The technological progress constantly pushes the development of intelligent innovations in the field of modern laboratory diagnostics. Today, neither ELISA nor immunoblots or immunofluorescence assays (IFA) need to be incubated manually. Automatic devices take over these tasks in laboratories throughout the world, significantly increasing the processing efficiency.
The EUROPattern system, which includes a microscope and special software, is now even going one step further: it is able to read and interpret immunofluorescence patterns of anti-nuclear antibodies (ANA) on human epithelial cells (HEp cells), as well as antibodies against double stranded DNA (anti-dsDNA; on Crithidia luciliae) and anti-neutrophile cytoplasmic antibodies (ANCA; on human granulocytes). Depending on their specificity, these autoantibodies may support the diagnosis of different systemic rheumatic autoimmune diseases (systemic lupus erythematosus, Sjögren’s syndrome, myositis or systemic sclerosis, beyond others) or vasculitis. The system takes focused images of the incubated slides and evaluates the recorded fluorescence patterns. Without having a single look through the microscope oculars, the user will receive the images and a complete result report on the computer screen.
Laboratories in Europe and South America already apply the EUROPattern-Suite in their daily routine, mainly for evaluation of ANA immunofluorescence. In April 2015, the corresponding software has also been released for commercial use in the US by the Food and Drug Administration (FDA).
With the development of this system, EUROIMMUN responds to scientists, physicians and diagnostic laboratories who have requested a much more standardized and efficient evaluation procedure of IFA. EUROPattern, therefore, has been equipped with some unique features:
- a capacity of up to 500 reaction fields;
- autofocus, image acquisition and evaluation of fluorescence signals (pattern and titer prediction) in less than 18 seconds per field;
- recognition of 8 different ANA patterns and variable mixed patterns;
- results from different sample dilutions or substrates are consolidated into one final report per patient;
- confirmation of software-generated results by the user ensures a consistently high quality of immunofluorescence interpretation compared to classical, visual microscopy;
- negative results can be validated batchwise – this saves a lot of time;
- EUROPattern software is integrated into the superordinate laboratory management system EUROLabOffice (ELO); ELO organizes the complete communication between the laboratory information system and the workstations, creates a patient’s history of all laboratory findings and archives the results digitally.
In the first study, classification of ANA by the EUROPattern-Suite was compared to visual microscopy and evaluation. This revealed an overall agreement of 99.4% regarding positive/negative classification. In 94% of the samples, also the main pattern was correctly recognized by the software. Since then, the system has been further optimized. A detailed description of the latest EUROPattern version together with a summary of previous studies is published in a new review article. In this publication, the additional applications (ANCA, anti-dsDNA) of EUROPattern are also introduced.
Summed up, EUROPattern is a system to support diagnostic laboratories. The automated evaluation is less influenced by subjective interpretation and streamlines the complete IFA workflow. ANA diagnostics will be accelerated and much more standardized.