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Test Code VZIKM Zika Virus, IgM Antibody Capture ELISA, Serum


Ordering Guidance


For specimens collected less than 14 days post-symptom onset or possible Zika virus exposure, reverse transcription polymerase chain reaction testing for Zika virus using serum and urine is recommended to exclude a false-negative Zika virus IgM result. For more information see VZIKU / Zika Virus, PCR, Urine and VZIKS / Zika Virus, PCR, Serum.



Additional Testing Requirements


This is a screening test for Zika virus. As required by your local health department, confirmatory testing of a presumptive positive result may be necessary.

 

Due to similar clinical presentation and cross reactivity, testing for IgM-class antibodies to dengue virus is recommended to occur concurrently with Zika virus IgM testing. Order DENVP / Dengue Virus Antibody/Antigen Panel, Serum.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Allow blood to clot at room temperature (20-25° C) for 30 to 60 minutes, then centrifuge and aliquot serum into plastic vial.

2. Send serum specimen frozen.


Useful For

Screening for the presence of IgM-class antibodies to Zika virus

 

This test is not intended for medical-legal use.

 

This test is not recommended for asymptomatic couples attempting conception.

Method Name

IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (MAC-ELISA)

Reporting Name

Zika Virus MAC-ELISA, IgM, S

Specimen Type

Serum

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen 30 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

Clinical Information

Zika virus is an RNA virus in the genus Flavivirus and is primarily transmitted through the bite of an infected Aedes species mosquito. Other means of transmission include through transfusion of blood and blood products, sexually through genital secretions, perinatally, vertically from mother to fetus, and potentially through contact with other body secretions such as tears and sweat.

 

Historically, most cases of Zika virus infection have occurred in parts of Africa and South-East Asia. However, Zika virus emerged in South America in early 2015 and is now endemic in over 50 countries in South, Central, and North America, including in several US territories and focal regions of the southern United States.

 

The majority (approximately 80%) of individuals infected with Zika virus are asymptomatic. Among symptomatic patients, fever, headache, retro-orbital pain, conjunctivitis, maculopapular rash, myalgias, and arthralgias are commonly reported. Notably, these symptoms are not distinct and can be seen with other emerging arboviruses, including dengue and chikungunya. Therefore, diagnostic testing for each of these viruses is recommended in patients returning for areas where these viruses cocirculate. Intrauterine or prenatal infection with Zika virus has been causally linked to development of microcephaly, with the greatest risk for fetal abnormality occurring if the infection is acquired during the first trimester. Finally, Zika virus has also been associated with development of Guillain-Barre syndrome.

 

A number of Zika virus serologic and nucleic acid amplification tests have received emergency use authorization through the US Food and Drug Administration. The recommended tests vary by the patient's symptoms, course of illness, and whether the patient is pregnant.

 

The most up-to-date information regarding Centers for Disease Control and Prevention testing guidelines is available at www.cdc.gov/zika/index.html.

 

These guidelines are reflected in Assessment for Zika Virus Infection.

 

Zika virus testing is not recommended for asymptomatic couples attempting conception, given the potential for false-positive and false-negative results. Additionally, it is well established the Zika virus may remain in reproductive fluids, despite negative serologic and molecular test results in blood and urine.

Reference Values

Negative

Interpretation

See Assessment for Zika Virus Infection for a review of the recommended testing and interpretation of results. For the most recent Centers for Disease Control and Prevention guidelines for Zika virus testing visit  www.cdc.gov/zika/index.html

 

Presumptive Zika Positive:

IgM-class antibodies to Zika virus (ZIKV) detected. This is a preliminary result and does not confirm evidence of ZIKV infection. Confirmatory testing may be required as determined by your local health department. False-positive results may occur in patients with other current or prior flavivirus infections (eg, dengue virus). For patients with less than 7 days of symptoms or last possible exposure to ZIKV, reverse transcription polymerase chain reaction (RT-PCR) for ZIKV on serum and urine is recommended. A positive ZIKV RT-PCR result on either specimen is confirmatory for ZIKV infection.

 

Other Flavivirus Positive:

Antibodies to a flavivirus, not ZIKV, were detected. Consider targeted testing for IgM-class antibodies to dengue and/or West Nile viruses as appropriate, taking into consideration patient exposure and presentation.

 

Negative:

No evidence of IgM-class antibodies to ZIKV. For specimens collected less than 7 days post symptom onset or possible ZIKV exposure, RT-PCR for ZIKV on serum and urine to exclude a false-negative ZIKV IgM result is recommended. For symptomatic patients with travel to dengue endemic areas, testing for IgM antibodies to dengue virus is also recommended.

Day(s) Performed

Bimonthly on the first and third Wednesday; fifth Wednesday when applicable

Report Available

Same day/1 to 14 days

Specimen Retention Time

90 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86794

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VZIKM Zika Virus MAC-ELISA, IgM, S 80824-6

 

Result ID Test Result Name Result LOINC Value
VZIKM Zika Virus MAC-ELISA, IgM, S 80824-6

Forms

If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.