On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.’s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests.
In response to Focus Diagnostics, Inc.’s request to amend this EUA, on October 7, 2016 FDA reissued the April 28, 2016, EUA in its entirety with the Focus Diagnostics, Inc.’s requested amendments incorporated. The amendments to the Zika Virus RNA Qualitative Real-Time RT-PCR Test: (1) allow use of a commercially sourced inactivated Zika virus as a positive control material in addition to the Zika virus strain FLR (live virus); (2) allow the addition of urine (when collected alongside a patient-matched serum specimen) as an authorized specimen type; (3) update the Instructions for Use with the results of the FDA Reference Material sensitivity studies; (4) combine the Pregnant Women and Patient Fact Sheets into one Patient Fact Sheet; and (5) enable, as described in Section IV (Conditions of Authorization) of this letter, certain changes or additions to be made by Focus Diagnostics, Inc. in consultation with, and with concurrence of, the Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The authorized Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.
- Letter of Authorization
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- Labeling