Concordance of Truvian's Benchtop Blood Testing Platform to Central Laboratory Testing

Abstract

Introduction - Routine blood tests play an essential role in modern healthcare, but their administration, processing, and reporting under the current centralized testing model is slow, inefficient, and cumbersome for patients and providers especially in outpatient settings. Truvian's benchtop blood testing platform, in late-stage development, aims to decentralize and streamline routine blood testing, replacing traditional send-outs to a central laboratory with a compact, easy-to-use benchtop platform at the point-of-action™ to ensure timely and actionable results between a patient and healthcare provider. Using only a small amount of blood from a single heparinized sample, the Truvian platform can simultaneously provide results for a full panel of routine blood tests spanning clinical chemistry, hematology, and immunoassays. Evaluation of the Truvian platform in independent external studies is important to understand its performance in real world settings and to identify opportunities for improvement to complete development. To assess the performance of a comprehensive wellness panel on the Truvian platform, a multi-site study was completed at Truvian's headquarters in San Diego, California, and at an independent clinical trial site in the Pacific Northwest. The study evaluated the panel's precision and accuracy against central laboratory analyzers. Methods - Precision and accuracy studies were performed with a panel of 32 routine blood tests including immunoassay, clinical chemistry and hematology assays on the Truvian platform. Precision studies were run across multiple days and instruments to assess repeatability and reproducibility for each test in the panel. A method comparison study included 237 patients and compared the Truvian platform to best-in-class FDA cleared central laboratory analyzers - the Roche Cobas and Sysmex analyzers. Bland-Altman and either Passing-Bablok, or Deming regression analyses were used to determine agreement for each analyte in the panel. Additionally, linearity, sensitivity, and endogenous interfering substance studies were carried out for tests within the panel. Results - Overall, the Truvian platform had a run reliability rate of > 95%. In the precision and detection capability studies, the evaluated tests successfully satisfied all predefined criteria for precision, linearity, and sensitivity. Moreover, the method comparison study revealed concordance with central laboratory analyzers. Conclusions - This multi-site study demonstrated that the Truvian platform, currently in late-stage development, is capable of delivering the clinical performance and reliability needed for decentralized blood testing. The study also provided additional areas of focus to complete development.