ASCENT™
The expert system for your production chromatography analysis and review
The challenge:
With dramatic improvements in mass spectrometry technology, high volume laboratories have been able to improve sample throughput by replacing low throughput instrumental methods with high throughput LC-MS and LC-MS/MS methods. However, these tools generate significantly more data than older methods and consequently chromatographic data analysis is limiting rates of sample result generation.
For example, in clinical diagnostics laboratories, a single LC-MS/MS instrument can now do the work of dozens of GC-MS systems. With very short chromatographic methods and very fast, high analyte count methods, the total number of chromatographic peaks produced per unit of time has dramatically increased. Scientists are virtually "drowning in data".
In most assays the vast majority of chromatographic data processed and forwarded for manual review is actually good data. Human attention and intervention is best reserved for the problem peaks. Humans are best suited for fixing problems with poorly picked peaks, not the mind-numbing task of finding them.
Indigo BioSystems has the solution - ASCENT™
Indigo BioSystems is a leader in automated laboratory data analysis and data integration. We have applied our expertise in mass spectrometry and laboratory automation and leveraged our software platform and algorithm technology to create a product that greatly reduces the amount of manual interaction needed for high throughput, high volume chromatographic assays.
ASCENT™ has two main features: first, we developed an automated chromatographic peak analysis capability which automatically adjusts parameters on a sample-by-sample basis for optimum peak processing; second we process the output of peak processing through a classification and business rules engine to generate a statistically correct assessment of assay quality.
ASCENT™ combines automated data handling with a new, more powerful peak processor, followed by a sophisticated automated quality assessment system. ASCENT™ automatically moves large volumes of data directly from instruments computed responses and uses human-trained, assay-specific classifiers to mark suspect peaks, samples or runs.
MRM Chromatogram of a compound of medical diagnostic interest. ASCENT™ utilizes patented Indigo Biosystems algorithms for both peak and baseline determination. Indigo uses a patented weighting process to provide a statistically correct peak area estimate. ASCENT™ works in difficult chromatographic analyses including clusters of overlapping peaks and low signal–to–noise situations
How it works:
ASCENT™ first converts raw proprietary data from instruments to an open and accessible format (XML). This allows the large volume of complex data to be accessed for high throughput processing and analysis.
The automation of data analysis requires powerful algorithms integrated into user-friendly applications. Since every lab, workflow and assay is different, Indigo developed a highly configurable approach to delivering solutions. ASCENT™ consists of a "Statistical Analysis Engine" that allows us to configure the system to meet specific customer requirements.
The key to automated chromatographic data review is our high performance peak picking solution. This innovative, patented pattern recognition-based algorithm correctly selects and integrates over 95% of peaks in a common clinical diagnostic assay. Additionally ASCENT™ utilizes user-selected QA rules to flag the bad peaks for manual review and correction. By correctly picking peaks on the large majority of the samples, the human workload for review and manual integration correction is dramatically reduced.
Features:
Auto-calibration:
ASCENT™ is used to rapidly perform chromatographic analysis with as little manual intervention as possible. In order to assist in the process, Indigo Biosystems developed an ASCENT™ feature called auto-calibration. During quantitation, most analysts must manually choose which calibrants to use and to employ lab or assay specific rules for quantitation. This is an analyst subjective exercise that is time consuming and error prone. Indigo Biosystems has configured ASCENT™ to fully automate the calibration process. The assay is configured with specific calibration rules and ASCENT™ automatically applies the rules to determine the best curve fit!
Auto calibration feature. ASCENT™ automatically dropped out the third calibrant and computed the statistically best fit.
The Terminal:
Results Screen 1.
Calculating Savings in a Laboratory Using ASCENT™:
ASCENT™ was designed to automate the complete process comprising data analysis and review of chromatographic assays as well as transfer of data and or results into the LIS/LIMS. This process is highly automated and provides significant benefits including enhanced quality, greater productivity and laboratory efficiency, reduced turn-around-time, reduction in personnel, and increased instrument utilization. ASCENT™ works with any vendor mass spectrometer software platform and applies to any chromatographic technique and any assay.
ASCENT™ replaces the technician manual steps with automated functions that:
- Retrieve the results from the instrument computer
- Establish baselines
- Select peaks
- Quantify results
- Calculate calibrations
- Apply all assay QC rules
- Flag results for review
- Transfer results to LIMS
In the ASCENT™ process, the technician is required to review only those results that are flagged, significantly reducing the time spent on data analysis and review:
- No need to manually transfer results from instrument computer to the area where the analyst will perform analysis and review
- No need to review all peaks
- No need to manually select baselines
- No need to manually optimize and calculate calibration curve
- No need to look at multiple screens or pieces of paper to make decisions
- No need to remember to apply all QC rules established for an assay
- No need to invoke Excel or other programs to execute additional calculations or data conversions
- No need to manually transfer the results to the LIMS, LIS or database
To learn more about savings with ASCENT™, a full report of savings information can be found in the following PDF:
Laboratory Savings With ASCENT™
Indigo professional services personnel work with your laboratory personnel to configure the Indigo solution for the laboratory facility housing the processes to be automated.
Facility Implementation/First Assay
All of the Indigo solutions require configuration services to adjust the solution to the specific laboratory requirements. This configuration service is staged in four phases lasting a total of about three months for each facility. This configuration service is required for the first solution installed at a particular facility. Implementation of additional assays to the configured framework requires substantially less work when using the configured assay template.
The Design Phase
In this phase, the Project Team identifies the requirements of the project and makes decisions about the configuration tasks needed to meet the requirements. Included in this phase are decisions about the hardware, network, and security requirements.
The Configuration Phase
In this phase, the Project Team executes the tasks needed to configure the Indigo solution to meet the client requirements and prepare it for installation into production.
The Validation Phase
In this phase, the Project Team executes the tasks needed to accept the configured solution for installation in production, as defined in the Validation Plan. This phase is the responsibility of the client; the role of Indigo BioSystems is to assist in delivering those documents needed to support the validation of the software and the configured solution.
The Implementation Phase
In this phase, the Project Team executes the Implementation Plan, which defines the tasks needed to install the configured solution into production.
Implementation of Additional Assays
Once automation of the first assay is implemented in a facility, implementation of additional assays requires substantially less work and can usually be done in less than 3 weeks.
Post Implementation Services
The partnership with Indigo is most evident post implementation. Indigo provides the following services:
Informatics Support
The solution is not a generic software package, like LIMS, for example. Its support requires not only knowledge of the software, but also scientific understanding of chromatography and statistics. Our staff provides this scientific support to your laboratory technicians in various situations:
- Changes in laboratory workflow
- Changes in standard operating procedures
- Adjustments to assay rules
- Implementation of new assays
- Implementation of new instruments, either same as or different from those installed
- Development of new reports or modifications to existing ones
- Screen modifications to accommodate these above changes
Solution configuration changes due to:
Troubleshooting of assay or batch quality
System Management Support
Assistance in the administration of user and system security
- User role administration
- User authorization administration
- Security administration
Hardware Platform Administration Support
Assistance in administration of hardware and network resources:
- Network configuration
- Hardware resource allocation
Data Integration Support
Our team modifies the interfaces needed in response to changes to the adjacent systems needed for our solution to perform. Among these are interfaces to instruments, LIMS, and other databases with which our software may need to exchange data.
Software Maintenance and Support
The software continues to be improved for easier integration, more user-friendly user interface, faster processing, and other enhancements. Our staff also compiles and promptly processes any fixes required and enhancements needed to implement system software changes (e.g., browser, operating system).
Pricing
Indigo Biosystems takes a unique approach to how we engage with clients in implementing solutions to automate laboratory data analysis and integration.
As deployment of a final solution can be a bit complex, we start by conducting laboratory workflow and data flow audits. We use this to drive the crafting of a recommended solution as well as to help provide insight into change management and ROI projections.
Once we have a clear understanding of the lab environment, data sources, analysis and reporting needs and overall objectives, we begin by conducting a “proof of concept” by providing an example of the solution utilizing your data set. This represents a small investment of time on both of our part but it is a useful exercise to deliver proof of the solutions technical feasibility.
Implementation of products and solutions requires a combination of professional services, as described above, for configuration, along with the purchase of software licenses. Again, Indigo takes a different approach for pricing of software licenses. We price our software based on delivery of value to our clients and we charge a software fee based upon delivery of value to the customer. In some deployments this is on a cost per sample basis, in other cases customers have chosen to purchase instrument licenses
Pricing of the various services and solutions varies. Please contact us for details at 317.493.2400.