FDA Gives Emergency Use Authorization to CDC-Developed Zika Test

At the end of February, the FDA authorized the emergency use of the CDC’s test for Zika infection. This test is called the CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), and detects antibodies against the Zika virus. This test will be distributed to qualified laboratories that perform high-complexity testing.

For more information, read the FDA and CDC press releases.

Along the same lines, Siemens Healthcare Diagnostics has developed a real-time PCR assay for Zika virus and intends to apply for Emergency Use Authorization for the test in the US, according to GenomeWeb.

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