The attention of the Agency has been drawn to the FDA’s alert to 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). It has been reported that some false positive results from the ZIKV Detect test. The FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility. 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.
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).
Healthcare providers’ action
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.
Don’t rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
Notify the laboratory of the patient’s pregnancy to facilitate prioritization of confirmatory testing by CDC or disqualified laboratories.