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Microchip for HBV testing using HIV-infected blood samples

Award Number: R01AI138800
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: 02/06/2023
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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Microchip for HBV testing using HIV-infected blood samples - PROJECT SUMMARY It is estimated that more than 240 million people are living with HBV infection and more than 36 million people with HIV infection worldwide, of which up to 60% of HBV-infected and 30% of HIV-infected individuals are unaware of their infection status. HBV coinfcetion in HIV-infected patients is linked to increased risk of cirrhosis and Hepatocellular carcinoma (HCC), higher rate of chronicity and occult HBV, and higher rate of liver-related morbidity. Accurate and timely knowledge of HBV/HIV coinfection status is essential to select the optimal ART regimen and tenofovir disoproxil fumarate (TDF) as well as treatment monitoring to identify if treatment switch is required. Previous studies showed that simultaneous detection of HIV and HBV using on-site POC tests can significantly improve the screening process and linkage to care for individuals at high risk for chronic viral infections. In addition, the undiagnosed, untreated, infected individuals can play a significant role in infection transmission to others. If untreated, the infection can lead to advanced stages, which increases the risk of mortality. The lack of appropriate diagnostic tools especially for people at high risk of infection is one of the reasons for the infection unawareness. The development of point-of-care (POC) multiplexed diagnostics is crucial in expanding hepatitis testing and disease management services for individuals with HIV/HBV co- infection in a timely manner. Viral load testing is the most accurate and preferred approach for HIV and HBV detection and treatment monitoring. Nucleic acid-based assays are currently used for viral load testing for disease diagnosis and treatment efficacy monitoring, however, these assays are still relatively expensive, laboratory-based, and technically complex. Multiplexing HIV/HBV using nucleic acid-based methods is also challenging due to simultaneous detection of RNA (HIV) and DNA (HBV) target molecules. Furthermore, current POC rapid tests (dipsticks) target antibodies/antigens against HIV/HBV generated after infection, cannot detect treatment failure and acute infection, and have low sensitivity/specificity. Thus, to increase access to HIV/HBV care with regular treatment monitoring and to improve treatment outcomes, there is an urgent need for inexpensive, rapid, sensitive, and specific HIV/HBV viral load testing tools at the POC. The main goal of this highly interdisciplinary project is developing a portable nanotechnology-empowered cellphone-based system for rapid (<30 minutes) multiplexing HIV/HBV in fingerprick volume (<100 µL) of whole blood placed on an inexpensive (<$2), disposable, and mass-producible microfluidic device. In our proposed method, (i) target viruses are captured on-chip using highly specific envelope antibodies, (ii) captured viruses are labeled with Pt nanoparticles conjugated with respective antibodies, (iii) Pt-labeled captured viruses generate bubbles through gas formation of Pt nanoparticles in the presence of hydrogen peroxide on-chip, (iv) the bubbles can be quantified using a low-cost (<$4) cellphone optical attachment for quantitative/qualitative viral load testing.


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: 2025 ( Subtotal = -$1,824 )
2025	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	5	2/12/2025	SUPPLEMENT FOR EXPANSION	-$1,824
2025	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	2/12/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = -$1,824

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	12/29/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,004,054 )
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	11/15/2022	NON-COMPETING CONTINUATION	$504,054
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	5	2/6/2023	SUPPLEMENT FOR EXPANSION	$500,000
														Subtotal = $1,004,054

Issue Date FY: 2022 ( Subtotal = $504,054 )
2022	2022	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	12/8/2021	NON-COMPETING CONTINUATION	$789,434
2022	2022	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	4	1/28/2022	NON-COMPETING CONTINUATION	-$285,380
														Subtotal = $504,054

Issue Date FY: 2021 ( Subtotal = $504,054 )
2021	2021	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	3	12/2/2020	NON-COMPETING CONTINUATION	$504,054
														Subtotal = $504,054

Issue Date FY: 2020 ( Subtotal = $506,768 )
2020	2020	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	12/4/2019	NON-COMPETING CONTINUATION	$506,768
														Subtotal = $506,768

Issue Date FY: 2019 ( Subtotal = $571,090 )
2019	2019	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	11/21/2018	NEW	$571,090
														Subtotal = $571,090

Grand Total All Awards = $3,088,196

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Microchip for HBV testing using HIV-infected blood samples

Award Number: R01AI138800

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: 02/06/2023

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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