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The US Food and Drug Administration (FDA) has approved the ZIKV Detect 2.0 IgM Capture ELISA (InBios International Inc) for routine use in detecting anti-immunoglobulin (IgM) antibodies to the virus. Zika in the human blood.
This is the first diagnostic test for Zika that the FDA has allowed to be marketed in the United States. Previously, Zika virus IgM antibody detection badays – including the ZIKV Detect 2.0 IgM capture ELISA – were only allowed for urgent use under the authority of the FDA, authorized by the FDA. emergency use (EUA).
"At the beginning of the Zika virus outbreak, while we knew little about the disease or how to diagnose it, the FDA quickly collaborated with manufacturers to encourage the development of diagnostic tests and make sure they were available through our authorities responsible for emergency situations, "said the FDA. Commissioner Ned Sharpless, MD, explains in a press release.
"[This] The marketing authorization is an excellent demonstration of the work done by the FDA to protect public health in emergency situations. We have ensured the rapid availability of testing within the framework of the EUA, but we have continued to work with the manufacturers of diagnostic systems to ensure that the products are reviewed by the FDA from the point of view of the safety and efficiency and approved by our respective authorities before commercialization, "he said.
Zika virus is transmitted mainly by the bite of an infected virus. Aedes mosquito species. Zika virus infection has been badociated with neurological complications (eg Guillain-Barré syndrome), microcephaly and other poor outcomes badociated with Zika virus infection during pregnancy, which increases the importance of having diagnostic tests, says the FDA.
The FDA reviewed data from a clinical study involving 807 samples and various badytical studies, which showed that the ZIKV Detect 2.0 IgM Capture ELISA was safe and effective in identifying IgM antibodies to the Zika virus in humans. the blood.
The test should be used only in patients with clinical signs and symptoms suggestive of Zika virus infection and / or who meet the epidemiological criteria of the Zika virus of the Centers for Disease Control and Prevention (CDC), such as history of residence in a geographic area country with active transmission of Zika 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, advised the FDA. Negative results can be observed on samples taken before the 4th day after the onset of symptoms or after the closure of the window of detectable IgM, and therefore do not exclude the possibility of Zika virus infection, past or present, notes the agency. This test should not be used to test Zika in blood or plasma donors.
The ZIKV Detect 2.0 IgM capture ELISA was examined via the early-stage commercialization pathway, a regulatory pathway for certain devices of a new low-to-moderate risk type. Along with this marketing authorization, the FDA is putting in place "special controls" intended to provide "reasonable badurance of the safety and effectiveness of such tests," the company said. agency.
This approval has no impact on the availability of the other 14 Zika nucleic acid diagnostic products available in the US, the FDA said.
Although there have been some cases of local transmission of the Zika mosquito-transmitted virus in the continental United States in 2016, the CDC reports that no new cases have been reported in 2018 or so far. Now in 2019.
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