A-323 Advancing Point-of-Care Testing: Independent Evaluation of the Truvian Platform

Abstract

Abstract Background To address the deficiencies of long turnaround time, increased cost and delayed medical intervention in the current paradigm of routine blood testing, Truvian has developed an automated blood testing platform that provides timely and lab-accurate results at the point of care. With 300 µL from a single Lithium Heparin blood sample, the Truvian solution generates 34 test results, including CMP, Lipid, HbA1c, TSH and CBC in under 30 minutes (TruWellness PanelTM).The present study focused on rigorous evaluation of the reliability and accuracy of Truvian's platform in a real-world clinical setting by untrained operators. Platform precision was measured over time on multiple Truvian instruments under standardized protocol. Accuracy and reliability were assessed independently at the UC San Diego Anti-Viral Research Center (AVRC) by testing samples from donors with chronic medical conditions and comparing against FDA cleared devices, Roche Cobas and Sysmex-XN. Methods Precision was assessed using the control workflow where three commercially available controls, were loaded as sample inputs into the Truvian consumables to perform the TruWellness Panel(TM). Three levels of controls were run in quadruplicate daily on 4 instruments (N > 100 per instrument). Within and between run, day, instrument, and consumable lot variance components were assessed.Accuracy was assessed as part of an IRB-approved method comparison study at AVRC by untrained operators. A total of 50 unique donors representing various disease states were consented and enrolled. Three 4-mL blood samples were collected from each donor: one Lithium Heparin (LiHep) sample for the Truvian System's TruWellness PanelTM, another LiHep gel tube for Roche Cobas clinical chemistry and TSH assays, and an EDTA sample for the Sysmex complete blood count with 3-part differential and HbA1c. All samples were tested on the Truvian System within an hour of collection or processed for central lab testing. Concordance to comparator devices was assessed via relative difference plots, Passing-Bablok and/or Deming regression analyses. Results Our results indicated that the performance of Truvian's instrument met pre-specified reliability, precision and accuracy criteria (per preliminary analysis of the first 50 patients). Reproducibility results showed 100% (69/69) of all tests met specifications. Interim analysis of the first 50 patients in the method comparison study indicates a robust concordance with predicate devices with 20 out of 23 tests showing a correlation coefficient of ≥ 0.9. During donor testing, the instrument demonstrated 96% (48/50) run reliability with only a single operator-induced error where the blood tube was not loaded correctly, highlighting the robustness and ease of use of the platform. Conclusions The present evaluation underscores Truvian's instrument as an easy-to-operate platform that can be run by untrained operators, maintain reliability in real-world clinical settings, and deliver accurate and precise results. Enrollment and sample testing are ongoing, with plans to expand the sample size to 200 donors and study completion planned for May 2024. Broadening the study to encompass a wider range of analyte measurements among chronic disease patients is expected to enhance performance data. This independent evaluation provided confidence in Truvian Platform’s performance and suitability for practical healthcare applications.