Zika Virus RNA Qualitative Real-Time RT-PCR

The Zika Virus RNA Qualitative Real-Time RT-PCR test contains 1 test with 6 biomarkers.

** This test is not available for California or Nevada patient testing

Clinical Significance

Most people with Zika virus infection are asymptomatic. Symptomatic individuals typically experience a mild illness characterized by fever, joint pain, rash, or conjunctivitis. Clinical illness is usually self-limited and lasts a week or less. Not all symptomatic patients report all of these clinical findings, and Zika manifestations overlap significantly with those seen in other viral infections. The incubation period is unclear, but likely to be several days. Symptoms generally resolve on their own within a week.

Pregnant women at risk for Zika virus in the U.S. and in endemic areas are of special concern due to the increased incidence of babies with microcephaly in infected mothers.

Infection with Zika during pregnancy has been linked to birth defects in babies as the Zika virus can sometimes be passed from a mother to her fetus during pregnancy. Zika virus can also sometimes be spread by a man to his sex partners and be spread before, during and after symptoms are present.

Zika virus RNA may be detected in serum for approximately 4-7 days following onset of symptoms; thus the optimum time to perform serum RNA testing is during the first week after the onset of clinical illness. For patients who are 2-12 weeks post-symptom onset, serologic testing should be considered. Test results should be used in conjunction with clinical signs and symptoms, epidemiological information and relevant travel history to diagnose Zika virus infection.

Zika infection shares epidemiologic and clinical features with Chikungunya, Dengue, and other infections. Molecular and/or serologic testing for Zika infection may be useful to diagnose the etiology of a given (usually travel-related) illness and guide further testing and management as needed.

About the Test
The Zika Virus RNA Qualitative Real-Time RT-PCR test is a Real-Time RT-PCR test intended for the qualitative detection of RNA from Zika virus in human serum specimens collected from individuals meeting Centers for Disease Control and Prevention (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). Testing is limited to qualified laboratories designated by Focus Diagnostics, Inc.

Test results are for the identification of Zika viral RNA. Zika viral RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities.

Negative results do not rule out Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Zika Virus RNA Qualitative Real-Time RT-PCR test is intended for use by trained clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the Zika Virus RNA Qualitative Real-Time RT-PCR test. The test is only for use under the Food and Drug Administration's Emergency Use Authorization.

• This test has not been FDA cleared or approved;

• This test has been authorized by FDA under an EUA for use by authorized laboratories;

• This test has been authorized only for the detection of RNA from Zika virus and not for any other viruses or pathogens; and