As the world sees the deadly Ebola outbreak grip large parts of Africa, scientists working for the Defense Threat Reduction Agency Chemical Biological Joint Science and Technology Office (DTRA CB/JSTO) are racing to develop ways to rapidly diagnose and counter the disease. This race may be running quickly now, but years of careful preparation led to what is now a possible game-changing assay.
On August 5, 2014, the U.S. Food and Drug Administration (FDA) announced the Emergency Use Authorization (EUA) of the EZ1 Diagnostic Assay, a molecular diagnostic assay effective for diagnosing Ebola Zaire virus. The test is for the presumptive and qualitative diagnosis of the Ebola Zaire virus strain in the current West African outbreak.
The assay is intended for use with whole blood (inactivated) or plasma from individuals with signs and symptoms consistent with Ebola virus infection, individuals who are deemed to be at risk for exposure or individuals who may have potentially been exposed to the Ebola Zaire virus strain based on epidemiological risk factors.
This is the first case of any biothreat agent assay that was pre-positioned (pre-EAU) with the FDA prior to an outbreak. It is also the first case of a DTRA CB/JSTO-funded diagnostic assay being implemented for emergency use.
Work on the EZ1 assay was a collaborative effort solicited and funded by DTRA CB/JSTO, developed by the U.S. Army Medical Research Institute for Infectious Disease (USAMRIID) and transitioned and manufactured by the Joint Program Executive Office (JPEO)-Medical Countermeasure Systems (MCS). In 2011, as part of a bio-preparedness initiative to pre-position the Department of Defense (DoD) in the case of an outbreak, the EZ1 Diagnostic Assay was submitted to FDA for pre-EUA status along with 72 other diagnostic assays determined to have a high-impact but a low prevalence.
Filovirus assays (including the Ebola Zaire virus strain) were identified as the highest priority group and were among the first to be reviewed by the FDA. In all, the 73 diagnostic assays cover 19 “high impact, low prevalence” biothreat agents. All of the data packages were officially registered with the FDA Office of In Vitro Diagnostics (OIVD), and information on the assays was reviewed and annotated by the FDA for pre-EUA status. Contributions by DTRA CB/JSTO, USAMRIID, the U.S. Army Medical Materiel Development Activity (USAMMDA) and JPEO-MCS assured standard data was provided for all assays.
The development of this assay was critical for DoD since it was first prioritized back in 2011, and those efforts are now paying off. Prior to the current Ebola outbreak, an EZ1 assay had also been established as the first-line of surveillance for the Ebola Zaire virus strain in West Africa.
The EZ1 surveillance assay has been used at the Kenema lab in Sierra Leone (established by DTRA Cooperative Biological Engagement Program (CBEP) and JPEO-Critical Reagents Program (CRP)) as well as at the USAMRIID lab in Monrovia, Liberia. Both laboratories have now been transitioned to the Centers for Disease Control and Prevention (CDC)-Lab Response Network (LRN) by DTRACBEP and are currently running the EZ1 Diagnostic Assay as well. EZ1 surveillance assay kits are also being provided by JPEO-CRP to the Naval Medical Research Unit (NAMRU)-2 laboratory in Cambodia based on a Ministry of Health support request.
During the current outbreak, EZ1 Diagnostic Assay Test Kits have been provided to multiple labs accredited as Clinical Laboratory Improvement Amendments-certified or DoD Clinical Laboratory Improvement Program certified labs, including:
- Naval Medical Research Unit-3, Cairo, Egypt
- Landstuhl Regional Medical Center, Landstuhl, Germany
- USAMRIID, Ft. Detrick, Md.
- USAMRIID, Monrovia, Liberia
In addition, the CDC-LRN is collectively considered a DoD-designated lab for the EUA, and many labs in the network have been validated for use by proficiency testing and can be called on at any time if needed. Other laboratory facilities, both internationally and domestically, are being triaged on a case-by-case basis thanks to the tireless efforts of JPEO-MCS and USAMMDA.
Source: Article and image courtesy of JSTO in the News, edited for context and length.