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Assessment of Accuracy and Safety of LabTest Checker

Assessment of Accuracy and Safety of LabTest Checker - Clinical Evaluation of a Patient-centered Clinical Decision Support System Based on AI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813938
Acronym
LTC-AI
Enrollment
101
Registered
2023-04-14
Start date
2022-12-22
Completion date
2023-03-31
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormalities in the Blood Test Results

Keywords

laboratory test interpretation, artificial intelligence, clinical decision support system, clinical implementation

Brief summary

The goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is: • how accurate and safe is LabTest Checker. A set of blood laboratory tests will be ordered for each participant. Participants will use LabTest Checker to obtain an interpretation of their test results. The interpretation provided by LabTest Checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.

Interventions

DEVICELabTest Checker

A set of blood laboratory tests is ordered. Test results are recorded in the LabTest Checker. LabTest Checker's diagnostic engine automatically generates a personalized questionnaire that is filled out by the patient. After obtaining all necessary information, including the patient's chronic diseases, medications taken, and symptoms, the tool presents an interpretation of test results.

Sponsors

Labplus Sp. z o.o.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult * requires laboratory test investigation

Exclusion criteria

* under 18 years old * pregnant * no need for laboratory test investigation

Design outcomes

Primary

MeasureTime frameDescription
accuracy7 daysthe ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients
sensivity to emergency7 daysthe ratio of the number of cases correctly identified as emergency by the LTC to the number of cases identified as emergency by the physician
sensivity to urgency7 daysthe ratio of the number of cases correctly identified as urgency by the LTC to the number of cases identified as urgency by the physician
safety7 daysthe ratio of the number of patients for whom a triage category assigned by the LTC was higher than or equal to the triage category assigned by the physician to the total number of cases

Secondary

MeasureTime frameDescription
reduction of unnecessary visits7 daysthe ratio of the number of patients who will avoid at least one unnecessary consultation by following the LabTest Checkers recommendations to the total number of patients

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026