Abstract
A major hurdle for blood-based proteomic diagnostics is efficient transport of specimens from the collection site to the testing laboratory. Dried blood spots have shown utility for diagnostic applications, specifically those where red blood cell hemolysis and contamination of specimens with hemoglobin is not confounding. Conversely, applications that are sensitive to the presence of the hemoglobin subunits require blood separation, which relies on centrifugation to collect plasma/serum, and then cold-chain custody during shipping. All these factors introduce complexities and potentially increased costs. Here we report on a novel whole blood-collection device (BCD) that efficiently separates the liquid from cellular components, minimizes hemolysis in the plasma fraction, and maintains protein integrity during ambient transport. The simplicity of the design makes the device ideal for field use. Whole blood is acquired through venipuncture and applied to the device with an exact volume pipette. The BCD design was based on lateral-flow principles in which whole blood was applied to a defined area, allowing two minutes for blood absorption into the separation membrane, then closed for shipment. The diagnostic utility of the device was further demonstrated with shipments from multiple sites (n = 33) across the U.S. sent to two different centralized laboratories for analyses using liquid chromatography/mass spectrometry (LC/MS/MS) and matrix assisted laser desorption/ionization-time of flight (MALDI-ToF) commercial assays. Specimens showed high levels of result label concordance for the LC/MS/MS assay (Negative Predictive Value = 98%) and MALDI-ToF assay (100% result concordance). The overall goal of the device is to simplify specimen transport to the laboratory and produce clinical test results equivalent to established collection methods.
Highlights
Blood is a common biofluid matrix for research use and clinical diagnostic test development as the information available provides valuable insight into the health of the individual
There is clear separation between the red blood cells and the liquid portion of the blood. It is typical for the red blood cells to travel approximately halfway across the device while the fluid fraction migrates to the end of the strip
The specimen is dried on the separation membrane fraction to flow freely through the device
Summary
Blood is a common biofluid matrix for research use and clinical diagnostic test development as the information available provides valuable insight into the health of the individual. Dried blood spots (DBS) are an attractive option as they eliminate the need for centrifugation and cold-chain logistics and have been amenable to numerous analytical techniques and assays [1,2]. Devices have been developed that separate the “plasma-like” fraction from whole blood without the need for centrifugation [15,16,17]. Since these devices separate the Red Blood Cells (RBCs) through filtration, the analyte concentration could be altered when compared to plasma generated with centrifugation. Correlation of analyte concentration from dried matrix specimen collection techniques should be compared with traditional sample matrices (blood, plasma, or serum) [18,19]. In this study we evaluated the hemoglobin content in the dried plasma region after separation in a Blood Collection Device (BCD) as a confounding residue
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
