A-379 Advancing Point-of-Care Diagnostics: Streamlining Patient Care with the Merlin

Background On-site, rapid lab testing is crucial in modern healthcare, enabling faster diagnosis and timely treatment. However, off-site labs and benchtop options are often inefficient, require multiple manual steps, and lead to delays in result availability. Genalyte’s Merlin device is an automated, diagnostic platform designed to simplify lab testing. By eliminating human intervention in critical tasks such as sample mixing, pipetting, and reagent handling, Merlin offers a streamlined process that delivers results in under 30 minutes, improving both diagnostic accuracy and workflow efficiency. Methods The Merlin device was evaluated through method comparison and precision studies at internal and three external Point-of-Care (POC) sites. A total of 36 analytes from the Lipid Panel, Hematology Panel (CBC), and Comprehensive Metabolic Panel (CMP) were tested. Merlin results were compared to those from FDA-cleared predicate devices. 239 hematology and 228 chemistry samples were tested at internal and three external sites. Samples were tested in single replicates on both Merlin and the predicate systems following assay instructions. Deming regression analysis assessed method equivalency for each analyte. Precision studies evaluated repeatability and site-to-site reproducibility across external POC sites. Results Merlin demonstrated exceptional accuracy across all 36 tested analytes from the Lipid, CBC, and CMP panels, with strong correlation (R² = 0.99) for most analytes. Lipid Panel: The regression analysis for Total Cholesterol, HDL, LDL, Triglycerides, and other lipid markers showed high correlation (R² = 0.99 for most analytes), with slopes close to 1.0 and percent differences within acceptable limits. CBC (Hematology) Panel: For key analytes like WBC, HGB, PLT, and HCT, Merlin showed R² values = 0.98 and slope values close to 1.0, indicating excellent method equivalency. CMP (Chemistry) Panel: Analytes such as ALT, ALP, BUN, CRE, ALB, GLU and others showed strong method comparison results, with R² values = 0.95 and slope values near 1.0. Test Not Performed (TNP) rates for Merlin were significantly lower (0.7%) than benchtop point of care devices (2%), and traditional send-out labs (3%). Precision studies demonstrated repeatability and site-to-site reproducibility with CVs = 5% for key analytes, including Total Cholesterol, LDL, and WBC. Operator feedback confirmed that Merlin’s automation significantly enhanced workflow efficiency, eliminating manual intervention and reducing the potential for human error. Operators praised the system for its simplicity and ease of use. Conclusion The Merlin offers a significant advancement in point-of-care diagnostics, providing operator-free automation, lower error rates, and faster result turnaround compared to off-site testing and other benchtop options. Merlin’s streamlined workflow enhances clinical efficiency, reduces delays in diagnosis and treatment, and improves patient care. These findings confirm that Merlin is a powerful tool for delivering high-quality diagnostic results in real time, helping healthcare providers make better decisions and improving patient outcomes.