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Nanopore-Based HIV Self-Test for Ultrasensitive p24 Quantification in FingerPrick Blood

Award Number: R61AI174295
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: 01/18/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2025

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Nanopore-Based HIV Self-Test for Ultrasensitive p24 Quantification in FingerPrick Blood - ABSTRACT Despite tremendous advances in treatment of HIV/AIDS and the decrease of HIV incidence, the overall infected population continues to grow. Progress on prevention of HIV transmission remains far too slow. It is estimated that 20% of new HIV infections are due to transmission from unaware infected individuals. Hence, early detection of HIV is particularly important for lowering transmission rates. To this end, extending testing accessibility beyond clinical settings through self-tests is highly desirable. HIV self-testing is a process in which an individual who wants to know his/her HIV status collects a specimen, performs the test, and interprets the result in private. Current HIV self-testing technologies include rapid protein tests and nucleic acid tests. The suboptimal sensitivity of current protein tests can only support antibody detection and will miss a significant portion of acute infections. Although nucleic acid tests can reach lower detection limit through amplification technologies such as PCR, they will miss the information that antigens can provide. Most current research efforts on HIV self-testing are focused on nucleic acid tests. However, there is no evidence showing that HIV RNA appears ahead of antigen. The major technological challenge for antigen detection is that proteins cannot be amplified like nucleic acids, leading to the widely held belief that antigen tests are relatively insensitive and therefore have a limited clinical utility. We previously demonstrated a click chemistry amplified nanopore (CAN) assay method for ultrasensitive antigen quantification. This assay achieved 0.5 pg/ml detection limit for HIV-1 p24 antigen and demonstrated reliable detection in clinical samples from patients missed by nucleic acid and/or ELISA assays. Quantitative p24 results from this method also indicated correlation between p24 and viral load, suggesting potential use for monitoring antiretroviral therapy adherence to minimize treatment failure. Based on the CAN assay, this project aims to develop an ultrasensitive quantitative HIV-1 p24 antigen self-test to improve early detection of acute infections and monitoring treatment efficacy. The test will be based on a streamlined automatic device including a cost- effective microfluidic chip for sample preparation and a nanopore reader for laypersons to test themselves using fingerprick blood. The R61 phase will develop a self-testing device for quantification of HIV-1 p24 antigen at ≤ 2 pg/ml in whole blood to support detection of acute infection and treatment failure. The R33 phase will perform a clinical evaluation at the Prisma Health Immunology Center to assess the performance, usability, and acceptability of the self-testing device. Through innovations in click chemistry amplified nanopore detection and microfluidic sample preparation, we anticipate the test would be able to quantify HIV-1 p24 antigen at as low as 0.5 pg/ml directly from 100µl or less finger prick blood and establish correlation between p24 and viral load levels. If successfully developed and validated, this CAN self-testing device should enable routine HIV self-testing as simple as a blood sugar test at home to support global HIV diagnostic and therapeutic efforts.


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 = $410,263 )
2025	2025	UNIVERSITY OF MASSACHUSETTS	101 COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Allergy and Infectious Diseases Research	003	3	4/10/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$364,361
2025	2025	UNIVERSITY OF MASSACHUSETTS	101 COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Allergy and Infectious Diseases Research	001	3	3/21/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$410,263
2025	2024	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Allergy and Infectious Diseases Research	000	2	3/21/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Allergy and Infectious Diseases Research	002	2	4/10/2025	NON-COMPETING CONTINUATION	-$364,361
														Subtotal = $410,263

Issue Date FY: 2024 ( Subtotal = $408,364 )
2024	2024	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Allergy and Infectious Diseases Research	001	2	5/20/2024	NON-COMPETING CONTINUATION	$40,836
2024	2024	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST # 414	COLUMBIA	SC	29208	RICHLAND	USA	Allergy and Infectious Diseases Research	000	2	12/22/2023	NON-COMPETING CONTINUATION	$367,528
														Subtotal = $408,364

Issue Date FY: 2023 ( Subtotal = $412,975 )
2023	2023	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST # 414	COLUMBIA	SC	29208	RICHLAND	USA	Allergy and Infectious Diseases Research	001	1	2/6/2023	NEW	$0
2023	2023	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST # 414	COLUMBIA	SC	29208	RICHLAND	USA	Allergy and Infectious Diseases Research	000	1	1/18/2023	NEW	$412,975
														Subtotal = $412,975

Grand Total All Awards = $1,231,602

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Nanopore-Based HIV Self-Test for Ultrasensitive p24 Quantification in FingerPrick Blood

Award Number: R61AI174295

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: 01/18/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2025

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