Zika virus is a mosquito-borne flavivirus and is closely related to dengue, yellow fever, Japanese encephalitis, and West Nile viruses. Most people infected with Zika virus do not have symptoms, but when present they are usually mild and last less than seven days. The most common symptoms of a Zika infection are fever, rash, joint pain, or conjunctivitits (red eyes). Other symptoms can also include muscle pain and headache1. Zika virus infection may lead to an increased risk for Guillain-Barre syndrome, an illness that causes temporary paralysis. Zika virus infection during pregnancy has been linked to adverse pregnancy and birth outcomes, most notably microcephaly and other serious brain anomalies2,3.
Virus-specific IgM and neutralizing antibodies are typically present after the first four days of illness and may be detectable for up to 12 weeks1. Combined with patient demography and clinical findings, detection of IgM antibodies to Zika virus provides an essential tool for diagnosing and following up an acute or recent infection.
Leveraging over 40 years of infectious disease immunoassay development DiaSorin has been able to develop a first-of-its-kind assay for Zika virus IgM detection. Using the proven LIAISON® XL platform along with an innovative assay format, utilizing the Zika NS1 antigen, an assay was developed that yields results in as little as 51 minutes. This format also allows for the LIAISON® XL Zika Capture IgM assay to have limited cross reactivity to other common flaviviruses such as Dengue and West Nile Virus.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- The Centers for Disease Control; http://www.cdc.gov/zika/index.html
- Rasmussen, Sonja; Jamieson, Denise; Honein, Margaret; Petersen, Lyle. (2016). Zika Virus and Birth Defects – Reviewing the Evidence for Causality. NEJM. 374:1981-1987
- Honein, Margaret A. et al. (2017). Birth Defects Among Fetuses and Infants of US Women with Evidence of Possible Zika Virus Infection During Pregnancy. JAMA. 317(1):59-68