The Food and Drug Administration has cleared the ZIKV Detect 2.0 lgM Capture ELISA (InBios) for testing of Zika virus immunoglobulin antibodies in blood.
The test is the first diagnostic to receive marketing clearance for Zika detection in the US. Previous tests were only available for emergency use under the Agency’s Emergency Use Authorization (EUA) authority.
The FDA approval was based on data from a clinical study of 807 test samples which showed that the test was safe and effective at identifying immunoglobulin antibodies against Zika virus in blood. The test is only intended for use in patients with clinical signs and symptoms consistent with Zika infection and/or meet the epidemiological criteria, such as travel in a region with active Zika transmission.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information and other laboratory evidence to make patient management decisions,” according to an FDA statement. “Negative results may be seen in specimens collected before day four after the onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
Zika, a flavivirus, has multiple modes of transmission, with the primary being the bite of an infected mosquito but also through vertical transmission and sexual contact. Although Zika infections are usually not life threatening, infection during pregnancy is associated with adverse fetal outcomes.
For more information visit FDA.gov