Zika Test Authorized by FDA for Emergency Use

The first test from a commercial lab provider to receive the US Food & Drug Administration (FDA)’s Emergency Use Authorization (EUA) for testing patients in the USA, including Puerto Rico, for Zika infection. The molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals.

Quest Diagnostics (Madison, NJ, USA), leading provider of diagnostic information services, was granted the EUA for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test). The proprietary test was developed by the reference laboratory business of Quest's subsidiary Focus Diagnostics, Inc. This test has not been FDA cleared or approved beyond the EUA designation.

Until now, the only FDA EUA authorized Zika tests were available from the US Centers for Disease Control and Prevention (CDC) and were only used in qualified laboratories designated by the CDC. "The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak," said Rick L. Pesano, MD, PhD, vice president, research & development, Quest Diagnostics, "Quest's expertise in molecular, infectious disease, and women's health diagnostics, and relationships with half of the country's physicians and hospitals, allow us to quickly make useful tests widely available for clinical use. This capability uniquely positions Quest to complement the response of public health laboratories for Zika outbreaks where access to FDA-authorized diagnostic tests can potentially influence the quality of patient management."

The EUA authorizes use of the Zika RT-PCR test by qualified laboratories designated by Focus Diagnostics, including potentially at any CLIA high-complexity laboratory in the Quest Diagnostics network. For now, only the Focus Diagnostics reference laboratory in San Juan Capistrano (CA, USA) will perform this test. Quest Diagnostics also plans to offer serological test services assuming FDA-authorization of serological test kits for emergency use.

The Zika RT-PCR test is intended only for qualitative detection of RNA from Zika virus in human serum specimens from patients meeting 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).

Within the US, 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 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.

Related Links:
Quest Diagnostics