Recently, the FDA warned that one of the main blood tests for ZIKA can fall prey to false positives. The FDA has issued the following recommendation and urging all positive test results get re-tested.

RECOMMENDATIONS: The FDA urges health care providers to be aware that:

  • Positive IgM Zika virus results are only presumptive for the detection of antibodies to Zika virus.
  • Confirmation of IgM Zika virus presumptive or possible positive results requires additional testing by CDC or by qualified laboratories.
  • The confirmatory testing may take a week to a month to be performed, but can be prioritized if CDC is aware that the sample is from a pregnant woman. Laboratories should be notified of the patient’s pregnancy status.

The FDA urges health care providers to:

  • Inform their patients that presumptive positive results need to be confirmed, so that pregnant women are not making health care decisions based on incomplete information.
  • Not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions. Take the following into consideration before diagnosing Zika virus infection in pregnant women:
    • clinical observations,
    • patient history,
    • epidemiological information, and;
    • results from other testing such as follow-up confirmatory testing.
  • Notify the laboratory of the patient’s pregnancy to facilitate prioritization of confirmatory testing by CDC or qualified laboratories.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

For more information, check out the FDA Safety Alert here.