Evaluation of a Compact, Portable Centrifuge for Separating Microvolume Blood Samples at the Point of Collection.

BACKGROUND: The increased demand for decentralized blood sample collection presents numerous operational challenges for diagnostics providers. Sample degradation including sample hemolysis due to time, temperature, and handling between collection and laboratory analysis leads to limited test menus and unreliable results. Here we introduce the lightweight, portable Labcorp TrueSpin™ for rapid point-of-care blood separation using commercially available microvolume blood collection tubes. The TrueSpin is a class I FDA-registered device designed for untrained users. The centrifuge runs on AA batteries and separates a blood sample in 5 minutes. METHODS: Here we describe a series of studies evaluating sample quality and analyte stability in serum samples collected into gel microtubes and processed using the TrueSpin. Hemolysis, residual red blood cell concentration, sample volume, and serum-based chemistry analyte stability were evaluated. RESULTS: No significant difference was seen in hemolysis or residual red blood cell concentration in serum samples prepared by TrueSpin compared to the reference method. Additionally, capillary and venous blood samples separated using the TrueSpin and exposed to International Safe Transit Association 3A-simulated shipping conditions were shown to yield acceptable sample volume and quality for laboratory analysis. Finally, we show that many common serum-based chemistry analytes have limited (< 1 day) stability if uncentrifuged but improve to ≥ 3-day stability following TrueSpin separation and refrigerated or room temperature storage. CONCLUSIONS: These findings suggest that the TrueSpin is a simple and effective solution for remote sample separation and may enable broader test menus and increased test result reliability for decentralized sample collection pursuits.

Maximizing Microsampling: Measurement of Comprehensive Metabolic and Lipid Panels Using a Novel Capillary Blood Collection Device.

BACKGROUND: Demand continues to grow for patient-centric sampling solutions that enable collection of small volumes of blood outside of healthcare facilities. Various technologies have been developed to facilitate sample collection but gaps in knowledge remain, preventing these technologies from replacing standard venipuncture. METHODS: A novel blood collection device, Touch Activated Phlebotomy (TAP) II® from YourBio Health, and standard fingerstick collection using a BD Microtainer® were utilized to collect capillary serum samples. Measurements of a comprehensive metabolic and lipid panels were measured on these samples and compared to results from venous serum samples that were collected in parallel. Hemolysis was used to assess sample quality. Sample volumes obtained from self-collected TAP II samples were also determined. RESULTS: Correlation of capillary serum with respect to venous serum was demonstrated (R > 0.9) for professionally collected TAP II samples, self-collected TAP II samples, and professionally collected fingerstick samples for alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, cholesterol, high-density lipoprotein, total bilirubin, and triglycerides. Results for creatinine demonstrated acceptable correlation, however, a consistent negative bias was observed. Biases (with unacceptable correlations) were also observed for measurements of carbon dioxide and potassium. Correlative results for albumin were not consistently acceptable across the collection techniques utilized while the remaining analytes tested did not demonstrate acceptable correlations under any condition. Correlation results, however, would improve with a wider distribution of analyte concentrations. CONCLUSIONS: Collections of small volumes of liquid blood continue to show potential as a patient-centric solution.