Zika Diagnostic Test 2.0 Approved

InBios International ZIKV Detect 2.0 IgM Capture ELISA identifies proteins produced by the immune system

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A diagnostic test that detects Zika virus immunoglobulin (IgM) antibodies in human blood has been approved by the U.S. Food and Drug Administration (FDA). 

This is important news since the states of California (17) and Florida (19) have reported travel-related Zika virus cases during 2019. 

The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the USA. 

The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body's immune system when it tests for Zika virus infection in the blood. IgM antibodies indicate an early immune response. 

This Zika test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the CDC’s Zika virus epidemiological criteria, such as a history of residence in or travel to a geographic region with active Zika transmission at the time of travel. 

Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions.

Every test has false positives and negatives.  It is important to test only when there are good clinical reasons.  

If testing is done on low-risk people most of the results are false positives.  The accuracy of any test is often underappreciated and doing a test should always have a solid reason; even then the interpretation is important.

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Previously, tests for detecting Zika virus IgM antibodies had been authorized only for emergency use under the FDA’s authority.   

The FDA’s Acting Commissioner Ned Sharpless, M.D., said in a press release, “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 Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to public health. 

Links between Zika virus infection and neurological complications (i.e., Guillain-Barré Syndrome), as well as microcephaly (abnormal smallness of the head) and other poor outcomes associated with Zika virus infection during pregnancy, have increased the importance of having diagnostic tests available for Zika virus. 

Recent Zika news:

The FDA granted marketing authorization of the ZIKV Detect 2.0 IgM Capture ELISA to InBios International, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.