The revised guidance recommends that all states and US territories screen individual units of donated whole blood and blood components with a blood-screening test authorized for use by the FDA under an investigational new drug application or with a licensed test when available.
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“Expanded testing will continue to reduce the risk for transmission of Zika virus through the USA blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced”, the statement reads.
The FDA first issued guidance in February recommending that only areas with active Zika virus transmission screen donated whole blood and blood components for Zika virus; use pathogen-reduction devices; or halt blood collection and obtain whole blood and blood components from areas of the US without active virus transmission.
Expanded testing should remain in effect until the risk of transmitting the virus through blood transfusions is reduced, the FDA recommended.
Procleix, the zika screening test from Hologics and a partner company, has been used by the American Red Cross to screen blood for HIV and hepatitis B and C for many years, Hologic spokeswoman Suzanne Clancy said.
The FDA previously advised screening only in areas with active Zika transmission, like parts of Florida and throughout Puerto Rico. Several blood centers have started screening for the virus voluntarily, including several in Texas.
“The Cobas Zika test is a blood-screening test for blood donations only”, Roche spokesman Bob Purcell said. The Maryland man went to the Dominican Republic, where there is a Zika outbreak. That means the total scope of Zika transmissions caused by sexual intercourse with asymptomatic individuals is a mystery, especially in USA territories like Puerto Rico, where sexually transmitted cases can not be tracked because they overlap so heavily with mosquito-borne transmission. Since February, blood banks have turned away people who had recently visited those regions, under a previous FDA directive.
“We’ve come to a critical juncture: the risk to the blood supply combined with the uncertainty about the nature and extent of Zika virus transmission”, Marks said.
Zika is spread primarily by mosquito bites, as well as sex. Only 29 of those cases pertain to acquisition via mosquitoes, with 2,487 associated with travel and 22 with sexual transmission.
The Department of Health also confirms three additional cases of travel related Zika virus, bringing the state total to 26.
Friday’s announcement follows recent pressure from members of Congress to expand Zika screening.
According to the CDC current reports reflect poor outcomes among pregnancies with laboratory evidence of possible Zika virus infection.
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The Centers for Disease Control and Prevention has documented birth defects in infants whose mothers have been infected. So far, there have been about 40 cases of homegrown Zika in Florida.
