Determination and Declaration Regarding Emergency Use of in Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection

The Policy

What it does

Justifies emergency use of in vitro diagnostic tests for detection and/or diagnosis of Zika virus infection.

Synopsis

The Secretary of Health and Human Services declared circumstances exist to authorize the use of in vitro diagnostic tests to identify the Zika virus (via Federal Register notice, 81 FR 10878, published on March 2, 2016).

Under Section 564 of the Federal (FDCA) (21 U.S.C. 360bbb-3), the Food and Drug Administration (FDA) Commissioner, acting under delegated authority from the Secretary of HHS, may declare through an “Emergency Use Authorization (EUA)” the use of unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.

In this notice, the Secretary of Health and Human Services (HHS), Sylvia Mathews Burwell, determines that the Zika virus threatens a national health emergency, thus potentially affecting the health and security of US citizens at home and abroad.

Context

<ul>
<li>On February 22, 2016, President Obama <a href="https://www.whitehouse.gov/the-press-office/2016/02/22/letter-president-... Congress to appropriate $1.9 billion dollars to respond to the threat of Zika domestically and internationally. House Republicans disagreed with this proposition and instead looked to divert unobligated Ebola funds to the Zika effort. This ignited concerns that if funds were not directly designated to the Zika effort, other valuable research into dangerous diseases would be sidetracked by the search for Zika funds.</li>
<li>At a <a href="http://docs.house.gov/meetings/IF/IF02/20160302/104594/HHRG-114-IF02-201... of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee entitled “Examining the U.S. Public Health Response to the Zika Virus,” CDC Director Dr. Thomas R. Frieden shared that the CDC was already scaling back research on other diseases in an effort to direct funds towards Zika virus research. Though this Federal Register announcement does not have to do with funding, it reflects the government’s collective urgency in response to the Zika virus.</li>
</ul>

The Science

Science Synopsis

  • The Zika virus is contracted primarily through an infected Aedes mosquito bite, but can also be spread through mother to child transmission, sexual transmission, and blood transfusion.
  • The most common symptoms of Zika are fever, rash, joint pain, or conjunctivitis (red eyes). Other common symptoms include muscle pain and headache. Infection does not necessarily confer demonstration of symptoms.
  • The incubation period, or time between exposure and symptoms, is unknown, but is thought to be between a few days and a week.
  • Zika virus poses an especially dangerous threat to pregnant women, as it is associated with microcephaly, a condition in which a baby’s head and brain are abnormally small and the brain does not properly develop. This can lead to cognitive impairment, vision and hearing problems, seizures, and other brain-related impairments.
  • Zika virus is also associated with Guillain-Barré Syndrome (GBS), a nervous system condition that can lead to muscle weakness or temporary paralysis.
  • The CDC developed the first commercial test to detect whether a person has been infected by the Zika Virus (Zika MAC-ELISA). This test must be conducted between 2 and 12 weeks post infection.  The MAC-ELISA test has the potential to identify a false positive if antibodies from a similar virus (dengue or chikungunya) are present.  The test can indicate a false negative if the sample is collected more that 12 weeks after the infection, or if antibody concentration is too low. Relevant samples include serum and cerebrospinal fluid.
  • The CDC also developed the Trioplex rRT-PCR laboratory test, which is designed to detect Zika virus and two other viruses (dengue and chikungunya) also spread by mosquito bites. This test must be conducted within 7 days of onset of symptoms.  The test is designed to have a low false positive rate. However, false negatives are also possible for this test; a negative result does not rule out infection by Zika. Samples from this test can be gathered from urine, cerebrospinal fluid, serum or amniotic fluid.
  • There is currently no cure or vaccine for Zika virus.