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Design and Implementation of an Automated Interpretation Algorithm for Lupus Anticoagulant Functional Testing.
Chiara Novelli1, Arianna Gatti1, Flora Ierna1
1Immunohematology and Transfusion Center, ASST Ovest Milanese, Legnano, Italy.
International Journal of Laboratory Hematology
|May 28, 2026
Summary
An automated algorithm for lupus anticoagulant (LA) testing standardized interpretation and improved efficiency in antiphospholipid syndrome (APS) diagnosis. This middleware-based system reduced workload and enhanced diagnostic accuracy in laboratory settings.
Area of Science:
- Clinical diagnostics
- Laboratory automation
- Hematology
Background:
- Lupus anticoagulant (LA) testing is crucial for diagnosing antiphospholipid syndrome (APS).
- Current LA testing involves complex workflows with potential variability from anticoagulants and reagents.
- Expert interpretation is often required due to these complexities.
Purpose of the Study:
- To implement a middleware-based automated algorithm for LA testing.
- To standardize interpretation and automate reflex testing for APS diagnosis.
- To support clinical decision-making and reduce laboratory workload.
Main Methods:
- Developed and implemented a rule-driven automated algorithm using the HemoHub system.
- Incorporated good laboratory practice rules for reflex testing, interpretation, and auto-validation.
- Validated the algorithm retrospectively on 190 cases and prospectively on 481 routine samples.
Main Results:
- Achieved 100% concordance between automated and manual interpretations for LA negative and positive cases.
- Automated interpretation provided useful comments when direct assignment was not possible.
- 58.4% of samples were auto-validated, significantly reducing manual workload and interpretation time.
Conclusions:
- The automated algorithm enhanced consistency and reduced interpretation time in LA testing.
- Integration of clinical context and historical data improved diagnostic accuracy.
- Middleware-based, rule-driven interpretation offers a reliable and efficient approach to standardize LA testing.
