BARDA partnership with Chembio bears fruit as Zika diagnostic test heads to market

For three years, the Biomedical Advanced Research and Development Authority (BARDA) has supported the development of Chembio Diagnostics’ DPP Zika IgM System diagnostic system, and now, the result has been approved for marketing by the U.S. Food and Drug Administration.

The test detects antibodies specific to a Zika virus immunoglobulin, IgM, as means of determining immune response within patients. Such antibodies are produced to fight viruses. Zika is a mosquito-carried flavivirus capable of inflicting fevers, rashes, conjunctivitis, muscle and joint pain, discomfort, and headaches. It is most known for its effects on pregnancies, however, which can cause infants to be born with microcephaly and other malformations.

DPP is intended for use with patients meeting the Centers for Disease Control and Prevention’s (CDC) Zika virus clinical criteria or its Zika virus epidemiological criteria. It is best used between eight days after symptom onset and up to 12 weeks after the initial infection. The system includes both a test device and micro reader capable of taking in fingerstick whole blood specimens to yield test results within 15 minutes.