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Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
Sponsor: Labplus Sp. z o.o.
Summary
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire. The purpose of the study is to determine how accurately and how safely the system assigns a patient to a category of urgency of medical contact, and how closely the interpretations produced by the system correspond to the assessment of an expert physician. Adults treated at two university hospitals in Katowice, Poland, who are referred for laboratory testing, complete an electronic medical history questionnaire after their laboratory results become available. The system then generates an interpretation for each laboratory result, including a category of urgency of medical contact, a suggested medical specialty and suggested further laboratory tests. The attending physician independently records a clinical assessment of the same laboratory results and medical history without access to the output of the system. An independent expert physician subsequently establishes the reference assessment, blinded to the authorship of the assessments being compared. The interpretation report is released to the participant only after the assessment of the attending physician has been recorded and locked. The study is conducted in two phases. The first phase (609 participants) is exploratory and uses the initial version of the system. The second phase (290 participants) is confirmatory and uses the final, frozen version of the system. All outcome measures are assessed in both phases; the pre-specified confirmatory hypothesis test applies to the second phase. The endpoints of this study are properties of the software system, namely the concordance of its output with an expert reference assessment. Health outcomes of participants are not measured.
Official title: Telemedicine Technology Supporting the Diagnostic Process Based on Automated Analysis of Laboratory Test Results With a Structured Medical History: A Prospective, Two-Center, Two-Phase Clinical Validation Study
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
899
Start Date
2026-08-19
Completion Date
2027-12-31
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
AI-based laboratory result interpretation software
A CE-marked class IIa medical device software for the automated interpretation of laboratory test results, operated within its intended purpose. The software administers a structured medical history questionnaire in which subsequent questions are selected dynamically on the basis of the laboratory results and of previous answers. For each laboratory result the software generates one interpretation, comprising a category of urgency of medical contact (immediate, urgent, routine, or no need for medical contact), a suggested medical specialty, a list of suggested further laboratory tests, and an explanatory text addressed to the patient. Interpretations are not aggregated by the software. The interpretation report is generated once per participant, after completion of the questionnaire, and is released to the participant after the assessment of the attending physician has been recorded and locked. The generated report is not used to direct the clinical management of the participant.
Locations (2)
Independent Public Clinical Hospital named after Andrzej Mielecki, Medical University of Silesia
Katowice, Poland
Prof. K. Gibinski University Clinical Center, Medical University of Silesia
Katowice, Poland