Zika Virus Antibody (IgM)

Test Code
94264

CPT Codes
86794

Preferred Specimen
3 mL serum

Minimum Volume
1 mL

Other Acceptable Specimens
Serum separator tube (SST®), received spun

Instructions
• Order Zika tests separately from other tests - on a separate requisition.
• Collect blood in a serum separator tube (preferred) or a standard red-top.
• Allow blood to clot at room temperature.
• Blood collection tube should be centrifuged as soon as possible and serum transferred to a plastic  
  transfer tube in order to avoid hemolysis.
• Transport refrigerated (cold packs) to local Quest Diagnostics accessioning laboratory.
IMPORTANT: If sample is being shipped directly to the performing laboratory facility by an overnight air courier, then transport it frozen on dry ice.
• Specimens must not be left in lock boxes.

Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Serum received in a frozen serum separator tube • Serum received in an unspun serum separator tube • Serum received in a standard red-top tube (not transferred to plastic transfer tube) • Plasma • Grossly lipemic • Gross hemolysis

Methodology
Immunoassay (IA)

FDA Status
The test is only for use under the Food and Drug Administration's Emergency Use Authorization.

Setup Schedule
Set up: Mon-Sat; Report available: 4-5 days

Clinical Significance
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 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 CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.