# Project-004

> **NIH NIH U19** · UNIVERSITY OF SOUTH FLORIDA · 2023 · $114,685

## Abstract

PROJECT 4 SUMMARY
Artemisinin-based combination therapies (ACTs) as the frontline treatment of uncomplicated Plasmodium 
falciparum malaria have played an indispensable role in reducing the global malaria burden. Thus, the 
circulation of falsified and substandard ACTs has become an emerging global crisis, which greatly threatens 
the gain made in malaria control. Yet, the extent of this problem is not known and there is a pressing need for 
systematic surveillance efforts of falsified ACTs. Since traditional methods for quality control of ACTs mostly
require expensive instruments and substantial technical support, the development of a point-of-care (POC) test 
for the detection of the active ingredients in ACTs under endemic settings is highly desired. In addition, as 
many malaria-endemic nations are moving towards malaria elimination, mass drug administration (MDA) and
seasonal malaria chemoprevention (SMC) programs are being increasingly deployed. A cheap and higher-throughput assay that could be used to measure the serum levels of the long-lasting ACT partner drugs will 
allow cost-effective assessment of the coverage and compliance rates in the MDA and SMC programs. To 
address these needs, we developed highly sensitive and reliable enzyme-linked immunosorbent assays
(ELISAs) for accurate quantitation of artemisinin and its derivatives. We further developed an antibody-based 
dipstick assay as a POC test for qualitative and semi-quantitative evaluation of ART and its derivatives in ACT 
drugs, which have been pilot-tested to be fast, convenient, and easy to perform in endemic sites. Based on 
these recent successes, we propose to 1) use the new POC diagnostic tools to systematically investigate the 
extent of falsified artemisinin drugs in the Greater Mekong Subregion, where the problem had been most 
serious, 2) to develop a series of specific monoclonal antibodies for three ACT partner drugs using an 
innovative design of immunogens, and 3) develop and optimize ELISAs and dipsticks for quantification and 
detection of ACT partner drugs in both commercial drugs and human plasma. We anticipate that the ELISAs 
will provide highly convenient tools for accurate quantification of active pharmaceutical ingredients in ACTs in 
the laboratory, while the combination dipsticks offer POC devices for quality control of ACTs in remote endemic 
settings.

## Key facts

- **NIH application ID:** 10821540
- **Project number:** 5U19AI089672-15
- **Recipient organization:** UNIVERSITY OF SOUTH FLORIDA
- **Principal Investigator:** LIWANG CUI
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $114,685
- **Award type:** 5
- **Project period:** 2010-07-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10821540

## Citation

> US National Institutes of Health, RePORTER application 10821540, Project-004 (5U19AI089672-15). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10821540. Licensed CC0.

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