The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Roche's LightMix Zika rRT-PCR test. The product is for use in patients meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. The test is used for the detection of Zika virus in EDTA plasma or serum samples using Roche's LightCycler 480 Instrument II or cobas z 480 Analyzer.
"The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. The FDA's granting of this EUA supports our commitment to help healthcare professionals who are working to combat this serious disease."
In addition to the LightMix Zika rRT-PCR Test, Roche has also developed the cobas Zika Test for use with the cobas 6800/8800 Systems. This test is available under an Investigational New Drug Application (IND) protocol to initiate collection and testing of blood samples for screening. It is currently being utilized in blood centres in the United States.
Manufactured by TIB MOLBIOL GmbH and exclusively distributed by Roche, the LightMix Zika rRT-PCR test is an assay for the qualitative detection of Zika viral RNA in combination with a full process RNA control that monitors all steps from extraction to PCR result. Nucleic acid extraction is authorised to be performed with Roche's MagNA Pure Compact Instrument (and Isolation Kit I – Large Volume) or, for laboratories wanting to process a higher number of samples, the MagNA Pure 96 Instrument (and DNA and Viral NA Large Volume Kit) for high-throughput automated extraction. The test was developed to run on the LightCycler 480 Instrument II or cobas z 480 Analyzer, allowing the utilization of a broad installed instrument base. The end-to-end automated process from sample preparation to results for up to 96 samples can be performed in just 2.5 hours.
The LightMix Zika rRT-PCR test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests, or by similarly qualified non-US laboratories. 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. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.