US health regulator approves new test for detecting Zika virus in donated blood
The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection.
US health regulators on Thursday approved a new test that can detect Zika virus in donated blood and its components, as well as living organ donors. The test is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.
"Today's action represents the first approval of a Zika virus detection test for use with screening the nation's blood supply," said Peter Marks, director of the US Food and Drug Administration (FDA)'s Center for Biologics Evaluation and Research.
"Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply," said Marks. In August 2016, the FDA had issued a final guidance
document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or a licensed (approved) test when available.
Earlier several blood collection establishments used the cobas Zika test under IND. The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection. 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.
The Zika virus is transmitted primarily by mosquitoes (Aedes aegypti), but it can also be spread through blood transfusion and sexual contact. Although most people infected with Zika virus do not develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes).
In addition, Zika virus infection can cause a serious neurological disease in adults, and infection during pregnancy can cause serious birth defects.
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