ZIKV Detect 2.0 Test Explained

Zika test detects virus infection in serum within 12 weeks of infection
pregnant woman

The signs of a Zika infection in adults, such as a rash, fever, headache, and body aches are often non-specific. 

But when a pregnant woman develops such symptoms after returning from an at-risk country, she can’t be sure if it is a Zika virus infection or something less risky for her fetus.

A diagnostic test newly granted market authorization by the Food and Drug Administration (FDA) promises to help resolve this diagnostic confusion.

The ZIKV Detect 2.0 test, developed by InBios International and based in part on technology licensed from Washington University School of Medicine in St. Louis, can detect signs of Zika infection in serum samples within 12 weeks of infection.

This new test uses the antibody – as well as other components – to detect anti-Zika antibodies in the blood of people recently infected with the virus, said these Washington University School of Medicine researchers in a September 3, 2019, press release.

“Pregnant women living in or visiting places where Zika is endemic will want to know if they have been exposed to the virus,” said Michael S. Diamond, M.D., Ph.D., a co-inventor of the technology that underlies the test. 

“This test, along with another that detects viral genetic material at very early stages of infection, will help women and their doctors make informed healthcare decisions.”

This discovery was a significant step toward developing a preventive vaccine and possibly new antibody-based therapies.

In 2016, Dr. Diamond and co-inventor David Fremont, Ph.D., a professor of pathology and immunology – along with then-graduate student Estefania Fernandez, M.D., Ph.D., and postdoctoral researcher Haiyan Zhao, Ph.D. – identified and characterized an antibody that detects Zika virus proteins.

The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body's immune system when it tests for Zika virus infection in the blood. The IgM antibodies indicate an early immune response.

The ZIKV Detect test is not meant to be used as stand-alone proof of Zika infection. This is because every diagnostic test has false positive and negative results.

And, positive test results should be confirmed in accordance with guidelines from the Centers for Disease Control and Prevention (CDC). 

In addition, for women with possible exposure to both Zika and dengue viruses, testing of serum for dengue by Nucleic acid amplification test and dengue virus IgM testing also should be performed.

It is important to test people when there are good clinical reasons. 

The FDA recommends that the new Zika test be used only for people with symptoms of recent infection, as well as a history of living in or traveling to geographic regions where Zika circulates.

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The FDA authorized the marketing of the ZIKV Detect 2.0 test in May 2019.  

The development of the Zika test was funded in whole or in part with federal funds to InBios from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600014C.

Diamond and Fremont’s research was funded by the National Institutes of Health (NIH), grant numbers R01 AI073755 and R01 AI104972 and contract numbers HHSN272201400018C and HHSN272201200026C. Washington University’s Office of Technology Management licensed the Zika technology to InBios International.

Washington University School of Medicine’s 1,500 faculty physicians also are on the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is linked to BJC HealthCare.

Published by Zika News