MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management DecisionsAUDIENCE: OBGYN, Internal Medicine, Infectious Disease, Family Practice ISSUE: 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. 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. BACKGROUND: The ZIKV Detect IgM Capture ELISA is used for the preliminary (presumptive) detection of Zika virus IgM antibodies in human sera collected from patients with a history of clinical signs and symptoms associated with Zika virus infection (Centers for Disease Control and Prevention [CDC] clinical criteria for Zika virus) and/or a history of residence in or travel to a geographic region with active Zika transmission at the time of travel (CDC Zika virus epidemiological criteria). In August of this year, the FDA authorized the ZIKV Detect IgM Capture ELISA manufactured by InBios International, Inc. as the first commercially available Zika serological IgM test. Since then, several commercial laboratories have started migrating their serological testing from the CDC assay authorized at the beginning of this year to the new commercial assay. The CDC test and the ZIKV Detect test report only presumptive positive results, and samples have to be sent for confirmation. Past performance characteristics indicate most of the presumptive positive results from both tests have been ultimately confirmed. After transitioning to the ZIKV Detect test, LabCorp observed higher than expected false positive results. The CDC confirmed less than half of those presumptive positive results captured by LabCorp through the ZIKV Detect test. RECOMMENDATIONS: The FDA urges health care providers to be aware that:
The FDA urges health care providers to:
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:
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