the Clinical LIMS Interface ?
Software that allows the automated exchange of information
between MassLynx and a hospital LIMS
– Removes the need for manual transcription of Clinical information
between MassLynx and a third party LIMS
Conforms to Health Level 7 protocol (HL7)
Version 2.0 of the Clinical LIMS interface was released in 2013
MassLynx
LIMS Interface`
LIMS
`
MassLynx
©2015 Waters Corporation 17
The Health of your patients cannot accept errors
right rignt rrgnt rront rrong wrong
right right right right right right
©2015 Waters Corporation 18
What is the Clinical LIMS Interface ?
The Clinical LIMS Interface allows
MassLynx to be connected to a 3rd party
LIMS system
The LIMS Interface is a TargetLynx option
that is sold and installed separately to
MassLynx
The option appears as a shortcut within
TargetLynx menu
©2015 Waters Corporation 19
3rd Party Vendors
The Clinical LIMS Interface has been integrated with a wide
range of 3rd party drivers:
– Roche Diagnostics
– Technidata
– Abbott
– Siemens
– Modulab / Telepath
– Sunquest
– Inpeco
– Medasys
– Orchard
– Soft Computing
©2015 Waters Corporation 20
What information can be exchanged?
It is extremely important that Waters, the hospital and the LIMs
provider all engage together to make it work
Everything that could be exported in the XML file, except
formulas
In practice, usually only a limited range of fields are sent
– for example
MassLynx ID HL7 Code
Test ID (Job) Name of configuration OBR 4-2
Subject Text MRN PID 2
Sample Text Patient last name PID 5
Sample id Container id (barcode) OBR-2
Compound Name Compound OBR 4-4
Concentration Result OBR 20
Instrument Name Model and serial no. OBR 21
©2015 Waters Corporation 21
Hammersmith Hospital- Leslie Brent Lab
TQD x2 and Quattro micro
Clinical research and TDM
Connected to Sunquest LIS PC, unidirectional
Installed and configured remotely
Tested by the user
Four drugs assays: Tacrolimus, Cyclosporine, Sirolimus, MPA
Transferring the following:
Test ID (Job) Name of configuration OBR 4-2
Sample id Container id (barcode) OBR-2
Compound Name Compound OBR 4-4
Concentration Result OBR 20
Instrument Name Model and serial no. OBR 21
©2015 Waters Corporation 22
University of California, San Diego
Xevo TQ-S x2
Standalone processing PC with LIMS Interface
Connected to Soft LIS PC, unidirectional
Vitamin D, Benzodiazepines, Amphetamines
Currently uploading the following to Soft:
– Order number
– Patient lastname
– Instrument Name
– No Solution Flag
– RT Tolerance Flag
– Target Ratio Flag
– Conc Deviation Flag
– Compound Name
– Conc
©2015 Waters Corporation 23
Laboratory Order Workflow: Bi-Directional Connectivity
ANALYSIS REQUEST
LIS/LIMS
EMR
2
clinic
EMR
clinic
3
4 5
Waters TargetLynx (implied in Steps 3 & 4)
Clinical LIMS (Steps 2 and 5)
Import Sample List (MassLynx) Complete Sample List
Run Sample List
Generate Test Results
1/6 Data Processing
TargetLynx
Data Analysis analyst
Accept and Review Data
©2015 Waters Corporation 24
Laboratory Order Workflow: Tecan
Tecan Printed Worklist Request
1 LIS/LIMS
2
Data Analysis analyst
Data Processing TargetLynx
4
5
6
Accept and Review Data
Tecan worklist to Waters MassLynx (Step 3)
Waters TargetLynx (implied in Steps 4 & 5)
Clinical LIMS (Step 6)
Generate Sample List (MassLynx) Run Sample List
Generate Test Results
3
Tecan File Converter
©2015 Waters Corporation 25
Workflow Software Demo
©2015 Waters Corporation 29
Key Points
Saves time and eliminates transcription errors entering
information into LIMS
Flow of information
– Uni-directional: send results from TargetLynx to LIMS only
– Bi-directional: LIMS generated worklist imported into MassLynx then
send results from TargetLynx to LIMS
– Information is customisable
Tecan Interface with Clinical LIMS provides most complete
sample tracking capabilities
©2015 Waters Corporation 30
Questions
Recommended