Commercial Zika Test too Often Inaccurate, FDA Says
The US Food and Drug Administration (FDA) is notifying doctors that LabCorp has reported false positive results from the ZIKV Detect test, made by InBios International. .
A commercially available test for the Zika virus may not offer a definitive diagnosis, the US Food and Drug Administration (FDA) is warning physicians who care for pregnant women.
The ZIKV Detect IgM Capture ELISA test, made by InBios International is used for preliminary detection of Zika virus IgM antibodies in human sera collected from patients with a history of clinical evidence of Zika infection. It is also used for women who have likely been exposed, such as by traveling to a Zika hot zone.
The Laboratory Corporation of America has reported that it is seeing false positives in test results, the FDA announced on December 23.
A more definitive test is offered by the US Centers for Disease Control and Prevention (CDC) and the CDC confirmed the LabCorp findings.
Going forward, the FDA said physicians should let patients know the test result may not be accurate and not rely on the test as the sole grounds for Zika diagnosis.
The agency said it is also working with the CDC, InBios, and LabCorp to identify the root cause of the problem.
The CDC had hoped commercial testing would take on some of its testing workload.
In its announcement, the FDA said it will "continue to monitor the situation and will keep the public informed."
