Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.
The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).
The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.
About the EUA
The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.
This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.
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. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).
About the test
Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.
The Zika RT-PCR test is intended for use by 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 certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.
The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.
Within the US, positive results of this test must be reported to the CDC.
The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:
- Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
- Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
- Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
- Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.
A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.
For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.
