Zika Virus by PCR is a real-time RT-PCR test intended for the qualitative detection of Zika virus RNA from individuals 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).
Health care providers are strongly encouraged to collect serum specimens alongside other specimen types to provide additional opportunities for diagnosing Zika. A positive RT-PCR result confirms Zika virus infection, and no additional testing is indicated. When test results are negative for urine, the patient-matched serum should be tested as outlined in the current CDC-issued algorithm (http://www.cdc.gov/zika/laboratories/lab-guidance.html).
The Zika Virus by PCR test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA). This test has not been FDA cleared or approved. In compliance with this authorization, please visit https://aruplab.com/zika for more information and to access the applicable information sheets.