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

Author:

Iacovetti Gabriella1ORCID,Collier Brad2,Setzer Shannon1,Peevler Mitchell1,Ragar Jason1,Hong Kyungjin1,Pan Tifany1,Brandon Whitney2,Chappell Mathew2,Grant Russell P2,Sommer Greg J1,Schaff Ulrich Y1

Affiliation:

1. Diagnostic Devices Research and Development, Laboratory Corporation of America Holdings , Pleasanton, CA , United States

2. Center for Esoteric Testing, Laboratory Corporation of America Holdings , Burlington, NC , United States

Abstract

Abstract 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.

Publisher

Oxford University Press (OUP)

Subject

General Medicine

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