A-392 Breaking barriers in blood testing with a phlebotomy-free approach to near-patient diagnostics with Truvian’s multi-modal platform using microneedle capillary collection

Abstract

Background Blood testing is the backbone of modern medicine, yet traditional lab-based testing remains inconvenient, costly, and often inaccessible—especially for those without easy access to phlebotomy services. Delays owing to phlebotomy appointments, specimen transport or fear of needles means that many healthcare decisions are made without up-to-date labs. Truvian’s novel multi-modal benchtop platform is designed to change that by bringing high-quality, comprehensive blood testing directly to the patient at the point of care for real-time lab results of the most commonly ordered tests. This fully automated benchtop device has been independently validated to deliver results concordant with central laboratory analyzers in previous studies. Capable of simultaneously running chemistry, immunoassay, and hematology panels from a single small-volume blood sample, the platform eliminates the need for large-volume venous draws and specially trained operators. However, venous draws remain standard-of-care for routine blood testing due to conventional capillary blood collection methods still struggling with sample integrity, volume, and reliability—particularly for tests like complete blood counts (CBC). To overcome these limitations and enhance test accessibility in settings where trained phlebotomists are unavailable, we developed a novel phlebotomy-free capillary self-collection device (TAP) designed to work seamlessly with the Truvian Platform and the TruWellness Panel™—a 34-test panel covering key biomarkers, including metabolic markers, lipids, HbA1c, TSH, and CBC. This study demonstrates the feasibility of using TAP to generate high-quality capillary blood samples compatible with comprehensive lab-grade near-patient real-time testing using the Truvian platform. Methods Paired venous and capillary whole blood samples were collected from consented donors (N = 50). Licensed phlebotomists performed venous draws, while participants self-collected capillary blood using different TAP device configurations. Samples were analyzed on the Truvian Platform to assess performance, accuracy, and concordance. Results Capillary samples self-collected with the primary TAP device yielded >350 µL of high-quality blood in under 75 seconds and showed low hemolysis (< 50 mg/dL plasma free hemoglobin) in 90% of samples. These samples demonstrated strong agreement for 21 of 23 measured analytes (mean bias within ± 10%) on the TruWellness Panel™ relative to venous samples. Initial capillary collections showed negative biases for white blood cell (WBC) and platelet (PLT) counts, primarily due to cell clumping. However, modified TAP device configurations designed to minimize and delay the blood clotting cascade significantly reduced clotting and improved WBC and PLT accuracy. Conclusion This study demonstrates the feasibility of using a blood sample collected from a phlebotomy-free capillary collection method to support high-quality, comprehensive blood testing on the Truvian Platform. Truvian plus TAP supports an ecosystem that has the potential to transform routine blood testing, bringing lab-quality results closer to patients, expanding access to care, and enabling more timely medical decisions based on up-to-date lab results.? Truvian’s multimodal platform with the TruWellness Panel™ paired with the microneedle-based capillary blood collection reduces complexity, improves patient experience, adds efficiency to a strained medical system, and ultimately promises to improve short- and long-term patient outcomes.