In August, the US Food and Drug Administration approved the emergency use of a polymerase chain reaction (PCR) based test for the diagnosis of the Ebola virus. This decision was based on the announcement by the US Department of Health and Human Services (DHHS) that it had determined that “the Ebola virus presents a material threat against the US population sufficient to affect national security”.
After the FDA formally authorized the new Ebola diagnostic assay, a group of 14 public laboratories in different parts of the US will now test this diagnostic assay. These labs are part of the Laboratory Response Network which was set up with the aim of ensuring rapid detection of various chemical or biological threats, including emerging infectious diseases. This select group of labs includes state facilities in Nebraska, Montana, Maryland, Florida, Minnesota, New York, Michigan, Virginia, North Carolina, Pennsylvania, and Washington, as well as local labs in New York City and Los Angeles County. They are supported by the CDC’s labs and the U.S. Army Research Institute of Infectious Disease (USAMRIID), which developed the RT-PCR test that the FDA authorized.
Secure, Streamlined Testing Procedure
World Health Organization officials predict that new cases of Ebola could reach 10,000 per week by December as the virus outbreak is on a rampage in West Africa. Laboratory tests are a vital element in the fight to control the outbreak of Ebola in West Africa and countries around the world. According to a recent report in MedPage Today, the testing process in the US will involve the following
- Identification of patient to determine characteristics typical of a possible Ebola victim which include fever and recent travel to West Africa
- Consultation between the hospital, local or state health department, and the CDC to decide if the case is serious enough to justify testing
- Blood collection by the hospital using standard precautions associated with blood-borne pathogens
- Shipping of samples in secure water-tight packaging to both the CDC and the designated laboratory
- Handling of shipment by designated staff members
Parallel testing at the CDC is necessary to confirm tests that give a “presumptive” positive or negative verdict.
PAHPRA Enabled FDA Clearance of Army’s RT-PCR
The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) which was passed in March 2013, is the law that allowed the FDA to grant clearance for the Ebola diagnostic in the emergency circumstance, according to a report published by the Regulatory Affairs Professional Society (RAPS). This piece of legislation is aimed at empowering the government to act proactively in health crises. It allows the FDA to:
- exercise “Emergency Use Authorization” – temporarily authorize a medical product if it determines that an emergency is likely to occur
- authorize those products without first ensuring that they meet current good manufacturing practice (CGMP) regulations
The Act is a major breakthrough from past legislation as it allows the FDA to bring products into the market easily in emergency situations, without the hassles of regulatory burdens. Since the law was passed, the FDA approved a few tests for diagnosing emerging diseases such as the H7N9 influenza virus and the Middle East Coronavirus (MERS CoV). The FDA granted emergency authorization for the USAMRIID’s diagnostic assay for Ebola on the basis of the “totality of the scientific evidence available to FDA” and as there are “no adequate, approved (or) available alternative” devices to detect Ebola.