January 4, 2017 | FDA Medical Countermeasures Initiative Update
Safety update for health care providers
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing
FDA is alerting physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp), has reported some false positive results from the ZIKV Detect™ IgM Capture ELISA test.
Because confirmation tests may take a week to a month to complete, the FDA is issuing this alert so that health care providers and patients know about a higher likelihood of false positive results.
While the FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility, it is important to remember that IgM tests remain useful in ruling out Zika exposure but require confirmatory testing.
FDA urges health care providers to inform patients that presumptive positive results need to be confirmed, so that pregnant women are not making health care decisions based on incomplete information.
Related information
- Read the full alert (December 22, 2016)
- Fact sheet for health care providers (PDF, 280 KB) about the ZIKV Detect™ IgM Capture ELISA (EUA issued August 17, 2016)
- CDC Zika information for health care providers
- Zika virus response updates from FDA
Image: A laboratory technician in the process of adding solution to an enzyme-linked immunosorbent assay (ELISA) plate during a CDC training course (Credit: Pamela Cassiday, M.S., Pertussis and Diphtheria Laboratory, CDC)
New platform to report drug shortage and supply notifications
FDA is releasing a new technology platform for industry to send drug shortage and supply notifications. The platform, CDER Direct NextGen Collaboration Portal, allows industry users to log in, enter shortage information, and submit to the FDA, minimizing manual data entry and ultimately allowing for better drug shortage monitoring and mitigation.
Starting January 4, 2017 industry can notify FDA of new discontinuances, GMP issues, an increase in product demand, recalls, supply interruptions, or other events via the CDER Direct NextGen Collaboration Portal. To request a login visit: https://edm.fda.gov. If you have any questions, please contact drugshortages@fda.hhs.gov.
Related information
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EUA amendments
More information about EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, implemented in November 2016.
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Guidance and information for industry
- Guidance - Postmarket Management of Cybersecurity in Medical Devices (PDF, 1.2 MB) (Federal Register notice) - FDA will host a webinar about this guidance on January 12, 2017 - also see FDA Voice: Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology(December 28, 2016)
Events
- January 9, 2017: The HHS National Advisory Committee on Children and Disasters and the National Preparedness and Response Science Board will hold a joint public meeting via teleconference from 2:00 - 3:00 p.m. ET
- January 11, 2017: HHS ASPR TRACIE Webinar - Learning More About the 2017-2022 Health Care Preparedness and Response Capabilities (PDF, 795 KB), 2:30 - 3:30 p.m. ET
- New! January 12, 2017: FDA Grand Rounds webcast - Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products - CE credits available
- New! January 25, 2017: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PAC-CARB) meeting (Washington, DC and webcast) - register to attend in-person by January 20, 2017
- February 2, 2017: Ninth Annual Sentinel Initiative Public Workshop (Washington, DC and webcast) - register before February 2, 2017 (there will be no on-site registration)
- New! February 8-9, 2017: Public workshop - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) (College Park, MD) Attendance for this workshop is in-person only, and seating is limited. Register by February 6, 2017.
In case you missed it
- CDC is sponsoring a special supplement issue of the American Journal of Public Health (AJPH) on “The Evolution of Public Health Emergency Management from Preparedness to Response and Recovery.” Submissions will be accepted until January 15, 2017. Submission information from AJPH (PDF, 92 KB)
- FDA annual summary report (PDF, 649 KB) on antimicrobials sold or distributed in 2015 for use in food-producing animals - more about this report (December 22, 2016) - also see: FDA Announces Implementation of GFI #213, Outlines Continuing Efforts to Address Antimicrobial Resistance (January 3, 2017)
- HHS ASPR has published the 2016 PHEMCE Strategy and Implementation Plan (PDF, 2.3 MB) - more (January 3, 2017)
- CDC awards nearly $184 million to continue the fight against Zika - CDC is awarding nearly $184 million in funding to states, territories, local jurisdictions, and universities to support efforts to protect Americans from Zika virus infection and associated adverse health outcomes, including microcephaly and other serious birth defects. (December 22, 2016)
- The White House Office of Science and Technology Policy (OSTP) and the National Science and Technology Council’s (NSTC) Committee on Environment, Natural Resources, and Sustainability and Committee on Homeland and National Security released a report (PDF, 1 MB), a plan (PDF, 916 KB), and a review (PDF, 517 KB) that will improve the Nation's preparedness for and resilience to potential disasters, whether natural or manmade - Summary: strategic reports released today on science and technology for National disaster preparedness and response(December 20, 2016)
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