NEW YORK (360Dx) – Siemens Healthineers has announced the commercial launch of a CE-marked immunoassay for Zika virus detection — the Novagnost Zika Virus IgM µ-capture Assay.
The firm said that the immunoassay enables enhanced patient outcomes through differential diagnostics in line with a World Health Organization test algorithm, and that the assay is available for sale in countries outside the US that accept the CE mark.
Siemens said that its Zika assay uses the same dilution and reagents as its other Novagnost assays, and lab professionals can run it with its Bep III and Bep 2000 Advance Systems, which are automated microtitration plate analyzers.
The test is validated for use with plasma and serum, and it detects Zika virus during the acute phase of infection, a few days after the beginning of symptoms.
"As the Zika virus continues to rise as a global public health concern, there is an increased focus on detecting [the virus] during the acute phase of infection," Franz Walt, president of laboratory diagnostics at Siemens Healthineers, said in a statement.
Siemens provides tests that enable immunoassay and molecular detection of Zika, he added.
In July, the US Food and Drug Administration had granted an Emergency Use Authorization for Siemens real-time molecular PCR Zika virus assay, the Versant Zika RNA 1.0 Assay Kit.