CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2015—Euroimmun US announced the FDA 510(k) clearance of its EuroPattern System, which consists of a fluorescent microscope (oculars included for manual interpretation) and software that acquires, interprets, archives, and displays digital images of stained IFA slides. The most important application for EuroPattern, the company says, is the antinuclear antibody screening using HEp-20-10 cells (Euroimmun IFA 40: HEp-20-10 EuroPattern) as a substrate. HEp-20-10 cells are a proprietary innovation of Euroimmun as they demonstrate 10-fold more mitotic cells than HEp-2 cells. Furthermore, they contain the full antigen spectrum necessary for ANA diagnostics and are thus well-suited for this purpose.
The system provides automated pattern recognition and endpoint titer suggestions, offers walkaway capability and maximizes throughput for ANA evaluation via the automated processing of up to 500 fields, and reduces turnaround time by allowing for batch validations of negative results and by abbreviating the evaluation process through consolidation of all pattern and titer results for each patient on one screen. Sample traceability is achieved through barcoded slide identification with bi-directional LIS interface. EuroLabOffice is the embedded software that allows the instrument to communicate seamlessly with the LIS and offers the ability to send results and images to any connected computer.
Euroimmun, 973-656-1000