Digital Pathology: Advantages, Limitations and Emerging Perspectives
Digital pathology is a dynamic, image-based environment that allows pathology information generated from a digitised glass slide to be acquired, managed, and interpreted.
Primary diagnosis, diagnostic consultation, intraoperative diagnosis, medical student and resident training, immunohistochemistry (IHC) manual and semi-quantitative evaluation, clinical research, diagnostic decision assistance, peer review, and tumour boards are just a few of the healthcare applications.
With specific support for education, tissue-based research, drug development, and the practise of human pathology around the world, digital pathology is quickly gaining traction as a proven and vital technology. It’s a breakthrough in laboratory cost-cutting, operational efficiency, productivity, to more knowledge gain attend the virtual conferences 11th Emirates Pathology & Digital Pathology Utilitarian Conference on May 9–10, 2022, Online, and getting the certification
2. Whole-Slide Imaging vs. Telepathology (WSI)
Initially, only single screenshots of histological pictures captured through the optics of a microscope were digitised, mostly for extensive evaluation in research settings for documentation and education. The term “telepathology” was coined in the 1980s to describe the usage of a remote-controlled, motorised microscope with a live view option of microscopic slides. The configuration was applied in a few scenarios, including frozen section evaluation, consulting practise, and niche applications (e.g., transplant pathology). Whole slide imaging (WSI) has become the benchmark for future, large-scale, high-throughput DP due to technological breakthroughs in scanning speed and lower prices. For a digital histopathology work-flow to entirely replace the optical microscope, i.e. for primary histological diagnosis, scanning of all relevant tissue is required. WSI necessitates a full-time employee.
3. WSI for Patient Diagnostics
WSI scanners are currently approved for use in the European Union under the European Commission’s directive 98/79/EC for in vitro diagnostic (IVDD) . The CE mark IVD-MD can be used to DP software that is used alone, such as WSI viewers or automated image analysis for specific tasks (e.g., immunohistochemistry quantification) (medical devices). Conformity is essentially defined as a manufacturer’s self-declaration. Several manufacturers, including Philips, Roche/Ventana, Leica/Aperio, Hamamatsu, and 3DHISTECH, have CE-IVD-certified scanners and related software. All in-vitro medical equipment, including slide scanners and microscopes, are subject to the new European Parliament’s in vitro diagnostic medical device regulation (IVDR).
As of May 20, 2022, digital pathology software will be eligible for CE-marking. A performance review, including a scientific validity report, as well as an analytical and clinical performance report, will be required by the IVDR. As a result, European DP clearances will be more similar to FDA approvals for the US market. In the United States, the FDA has approved just two WSI systems for primary surgical pathology (histopathological diagnosis). The Philips IntelliSite Digital Pathology Solution was the first to receive approval in 2017. It’s a closed system with a scanner, image management system, and a display. A non-inferiority investigation of over 2000 slides of various histologic entities led to approval. Frozen sections, cytology, and non-formalin-fixed paraffin are not included in the approval.
4. Concordance and Digital Pathology
WSI glass slides and digital slides have been compared and their concordance tested in multiple studies. There were no consistent mistakes due to WSI in the non-inferiority trial stated earlier, which was used for FDA market authorization evaluation of discordant instances. The most difficult diagnoses (26 percent), such as focally invasive/malignant lesion, and the identification of tiny items, came in second and third, respectively (16 percent , e.g., Helicobacter pylori, mitoses). Detecting germs (Helicobacter pylori), as well as recognising mitoses and nuclear characteristics in dysplasia, are the most commonly and consistently stated issues in routine DP.
5. WSI Diagnostic Imaging Critical Quality Parameters
If the producer has not conducted external validation, in-house validation should be managed to perform on a sufficient number of representative cases, which include evaluating auxiliary techniques (immunohistochemistry, special stains). A minimum of 60 hematoxylin and eosin (HE) slides and at least an extra 20 slides for each auxiliary technique are recommended by the College of American Pathologists (CAP). To ensure fair evaluation (“washout period”) by the same person, the duration between digital and glass slide comparison should be at least two weeks. The following is an overview of important points for DP accreditation in accordance with ISO 15189.
Individual pathologists, institutions, and the use-case, i.e. whether DP is utilised for primary diagnosis, all have different perceptions of the basic needs for dedicated DP gear.