Industry guidelines have helped enable the use of pathogen reduction (PR) in place of certain tests and/or procedures.
|RISK||GUIDANCE or STANDARD||PATHOGEN REDUCTION (PR)|
|FDA Draft Guidance:1
Recommends PR or bacterial testing.
|PR can eliminate the need for primary and secondary testing, including rapid testing.|
|AABB Standard 126.96.36.199:2
Methods required to detect bacteria or use PR in platelet components
|PR can be used as an alternative to bacterial detection.|
ZIKA VIRUS TTI
|FDA Guidance for Zika:3
Recommends testing, import or PR in active Zika areas
|PR can be used in place of Zika testing for platelet and plasma components.*|
|FDA Guidance for Babesia:4
Recommends testing, import or PR in active Babesia areas
|PR can be used in place of Babesia testing for platelet and plasma components.*|
|AABB Standard 5.19.2:2
Policy requires to reduce the risk of CMV
|INTERCEPT PR demonstrates inactivation of CMV in platelets in PAS-3 with ≥4.9 pfu/mL log reduction.5|
|AABB Standard 188.8.131.52:2
Methods known to prevent TA-GVHD required; include gamma irradiation or PR
|PR meets AABB standard which allows for gamma irradiation or pathogen reduction.|
Bacterial contamination of platelet products is the most significant infectious risk in transfusion today.6 About 1 in 1,500 platelet units is estimated to contain bacteria, even after culture detection,7 translating to a 1 in 250 per patient risk.1 An FDA draft guidance1 and AABB standard 184.108.40.206 recommend the use of pathogen reduction as an alternative to bacterial detection. Read More >
The Zika virus is a flavivirus transmitted through mosquito bites. Zika has been associated with recent cases of microcephaly and Guillain–Barré syndrome. Outbreaks have been reported in the Western Hemisphere, including Mexico, the Caribbean, and Central and South America.
In February 2016, FDA issued a guidance document3 which acknowledges the risk of Zika virus transmission via blood transfusion and identifies appropriate blood safety measures to reduce transfusion risks, including pathogen reduction. In areas with active local Zika virus transmission, blood centers have the option to either use pathogen reduction to maintain local platelet and plasma collections, or alternatively, to source components from areas without local transmission risk.*
Babesia is a parasite that is transmitted by ticks and can also be transmitted by transfusion of blood components.
Babesia is most prevalent in the Northeast and upper Midwest of the United States.4 In May 2019, FDA issued a guidance document which identifies appropriate blood safety measures to reduce transfusion risks, including pathogen reduction.4
Cytomegalovirus (CMV) is a leukocyte-associated herpesviruses and is common in the general population. While most experience no symptoms, CMV can cause serious disease, morbidity and mortality in immunocompromised individuals.8,9 Current methods to mitigate risk of transfusion transmission include leukoreduction and/or use of CMV seronegative blood components. Though effective, residual risks still exists due to residual leukocytes and/or due to cell-free CMV.9,10
AABB Standard 5.19.2 states that a policy is required to reduce the risk of CMV TTI.2 INTERCEPT PR demonstrates inactivation of CMV in platelets in PAS-3 with ≥4.9 pfu/mL log reduction.5
Viable donor leukocytes pose a number of risks for transfusion recipients, including TA-GVHD. Because residual viable leukocytes remain after leukofiltration, inactivation of components using gamma irradiation is often considered to be the standard of care for immune-compromised patients. AABB Standard 220.127.116.11 lists pathogen reduction as a method known to reduce residual leukocytes and to prevent TA-GVHD, therefore allowing for the use of pathogen reduction as an alternative to gamma irradiation.2,5
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry, December 2018.
- “Standards for Blood Banks and Transfusion Services,” AABB, 31st edition, 2018.
- “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components. FDA Guidance for Industry, July 2018.
- “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. FDA Guidance for Industry, May 2019.
- The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; July 17, 2018.
- Kleinman S et al. Transfusion 2013;53:1603-1618.6. Kleinman S et al. Transfusion 2013;53:1603-1618.
- Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.
- http://www.cdc.gov/cmv/overview.html - June 10, 2016.
- Furui F, Satake M, Hoshi Y, et al. Transfusion 2013;53:2188-2195.