DiaSorin, Saluggia, Italy, has received FDA emergency use authorization (EUA) for the Liaison XL Zika Capture IgM assay, a fully automated serology assay for the detection of Zika virus infections.
“Leveraging over 40 years of infectious disease immunoassay product development and commercialization, we were able to develop a first-of-its-kind assay for Zika virus IgM detection,” says John Walter, president of DiaSorin Inc. “Using the proven Liaison XL platform along with an innovative assay format, utilizing the Zika NS1 antigen, DiaSorin was able to produce an assay that yields results in as little as 37 minutes after the specimen is placed on the platform.”
The assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting US Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (eg, a history of clinical signs and symptoms associated with Zika virus infection) or Zika virus epidemiological criteria. Specimens used with the assay should be collected between 8 days and 10 weeks after onset of symptoms or risk of exposure. The assay is intended for use in laboratories in the United States that are certified to perform high- or moderate-complexity tests, or by similarly qualified non-US laboratories, consistent with the latest CDC testing algorithms for the diagnosis of Zika virus infection.
The test has not been FDA cleared or approved, and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus or diagnosis of Zika virus infection.
The most common symptoms of Zika are fever, rash, joint pain, and conjunctivitis, or red eyes. The illness usually is mild with symptoms lasting for several days to a week. People typically do not get sick enough to require hospitalization and they very rarely die of Zika. For this reason, many people might not realize they have been infected. However, Zika virus infection during pregnancy can cause a serious birth defect called microcephaly, as well as other severe fetal brain defects.
Funding for the Liaison XL Zika Capture IgM assay was provided by the US Department of Health and Human Services, which granted DiaSorin a $2.6 million contract in the fall of 2016. The project is funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority; Office of the Assistant Secretary for Preparedness and Response; and the Department of Health and Human Services.
“I am extremely proud for the excellent job done by our research and development team based in Stillwater, Minn, in achieving this important milestone,” says Carlo Rosa, CEO of DiaSorin Group. “Also, I would like to thank the US Department of Health and Human Services for the continuous support provided to DiaSorin during the development of this very innovative assay. Authorization of our Zika test confirms our group’s ability to continuously innovate in the immunoassay market, providing sound and reliable solutions to customers around the globe to rapidly diagnose harmful diseases and support physicians to provide better care to patients.”