Celadon Immuno-Fit™
Celadon ImmunoFIT
Increases Productivity and Reduces Costs
Background
Judy is the director of a VA clinical laboratory that serves a large VA hospital in a major city.
Problem
To meet patient needs, her laboratory must provide an increased number of tests at a higher volume and make best use of limited resources. The analysis of one test in particular, Cellestis' QFT-GIT for tuberculosis, has been problematic. Clinical interpretation of this Interferon Gamma Release Assay requires the integrated assessment of three sub-tests. However, her instrument software can only make interpretations for tests that occupy a single tube. Cellestis provides desktop analysis software, but it cannot be electronically connected to the test instrument or to Judy's data management system.
Solution
Judy makes use of a free trial of Celadon's ImmunoFIT software, which the USAF commissioned for automating recruit screening, monitoring public health workers, and assessment of personnel located in TB-endemic countries.
Outcome
Judy is able to electronically import her instrument file, perform analysis, and electronically export her result file. After a brief training session, her technicians spend 90% less time processing QFT-GIT results, and make many fewer mistakes. Judy is able to track QC standards from her office, her home, or while traveling.
Judy licenses ImmunoFIT and commissions full integration of the software with her instrument and laboratory system.
Applicable Markets
Immunoassays are fundamental to many markets, including diagnostics, personalized medicine, companion diagnostics, public health and biodefense.
Immunoassay Analysis Software
Immuno-Fit automates analysis of immunoassay assays from instrument to electronic health record: it's the world's first web-based ELISA analysis software. Originally commissioned by the U.S. Air Force to automate analysis of an existing complex (multiple values per patient) diagnostic test for tuberculosis, Celadon used its web-based Celadon Platform as a foundation to build out a full suite product implementing adaptable general case capabilities for clinical use.
Celadon completed the 3 year, $1,800,000 project in July 2010 with excellent indications for continued support by the funding agency pending a probable one to two year hiatus due to a base realignment moratorium. Celadon retained full ownership of the right to modify or sell the product to other customers in DoD or elsewhere, such as CDC, NIH, the VA, state & local Public Health departments, CLIA Labs, diagnostic, research kit vendors or instrument manufacturers.
Applications: Research, Diagnostics, Multiplex, Pathogen Identification, Personal Genomics, Companion Diagnostics.
Initial Methods: TB Infection, Interferon Gamma Release Assays, Cellestis QFT Kits
Future Methods: Diagnostic Kits, Research Kits, Food Testing, AgBio, MicroArrays
Immuno-fit saves time and reduces laboratory errors while handling a continuum of analytical, administrative and security tasks within a 21 CFR Part 11 Compliant framework ready for FDA certification and further prepared for DoD adoption with easy upgrade to revised CDC guidelines or other analytical improvements.
It fully analyzes sub-tests from multiple wells; automates clinical interpretation for high-volume testing; tracks quality control samples; generates electronic reports ready for LIMS integration; handles clinical interpretation and quality control rules of package inserts, and is fully functional as ELISA, not just IGRA, software. Since it's built on the Celadon Platform for Web softwre, it can be accessed anywhere, with no software to download or install, centralized reporting, or with flexible deployment in a hosted internet, intranet (behind firewall), or stand-alone environment, as well as a slim desktop “Validator” application for instruments not connected to Internet or Intranet.
Immuno-fit is highly customizable, covering multiple calibration and fit models (Ln/Ln; 4PL; r2; etc.) using concentration, replicates, OD mean & CV rules; confidence intervals; and package insert rules for Pass/Fail/Warning. Its data handling capacities include sample replicates, rules, and multiple sub-tests; assay run archiving; a plate viewer; data reanalysis features; etc. Instrument files can be uploaded from network manually or through LIMS or CLSI formats; with equivalent flexibility for patient clinical results output or upload. Fully configured security features equivalent to Celadon Genotyper are implemented through Celadon Platform.
First Application of Celadon ImmunoFIT: Reducing Healthcare Costs for the US Air Force
In 2007, the U.S. Air Force contracted with Celadon to develop software that automates the process of tuberculin testing, from laboratory instrument to update of patient health record. In addition, Celadon was tasked with, and was able to show, that a proposed statistical method provided more accurate interpretation of test results. This improvement is expected to reduce the number of indeterminate test results and lower costs associated with failed tests.
The web-based software developed by Celadon can be adapted to any diagnostic or research immunoassay. Due to excellent results obtained during the contract, the Air Force sponsor submitted a description of the project to the DoD small business office as a success story to be showcased on the DoD web site.
Future Applictions of Celadon ImmunoFIT
- Manufacturers of immunoassay instruments can use ImmunoFIT to:
- Improve customer experience by providing easy-to-use interface that is - consistent across product versions and product lines.
- Reduce customer service costs via integration with technical support systems.
- Broaden the utility and appeal of instruments by supporting more methods.
- Attract and retain high-volume, high-profit customers by providing enterprise-class automation software.
- Vendors of immunoassay reagents can:
- Enhance and complement broad range of immunoassay products.
- Develop catalog of pre-made assays.
- Point-of-care and other diagnostic device or assay developers can:
- Provide single-interface that is pre-configured for each kit and analysis protocol.
- Develop research and diagnostic assays faster, with less optimization and cost.
- Developers of pre-designed research assays can:
- Expand capacity and increase productivity of assay development department.
- Large pharmaceutical, biotechnology, and other life science institutions can:
- Improve consistency and quality control with application of a single interface for all kits, with direct connection from instrument to data management system.
- Lower the cost of research and development by providing consistent, enterprise-wide analysis process and standards.
- Integrate analysis with laboratory data management systems so as to increase productivity and reduce errors.
- Academic and industry researchers can:
- Speed research; increase productivity; generate more consistent results; lower analysis costs; and better utilize student efforts.
- Diagnostic laboratories, immunoassay service and CRO organizations can:
- Automate analysis and integrate it into electronic workflow.
- Customize ImmunoFIT for preferred method and conditions.
- Comply with FDA and CLIA regulations.Lower costs and barriers, eliminate mistakes, and simplify processes by providing or enhancing online communication with customers.
- Provide consistent, enterprise-wide analysis process and standards.
- Life science software vendors:
- Create new sources of revenue with software subscriptions and enterprise licenses.
- Provide customers with a more complete product offering.
- Establish or increase web-based and Cloud informatics capability.
- Integrate with and complement existing products.
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