US health regulators on Thursday approved a fresh test that can detect Zika virus in the donated blood and its own components, as well as living organ donors.
The test is supposed for use by blood collection organizations to identify Zika virus in blood donations, not for the average person analysis of Zika virus infection.
“Today’s action represents the first authorization of the Zika virus detection test for use with testing the nation’s blood supply,” said Peter Marks, director of the united states Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research.
“Screening blood donations for the Zika virus is crucial to preventing infected donations from getting into the US blood supply,” said Marks.
In 2016 August, the FDA experienced issued a final guidance a document recommending that says and territories screen person units of whole blood and blood components with an investigational blood screening test available under an investigational new medication (IND) application, or a certified (approved) test when available.
Previously several blood collection organizations used the cobas Zika test under IND.
The info collected out of this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to display blood donors for Zika virus infection.
The test’s clinical specificity examined by examining individual samples from blood donations at five external laboratory sites, producing a clinical specificity greater than 99 %.
The Zika virus transmitted mainly by mosquitoes (Aedes aegypti), but it can be spread through blood transfusion and sexual contact also.
Although most people contaminated with Zika virus do not develop symptoms, when symptoms do occur they could include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes).
Furthermore, Zika virus infection can result in a serious neurological disease in adults, and infection during pregnancy can cause serious birth defects.