FDA Issues Emergency Use Authorization for Zika RT-PCR test


In the mission of fighting down the Zika virus infection, U.S. FDA has deployed another weapon in the combat. FDA granted Emergency Use Authorization (EUA) to the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test) of US headquartered Quest Diagnostics.

Zika RT-PCR test is the first FDA EUA approved test for Zika virus RNA from a commercial laboratory provider. Till now FDA only approved CDC (Centers for Disease Control and Prevention) under EUA to carry out Zika tests in its qualified laboratories. Any CLIA (Clinical Laboratory Improvement Amendments) certified high-complexity laboratory in Quest Diagnostics Network can perform this test. The EUA authorization of the test by FDA means the test is permitted to use only for the declared period of time.


Figure 1. An employee shows a test kit for the Zika virus at Genekam Biotechnology AG in Duisburg, Germany. (Photo credit: REUTERS/INA FASSBENDER)

RT-PCR test stands for Reverse Transcription-Polymerase Chain Reaction test. It is currently the most sensitive technique for mRNA detection. Zika RT-PCR test will qualitatively detect the RNA from Zika virus present in human serum specimens of patients who satisfy CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria.

Fetal microcephaly and other birth defects in the Zika virus infected pregnant women has been confirmed by international and US health officials. CDC has provided a complete guidelines regarding who should get themselves checked by RT-PCR testing for Zika virus infection.

Quest Diagnostics is also planning to provide serological test kits for emergency use after securing FDA authorization.

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, M.D., Ph.D., vice president, research and 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.”  

Featured image credit: Cell cultures in micro tubes with lids © trans961 (Stock Photo ID: 26362667)

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