EBOLA Continues to Warrant Attention From Labs

While public interest and mainstream media coverage of Ebola may appear to be waning, the outbreak has not ended and the latest CDC reports indicate the total cases exceeds 20,000 and is still rising. The virus is also continuing to receive attention from government agencies. Emergency Use Authorized for Unapproved Tests The FDA announced two emergency use authorizations of in vitro diagnostic devices for detecting the Ebola virus. The two in vitro diagnostic tests authorized are the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real Time RT-PCR Assay. Both authorizations are subject to conditions and the assays may be used only by qualified laboratories the CDC designates and with the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument. These two assays are authorized for use for "individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors," according to the FDA. The assays are used to detect the virus in whole blood, serum, and plasma specimens. They can be used with urine specimens, "tested in conjunction with a patient-matched whole blood, serum or plasma specimen." Additional conditions to the emergency use require that the CDC provide fact sheets for health care providers and patients about the assay, make those fact sheets available on its website and inform qualified laboratories using the tests that the use is subject to an emergency use authorization and explain the terms and conditions of the authorization. The CDC also must track and report adverse events, and record device usage and suspected false positives or false negatives, as must the laboratories that use the tests. Likewise, qualified laboratories must also provide the fact sheets to providers and patients when they report the results of the test. Laboratory staff utilizing the assays must be properly trained and use appropriate personal protective equipment. Finally, any advertising or promotion concerning these assays must clearly indicate that it is not FDA approved and authorized only for emergency use for testing for Ebola Zaire virus. Grounds for Emergency Use Certain conditions and threats to public health must exist to support authorizing use of unapproved products. Such emergency authorization can be granted when the HHS determines one of the following situations exists:

1. Homeland Security finds a domestic emergency or significant potential for such emergency exists relating to a "heightened risk of attack with a biological, chemical, radiological, or nuclear agent."
2. The Secretary of Defense finds a military emergency or significant potential for same, involving heightened risk of attack against military forces involving such agents.
3. The Secretary of HHS finds a public health emergency or significant potential for same, relating to such an agent, which could effect national security or US citizens living abroad.
4. Homeland Security identifies a material threat that affects national security or the health or security of US citizens abroad.

The FDA decision here is supported by a 2006 Homeland Security determination that the Ebola virus is a "material threat" that could affect national security. Not only must there be an emergency situation, such as those described above, but the test itself must meet certain criteria. The FDA must consult with CDC, NIH and the HHS Assistant Secretary or Preparedness and Response and find that 1) an agent can cause a serious or life threatening condition, 2) scientific evidence including any data available from "adequate and well controlled clinical trials" indicate it's reasonable to believe the unapproved product could help diagnose, treat or prevent a condition caused by one of the agents discussed above and that the "known and potential benefits" outweigh the "known and potential risks" of using the product, 3) no are no other "adequate, approved and available" products, plus 4) any other criteria set by regulation. Comment Sought on Ethical Issues On a related note, the Presidential Commission for the Study of Bioethical Issues recently sought public comment regarding "ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic." The Commission cited three concerns relating to the Ebola virus: 1) policies requiring the quarantine or restricted mobility of individuals' and the effect of such restrictions on public fear and anxiety or the willingness of workers to serve affected areas; 2) the ethics of using placebo-controlled trials in a public health emergency if the drug being studied "might be effective against the disease causing the emergency;" and most relevant to laboratories, 3) the ethics and standards relating to collecting and storing biospecimens in public health emergencies, and international sharing of these specimens and related data. Comments on these issues can be submitted until February 6 and will be made publicly available. Lab Handling of Specimens Questioned Interestingly, the same day the FDA authorization was published in the Federal Register, The Washington Post and The New York Times both reported that CDC laboratory staff might have been exposed to the virus when researchers permitted "potentially lethal specimens" from a highly secure CDC laboratory to be handled by a lesser secured CDC laboratory. PPE Supplies for Ebola Protection Finally, on a related note, the CDC issued a document as 2014 came to a close, discussing Ebola preparedness, the status of PPE supplies in the United States and how hospitals and other health care facilities can estimate the PPE they need to be adequately prepared. That document acknowledges that given demand, some orders for PPE may be delayed or desired quantities may not be available. The CDC advised facilities to contact their state and local health departments for assistance in obtaining PPE if they are having difficulties. This document is available on the CDC website at: http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/supplies.html Takeaway: While public interest may be lessening, government concern and action with regard to Ebola is not, and the outbreak has not ended.