Streamline operations while reducing the risk of Transfusion Transmitted Infections (TTI) with the INTERCEPT Blood System

Industry guidelines from FDA and AABB have helped enable the use of pathogen reduction technology (PRT) as an option, in place of certain tests and/or procedures to address residual TTI risk including bacterial contamination, Zika virus, and transfusion-associated graft vs host disease (TA-GVHD).

RISK GUIDANCE or STANDARD PATHOGEN REDUCTION TECHNOLOGY (PRT)
B 1

Bacterial Contamination
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 FDA Draft Guidance:1
Recommends PRT or bacterial testing.		 PRT can eliminate the need for primary and secondary testing, including rapid testing.
AABB Standard 5.1.5.2:2
Methods required to detect bacteria or use PRT in platelet components		 PRT can be used as an alternative to bacterial detection.
M1

ZIKA Virus TTI
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 FDA Guidance for Zika:3
Recommends testing, import or PRT in active Zika areas		 PRT can be used in place of Zika testing for platelet and plasma components.*
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CMV TTI
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 AABB Standard 5.19.2:2
Policy requires to reduce the risk of CMV		 INTERCEPT PRT demonstrates inactivation of CMV in platelets in PAS-3 with ≥4.9 pfu/mL log reduction.4
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TA-GVHD
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 AABB Standard 5.19.3.1:2
Methods known to prevent TA-GVHD required; include irradiation or PRT		 PRT meets AABB standard which allows for irradiation or pathogen reduction.

Bacterial Contamination

B 1

Bacterial contamination of platelet products is the most significant infectious risk in transfusion today.1 About 1 in 1,500 platelet units is estimated to contain bacteria, even after culture detection,5 translating to a 1 in 250 per patient risk.6 An FDA draft guidance1 and AABB standard 5.1.5.22 recommend the use of pathogen reduction as an alternative to bacterial detection.

FDA Draft Guidance on Bacterial Contamination
In March 2016, the FDA issued a draft guidance1 which includes options that blood centers and/or hospitals can use to mitigate the risk of bacterial contamination, including primary culture detection with secondary bacterial detection or pathogen reduction.

  1. Current methods consist of early culture with an initial hold. Culture has improved blood safety, yet can miss >50% of contaminated components due to slow growing bacteria.1

  2. FDA Draft Guidance1 recommends that:
    • Blood Centers either perform pathogen reduction or perform primary bacterial testing
    • Hospital transfusion service may use pathogen reduced platelets, with no further measures necessary, or use platelets already negative in primary bacterial testing, and perform secondary testing at day 4 and day 5.

fdg 1

View the FDA Draft Guidance on Bacterial Contamination

Zika Virus

M1The Zika virus is a flavivirus transmitted through mosquito bites. Zika has been associated with recent cases of microcephaly and Guillain–Barré syndrome. Most recently, Zika virus outbreaks have been reported in the Western Hemisphere, including Mexico, the Caribbean, and Central and South America. Those infected with Zika are largely asymptomatic, and both transfusion and sexual transmission of the virus has been confirmed.7


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.*

CMV

c1Cytomegalovirus (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, such as in infants and those undergoing marrow transplantation.7,8 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.8,9

AABB Standard 5.19.2 states that a policy is required to reduce the risk of CMV TTI.2 INTERCEPT PRT demonstrates inactivation of CMV in platelets in PAS-3 with ≥4.9 pfu/mL log reduction.4

TA-GVHD

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Viable donor leukocytes are recognized to 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 5.19.3.1 lists pathogen reduction technology as a method known to inactivate residual leukocytes and to prevent TA-GVHD, therefore allowing for the use of pathogen reduction technology as an alternative to gamma irradiation.2
  1. "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” FDA Draft Guidance for Industry, March 2016.
  2. "Standards for Blood Banks and Transfusion Services," AABB, 30th edition, 2015.
  3. "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus," FDA Guidance for Industry, August 2016.
  4. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; Mar 15, 2016.
  5. Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.
  6. Kleinman S et al. Transfusion 2013; 53:1603-1618.
  7. http://www.cdc.gov/zika/transmission/
  8. http://www.cdc.gov/cmv/overview.html - June 10, 2016.
  9. 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