To speed the development of diagnostic tests for Zika virus infection, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will support the collection of blood samples from people in the continental United States and Puerto Rico who have been infected with Zika virus.
There is an urgent need to expand diagnostic capacity for serological tests that identify Zika virus-specific Immunoglobulin M, or IgM, antibody to definitively determine whether people who have been potentially exposed to Zika virus were actually infected. Diagnostic developers have identified a lack of access to blood samples positive for Zika virus antibodies, which are needed to validate whether serological tests are performing as expected, as a significant barrier to advancing the development of their products.
Under a six month, $692,000 project funded by ASPR’s Biomedical Advanced Research and Development Authority (BARDA), Clinical Research Management Inc. of Hinckley, Ohio, will collect blood samples from people who have had confirmed Zika virus infection, in coordination with state and local health departments and the Centers for Disease Control and Prevention. These samples will be collected and made available to diagnostic companies for use in validating the performance of their tests.
“Accurate diagnostic tools are vital for health care providers and their patients to determine whether people have been infected with Zika, especially pregnant women and their partners,” said Dr. Richard Hatchett, acting director of BARDA. “Today’s agreement will help ensure manufacturers will have access to resources they need to improve and ensure the accuracy of their diagnostic tools and help us better protect our nation against Zika.”
The Zika virus is spread to people primarily through the bites of infected Aedes aegypti mosquitoes. In past outbreaks, many people infected with Zika have not exhibited symptoms. However, the virus can cause a serious birth defect called microcephaly, as well as other severe fetal brain defects. Zika also has been found to be transmitted sexually.
In most people with acute infection, Zika virus can be detected in the blood for only about seven days. However, the body’s immediate immune response to the virus results in the production of the antibody IgM, which can be detected in the blood for up to 12 weeks. Knowing whether someone recently has been infected with Zika could lead to better monitoring for pregnant women and inform sexual partners of pregnant women that they should take precautions to avoid transmission.
There are no commercially available diagnostic tests cleared or approved by the U.S. Food and Drug Administration (FDA) to detect patients who have been infected with Zika virus. However, with respect to Zika diagnostic tests, the FDA is authorized to issue an Emergency Use Authorization (EUA) when, among other circumstances, there are no adequate, approved and available alternatives and certain additional criteria are met. To date, the FDA has authorized the use the use of two diagnostic tests for Zika virus—developed by the CDC—under its EUA authority; one is an RT-PCR test to diagnose acute infection and the other is an antibody test to assess whether individuals potentially exposed to Zika virus were actually infected.
Clinical Research Management Inc. is a member of BARDA’s clinical studies network, which supports BARDA-funded medical countermeasure developers and conduct clinical studies on behalf of BARDA. In addition to the clinical studies network, BARDA oversees a nonclinical development network, Centers of Innovation in Advanced Development and Manufacturing and a fill finish manufacturing network.
Advancing development of Zika antibody tests is part of BARDA’s integrated portfolio for advanced research and development of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiologic, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.