Clinical validation of the Hilab lens for AI supported point of care CBC testing in pediatric oncology.

BACKGROUND

Complete blood count (CBC) testing is critical for diagnosing and monitoring hematological conditions, including leukemia. However, conventional analyzers require specialized infrastructure and trained personnel, limiting access in resource-constrained settings. Point-of-care hematology devices provide a promising alternative by delivering rapid results with minimal complexity. This study aimed to evaluate the analytical performance of the Hilab Lens versus XE-2100.

METHODS

Blood samples (n = 555) were analyzed using both devices at Erastinho Hospital, a pediatric oncology center. Device performance was assessed through precision testing, method comparison, sample type equivalence, evaluation of potential interferences, and caregiver satisfaction surveys. Agreement and correlation were evaluated using Bland-Altman plots and Passing-Bablok regression.

RESULTS

Here we show that the Hilab Lens demonstrates high precision and consistency, meeting European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Method comparison revealed strong correlations (key analytes r ≥ 0.95), minimal bias, and robust agreement with the reference analyzer across all CBC parameters. The Hilab Lens achieved high accuracy in flagging studies (≥ 98.8%), particularly for band neutrophils and immature cells. No significant interferences were detected (p > 0.5). Caregivers reported high satisfaction with the test (mean score 4.65 on a 5-point scale).

CONCLUSIONS

These results support the Hilab Lens as a reliable and accessible alternative to conventional hematology analyzers. Its ease of use and rapid turnaround make it suitable for environments where timely CBC testing is essential. The high acceptance observed in pediatric oncology suggests its potential for broader implementation in clinical practice.