FDA issues safety alert for Zika tests due to false positives

The Food and Drug Administration issued a safety alert on Dec. 23 warning physicians who care for pregnant women to not make healthcare decisions for their patients based on test results from a commercial Zika test.

The alert was issued after the regulatory agency received reports from the Laboratory Corporation of America of the ZIKV Detect IgM Capture ELISA assay — manufactured by InBios International — producing false positives. The FDA has not yet determined if the false positives are attributable to the Zika test or potential missteps on the part of the testing facility.

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In August, the FDA authorized commercial use of the test. Since the approval, several commercial laboratories have moved their serological testing away from the CDC's assay to the new commercial assay. After that transition, LabCorp began identifying higher rates of false positives than expected.

The FDA now recommends results of the commercial test be considered presumptive and that these results need to be confirmed by the CDC or another qualified laboratory. The regulatory agency is also urging providers to communicate the test's presumptive status to their patients.

More articles on the Zika virus: 
CDC adds $184M to Zika fight 
CDC issues Zika-related travel guidance for Brownsville, Texas 
Microcephaly 'the tip of the iceberg' — 4 in 10 Zika-infected babies may have serious birth defects

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