First Zika test on market
The first US test for the Zika virus is available after Quest Diagnostics received an Emergency Use Authorization (EUA) for its Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).
Quest plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, early in the week of May 2.
Until now, the only Zika tests authorized by FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC.
The effects of the Zika virus are worse than previously believed. A new study in the New England Journal of Medicine found that, in pregnant women infected with Zika, 29% of scans showed abnormalities with the infants in womb.
Meanwhile, the test was developed by the reference laboratory business of Quest's Focus Diagnostics, Inc., subsidiary. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals.
The CDC recommends RT-PCR testing during approximately the first 7 days of symptoms onset for certain patients. A negative 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.
The CDC recommends testing for 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; and infants born to mothers who live 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.
In addition, Quest Diagnostics plans to offer serological test services, assuming FDA authorization of serological test kits for emergency use.
The EUA authorizes 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, to perform the Zika RT-PCR test.
“This 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 United States, including in Toa Baja, Puerto Rico,” Quest Diagnostics in a statement. However, “for now, only the company's Focus Diagnostics reference laboratory in San Juan Capistrano, Calif., which developed and validated the new test, will perform this test.”