The complete blood count (CBC) is one of the most requested tests by physicians. CBC tests, most realized in conventional hematological analyzers, are restricted to centralized laboratories due to frequent maintenance, large devices, and expensive costs required. On the other hand, most handheld CBC devices commercially available show high prices and are not liable to calibration or control procedures, which results in poor quality compared to standard hematology instruments. The Hilab system is a small-handed hematological platform that uses microscopy and chromatography techniques for blood cells and hematimetric parameters analysis through artificial intelligence, machine learning, and deep learning techniques. For clinical evaluation of the handheld CBC device, 450 blood samples were analyzed. The samples encompassed normal (82%) and pathological conditions (18%), such as thalassemias (2.2%), anemias (6.6%), and infections (9.2%). For all analytes, accuracy, precision, method comparison, and flagging capabilities of the Hilab System, were compared with the Sysmex XE-2100 (Sysmex, Japan) results. The sample source (venous and capillary) influences were also evaluated. Pearson correlation, Student t test, bias, and the Bland–Altman plot of each blood count analyte were calculated and shown. The significance level was set at p ≤ 0.05. For clinical evaluation, Hilab System and the Sysmex XE-2100 showed a strong correlation (r ≥ 0.9) for most evaluated parameters. In the precision study, analytes showed CV inside the limits established according to European Federation of Clinical Chemistry and Laboratory Medicine guidelines. The flagging capabilities of the Hilab system, compared to the manual microscopy technique, presented high sensibility, specificity, and accuracy. Venous and capillary samples (p > 0.05) do not differ statistically. Considering the need for point-of-care CBCs, the study indicated that the Hilab system provides fast, accurate, low cost, and robust analysis for reliable clinical use.

The complete blood count (CBC) is a highly requested test that is generally restricted to centralized laboratories, which are limited by high cost, being maintenance-demanding, and requiring costly equipment. The Hilab System (HS) is a small, handheld hematological platform that uses microscopy and chromatography techniques, combined with machine learning (ML) and artificial intelligence (AI), to perform a CBC test. This platform uses ML and AI techniques to add higher accuracy and reliability to the results besides allowing for faster reporting. For clinical and flagging capability evaluation of the handheld device, the study analyzed 550 blood samples of patients from a reference institution for oncological diseases. The clinical analysis encompassed the data comparison between the Hilab System and a conventional hematological analyzer (Sysmex XE-2100) for all CBC analytes. The flagging capability study compared the microscopic findings from the Hilab System and the standard blood smear evaluation method. The study also assessed the sample collection source (venous or capillary) influences. The Pearson correlation, Student t-test, Bland–Altman, and Passing–Bablok plot of analytes were calculated and are shown. Data from both methodologies were similar (p > 0.05; r ≥ 0.9 for most parameters) for all CBC analytes and flagging parameters. Venous and capillary samples did not differ statistically (p > 0.05). The study indicates that the Hilab System provides humanized blood collection associated with fast and accurate data, essential features for patient wellbeing and quick physician decision making.

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.

The complete blood count (CBC) is one of the most requested tests by physicians. Mostly realized in conventional hematological analyzers, CBC tests are restricted to centralized laboratories, due to frequent maintenance, size of devices, and expensive costs that these analyzers require. On the other hand, most handheld CBC devices commercially available present high costs and are not liable to calibration or control procedures, which results in poor quality compared to standard hematology instruments. The Hilab system is a small-handed novel hematological platform that uses microscopy and chromatography techniques for blood cells and hematimetric parameters analysis. Combining artificial intelligence, machine learning, and deep learning techniques, provides the main parameters evaluated in the CBC test and four-part differential WBC. For clinical evaluation, accuracy, precision, method comparison, and flagging capabilities of the Hilab System were compared with the Sysmex XE-2100 (Sysmex, Japan) results. Over the entire measuring range, a strong correlation (r > 0.9) between both methodologies was obtained for most parameters evaluated. Also, high accuracy (> 0.85), and adequate precision values were observed. The anticoagulant influence and the sample source (venous and capillary) effect were also evaluated, and no significant differences were observed (p > 0.05). Thus, considering the need for blood count point-of-care tests, especially for quickly patient management, the study indicated that the Hilab system provides fast, accurate, low cost, and robust blood cell analysis for reliable clinical use. Key points The Hilab system presents a high correlation with a standardized reference analyzer for all evaluated CBC parameters; The flagging capabilities of the Hilab system present high accuracy compared to results provided by specialized hematologists.