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Operational Efficiencies

Streamlined Operations and Reduced Risk of Transfusion Transmitted Infections

Industry Guidelines Have Helped Enable the Use of Pathogen Reduction (PR) in Place of Certain Tests and/or Procedures

 

Bacteria

 BACTERIAL
CONTAMINATION

Guidance or Standard:

Pathogen Reduction (PR):

FDA Final Guidance:1 Recommends PR or bacterial testing.

AABB Standard 5.1.5.2:2 Methods required to detect bacteria or use PR in platelet components

Pathogen reduction can eliminate the need for primary and secondary testing, including rapid testing.

Pathogen reduction can be used as an alternative to bacterial detection.

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 The FDA final guidance1 and AABB standard 5.1.5.22 recommend the use of pathogen reduction as an alternative to bacterial detection.  Read More >

ZIKA VIRUS TTI

Guidance:

Pathogen Reduction (PR):

FDA Guidance for Zika:3 Recommended testing, import or PR in active Zika areas Pathogen reduction can be used in place of Zika testing for platelet and plasma components.*

In February 2016, FDA issued a guidance document3 which acknowledged the risk of Zika virus transmission via blood transfusion and identified appropriate blood safety measures to reduce transfusion risks, including pathogen reduction. In areas with active local Zika virus transmission, blood centers had 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plasma collections, or alternatively, to source components from areas without local transmission risk.* Guidance was withdrawn in May 13, 2021. 

Tick

BABESIA TTI

Guidance:

Pathogen Reduction (PR):

FDA Guidance for Babesia:4 Recommends testing, import, or PR in active Babesia areas. Pathogen reduction can be used as an alternative to bacterial detection.

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

TA-GVHD

Standard:

Pathogen Reduction (PR):

AABB Standard 5.19.3.1:2 Methods known to prevent TA-GVHD required; include gamma irradiation or PR Pathogen reduction meets AABB standard which allows for gamma irradiation or pathogen reduction.

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 5.19.3.2 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

CMV

CMV TTI

Standard:

Pathogen Reduction (PR):

AABB Standard 5.19.2:2 Policy requires to reduce the risk of CMV INTERCEPT Pathogen reduction demonstrates inactivation of CMV in platelets in PAS-3 with ≥4.9 pfu/mL log reduction.5

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

You May Also Be Interested In

1. 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 2020.  2. “Standards for Blood Banks and Transfusion Services,” AABB, 32nd edition, 2020.  3. “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.” FDA Guidance for Industry, July 2018.  4. “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis.” FDA Guidance for Industry, May 2019.  5. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; July 17, 2018.  6. Kleinman S et al. Transfusion  2013;53:1603-1618. 7. Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.  8. https://www.cdc.gov/zika/transmission 9. https://www.cdc.gov/cmv/overview.html – June 10, 2016.  10. Furui F, Satake M, Hoshi Y, et al. Transfusion 2013;53:2188-2195.

*Data for pathogen reduction of the Zika virus by the INTERCEPT Blood System has not been submitted for FDA review.