The U.S. Food and Drug Administration (FDA) today approved the cobas® Zika test to screen for the presence of the Zika virus in blood donations.
Developed by Roche, the test extracts and purify RNAs from blood plasma, and then detects the presence of the Zika virus RNA through PCR (amplifying the genetic material of the virus using primer sequences that are specific to the virus).
Prior to this approval, the cobas Zika test had been used under the Investigational New Drug Application (IND) protocol. According to the FDA website: “The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99 percent.”
This is the first commercially available test to detect the Zika virus. It will now be used alongside other routine tests for the screening of blood and plasma donations in the United States.
Link to FDA here.