# Ending the HIV Epidemic through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore

> **NIH ALLCDC U01** · JOHNS HOPKINS UNIVERSITY · 2020 · $1,644,512

## Abstract

PROJECT ABSTRACT
High-quality, rapid HIV assays that can diagnose HIV at point-of-care will be critical for achieving the CDC’s
Ending the HIV Epidemic objectives. Thoroughly evaluating the relative performance of the pipeline of POC HIV
assays requires access to high-risk populations, stable HIV cohorts, and the expertise to select participants to
stringently test new assays. Our group has robust infrastructure and a clinical research pipeline for evaluating
the performance of serologic tests and nucleic acid amplification POC HIV tests from proof-of-concept through
prototype pre-clinical testing to FDA-approvable clinical studies of performance against laboratory-based gold-
standard comparators. We will expand existing biorepositories of well-characterized and curated participants
that we will enroll prospectively for our evaluation studies. We will store remnant samples for future use in
evaluating HIV assay prototypes to inform development. Located in a CDC designated hotspot, Baltimore, we
have large clinical populations of people living with HIV (PLWH) and well-characterized longitudinal cohorts of
high-risk patients. We also have extensive experience with needs assessments and use case-based
implementation of novel POC diagnostic tests with consideration of provider workflows in diverse settings such
as the Emergency Department. This holistic, value-based approach is needed to maximize future access and
adoption of new tests and test methods which will be needed to decrease HIV incidence and improve public
health.

## Key facts

- **NIH application ID:** 10145218
- **Project number:** 1U01PS005204-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Yukari C Manabe
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $1,644,512
- **Award type:** 1
- **Project period:** 2020-09-30 → 2023-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145218

## Citation

> US National Institutes of Health, RePORTER application 10145218, Ending the HIV Epidemic through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore (1U01PS005204-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10145218. Licensed CC0.

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