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Zika Virus RNA, Qualitative, Real-Time RT-PCR
- Ordering Info
Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
|Zika RNA Real-Time RT-PCR||Not detected|
Testing should only be performed on 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, such as possible sexual transmission). 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 or other congenital defects if mothers are infected during pregnancy. Please refer to the CDC guidelines for the appropriate testing in pregnant women (http://www.cdc.gov/zika/hc-providers/pregnant-woman.html).
Zika virus RNA may be detected in serum for approximately 4-7 days following onset of symptoms; but may be detected longer in a pregnant woman, thus the optimum time to perform serum RNA testing is during the first week after the onset of clinical illness in non-pregnant patients. During pregnancy, the duration of viremia and/or viruria may be prolonged. Evidence suggests that pregnant women may have detectable virus in serum for up to 14 days or longer, therefore PCR testing is recommended at least up to 14 days or longer in a pregnant woman. 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 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).
Test results are for the identification of Zika viral RNA. Zika viral RNA is generally detectable in serum during the acute phase of infection. Following the onset of symptoms RNA may be detected in serum for approximately 7 days, or longer in a pregnant patient. A positive result provides evidence of Zika virus 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. Serological testing should also be considered. Laboratory test results should always be considered in the context of clinical observations, patient history, and epidemiological information in making a final diagnosis and patient management decisions.
The Zika Virus RNA Qualitative Real-Time RT-PCR 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
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(l) of the Act, 21 U.S.C. 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
To view specimen requirements and codes please Select a regional laboratory.
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Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
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