The validation was done through a prospective cohort study, a strong type of clinical study that tracks a group of people over time to see how a new tool performs in real-world situations. To conduct it, we partnered with Silesian Medical University, a leading scientific institution.

The study was led by Prof. Jerzy Chudek, MD, PhD, Head of the Department of Internal Medicine and Oncology Chemotherapy at Silesian Medical University in Katowice, corresponding member of the Polish Academy of Sciences, who has interdisciplinary clinical experience as a specialist in internal medicine, nephrology, angiology, hypertension, clinical oncology and transplantation. 

The study adhered to strict ethical and scientific standards. Official registration on ClinicalTrials.gov (NCT05813938) provided public transparency, while full ethical approval from the Bioethics Committee of the Medical University of Silesia confirmed patient safety and privacy protection. All participants provided informed consent, and their information remains completely anonymous.

This comprehensive process gives healthcare executives confidence that LTC has been tested to the highest standards of research ethics and scientific validity.

Understanding LTC’s clinical validation requires examining the careful study design that compared LTC’s performance against expert clinical judgment. The study included 101 adult patients who were stable but required a detailed assessment that couldn’t be determined through conversation or simple physical examination alone.

1. Extensive laboratory testing 

Each patient underwent extensive blood testing, more comprehensive than typical emergency room protocols. These tests covered cholesterol, inflammation markers, kidney and liver function, and complete blood counts, among others. This extensive testing demonstrated LTC’s ability to handle and interpret broad, complex laboratory data sets, suggesting capacity for deeper insights that might otherwise be overlooked.

2. Comparison against expert clinical judgment

LTC provided interpretations and recommendations based on these detailed results. Performance was compared to recommendations from an experienced internal medicine specialist. The specialist reviewed urgency levels suggested by emergency room doctors and the system’s recommendations without knowing LTC’s conclusions, ensuring unbiased comparison.

The specialist didn’t examine patients directly but reviewed their data and initial assessments. This methodology measured LTC’s performance against expert interpretation of existing patient information and laboratory results.

3. Four-tier urgency classification system (triage)

The study evaluated LTC’s accuracy and safety by comparing recommendations to specialist assessments. The consultant, remaining unaware of LTC results, categorized physician interaction urgency for each test into four groups: emergency, urgent, routine, and self-care.

After this assessment, LTC results were revealed to determine whether following its advice could prevent unnecessary doctor visits and whether LTC’s insights correctly identified the underlying causes of abnormal results.

4. Focus on patient safety in accuracy measurements

To maintain focus on patient safety, some interpretations were excluded from accuracy calculations:

• Very urgent cases requiring immediate doctor contact, as the primary goal was to help them. 
• Results indicating no health problems.

Exceptional triage accuracy compared to existing systems

LTC achieved 74.3% overall triage accuracy across all 101 patients, demonstrating strong capability in correctly assessing patient urgency for physician consultation. This represents great performance, especially compared to similar systems showing accuracy between 19% and 70%.

Perfect safety record for critical cases

Patient safety results were particularly impressive. LTC correctly identified 100% of cases requiring emergency attention, meaning no situations needing immediate, life-saving help were missed. It correctly identified 92.3% of cases requiring urgent attention, showing the ability to correctly flag patients needing prompt care.

Substantial operational efficiency gains

The 41.6% reduction in unnecessary medical visits (42 out of 101 patients) provides major operational benefits. This directly reduces costs for healthcare facilities by eliminating unneeded appointments, easing staff burden, improving patient flow, and potentially increasing patient satisfaction by avoiding inconvenient trips. This represents clear, measurable benefits that optimize healthcare delivery.

Strong diagnostic support capabilities

LTC also demonstrated strong capability in identifying health problems, with 82.9% accuracy in providing insights into underlying pathologies. This accuracy applies mainly to less immediately critical conditions, where the system focuses on precise insights. This means LTC reliably assists in flagging a wide range of conditions while ensuring critical, life-threatening issues receive top priority.

While LTC has demonstrated significant capabilities, like all advanced systems, opportunities for improvement always exist. The study identified specific areas where urgency classifications could be further refined.

Areas for enhanced precision

LTC overestimated urgency for 25 patients, sometimes suggesting higher care levels than specialists recommended. While this cautious approach helps ensure safety, refining the system could improve precision.

The study found one instance where LTC misjudged patient urgency, suggesting routine contact when the specialist felt urgent contact was necessary.

These findings don’t diminish LTC’s overall effectiveness but provide valuable information for ongoing development. Like any evolving technology, continuous learning and refinement are part of its journey. Since 2023, we’ve 

The comprehensive study of LabTest Checker by Labplus® marks a significant advancement in intelligent systems for patient support. The prospective cohort study demonstrates LTC’s high accuracy and excellent safety in interpreting complex laboratory results, proving its value for healthcare and laboratory facilities.

Acknowledgements

We would like to express our sincere gratitude to the extraordinary research team from the Silesian Medical University in Katowice, our Chief of Science, Bartłomiej Bartoszewicz, our Medical Director, Dr. Agnieszka Kuś, Dr. Leopold Rehan, the Medical Advisory Board, and the entire Labplus team.

Study published in JMIR Medical Informatics.

ClinicalTrials.gov registration: NCT05813938.