Laboratory Corporation of America Holdings announced the nationwide availability of testing for Zika virus using the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) developed by the Centers for Disease Control and Prevention (CDC).
The test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), initially on Feb. 26, 2016, and reissued on June 29, 2016, for the qualitative detection of Zika virus IgM antibodies in serum or cerebrospinal fluid (collected alongside a patient-matched serum specimen), and is being made available for the first time to commercial laboratories, according to a press release from Lab Corp.
It is intended to be used in the diagnosis of Zika virus infection in individuals meeting clinical and/or epidemiological criteria established by CDC for Zika virus infection risk.
The Zika MAC-ELISA testing is clinically appropriate for use in indicated persons during the period beginning soon after the onset of symptoms through approximately 12 weeks following infection and is intended for use in serum or cerebrospinal fluid when submitted with a patient-matched serum sample, the press release notes.
By comparison, RT-PCR tests for Zika virus are clinically appropriate as a primary test only up to the first 7 to 14 days after the onset of symptoms, depending on the sample type tested. The RealStar® Zika Virus RT-PCR Kit U.S., which is offered by LabCorp and is tested on urine paired with serum, is clinically appropriate up to the first 7 days following infection, according to Lab Corp.