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A nanopore biosensor for leveling Mtb antigens in blood

Award Number: R01AI144168
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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A nanopore biosensor for leveling Mtb antigens in blood - Tuberculosis (TB) is a global health threat but can be difficult to diagnose and manage due to the sub-optimal performance and non-quantitative nature of frontline diagnostic assays, which require sputum or tissue biopsies and exhibit reduced performance when applied to diagnose paucibacillary or extrapulmonary TB cases. There is an unmet need for a rapid, non-sputum-based assay that can sensitively diagnose active TB and measure treatment responses in clinically diverse populations. We have previously reported that serum levels of two peptides derived from the Mycobacterium tuberculosis (Mtb) virulence factors CFP-10 and ESAT-6 can act as specific biomarkers of active TB and, using a mass spectrometry (MS) assay, validated their diagnostic performance in relevant cohorts of adults and children. This included HIV+/HIV-, pulmonary / extrapulmonary, and culture-positive / negative TB cases, as well as those with latent TB and nontuberculous mycobacteria infections. This MS assay had similar diagnostic sensitivity (88.6 vs 88.2%) and specificity (93.8 vs 97.2%) in adults and children and exceeded the reported performance of frontline tests in comparable populations. Serum Mtb antigen levels were also informative in monitoring anti-TB treatment responses. However, this MS assay is not suitable for use in resource limited settings. The proposed studies will therefore refine and evaluate the performance of a protein-based nanopore biosensor assay to diagnose active TB cases using the same serum biomarkers. This system is easy to operate, has low fabrication and instrument costs, and can perform high- throughput and ultra-sensitive measurements of specific Mtb-derived peptides. Its robust nature and portability also allow its use in resource-limited areas subject to high TB prevalence. Our results show that a nanopore assay can accurately detect CFP-10 and ESAT-6 peptides, and this data has significant diagnostic promise. Based on these findings, we propose that the portable protein nanopore biosensor assay that will be analyzed in these studies can improve TB diagnosis in adults and children, particularly in resource-limited areas with high TB prevalence. We will utilize this system to measure serum levels of Mtb antigen-derived peptide biomarkers in order to: (1) develop a sensitive and robust nanopore-based TB diagnostic assay; (2) validate this assay in well-organized cohorts, containing patients with pulmonary and extrapulmonary TB cases; and (3) evaluate how serum levels of Mtb antigens change in adult PTB cases in during anti-TB therapy. Given the success of these proof-of-concept studies, the long-term goal of the proposed research program is to build prototype devices for large-scale on-site clinical validation studies in high TB burden regions, and to modify and extend this system to detect other disease biomarkers. This research program should hasten the translation of a promising biosensor platform into a practical assay suitable for rapid translation to clinical applications for disease diagnosis.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $735,829 )
2026	2026	THE ADMINISTRATORS OF TULANE EDUCATIONAL FUND	6823 SAINT CHARLES AVE	NEW ORLEANS	LA	70118	ORLEANS	USA	Allergy and Infectious Diseases Research	001	4	5/28/2026	NON-COMPETING CONTINUATION	$735,829
2026	2025	THE ADMINISTRATORS OF TULANE EDUCATIONAL FUND	6823 SAINT CHARLES AVE	NEW ORLEANS	LA	70118	ORLEANS	USA	Allergy and Infectious Diseases Research	000	3	3/16/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $735,829

Issue Date FY: 2025 ( Subtotal = $727,944 )
2025	2025	THE ADMINISTRATORS OF TULANE EDUCATIONAL FUND	6823 SAINT CHARLES AVE	NEW ORLEANS	LA	70118	ORLEANS	USA	Allergy and Infectious Diseases Research	000	3	7/16/2025	NON-COMPETING CONTINUATION	$727,944
														Subtotal = $727,944

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	ADMINISTRATORS OF THE TULANE EDUCATIONAL FUND, THE	6823 SAINT CHARLES AVE	NEW ORLEANS	LA	70118	ORLEANS	USA	Allergy and Infectious Diseases Research	000	2	6/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $752,604 )
2023	2023	ADMINISTRATORS OF THE TULANE EDUCATIONAL FUND, THE	6823 SAINT CHARLES AVE	NEW ORLEANS	LA	70118	ORLEANS	USA	Allergy and Infectious Diseases Research	000	2	5/3/2023	NON-COMPETING CONTINUATION	$752,604
														Subtotal = $752,604

Issue Date FY: 2022 ( Subtotal = $757,909 )
2022	2022	ADMINISTRATORS OF THE TULANE EDUCATIONAL FUND, THE	6823 SAINT CHARLES AVE	NEW ORLEANS	LA	70118	ORLEANS	USA	Allergy and Infectious Diseases Research	000	1	6/15/2022	NEW	$757,909
														Subtotal = $757,909

Grand Total All Awards = $2,974,286

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A nanopore biosensor for leveling Mtb antigens in blood

Award Number: R01AI144168

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/15/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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