The US Food and Drug Administration (FDA) has authorized marketing
of the ZIKV Detect 2.0 IgM Capture ELISA, the first diagnostic test to detect Zika virus immunoglobulin antibodies in human blood.
This test is the first Zika diagnostic test that the FDA has permitted to be marketed in the United States, as previous tests have only been authorized for emergency use. With this marketing authorization, the FDA has revoked the Emergency Use Authorization for this product, which was previously granted in 2016.
The FDA’s decision was based upon data from a clinical study of 807 test samples and a multitude of analytical studies, which demonstrated that the test was safe and effective at identifying immunoglobulin antibodies against Zika virus in the blood.
The test, which is marketed by InBios International, Inc., has been designed to identify antibodies produced by the immune system when testing for Zika virus infection in the blood. The immunoglobulin antibodies indicate an early immune response.
Results of the test are intended to be used alongside clinical observations, epidemiological information, patient history, and other laboratory evidence to make decisions on patient management.
Negative results may be observed in specimens collected before day 4 of the onset of symptoms or after the window of detectable immunoglobulin closes, and “therefore does not preclude the possibility of Zika virus infection, past or present.”
ZIKV Detect 2.0 IgM Capture ELISA is intended for use solely in patients with clinical signs and symptoms of Zika and/or who meet the US Centers for Disease Control and Prevention’s Zika virus epidemiology criteria, which include individuals with a history of residence in or travel to a region with active Zika transmission at time of travel.
The test is not authorized for screening blood or plasma donors.
According to the FDA, the agency is considering whether the ZIKV Detect 2.0 IgM Capture ELISA test is an adequate, approved, and available alternative to the 18 other available Zika virus antibody diagnostic tests that are permitted for use under Emergency Use Authorization. The FDA is communicating with the 4 EUA holders that produce products that detect Zika virus antibodies like the ZIKV Detect 2.0 IgM Capture ELISA to gather information to evaluate whether the Emergency Authorization Use for these specific tests should be revoked. However, the FDA indicates that the marketing authorization does not impact the availability of the 14 other Zika nucleic acid diagnostics available under EUAs.
The marketing authorization was conducted through the de novo premarket review pathway. Along with this authorization, the FDA is establishing criteria that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Zika virus antibodies.
“Today’s marketing authorization is a great demonstration of the FDA’s work to protect the public health in emergency response situations,” FDA Acting Commissioner Ned Sharpless, MD, said in the 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.”
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