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Test ID MZIKV Zika Virus IgM Antibody Capture ELISA, Serum

Useful For

Screening for the presence of IgM-class antibodies to Zika virus in patients presenting with symptoms for 14 or more days

 

Establishment of baseline serologic levels of IgM-class antibodies to Zika virus in women who have traveled to a Zika virus endemic region or who have had sexual exposure to Zika virus and who are considering conception

 

This test is not intended for medical-legal use.

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 and requires confirmatory testing by plaque reduction neutralization testing (PRNT) performed at the CDC or a CDC-designated laboratory. 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 postsymptom onset or last possible exposure to Zika virus. Reverse transcription-polymerase chain reaction (RT-PCR) 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 ELISA should not be used to rule-out infection as the specimen may have been collected prior to the development of detectable antibodies.

Method Name

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

Reporting Name

Zika Virus MAC-ELISA, IgM, S

Specimen Type

Serum


Advisory Information


If the patient is pregnant, order PNZIK / Prenatal Zika Virus IgM Antibody Capture-ELISA, Serum.

 

For specimens collected less than 14 days postsymptom onset or possible Zika virus exposure, the Centers for Disease Control and Prevention (CDC) recommends reverse transcription-polymerase chain reaction (RT-PCR) for ZIKV on serum and urine to exclude a false-negative Zika virus IgM result. These are available as RZIKU / Zika Virus, PCR, Molecular Detection, Random, Urine and RZIKS / Zika Virus, PCR, Molecular Detection, Serum.



Additional Testing Requirements


This is a screening test for Zika virus. A presumptive positive result requires confirmatory testing available from the Centers for Disease Control and Prevention (CDC) or a CDC-designated laboratory.

 

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



Necessary Information


Three answers are required for order entry questions. The only acceptable answers are Yes or No.

If ordering electronically, record at order entry.

If not ordering electronically, provide the answers to the following questions with the specimen:

1. Could the patient be pregnant?

2. Has the patient traveled to or is a resident of a Zika endemic region?

3. Does the patient currently have or recently had Zika symptoms?



Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 2.5 mL


Specimen Minimum Volume

2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen 30 days

Reference Values

Negative

Day(s) and Time(s) Performed

Tuesday; 9 a.m.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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
MZIKV Zika Virus MAC-ELISA, IgM, S 80824-6

 

Result ID Test Result Name Result LOINC Value
SZIKV Zika Virus MAC-ELISA IgM, S 80824-6
PREGO Pregnant? 11449-6
TRVL Travel to/Resident of Zika Region? 8691-8
SYMPS Current or prior Zika symptoms? 75325-1

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.