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.