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).

Pregnancy status must be captured. 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.

Gold serum separator (SST) tube

Immediatley following collection, mix sample by gently inverting 5 times

1. Allow sample to clot for a minimum of 30 minutes
2. Spin within two (2) hours of sample collection

Gold serum separator (SST) tube

Red serum vial/tube - 5 mL

1. Allow sample to clot
2. Spin
3. Transfer serum to a Transfer vial/tube with cap - 12mL (LabCorp), labelled as serum, within two (2) hours of sample collection

Transfer vial/tube with cap - 12mL (LabCorp)

Refrigerated (preferred) – 7 days

Ambient – 24 hours

Frozen – >7 days

Freeze/thaw cycles: Stable x3

• Gross hemolysis
• Gross lipemia
• Samples containing particulate or exhibiting obvious microbial contamination

Antibody Capture Chemiluminescence Immunoassay (CLIA)

Negative

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. If Zika virus IgM antibody testing is positive, the specimen will be forwarded to the CDC or appropriate state health department for confirmatory plaque reduction neutralization testing (PRNT). Health care decisions should wait until confirmatory testing is conducted at the CDC or a state health department. 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.