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Test Code 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

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.

 

This is a screening test for Zika virus. A presumptive positive result requires confirmatory testing available from the CDC or a CDC-designated laboratory.



Additional Testing Requirements


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

Clinical Information

Zika virus is a 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 CDC testing guidelines visit www.cdc.gov/zika/.

 

These guidelines are reflected in the following testing algorithms in Special Instructions:

-Assessment for Zika Virus Infection in Nonpregnant Individuals

-Assessment for Zika Virus Infection in Pregnant Women

 

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

Please 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 virus infection:

This result is a preliminary result and does not confirm evidence of Zika virus infection. Definitive healthcare decisions should not be made based on this result alone. 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 2 weeks of symptoms or last possible exposure to Zika virus, RT-PCR for Zika virus on serum and urine is recommended. A positive Zika virus RT-PCR result on either specimen is confirmatory for Zika virus infection.

 

Possible Zika virus or flavivirus infection:

This result is a preliminary result and does not confirm evidence of Zika virus infection. Definitive healthcare decisions should not be made based on this result alone. 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 2 weeks of symptoms or last possible exposure to Zika virus, RT-PCR for Zika virus on serum and urine is recommended. A positive Zika virus RT-PCR result on either specimen is confirmatory for Zika virus infection.

 

Negative-No evidence of recent Zika virus infection:

For specimens collected less than 2 weeks post symptom onset or possible Zika virus exposure, the CDC recommends RT-PCR for Zika virus on serum and urine to exclude a false negative Zika IgM result. For specimens collected 2 or more weeks post symptom onset or possible exposure to Zika virus, no further testing is required.

Other Flavivirus Positive-Antibodies to a flavivirus, not Zika virus, were detected:

Consider targeted testing for antibodies to dengue and/or West Nile viruses.

Cautions

A presumptive positive result by this test only suggests infection with Zika virus. This result should not be considered as diagnostic for Zika virus infection. False-positive results may occur in patients infected with other, closely related flaviviruses, including dengue virus, or in patients who have been vaccinated against yellow fever virus. Only limited evaluation of cross-reactivity with flaviviruses or arboviruses has been conducted. Therefore, confirmatory testing of presumptive or possible positive samples is required and should be performed at the CDC by plaque reduction neutralization testing (PRNT). Evaluation of sample by real-time PCR for Zika virus may also be warranted.

 

False-negative results can arise from specimen collection prior to development of an IgM antibody response (less than 4 days postsymptom onset) or after IgM levels have decreased below detectable levels. Negative results from at-risk individuals who are immunosuppressed should be interpreted with caution.

 

Negative results do not preclude infection with Zika virus and should not be used as the sole basis of patient treatment or management decisions. All results should be interpreted by a trained professional in conjunction with review of the patient's exposure history and clinical signs and symptoms.

 

Zika and dengue virus infections presents with symptoms similar to other arboviruses that cocirculate in areas where Zika virus is currently endemic. Diagnostic testing to rule out these infections (eg, chikungunya) and other similar presenting infection should be considered.

Clinical Reference

1. Oduyebo T, Polen KD, Walke HT, et al: US Update: Interim Guidance for Health Care Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure - United States. MMWR 2017;Jul 24;66

2. Zika MAC-ELISA: CDC. Emergency Use Authorization Instructions for Use. Available at www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM517147.pdf

3. Waggoner JJ, Pinsky BA: Zika Virus: Diagnostics for an Emerging Pandemic Threat. J Clin Micro 2016;54(4):860-867

Method Description

The ZIKV Detect IgM capture enzyme-linked immunosorbent assay (ELISA) is an enzyme-linked capture immunoassay for the detection of human IgM antibodies targeting the ZIKV envelope glycoproteins. Polystyrene microtiter wells are precoated with polyclonal capture antibodies against human IgM. Positive Control, Negative Control, and unknown test samples are diluted into a sample dilution buffer and then added to the ELISA plate in appropriate locations. After incubation and washing, a subsequent ready-to-use (RTU) ZIKV antigen (Zika Ag), a cross-reactive control antigen (CCA), and a normal cell antigen (NCA) are added separately to each corresponding well. After a subsequent incubation step and wash step, an enzyme conjugate solution comprising horseradish peroxidase-labeled monoclonal anti-flavivirus antibody is added to each well. After washing, wells are incubated with a tetramethylbenzidine (TMB) substrate. An acidic stop solution is then added and the degree of enzymatic turnover is determined by the absorbance (optical density) measurement at 450 nanometers. If human IgM antibodies targeting the ZIKV envelope glycoproteins are present, a complex is formed consisting of the IgM, antigen, and conjugate. If IgM antibodies targeting the ZIKV envelope glycoproteins are not present, then the antigen and conjugate are washed away.(Package insert: InBios Zika Detect IgM Capture ELISA, InBios International, Inc, Seattle, WA)

Day(s) and Time(s) Performed

Monday, Wednesday, Friday; 9 a.m.

Analytic Time

Same day/1 day

Specimen Retention Time

90 days

Performing Laboratory

Mayo Medical 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