Test Details
Methodology
Antibody Capture Chemiluminescence Immunoassay (CLIA)
Result Turnaround Time
2 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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).
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.
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.
Custom 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.
Specimen Requirements
Specimen
Serum
Volume
2 mL
Minimum Volume
1 mL
Container
Gel-barrier tube or red-top tube or serum transfer tube
Collection Instructions
Blood collection aseptically by venipuncture. Samples should be allowed to clot and should be centrifuged and separated from the clot as soon as possible.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 24 hours (stability provided by manufacturer or literature reference) |
Refrigerated | 7 days (stability provided by manufacturer or literature reference) |
Frozen | >7 days (stability provided by manufacturer or literature reference) |
Freeze/thaw cycles | Stable x3 (stability provided by manufacturer or literature reference) |
Storage Instructions
Refrigerate.
Causes for Rejection
Grossly hemolyzed or lipemic samples, as well as samples containing particulate or exhibiting obvious microbial contamination
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 163084 | Zika Virus Antibody, IgM | 80824-6 | 163085 | Zika Virus Antibody, IgM | 80824-6 | |
| Order Code | 163084 | |||||
| Order Code Name | Zika Virus Antibody, IgM | |||||
| Order Loinc | 80824-6 | |||||
| Result Code | 163085 | |||||
| Result Code Name | Zika Virus Antibody, IgM | |||||
| UofM | ||||||
| Result LOINC | 80824-6 |