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Today, the FDA has announced the availability of a revised final guideline: "Revised Recommendations to Reduce the Risk of Transmission of Zika Virus Through Blood and Blood Components."
This revised directive replaces the August 2016 guideline, which recommended universal nucleic acid tests for the Zika virus of individual blood units given to the states. and territories of the United States. The revised guidelines explain that, in order to comply with applicable testing regulations, blood establishments must continue to test all donations of whole blood and blood components for the Zika virus using a blood test. nucleic acid. The revised guidelines explain the rationale for the FDA's decision that group testing of donations using an FDA-approved test is a sufficient method to comply with these regulations and effectively reduce the risk of Zika virus transmission. least the risk of local transmission of Zika virus by mosquitoes in a specific geographic area that would trigger individual donation testing at that location. Blood establishments may also use an FDA-approved pathogen reduction device for plasma and certain platelet products.
The change comes after careful consideration of all available scientific evidence, including consultation with other public health agencies. December 2017 meeting of the Blood Products Advisory Committee. The agency is confident that today 's recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission, while reducing the risk of HIV transmission. burden of testing for blood establishments.
ensures the safety of the nation's blood supply. To help protect the blood supply from infectious diseases, the FDA is continually evaluating the latest scientific information available to ensure that our blood exclusion and testing recommendations better protect the millions of people who depend on them. donations of blood every year, "said Peter Marks. .D., Director of the FDA's Center for Evaluation and Biological Research. "Today, we announce that we have revised our recommendations to test blood donations for the Zika virus.When the Zika virus first appeared, the unknown evolution of the epidemic and the serious observed effects of the disease showed that individual tests were necessary to ensure the safety of the blood supply.Now, given the significant decrease in cases of Zika virus infection in the United States, In the United States and in its territories, we avoid testing each individual donation to test group donations, which is generally more cost-effective and less burdensome for blood establishments, but the FDA will continue to monitor the situation closely and, where appropriate, reconsider the measures necessary to maintain the safety of the blood supply. "
The Zika virus is mainly transmitted by the Aedes mosquito, but it can also spread in other ways, including blood and badual contact. Many people infected with the virus never develop symptoms, but when symptoms appear, they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps) and conjunctivitis (red eyes, irritated). Zika virus can also be badociated with Guillain-Barré syndrome and serious neurological complications. Zika virus infection during pregnancy can cause serious birth defects and is badociated with other adverse outcomes of pregnancy.
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