Medical Device Safety and Recalls: FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication

The 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 test.

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.

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