Zika Virus Antibody, IgM

Use: Presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (eg, a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

Limitations: Interpretation of Zika IgM results must account for the possibility of false-negative and false-positive results.

False-negative results can arise from:

a) Specimen collection conducted before IgM has reached detectable levels (typically around 4 days post onset of symptoms);

b) Specimen collection conducted after IgM levels have decreased below detectable levels (around 12 weeks post onset of symptoms);

c) Improper collection, storage, or transport of specimens.

False-positive results can arise from:

a) Specific cross-reactivity with IgM for other flaviviruses (eg, Dengue virus);

b) Non-specific cross-reactivity with other immunoglobulins;

c) Cross-reactivity with Dengue IgM, Parvovirus B19 IgM, Chikungunya virus IgM, and Rheumatoid Factor.

This assay has not been evaluated in a pediatric population.This assay is not indicated for testing blood or plasma donors. Screening of the general population should not be performed.

Methodology: Antibody Capture Chemiluminescence Immunoassay (CLIA)

Special Instructions: Please refer to CDC guidance prior to submitting specimens for testing. This assay is intended for individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. Specimens from symptomatic patients or returning travelers from endemic areas must not be collected earlier than day 8 after the onset of symptoms or risk of exposure. Zika virus serologic testing is not recommended for asymptomatic pregnant women.

Additional Information: IgM levels are variable, but typically become positive starting in the first week after onset of symptoms and continuing for up to 12 weeks post symptom onset or exposure, but may persist for months to years. Zika virus antibody testing is complicated by cross-reactivity with other flaviviruses, which may make conclusive determination of which flavivirus is responsible for the person's recent infection difficult. Negative results do not preclude infection with Zika virus, past or present, and should not be the sole basis of a patient treatment/management or public health decision. All results should be interpreted by a trained professional in conjunction with review of the patient's history and clinical signs and symptoms.

References: AABB. Updated Recommendations for Zika, Dengue, and Chikungunya Viruses. AABB Association Bulletin No. 16-07 September 28, 2016.
Bingham AM, Cone M, Mock V, et al. Comparison of Test Results for Zika Virus RNA in Urine, Serum, and Saliva Specimens from persons with Travel-Associated Zika Virus Disease - Florida, 2016. MMWR Morb Mortal Wkly Rep. 2016 May 13;65(18):475-478. PubMed 27171533
Centers for Disease Control and Prevention. Testing for Zika Virus guidance: CDC web site. http://www.cdc.gov/zika/hc-providers/testing-for-zika-virus.html. Accessed April 2020.
Centers for Disease Control and Prevention. Zika MAC-ELISA Assay Instructions for Use. Version: June 29, 2016.
DiaSorin LIAISON XL Zika Capture IgM II (Ref 317150). US-52649-2019-11.
InBios Zika Detect IgM Capture ELISA Instructions for Use. August 17, 2016.
Petersen EE, Polen KN, Meaney-Delman D, et al. US Update: Interim Guidance for Health Care Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure - United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 1 Apr;65(12):315-322. PubMed 27031943
Rabe IB, Staple E, Villanueva J, et al. Interim guidance for interpretation of Zika virus antibody test results. MMWR Morb Mortal Wkly Rep. 2016 Jun 3;65(21):543-546. PubMed 27254248
World Health Organization. Laboratory testing for Zika virus infection. Interim guidance. 23 Mar 2016. WHO/ZIKV/LAB/16.1.
World Health Organization, Pan American Health Organization. Zika virus (ZIKV) Surveillance in the Americas: Laboratory detection and diagnosis. Algorithm for detecting Zika Virus (ZIKV). Available at: http://www.paho.org/hq/index.php?option=com_docman&task=doc _view&Itemid=270&gid=30176&lang=en. Accessed March 2020.