From promise to practice: Assessing middleware characteristics in autoimmune diagnostics

Middleware systems connect analytical instruments with laboratory information systems and may support workflow control, result review, and data management. We conducted a nationwide descriptive survey to characterize middleware adoption, reported functionality, and user perceptions in Italian autoimmune diagnostic laboratories affiliated with the Autoimmunology Study Group of the Italian Society of Clinical Pathology and Laboratory Medicine. The questionnaire was administered in January 2026. Of 38 invited laboratories, 36 responded and 33 reported using middleware. Thirty laboratories provided complete Yes/No/I-don't-know responses for 24 detailed functionality items. Cross-vendor interoperability was reported in 20 of 29 records (69.0%); six reported no interoperability and three were nonresponses. Reported capabilities varied: worklist generation (70.0%), previous-result display (86.7%), personalized comments (80.0%), remote assistance (83.3%), and online updates (80.0%) were common, whereas warehouse management (3.3%), access to the clinical question (6.7%), delta-check flagging (13.3%), redundant-test cancellation (20.0%), and automated dilution suggestions (20.0%) were less common. Agreement (Likert scores 4-5) with perceived benefits ranged from 54.2% for reduction of reporting errors to 88.5% for improved diagnostic quality. These findings describe respondent-reported capabilities and perceived benefits; they do not demonstrate objective improvements in quality, turnaround time, error rates, or patient outcomes. The results identify potential priorities for interoperability, configurable rules, user training, and future objective evaluation.