Additional Relevant Details The test is the first from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. Quest Diagnostics plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, early in the week of May 2.
Zika Virus RNA Qualitative Real-Time RT-PCR test is a real-time RT-PCR test intended only for the qualitative detection of RNA from the Zika virus in human serum specimens from patients 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 ). Testing is limited to qualified laboratories designated by Focus Diagnostics, Inc.This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA and is only authorized for the duration of the declaration. Within the United States, positive results of this test must be reported to CDC. The diagnosis of Zika virus infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of Zika virus. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions.This test is intended for use by trained clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under CLIA to perform high complexity tests.