FDA Approves Emergency Use of First Test to Detect Zika Virus in Whole Blood

Assay provides results within five to seven hours

The FDA has authorized the RealTime ZIKA molecular test (Abbott) to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency use. It is the first molecular test made by a commercial manufacturer authorized to detect Zika in whole-blood samples. This is significant because recent research suggests that Zika virus can be detected in whole blood for a longer period (up to two months) and at higher levels compared with testing using serum and urine sample types.

The RealTime ZIKA test is designed for use on the m2000 RealTime system––Abbott’s molecular diagnostics instrument used in hospital and reference laboratories in the United States and around the world. Providing results within five to seven hours, the test can detect whether someone is infected with the Zika virus.

According to the World Health Organization, Zika remains a significant public health challenge. More than 4,800 people in the U.S. have been infected with Zika (primarily from travel outside the U.S.), and more than 35,000 people are infected and reside in U.S. territories, mainly in Puerto Rico. Zika virus is primarily spread to people through bites from infected mosquitoes, but it can also be passed from pregnant women to their fetuses or through sexual transmission.

Source: PR Newswire; February 2, 2017.