Interim Guidance for Interpretation of Zika Virus Antibody Test Results

Ingrid B. Rabe, MBChB; J. Erin Staples, MD, PhD; Julie Villanueva, PhD; Kimberly B. Hummel, PhD; Jeffrey A. Johnson, PhD; Laura Rose, MTS; Susan Hills, MBBS; Annemarie Wasley, ScD; Marc Fischer, MD; Ann M. Powers, PhD


Morbidity and Mortality Weekly Report. 2016;65(21) 

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CDC Zika Virus Diagnostic Tests

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization for the CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for antibody testing.[3] This assay has been introduced and is being used in qualified public health and Department of Defense laboratories in the United States. The Zika MAC-ELISA is used for the qualitative detection of Zika virus IgM antibodies in serum or cerebrospinal fluid collected from persons meeting the clinical and epidemiologic criteria for suspected Zika virus disease.[3,22] Results are reported as positive (termed "presumptive positive" to denote the need to perform a confirmatory PRNT), equivocal, negative, or inconclusive (i.e., results uninterpretable because of high background optical density). To resolve false-positive results that might be caused by cross-reactivity or nonspecific reactivity, presumptive positive results should be confirmed with PRNT against Zika, dengue, and other flaviviruses to which the person might have been exposed.[3,23] In addition, equivocal and inconclusive results that are not resolved by retesting also should have PRNT performed to rule out a false-positive result.