A-334 Vital one: a point-of-care platform for rapid, comprehensive, central-lab quality blood testing
Authors: Koussa M , Barreiros M , Ehrlich Perez P , Jean S , MacLeod R , Witham A , Venkateswaran A , Yang D , Alfaqheri W , Ardalan A , Chand R , Ho K , Kumar P , Lengyel M , Luo W , Masum F , Piñeros L , Rajagopal Kozhipuram A , Sanders S , Santos D , Bhat G , Nadella V , Kazemzadeh F , Khodadad I 
Published: October 2024

Abstract

Background
Diagnostic tools are fundamental to informed healthcare decisions, but the current state of in vitro diagnostics presents barriers to providing timely access to a wide menu of tests. This poster discusses a method for overcoming these challenges with a novel and miniaturized point-of-care (PoC) solution, the VitalOneTM. While many PoC solutions have limited test menus tailored for specific scenarios, Vital Biosciences introduces a comprehensive test menu in a compact PoC format that uses centrifugal microfluidic workflows to deliver quantitative results for over 50 analytes spanning hematology, clinical chemistry, and immunoassay modalities, ensuring central-lab quality results for a wide variety of use cases in a 20-min time frame (or 15 min for a Comprehensive Metabolic Panel (CMP) lipid panel, and liver panel). The VitalOneTM is designed to perform a complete blood count (CBC), a comprehensive panel with a full array of immunoassays and clinical chemistry assays, returning over 50 results with as little as 300-750 µL of whole blood. This poster provides a comprehensive and transparent view of both our results and underlying methods of operation. By comparing the VitalOneTM system with established benchmarks like Roche, Sysmex, and Beckman Coulter instrument systems, we demonstrate consistent assay performance, resilience to interference, and performance that is compliant with CLIA Total Allowable Error standards.

Methods
A method comparison analysis of measurements on VitalOneTM platform was performed against predicate instruments that are commonly used in centralized laboratories (Roche Cobas, Beckman AU480, Beckman Coulter DxH500, Beckman Access 2, and Sysmex 140). Additionally, a 5-8 point calibration curve was generated for each analyte across the desired assay measuring range (AMR) using commercially available validation kits on three separate days, resulting in a master calibration curve. To check for sensitivity to potential interferences that may be present in patient samples, endogenous and exogenous interference testing was performed following Clinical & Laboratory Standards Institute (CLSI) guidelines. Lastly, robustness testing was carried out to mimic the extremes of variances in volumes, times, or temperatures that may be encountered when running an assay protocol.

Results
The method comparison analysis (n = 840 samples) and precision studies revealed that the VitalOne exhibited a strong correlation with the benchmark instruments and were in compliance with CLIA's total allowable error limits, reinforcing the reliability and clinical relevance of our diagnostic system. Assays across Hematology, Clinical Chemistry, and immunoassays demonstrated &gt;95% of data within CLIA TEa% and run-to-run imprecision ≤ 5%. Additionally, linearity studies revealed that each analyte AMR spans across physiologically relevant concentrations, defined by medical decision levels and reference intervals for each analyte. Our robustness and endogenous and exogenous interference testing performed as per CLSI guidelines has demonstrated that the VitalOneTM system closely matches, and in certain parameters, such as biotin interference, even surpasses that of the predicate instruments.

Conclusions
In summary, the VitalOneTM platform represents a significant advancement in point-of-care diagnostics, offering a comprehensive, accurate, and efficient alternative to traditional laboratory testing. This innovation is poised to transform the way clinicians approach diagnostics, enabling more informed decision-making and ultimately enhancing patient outcomes.