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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

Testing Algorithm

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Method Name

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

Reporting Name

Zika Virus MAC-ELISA, IgM, S

Specimen Type

Serum


Ordering Guidance


This test is not intended for medical-legal use.

 

For specimens collected less than 14 days post-symptom onset or possible Zika virus exposure, reverse transcription-polymerase chain reaction (RT-PCR) for Zika virus (ZIKV) on serum and urine to exclude a false-negative Zika virus IgM result is recommended. 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. 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, 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

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 (NAAT) have received emergency use authorization (EUA) through the Food and Drug Administration (FDA). The recommended tests vary by the patient's symptoms, course of illness, and whether or not the patient is pregnant.

 

For the most up-to-date information regarding Centers for Disease Control and Prevention (CDC) testing guidelines visit www.cdc.gov/zika/.

 

These guidelines are reflected in Assessment for Zika Virus Infection Special Instructions:

 

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 in Special Instructions for a review of the recommended testing and interpretation of results. For the most recent Centers for Disease Control and Prevention (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. 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.

Clinical Reference

1. Oduyebo T, Polen KD, Walke HT, et al: Update: Interim guidance for health care providers caring for pregnant women with possible Zika virus exposure - United States (Including U.S. Territories), July 2017. MMWR Morb Mortal Wkly Rep. 2017;66:781-793

2. Waggoner JJ, Pinsky BA: Zika virus: Diagnostics for an emerging pandemic threat. J Clin Microbiol. 2016;54(4):860-867

3. Theel ES, Hata DJ: Diagnostic testing for Zika virus: A post outbreak update. J Clin Microbiol. 2018;56(4) pii: e01972-17. doi: 10.1128/JCM.01972-17

Day(s) Performed

Bimonthly on the first and third Wednesday

Report Available

Same day/1 to 7 days

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
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

Forms

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

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-mosquitoborne