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Test ID 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.

Highlights

This assay is a screening test for IgM-class antibodies to Zika virus. A presumptive positive result by this assay is not diagnostic for Zika virus infection. Confirmatory testing may be required as determined by your local health department. Confirmatory testing by a molecular assay for detection of Zika virus RNA may also be considered.

 

This assay should be used in patients presenting at least 2 weeks post-symptom onset or last possible exposure to Zika virus. Reverse transcription-polymerase chain reaction for Zika virus RNA detection should be ordered in patients with less than 2 weeks of symptoms or postexposure.

 

A single negative result by the Zika IgM enzyme-linked immunosorbent assay should not be used to rule-out infection as the specimen may have been collected prior to the development of detectable antibodies.

 

Asymptomatic pregnant women with ongoing exposure to Zika virus (eg, residence in Zika virus endemic region) should not be tested for IgM antibodies to Zika virus but rather by molecular assays for Zika virus at least 3 times during pregnancy. Due to seropersistence of IgM-class antibodies to Zika virus for months after infection, this test cannot be used to reliably distinguish recent from past infection.

 

Testing of asymptomatic pregnant women without ongoing exposure to Zika virus is no longer routinely recommended. Testing consideration should be made using a shared patient-provider decision-making model, one in which patients and providers work together to make decisions about testing and care plans.

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

Reference Values

Negative

Day(s) Performed

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

Report Available

Same day/1 to 14 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

NY State Approved

Yes

Forms

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