# Serologic assays for detection of Zika virus antibodies for clinical diagnosis and blood donor counseling

> **NIH NIH R44** · KEPHERA DIAGNOSTICS, LLC · 2020 · $1,000,000

## Abstract

PROJECT SUMMARY
Zika virus, until recently an obscure mosquito-borne flavivirus from Africa, emerged rapidly in 2015-2016 to pose
a major threat to public health in the Western Hemisphere. Having traveled across the Pacific, it quickly became
endemic in South and Central America, Mexico and the Caribbean, carried by a compatible Aedes mosquito
vector population. While Zika virus infection is typically relatively benign in the acute stage, it is has been causally
linked to Congenital Zika Syndrome (CZS) exemplified by microcephaly in infants born to infected women, and
to Guillain-Barré syndrome and meningitis. In addition to transmission by mosquito bite, Zika can be transmitted
by sexual contact and through blood transfusions. The World Health Organization (WHO) declared Zika to be
an international public health emergency, and the U.S. Centers for Disease Control (CDC) and the U.S. Food
and Drug Administration (FDA) promptly ramped up efforts to prepare for and respond to the threat posed by
Zika in the United States. Accordingly, FDA advised the temporary deferral of blood donors who had potential
exposure in endemic areas such as Puerto Rico, and approved the Emergency Use Authorization (EUA) of
investigational blood screening assays detecting viral RNA. However, the duration of viremia is very short, such
that most individuals exposed to Zika virus are likely to be negative when tested for viral RNA, and the only
means to detect prior exposure and associated health risks in such cases is through serologic tests for antibodies
to the virus. As the emergence of Zika as a significant human health threat is quite recent, the development of
diagnostic assays is still at an early stage, with the first generation of commercial products for serologic testing
falling short of ideal performance. A major challenge has been the differentiation of Zika from Dengue virus
infection, given that the two viruses are genetically closely related, are carried by the same mosquito vectors,
and overlap geographically in regions of endemicity. A large fraction of the endemic population carries IgG to
Dengue as a result of prior exposure, and the presence of this background Dengue IgG complicates the detection
of Zika antibodies in the same individuals. While the 2015-2016 Zika outbreak has subsided, the potential for a
recurrence requires public health readiness, including accurate assays to detect infection. This project addresses
the critical need for a highly sensitive and specific serological assay for Zika virus infection that avoids cross-
reactivity with Dengue and other viral infections. This assay is needed clinically to identify pregnant women at
risk of CZS due to an earlier exposure, as well as epidemiologically to monitor the extent of Zika exposure in a
possible outbreak where NAAT testing is impractical due to the time limitations for detection of viremia. In Phase
I, we demonstrated feasibility of a prototype assay specific for the Zika virus that ac...

## Key facts

- **NIH application ID:** 10081089
- **Project number:** 2R44AI134502-03
- **Recipient organization:** KEPHERA DIAGNOSTICS, LLC
- **Principal Investigator:** Andrew E. Levin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 2
- **Project period:** 2017-08-18 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081089

## Citation

> US National Institutes of Health, RePORTER application 10081089, Serologic assays for detection of Zika virus antibodies for clinical diagnosis and blood donor counseling (2R44AI134502-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10081089. Licensed CC0.

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