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An FDA-Authorized Zika Test
Chris Newmarker
June 9, 2016
2 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "An FDA-Authorized Zika Test")
Quest Diagnostics in April announced FDA emergency use authorization for its Zika virus RNA qualitative real-time test (Zika RT-PCR test).
The proprietary molecular test allows for detection of RNA from the Zika virus in serum from human blood. Quest's test, made by its Focus Diagnostics business, was the first commercial test to receive an emergency use authorization from FDA. Previously the only FDA-authorized tests under emergency use authorization had to be used in CDC-qualified laboratories.
Quest made its Zika RT-PCR test broadly available to physicians in May. The tests go to labs designated by Quest's Focus business, and certified to perform high complexity tests under the U.S.'s Clinical Laboratory Improvement Amendments of 1988.
"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," Quests's R&D vice president Rick Pesano, MD, PhD, said in a news release.
FDA's emergency use authorization letter for the test describes it as a real-time reverse transcriptase PCR (rRT-PCR) test. Here's how FDA describes how it works:
"The Zika Virus RNA Qualitative Real-Time RT-PCR includes primers and dual-labeled hydrolysis (Taqman ) probes targeting two separate nucleotide sequences within the Zika virus genome to be used in the in vitro qualitative detection of Zika virus RNA isolated from human serum and any other authorized specimens. The purified nucleic acids are first reverse transcribed into cDNAs. In the process, the probes anneal to the specific target sequences located between the respective forward and reverse primers. During the extension phase of the PCR cycle, the 5' nuclease activity of Taq polymerase degrades the probes, causing the reporter dyes to separate from the quencher dyes, generating fluorescent signals. With each cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity."
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