The Zika virus is a flavivirus transmitted by mosquito bites. Since May 2015, this virus has been the source of a major epidemic in Brazil, which then quickly spread in Central and South America, as well as in the Caribbean, and today affects the French Departments of the Americas (DFA), in particular Martinique and Guyana. Most infected individuals do not have any symptoms and in symptomatic cases, the disease is usually mild. However, an unusual increase in cases of foetal or neonatal microcephaly as well as Guillain-Barré syndrome (GBS), concurrent with the Zika virus epidemic, led the WHO to declare that this epidemic constituted a “public health emergency of international concern”, even if the causal links are not fully demonstrated to date. In this context, considering the current epidemiological situation in the DFA and the potential risk in mainland France in areas where the mosquito is present, HAS was asked by the Ministry of Health to urgently obtain an opinion on the direct detection test of the virus by RT-PCR in blood and urine. This test can confirm or refute the diagnosis of Zika virus infection in a subject suspected to be infected due to the occurrence of certain suggestive symptoms. This opinion will allow the registration of this test in the Nomenclature of Procedures in Laboratory Medicine (NABM).

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