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Principal Investigator: James Lai
Organization: TRULY TECHNOLOGIES LLC
Fiscal Year: 2024
Award: $55,000
Funding agency: National Institute of Allergy and Infectious Diseases
PROJECT SUMMARY/ABSTRACT
Urine is an attractive biospecimen for point-of-care diagnostics because it can be collected in large quantities
with noninvasive procedures. Urine-based lateral flow assays (LFAs) are low-cost devices suitable for
point-of-care testing, particularly in low-resource settings. However, many urine-based LFAs exhibit sensitivity
levels well below diagnostic utility due to the low concentration of diagnostic biomarkers present in urine. This
is the case with LFAs for tuberculosis (TB) diagnostics and is a major barrier to rapid TB testing and treatment
in endemic areas. Mainstream clinical and laboratory tests for diagnosing active TB, including bacterial culture,
sputum smear microscopy and nucleic acid amplification tests, present limitations in speed, sensitivity,
accessibility, respectively. These tests also require sputum samples that present additional difficulty and
exposure risks for healthcare staff during the collection procedure.
To address this, we developed an osmotic processor that statically and spontaneously concentrates urinary
biomarkers for use in LFAs. Urea and small molecules that can interfere with downstream assays are removed
in the concentration process. Using human chorionic gonadotropin (hCG) protein as a model analyte, we
showed near 100-fold concentration of a 20 mL sample in an early prototype. By exploiting the principles of
osmosis, recent prototypes developed by the company show promise in significantly reducing processing time
to within 30 minutes. With its simplicity and flexibility, the device demonstrates a great potential to be interfaced
with existing LFAs to enable highly sensitive detection of dilute target analytes in urine, while still retaining a
diagnostic time suitable for point-of-care diagnostics. The project aims to validate molecule concentration
quantitatively with mass spectrometry in newer prototypes, perform spike-and-recovery tests with simulated
urine and lab-based LAM, and then test qualitatively with TB-positive clinical samples and LFAs.
If awarded the Phase I SBIR grant, the team will hire another full time research scientist, register our device as
a General Controls Device through the FDA, continue business collaborations with companies developing
LFAs, research other applications of the device to process other biomarkers for diagnostic, disease monitoring
and therapeutic purposes, and plan scale-up of device production for commercial distribution in preparation of
Phase II.
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