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Test ID MZIKV Zika Virus IgM Antibody Capture MAC-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

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.

Testing Algorithm

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection in Nonpregnant Individuals

-Assessment for Zika Virus Infection in Pregnant Women

Method Name

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

Reporting Name

Zika Virus MAC-ELISA, IgM, S

Specimen Type

Serum


Advisory Information


This test is not intended for medical-legal use.



Additional Testing Requirements


This is a screening test for Zika virus. A presumptive positive result requires confirmatory testing available from the 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 (DENVP / Dengue Virus Antibody/Antigen Panel, Serum).



Necessary Information


There are 3 ask-at-order entry questions that are required. The only acceptable answers are Yes or No.



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
Serum Frozen 30 days

Reference Values

Negative

Day(s) and Time(s) Performed

Monday,Thursday; 9 a.m.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test received Emergency Use Authorization from the U.S. Food and Drug Administration on August 17, 2016. The approval letter can be accessed here: http://www.fda.gov/downloads/medicaldevices/safety/emergencysituations/ucm517143.pdf This test is used per manufacturer's instructions. Details regarding the performance characteristics for the InBios ZIKV Detect IgM Capture ELISA, can be viewed here: http://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM517147.pdf 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