Delivering end-to-end traceability in in vitro diagnostics
Inova Diagnostics in San Diego – part of the international healthcare company Werfen – is a global market leader in autoimmune diagnostics. The company provides efficient automation and high quality reagents for autoimmunity testing to labs worldwide, as well as working on precision medicine applications in this sector. Inova has a wide range of offerings to address autoimmune conditions, from rheumatological diseases such as systemic lupus erythematosus and rheumatoid arthritis, to diseases of the gastrointestinal tract, including celiac disease and inflammatory bowel disease.
Meeting traceability requirements in clinical laboratories
With increased awareness and testing of autoimmune diseases across the globe, Inova’s customers were finding themselves having to cope with higher volumes of testing, and so required more efficient automation solutions. Bryan Hoenig, Vice President of Commercial Operations at Inova, explained: “Most clinical laboratories must meet accreditation requirements under ISO 15189, or similar local standards, for establishing a comprehensive quality management system. Those new requirements come with added demands for traceability: documentation of analytical methods, operator training and certification, as well as full traceability of reagents, and positive patient identification for samples throughout processing and result reporting.”
To help the laboratories meet the traceability elements of these needs Inova developed the Integrated Laboratory – a portfolio of Inova Diagnostics instruments that can be networked, allowing the systems to communicate with one another. Bryan continued: “From an accreditation perspective, this enables laboratories to make improvements that enhance their workflow efficiency, decreasing turnaround times, increasing productivity and, at the same time, optimizing quality control.”
Developing a combined platform
An important feature of the Integrated Laboratory is the QUANTA-Lyser® family of enzyme immunoassay (EIA)/immunofluorescence assay (IFA) processing instruments, which are manufactured under an OEM arrangement with Tecan. Bryan added: “Typically, laboratories want a single system that can perform both ELISAs and IFAs, as they like the convenience of having everything combined in one platform. Our QUANTA Lite® and NOVA Lite® reagents and slides are barcoded, enabling verification and traceability, and results are reported directly to the laboratory information system via the QUANTA Link data management software.”
Each QUANTA-Lyser model is based on the same Tecan liquid handling system, and customized according to its intended throughput and application. “Our most recent platform, the QUANTA-Lyser 3000, is an open system with four independent probes, offering high throughput processing of up to 240 samples at a time. Increasingly, laboratories are trying to reduce the amount of plastic they use, and the nice thing about this system is that it uses washable probes. This eliminates the need for plastic disposable tips, which is not only eco-friendly, but also delivers huge savings in terms of costs.”
“When you enter into an OEM agreement, you need a partner with a specialized skill set; it is a collaborative process, working together to design the ideal system for the application. We wanted to build a relationship with a company that understood autoimmunity applications – immunofluorescence, in particular, is a specialized area – and also offered the hardware options we needed. Tecan had the best capabilities in this area, with extensive knowledge of automation, which helped bring our vision to life. Not only that, but our organization is highly oriented towards quality, and Tecan has the same focus. It's all about having a relationship that you nurture and maintain, and knowing that you can trust one another.”
