ENHANCING IMMUNOPHENOTYPING EFFICIENCY: VALIDATION OF AUTOMATED SAMPLE PREPARATION SYSTEM IN ONCOHEMATOLOGY REMOTE LABORATORY SETTINGS

Abstract

Introduction: Immunophenotyping is pivotal in diagnosing and monitoring oncohematologic diseases, yet it remains predominantly manual, involving lengthy processes of marking, pipetting, and centrifugation, significantly impacting turnaround time (TAT). Objectives: This study aims to validate results obtained using the automated preparation with CellMek, Beckman Coulter Life Sciences, an automated sample preparation system (ASPS) compared to the current manual methodology (MAN), assessing efficacy and reproducibility. Materials and methods: We evaluated 31 samples for lymphocyte counting and subclassification (CD3/CD4/CD8), 20 multiple myeloma (MM) cases, and 15 chronic lymphocytic leukemia (CLL) cases. Additionally, a descriptive tube containing 14 markers (kappa, lambda, CD4, CD8, CD3, CD14, CD5, CD33, CD34, CD10, CD19, CD45, CD56, CD20) in 32 cases for hematologic disease screening was used for qualitative method comparison. Results: Correlation analysis of CD19 cell counts in CLL cases using ASPS and MAN revealed medians of 53.21 and 54.85, respectively (paired t-test p = 0.46), with highly correlated results r2 = 0.90 (Pearson 0.95, p < 0.0001). In 20 MM cases, plasma cell quantification showed means of 7.8% (ASPS) and 5.3% (MAN) (p = 0.07) and a correlation of r2 = 0.98 (p < 0.0001). Furthermore, a more appropriate separation of kappa and lambda was observed. The average CD4/CD8 lymphocyte ratio in ASPS was 1.51 versus 1.52 in MAN (paired t-test p = 0.55). Although ASPS did not reduce TAT, batch sample allocation reduced operator interaction, ensuring standardized processing of marking, washing protocols, and traceability of the entire process through system integrations. All 32 cases of disease screening with 14 markers produced identical qualitative results (100% qualitative correlation). Discussion: The results indicate that automating the immunophenotyping process with ASPS maintains result accuracy and reproducibility while offering advantages in standardization and traceability. Despite similar processing times to manual methods, batch processing capability and reduced operator interaction provide significant benefits, potentially reducing operational costs and TAT for medium-sized flow cytometry laboratories. Conclusion: This study describes the first clinical validation of an ASPS for immunophenotyping in oncohematology in South America. The findings suggest that, despite similar processing times to manual methods, batch processing capability and high result reproducibility may lead to cost reductions and improved TAT for medium-sized flow cytometry laboratories.