Test Catalog

Test Id : MZIKV

Zika Virus IgM Antibody Capture ELISA, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for the presence of IgM-class antibodies to Zika virus

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 confirmatory testing may be required as determined by your local health department. 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 post-symptom 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 enzyme-linked immunosorbent assay (ELISA) should not be used to rule-out infection as the specimen may have been collected prior to the development of detectable antibodies.

 

Asymptomatic pregnant women with ongoing exposure to Zika virus (eg, residence in Zika virus endemic region) should not be tested for IgM antibodies to Zika virus, but rather by molecular assays for Zika virus at least 3 times during pregnancy. Due to seropersistence of IgM-class antibodies to Zika virus for months after infection, they cannot be used to reliably distinguish recent from past infection.

 

Testing of asymptomatic pregnant women without ongoing exposure to Zika virus is no longer routinely recommended. Testing consideration should be made using a shared patient-provider decision-making model, one in which patients and providers work together to make decisions about testing and care plans.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

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

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Zika Virus MAC-ELISA, IgM, S

Aliases
Lists additional common names for a test, as an aid in searching

Zika

MZIKV

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Specimen Type
Describes the specimen type validated for testing

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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 2.5 mL

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 30 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for the presence of IgM-class antibodies to Zika virus

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

The following algorithms are available in Special Instructions:

-Assessment for Zika Virus Infection

-Mosquito-borne Disease Laboratory Testing

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 may be required and should be performed as determined by the local health department. Evaluation of sample by real-time polymerase chain reaction (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.

 

Testing of asymptomatic pregnant women with possible exposure, but without ongoing exposure to Zika virus, is not routinely recommended.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

The ZIKV Detect 2.0 IgM Capture enzyme-linked immunosorbent assay (ELISA) is for the detection of human IgM antibodies targeting the Zika virus (ZIKV) envelope glycoproteins. Polystyrene microtiter wells are precoated with polyclonal capture antibodies against human IgM. Positive control, negative control, and patient serum 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 incubation and washing, a RTU secondary antibody solution is added to each well. After a subsequent incubation and wash steps, an enzyme conjugate solution comprising horseradish peroxidase-labeled antimouse 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, secondary antibody, and conjugate. If IgM antibodies targeting the ZIKV envelope glycoproteins are not present, then the antigen, antibody, and conjugate are washed away.(Package insert: InBios Zika Detect 2.0 IgM Capture ELISA. InBios International, Inc; 05/23/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Bimonthly on the first and third Wednesday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

90 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86794

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports