A-380 Concordance of Truvian's Point-of-Care Blood Testing Analyzer to Central Laboratory Testing
Authors: Higgins R L , Adams M , Arndt D , Desmond P , Fernandez B , Grabarek G , Haase N , Kim J , Krupa R , Mina G , Morgan R , Poland J , Reed G , Richardson R , Schroeder A , Lee F , Marrinucci D 
Published: September 2023

Abstract

Background
Truvian has developed a fully automated blood testing analyzer (TruAnalyzer) capable of running a panel of clinical chemistry, immunoassay and hematology assays from a low-volume blood sample. Truvian's compact instrument was designed to deliver a convenient and affordable alternative to off-site traditional labs, providing lab-accurate rapid insights from a single, small sample of blood with no upfront pre-processing required to inform health decisions at the point of care. Here, we evaluate the precision and accuracy of a comprehensive wellness panel tested on the TruAnalyzer and compare its performance to FDA cleared devices.

Methods
TruAnalyzer performance was assessed for both precision and accuracy. For the precision studies, two commercially available controls (one for plasma-based assays and one for blood-based assays) were added to the Truvian consumables and loaded into the TruAnalyzer. Six replicates were run on each of the ten instruments (N = 60). Coefficient of variance (CV) analysis was performed and compared against pre-established requirements. For method comparison studies, 50 unique donors were consented and enrolled in an IRB approved study and 68 donor samples were collected over a 3-day period. For each donor, three 4-mL tubes of blood were drawn: 1) a Lithium Heparin (LiHep) sample for the TruAnalyzer clinical chemistry and hematology panel, 2) a LiHep gel tube for the Roche Cobas c311 clinical chemistry assays, and 3) an EDTA sample for the Sysmex PocH-100i complete blood count with 3-part differential. All samples were processed within 1 hour of collection. Using only 300 µL sample volume, the TruAnalyzer reported results for 23 analytes including CMP (no electrolyes), Lipid, HbA1c, and CBC with 3-part differential. Concordance to comparator devices was determined by Bland-Altman analysis.

Results
For the precision study, 13 out of 14 (93%) chemistry analytes had a between-system CV of ≤5.8%. For hematology, 5 out of 5 (100%) analytes had a between-system CV of ≤6%. For the method comparison study, RBC counts showed 98% of samples tested being within 6% of comparator values. WBC and platelet counts had 97% of samples tested being within 10% and 15% of comparator values respectively. 95% of hematocrit samples were within 6% of comparator values and 98% of hemoglobin samples were within 7% of comparator values. All hematology analytes showed equivalency to Sysmex PocH-100i as determined by Bland-Altman equivalency analysis. For clinical chemistry analytes, 14 out of 15 (93%) analytes showed equivalency to Roche Cobas c311 as determined by Bland-Altman equivalency analysis when CLIA ATE guidelines were applied. 7 out of 15 clinical chemistry analytes had ≥90% of results within ATE. 5 out of 15 clinical chemistry analytes had ≥80% of results within ATE.

Conclusion
The Truvian blood testing analyzer is the first multi-modality system capable of running hematology, clinical chemistry and immunoassays from a single, low-volume blood sample. Results from this study demonstrate good precision for the majority of panel analytes and excellent concordance to FDA cleared comparators for assays evaluated in this study.