FDA recommends pooled Zika testing of blood donations

The Food and Drug Administration has released revised guidance regarding testing blood donations for Zika virus, moving away from individual testing of donations and toward pooled testing.

“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The revised guidance replaces recommendations made in 2016 that had advised individual testing for all whole blood and blood component donations using a nucleic acid test. The new guidance explains that, although nucleic acid testing is still required, pooled testing is “a sufficient method for complying with these regulations” and that doing so will effectively reduce the risk of Zika virus transmission.

The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.

The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.

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The Food and Drug Administration has released revised guidance regarding testing blood donations for Zika virus, moving away from individual testing of donations and toward pooled testing.

“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The revised guidance replaces recommendations made in 2016 that had advised individual testing for all whole blood and blood component donations using a nucleic acid test. The new guidance explains that, although nucleic acid testing is still required, pooled testing is “a sufficient method for complying with these regulations” and that doing so will effectively reduce the risk of Zika virus transmission.

The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.

The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.

[email protected]

The Food and Drug Administration has released revised guidance regarding testing blood donations for Zika virus, moving away from individual testing of donations and toward pooled testing.

“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

The revised guidance replaces recommendations made in 2016 that had advised individual testing for all whole blood and blood component donations using a nucleic acid test. The new guidance explains that, although nucleic acid testing is still required, pooled testing is “a sufficient method for complying with these regulations” and that doing so will effectively reduce the risk of Zika virus transmission.

The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.

The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.

[email protected]