Path to Commercialization for An Accurate, Comprehensive, Small-Volume Blood Diagnostics Device for Handheld Analysis of Rapidly Solidified Blood Drops: ​​InnovaStrip™*

About 4 billion Blood Diagnostics (BD) tests are performed yearly. The BD market is valued at US$ 91.61 billion per year [1]. Most blood tests require 7-10 mLs each and take hours to days. Drawing mLs of blood leads to Hospital-Acquired Anemia (HAA) in 74% of patients.

 

A Small Blood Volume Diagnostic (SBVD) medical device, called InnovaStrip™ has been prototyped on both canine and human blood using Hand-held X-Ray Fluorescence (HH-XRF) for reliable, comprehensive blood analysis of electrolytes and metals such as Fe, Cu, Se, and toxic metals such as Hg, Cd, and Pb.

InnovaStrip™ requires 3 blood drops (~ 0.1 mL), decreasing the blood volume sampled by a factor of 1000. 

By using microliters instead of nanoliters (unlike Theranos' fraudulent claims to use nanoliters for SVBD), InnovaStrip™ uses 1000 X more blood than Theranos, but 1000 X less than conventional BD. 

InnovaStrip™ uses a hyper-hydrophilic coating, HemaDrop™, that can solidify blood drops in minutes into Homogeneous Thin Solid Films (HTSF), without coagulation in blood collection wells.

HTSF are analyzed via HH-XRF within minutes, to yield accurate BD to ± 10%.

This handheld, low-cost device ($1-2k) uses test strips at a cost of $2.5 -5 each.

Inexpensive BD can be deployed in ERs, remote areas, refugee camps, and war zones.

 

Peer-reviewed [2-4] InnovaStrip™ yield fast accurate, reliable BD, based on three different spectrometries on hundreds of samples, and independent calibration using Extended X-Ray Absorption Fine Structure.