The Food and Drug Administration of the United States (FDA) has cleared the ZIKV Detect IXM Capture ELISA (InBios International Inc) to use it regularly in detecting immunoglobulin antibody Zika virus (IgM). ) in human blood.
This is the first diagnostic test for the FDA Zika which has been marketed in the United States. Previously, it was only for urgent use under the authorization of emergency use (EUA) of the FDA that authorized tests for detecting antibody IgM Zika virus – including the ZIKV Detect IgM Capture ELISA.
"At the start of the Zika virus case, when little was known about the disease or how to do it, FDA worked quickly with manufacturers to encourage the development of diagnostic tests and make them available using our emergency use authorities. T , "FDA Acting Commissioner Ned Sharpless, MD, explains in a news release.
"[This] marketing authorization is an excellent example of the FDA's work to protect public health in emergency response situations. We ensured that tests were available quickly under EUA, but we continued to work with diagnostic manufacturers to take the next step in ensuring that products were reviewed for safety and efficacy and authorized under our supermarket authorities. traditional, "he noted.
The Zika virus is spread to humans mainly by biting infection Aedes species mosquito. Zika virus infection has been linked to neurological complications (eg Guillain-Barré Syndrome), as well as microceffal and other poor outcomes associated with Zika virus infection during pregnancy, increasing the importance of having diagnostic tests available, the FDA says.
The FDA reviewed data from a clinical study of 807 test samples and a range of analytical studies, which showed that the ZIKV Detect 2.0 IgM Capture ELISA was safe and effective in identifying IgM antibodies against the Zika virus in blood.
The test should only be used in patients with clinical signs and symptoms consistent with Zika virus infection, and / or meeting the epidemiological criteria of the Zika virus for Disease Control and Prevention (CDC). , such as the history of residence, or travel to, geographical region with Zika active transmission at the time of travel.
The test results should be used in conjunction with clinical observations, patient history, epidemiological information and other laboratory evidence to make patient management decisions, the FDA advised. Negative results can be seen in specimens collected before day 4 after the symptoms start or after a closed IgM window is closed, and so does not prevent the possibility of Zika virus infection, in the past or present, the agency notes it. This test should not be used to test blood donors or plasma for Zika.
ELISA Capture ZIKV 2.0 IgM Capture was reviewed via de novo pre-market route, a regulatory route for some low to moderate risk devices of a new type. Along with this marketing authorization, the FDA is setting up "special controls" designed to provide "reasonable assurance of security and effectiveness for testing of such," the agency said. T .
This approval does not affect the availability of 14 other Zika nucleic acid diagnostics available under EUAs, says the FDA.
Although there are some local Zika mosquito virus transmissions in the USA in 2016, the GDC reports that no new cases were reported in 2018 or so far in 2019.
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