This site provides INTERCEPT product information for Health Care Professionals in the United States. Learn more

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Why INTERCEPT

Infectious Risk

Each and Every Day, Transfusions Save Lives

Transfusions, however, are not without risk.

Blood and blood components may be contaminated with harmful bacteria, viruses, parasites, and emerging pathogens. Testing can reduce some of the known infectious risks, but these tests do not always detect emerging or re-emerging pathogens.

Help maximize success in patient treatment with platelets treated with the INTERCEPT® Blood System for Platelets Pathogen Reduction System (INTERCEPT Platelets).

  • Reduce the risk of bacterial, viral, or protozoan transfusion-transmitted infections (TTIs) which could jeopardize critical procedures, such as hematopoietic stem cell transplantations.
  • Lower bacterial contamination risk which may be associated with prolonged hospital length of stay.1
  • Reduce septic reaction risk, including delayed reactions, which require follow up; gives greater assurance when discharging patients.2,3

Bacteria

Bacterial contamination of platelets is the highest risk for TTI in the United States.4-7 Furthermore, transfusion-related sepsis is greatly under-reported due to passive versus active surveillance methods. Patient risk may be up to 40-fold higher when comparing active versus passive surveillance.3

The INTERCEPT Blood System complies with current FDA Guidance on Bacterial Contamination as the only approved pathogen reduction mitigation strategy.

Viruses and Emerging Pathogens

The unpredictable emergence of new pathogens, such as arboviruses, continues to be a risk. Globalization and climate change lead to rapid spread of mosquitos (that carry arboviruses) and emerging pathogens.8,9

A reactive approach such as testing alone may not be a sustainable approach as new pathogens continue to emerge. Test development and regulatory approvals take time, and the continual addition of incremental tests becomes costly.8,10

Unlike reactive measures, INTERCEPT Platelets present a proactive approach in which viruses, bacteria, and parasites are inactivated.*2

Protozoan Parasites

Certain parasites may be transmitted by the transfusion of blood components from infected, asymptomatic donors. Examples are Babesia and Plasmodium spp, and Trypanosoma cruzi.

  • Symptoms of babesiosis, a disease caused by the Babesia spp, include fever, chills, body aches, weakness, malaise, and fatigue, with severe disease and hospitalization typically seen in immunosuppressed patients such as neonates, the elderly, and those on cancer therapy.11
  • Malaria is a mosquito-borne parasitic infection caused by the Plasmodium spp with symptoms such as hemolytic anemia, thrombocytopenia, fever and chills, affecting recipient health and potentially leading to fatalities.12 In 2023, reports of the first locally acquired malaria cases in 20 years were recently described in Florida and Texas.13

INTERCEPT Platelets may be implemented as an alternative to testing and certain travel-related deferrals.2,11,12

Learn more

FDA Guidance on Transfusion-Transmitted Babeiosis

FDA Guidance on Transfusion-Transmitted Malaria

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*There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19, and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process. For a full list of pathogens, please refer to Package Insert.

References

  1. Rosa RG, et al. PLoS One. 2014 Oct 6;9(10):e108969
  2. INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation.
  3. Hong, H , et al , Blood, 2016 127(4): p 496-502.
  4. Dumont, L.J., et al. Screening of single-donor apheresis platelets for bacterial contamination: the PASSPORT study results. Transfusion, 2010. 50: p. 589-599.
  5. Pearce, S., G.P. Rowe, and S.P. Field. Screening of platelets for bacterial contamination at the Welsh Blood Service. Transfus Med, 2011. 21(1): p. 25-32.
  6. Murphy, W.G., et al. Screening platelet concentrates for bacterial contamination: low numbers of bacteria and slow growth in contaminated units mandate an alternative approach to product safety. Vox Sang, 2008. 95(1): p. 13-19.
  7. Walther-Wenke G, et al. Working Party on Bacteria Safety in Transfusion Medicine, Advisory Board of the German Ministry of Health, Berlin. Monitoring bacterial contamination of blood components in Germany: effect of contamination reduction measures. Vox Sang. 2011 May;100(4):359-66.
  8. Howard, C et al Emerging Microbes and Infections, 2012 1(e46).
  9. Diuk-Wasser, M Scientific American, A Division of Nature America 2013.
  10. Galel, S., et al. Transfusion, 2017. 57(3pt2): p. 762-769.
  11. “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis”, FDA Guidance for Industry. May 2019.
  12. “Recommendations for Reducing the Risk of Transfusion-Transmitted Malaria”, FDA Guidance for Industry. December 2022.
  13. Health Alert Network (HAN) – 00494 | Locally Acquired Malaria Cases Identified in the United States (cdc.gov).