miércoles, 4 de enero de 2017

Safety update for health care providers: IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing

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January 4, 2017  |  FDA Medical Countermeasures Initiative Update

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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.
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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)

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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

  • December 19, 2016 - VERSANT® Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics, Inc.)
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.

Guidance and information for industry


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