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Test Code LAB1323 Zika Virus IgM Antibody Capture MAC-ELISA, Serum

Additional Codes

Mayo Test ID
MZIKV

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

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

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

NA

Other

Heat-inactivated specimen

Reference Values

Negative

Interpretation

See the Zika virus algorithms in Special Instructions for a review of the recommended testing and interpretation of results. For the most recent CDC guidelines for Zika virus testing visit www.cdc.gov/zika/.

 

Presumptive Zika Positive:

IgM-class antibodies to Zika virus (ZIKV) detected. This is a preliminary result and does not confirm evidence of ZIKV infection. Definitive healthcare decisions should not be made based on this result alone. False-positive results may occur in patients with other current or prior flavivirus infections (eg, dengue virus). This specimen has been referred for confirmatory plaque reduction neutralization testing (PRNT) to the CDC or a CDC-designated laboratory. For patients with less than 14 days of symptoms or last possible exposure to ZIKV, real-time (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 Zika virus, 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 Zika virus (ZIKV). For specimens collected less than 14 days postsymptom onset or possible ZIKV exposure, the CDC recommends RT-PCR for ZIKV on serum and urine to exclude a false-negative ZIKV IgM result.

Day(s) and Time(s) Performed

Monday,Thursday; 9 a.m.

Analytic Time

Same day/1 day

Specimen Retention Time

90 days

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