Linked to the birth defect microcephaly, Zika virus is primarily mosquito-borne and can also be sexually transmitted. Accurate diagnosis is of paramount importance for management of the disease and to prevent neonatal infections. The latest development is that the Office of the Assistant Secretary for Preparedness and Response (ASPR) of the US Department of Health and Human Services has announced an award of $8.9 million for Siemens Healthineers to advance the development of a Zika assay.
Zika infection during pregnancy can result in serious birth defects and is associated with other pregnancy problems. A new report from the US Centers for Disease Control and Prevention shows that as many as one in 20 babies born to mothers infected by Zika have birth defects. Improved detection methods are critical to better react to the outbreak of Zika virus.
Rick Bright, director of ASPR's Biomedical Advanced Research and Development Authority (BARDA) said, "This new diagnostic test will greatly enhance our domestic testing capacity and speed the availability of test results to help more people know whether they recently have been infected with the Zika virus, which can have devastating effects for pregnant women and their babies."
Siemens Healthineers ADVIA Centaur Zika IgM Assay is a serological test and its intended use is to determine whether someone was recently infected with Zika virus. It may augment other types of tests that specifically identify the nucleic acid (RNA) of the virus. The assay detects IgM antibodies that are specific to the Zika virus. IgM antibodies remain detectable for about 12 weeks after infection.
The aim is to develop an immunoassay that can be used on the following Siemens' analyzers:
- Advia Centaur XPT
- Advia Centaur XP, and
- Advia Centaur CP systems
This is the second high-throughput laboratory diagnostic test for Zika that BARDA has supported. These tests aim at reducing the time between testing and patients receiving test results compared to manual testing. If the test proves successful, it could become available at nearly 2,000 testing sites nationwide.
Siemens Healthineers is a a global leader in medical imaging, laboratory diagnostics, and healthcare information technology. In July 2016, the US Food and Drug Administration granted Emergency Use Authorization for Siemens' Versant Zika RNA 1.0 Assay Kit, a real-time molecular PCR Zika virus assay.