Zika Virus Antibody (IgM), MAC-ELISA

Message
Order Zika tests separately from other tests - on a separate requisition.
Zika collections should be performed at CompuNet Patient Service Centers since they are best equipped to maintain specimen stability and integrity.
Specimens must NOT be left in lock boxes.

Test Code
94264

CPT Codes
86794

Preferred Specimen
3 mL serum

Minimum Volume
1 mL serum

Instructions
Collect blood in a serum separator vacutainer 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 tube, in order to avoid hemolysis.


Transport Container
Transport tube (plastic)

Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature = unacceptalbe Refrigerated = 7 days Frozen = 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
serum received in spun serum separator tubes

Methodology
Immunoassay

This test is only for use under the Food and Drug Adminstration's Emergency Use Authorization.

Setup Schedule
Monday - Saturday

Report Available
2 - 3 days

Clinical Significance
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.

Zika IgM levels over the course of illness are not well characterized. IgM levels are variable, but generally are positive starting near day four post onset of symptoms and continuing for 12 or more weeks following initial infection. Zika Virus IgM MAC-ELISA should be tested as a part of a multi-test algorithm recommended by the CDC. http://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. http://www.cdc.gov/zika/hc-providers/pregnant-woman.html

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 help identify the etiology of a given (usually travel-related) illness and guide further testing and management as needed.

About the Test
The Zika MAC-ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera 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). All Zika testing must be conducted following the CDC-issued Zika laboratory guidance and testing algorithms: http://www.cdc.gov/zika/hc-providers/index.html

The assay is intended for use in qualified laboratories designated by the CDC, as a part of a multi-test algorithm. Assay results are for the presumptive identification of IgM antibodies to Zika virus. Positive and equivocal 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 such as dengue virus. Confirmation of the presence of anti-Zika IgM antibodies in equivocal or presumptive positive specimens requires additional testing using the CDC-issued algorithm. Positive or equivocal results must be considered in conjunction with additional testing using the CDC-issued algorithm and/or considered alongside test results for other patient-matched specimens using the CDC-issued algorithm.

Results of this 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. IgM levels are variable, but generally are positive starting near day four post onset of symptoms and continuing for 12 or more weeks following initial infection.

Negative results do not preclude the possibility of Zika virus infection, past or present. Negative results may be seen in specimens collected before day four (prior to antibody development), or after the window of detectable IgM (approximately 12 weeks) post onset of symptoms. The Zika MAC-ELISA is intended for use by trained laboratory personnel who are proficient in performing and interpreting immunoassays in qualified laboratories designated by the CDC.

The Zika MAC-ELISA 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 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

Performing Laboratory
Quest Diagnostics Infectious Disease
33608 Ortega Highway
Building B - West Wing
San Juan Capistrano, CA 92675



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.