M. Sun, H. Feng, J. Zhiguo Zhou
MicroFAST Dx,
United States
Keywords: rapid plasma separation, portable microfluidic device, decentralized blood testing, accessible diagnostics
Summary:
We present RapiSep, a thumb-sized, self-contained device for rapid plasma separation from whole or diluted blood, requiring only three simple actions to eliminate the need for any aiding equipment. The RapiSep series contains three versions of varied sizes, offering separation of plasma in volumes of 10 µL (RapiSep-S), 50 µL (RapiSep-M), and 200 µL (RapiSep-L), targeting to meet the most pivotal tests, including for at-home, in-clinic, and PoC diagnostic demands. RapiSep delivers instrument-free, reagent-less plasma separation from finger-prick capillary blood drops to milliliter venous blood, achieving centrifuge-grade plasma quality. Three simple actions SIP-TAP-CAP by any person anywhere, produces plasma in under one minute. By eliminating centrifugation or reagents and reducing processing time by up to 90%, RapiSep empowers non-expert users to perform rapid blood diagnostics outside of clinical laboratories. Currently at TRL 5, RapiSep seamlessly integrates with upstream blood collection (finger pricking, venipuncture or alternative collection methods like microneedle) and downstream assays (molecular tests, immunoassays and biomarkers), ensuring streamlined workflows and broad compatibility. RapiSep offers centrifuge-grade plasma in quality. The clearness of plasma measured by hemoglobin value showed no bias on blood samples with varied hematocrits (36%, 42%, 48%) in minimizing cell lysis during the separation process, producing plasma with Hb value close to 0.05 g/dL of centrifuged plasma. RapiSep is superior to the potential competitors in the current market. RapiSep takes less than 60 seconds for plasma separation. It delivers free plasma in liquid form. The plasma yield is 34%, which is the highest compared to the current potential competitors could achieve. The plasma separated from RapiSep has been verified with two major types of diagnostic tests, i.e. an IgG antibody (cytomegalovirus, CMV) test and a molecular test (HCV RNA). Both showed comparable quantitative results between RapiSeped and centrifuged plasma and the potential of RapiSep to be used for clinically relevant diagnostic testing. Further development plan of RapiSep towards TRL 8-9 includes partnerships with blood lancet manufacturers for upstream blood collection and with diagnostic assay developers for downstream detection. RapiSep was invented with versatile interfaces to sample input from a blood source and to plasma output to an analytical device. The RapiSep device will enter the market included in a diagnostic kit with a blood collection and a test device. The concept and technology could be revolutionary for the current blood test regime that relies on a central laboratory, to transition to decentralized, PoC, and at-home settings with the capability of test by anyone at anywhere. It can certainly enhance worldwide healthcare testing and management with easy access to early and frequent tests, leading to proper treatment, timely and effective. With the simple operation and rapid separation in just one minute that RapiSep offers, the healthcare diagnostic regime for widespread applications of blood testing in both remote and laboratory settings can be transformed with affordable, accessible and expeditious solutions.