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Zika Virus Antibody (IgM)
- Ordering Info
Negative or Presumptive Recent Zika Negative
Testing should only be performed on individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection); 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 epidemiological criteria for which Zika virus testing may be indicated); and/or the CDC guidelines. 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.
Zika IgM levels over the course of illness are not well characterized. IgM levels are variable, but can usually be detected within the first 2 weeks of symptoms and continuing in some patients for 12 or more weeks. Zika Virus Antibody (IgM) should be tested as a part of a multi-test algorithm recommended by the CDC. https://www.cdc.gov/zika/hc-providers/index.html.
Assay results are for the presumptive identification of IgM antibodies to Zika virus.
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. https://www.cdc.gov/zika/hc-providers/pregnant-woman.html
Zika infection shares clinical and epidemiologic features with chikungunya, dengue, and other infections. Molecular and/or serologic testing for Zika infection may be useful to help identify the etiology of a given (usually travel-related) illness and guide further testing and management as needed.
About the Test
The Zika Virus Antibody (IgM) assay is intended for the qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria: https://www.cdc.gov/zika/hc-providers/index.html
The Zika Virus Antibody (IgM) assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Reactive results are not definitive for diagnosis of Zika virus infection. False positive results are possible in patients with a history of infection with other Flaviviruses. Confirmation of the presence of anti-Zika IgM antibodies requires additional testing according to the latest CDC testing algorithms for the diagnosis of Zika virus infection. Within the United States and its territories, presumptive positive Zika test results are reported, as required, to the appropriate public health authorities.
Results of the Zika Virus Antibody (IgM) test cannot be used as the sole basis of patient management decisions and must be combined with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IgM levels over the course of illness are not well characterized.
Negative results do not preclude the possibility of Zika virus infection, past or present. Negative results may be seen in specimens collected before detectable levels of IgM antibody develop or after the window of detectable IgM is present.
The Zika Virus Antibody (IgM) assay is intended for use by trained laboratory personnel who are proficient in performing and interpreting immunoassays in laboratories certified under CLIA. The Zika Virus Antibody (IgM) assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
• The Zika Virus Antibody (IgM) test has not been FDA cleared or approved;
• The Zika Virus Antibody (IgM) test has been authorized by FDA under an EUA for use by authorized laboratories;
• The Zika Virus Antibody (IgM) test has been authorized only for the diagnosis of Zika virus infection 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.
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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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