Last week FDA issued an Emergency Use Authorization (EUA) for the use of LightMix Zika rRT-PCR Test for qualitative detection of RNA from the Zika virus. The test has not been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests.
“The test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens,” according to a Roche press release.
The assay is manufactured by TIB MOLBIOL GmbH and exclusively distributed by Roche Molecular Systems. It can detect the Zika virus in EDTA plasma or serum samples using Roche’s LightCycler 480 Instrument II or cobas z 480 Analyzer. The test enables an end-to-end automated process from sample prep to results for up to 96 samples, and can be performed in 2.5 hours.
Related Articles
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
