The Centers for Disease Control and Prevention (CDC) has transferred Zika virus specimens and CDC-developed diagnostics since CDC became involved to support the public health response for the Zika virus outbreak in February 2016. Such efforts continue today.
To date, CDC has shipped relevant Zika specimens over 9 months to 18 countries and 33 U.S. states and territories, and continues to conduct transfers. The different strains/isolates of the Zika virus are essential to further Zika research, increase knowledge about the virus, and support vaccine and diagnostic test development.
CDC was the first organization to develop and receive the Food and Drug Administration’s (FDA) Emergency Use Authorizations (EUAs) for the Zika MAC-ELISA and Trioplex rRT-PCR assays, two gold-standard Zika virus diagnostic tests. These diagnostic assays were, at first, the only tools for clinical testing of people exposed to Zika virus, symptomatic or not.
The tests are still in use. The first Zika MAC-ELISA was approved by the FDA on February 26, 2016. CDC developed a second Zika MAC-ELISA version using virus-like particle (VLP) technology, and received EUA approval on June 29, 2016. CDC has also developed a method (Trioplex reverse real-time-polymerase chain reaction) to detect Zika, dengue, and chikungunya virus in samples. CDC has shared these technologies, at no cost to partners, to improve the detection of Zika virus. CDC scientists and staff have worked tirelessly to facilitate research and development of Zika, design and commercialize related diagnostic assays, and protect America’s health and quality of life.
CDC scientists and staff have worked tirelessly to facilitate research and development of Zika, design and commercialize related diagnostic assays, and protect America’s health and quality of life.
CDC is using both patented and non-patented technologies to support the Zika response. Working rapidly to develop an unprecedented Zika detection test in the Zika MAC-ELISA assay, CDC has distributed it to more than 60 public health laboratories and added commercial partners. CDC has executed licenses with four major reference laboratories for the Zika MAC-ELISA assay for diagnostic development and clinical testing for Zika infections in patients. CDC is working to license the Zika MAC-ELISA assay with new VLP technology to a company for mass production/diagnostic development and commercialization.
These technologies provide both an important backdrop for Zika research and breakthrough inventions to diagnose Zika infections. The public health importance of this development is that the Zika virus infection during pregnancy can result in serious birth defects. Additionally, some people infected with Zika may experience Guillain-Barré syndrome. Interest in this technology has yielded additional private sector work and resources directed at this problem. Finally, this successful technology transfer to the private sector has enabled the scale-up for mass production of Zika diagnostic tests and contributed to further Zika research and development.