Skip to main content

FDA Clears InBios International Zika Antibody Test

NEW YORK (360Dx) – The US Food and Drug Administration today granted marketing authorization for the InBios International ZIKV Detect 2.0 IgM Capture ELISA — the first diagnostic test for detecting Zika virus immunoglobulin (IgM) antibodies that the agency has allowed to be marketed in the US.

The test identifies protein antibodies produced by the body's immune system in response to Zika virus infection in the blood.

Tests for detecting Zika virus IgM antibodies — including the InBios ZIKV Detect 2.0 IgM Capture ELISA — had already been authorized only for emergency use in which the agency permits use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.

"At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities," FDA Acting Commissioner Ned Sharpless, said in a statement. "We ensured there were tests made available quickly under EUA, but we continued to work with diagnostic manufacturers to take the next step of ensuring products were FDA reviewed for safety and effectiveness and authorized under our traditional premarket authorities."

The FDA said it reviewed data from a clinical study of 807 test samples and a variety of analytical studies that demonstrated that the InBios International test was safe and effective at identifying IgM antibodies against Zika virus in blood.

The ZIKV Detect 2.0 IgM Capture ELISA is for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and who meet the US Centers for Disease Control and Prevention's Zika virus epidemiological criteria. The test is not authorized by the FDA for testing blood or plasma donors.

The FDA granted its marketing authorization after reviewing data for the ZIKV Detect 2.0 IgM Capture ELISA test through its de novo premarket review regulatory pathway for low-to-moderate-risk devices of a new type. Subsequent devices of the same type with the same intended use go through the FDA's 510(k) pathway, whereby they can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA said it is considering whether the ZIKV Detect 2.0 IgM Capture ELISA test is an adequate, approved, and available alternative to other currently available Zika virus antibody diagnostic tests available under EUAs.

There are 18 other active EUAs for tests to diagnose Zika virus infection, four of which detect Zika virus antibodies. The FDA is communicating with the four EUA holders to evaluate whether it should revoke the EUAs for these specific tests. However, the marketing authorization granted today does not impact the availability of the 14 other Zika nucleic acid diagnostics available under EUAs, the FDA said.