Aptiva applies a PMAT technology to process multiple analytes simultaneously from a patient sample
US-based Inova Diagnostics has secured CE mark approval for its Aptiva and Aptiva Celiac Disease IgA and IgG assays.
Aptiva, a fully automated digital multi-analyte system, is said to represent the next generation of high-throughput processors for the clinical laboratory.
The company has designed Aptiva to address multiple health economic drawbacks in the autoimmune laboratory.
In the future, Aptiva will also be developed to target seven additional autoimmune disease states. More than 60 analytes are in various stages of advanced development to help clinicians close the seronegative gap and enhance diagnostic capabilities.
Inova research and development vice president Dr Michael Mahler said: “Aptiva’s broad disease and syndromic-based analyte portfolio is a breakthrough that fundamentally enhances the utility of diagnostic testing in the laboratory.
“Aptiva will bring efficiency and reliability to the autoimmune laboratory and provide expanded information to clinicians for management of patients with autoimmune diseases.”
Aptiva is provided with 150-sample rack capacity
Aptiva has the 150-sample rack capacity that enables to minimise the number of daily interventions, while its 6.5-hour consumable walkaway time allows improving workflow efficiencies.
The fully automated system applies a particle-based multi-analyte technology (PMAT) to process multiple analytes simultaneously from a patient sample.
PMAT helps Aptiva to deliver up to 720 results per hour with the support of a 12-analyte test cartridge, as well as enables the laboratory to complete its workflow in a single shift.
Inova Diagnostics CEO Roger Ingles said: “Inova Diagnostics is pleased to launch Aptiva in the EU.
“Inova Diagnostics has a 33-year history of providing laboratories with innovative products required for autoimmune diagnosis. Aptiva continues this tradition.”
In February 2017, Inova Diagnostics secured 510(k) clearance from the US Food and Drug Administration (FDA) for its immunofluorescence assays (IFA).