VitalOne™: a point-of-care platform for rapid, comprehensive, central-lab quality blood testing†

Abstract

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 paper discusses a method for overcoming these challenges with a novel and miniaturized point-of-care (PoC) solution, the VitalOne. While many PoC solutions have limited test menus tailored for specific scenarios, Vital Bio introduces a comprehensive test menu in a compact PoC format that uses centrifugal microfluidic workflows to deliver quantitative results across three modalities that have traditionally required three separate instruments. VitalOne has combined three modalities into a single instrument: hematology, clinical chemistry, and immunoassay. This breadth of central-lab quality results covers a wide variety of use cases and helps to eliminate the send-out gap that impedes the adoption of PoC technologies. This paper provides a comprehensive and transparent view of both our assay performance data and underlying methods of operation. By comparing the VitalOne system with established benchmarks commercialized devices including Roche cobas® c701, Sysmex 140, Beckman DxH® 500, Beckman AU® 480, and Beckman Access® 2 instrument systems, we demonstrate consistent assay performance, resilience to interference, and performance that is compliant with Clinical Laboratory Improvement Amendments (CLIA) total allowable error standards. Additionally, this article elucidates our system's operational intricacies and showcases performance data from a diverse set of analytes.