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AABB Authorizes Use of the INTERCEPT Blood System for Platelets to Reduce the Risk of Transfusion-Associated Graft versus Host Disease | Seven-Year Study Highlights Failure to Detect Septic Transfusion Reactions, Need for Additional Safety Measures |
Zika Virus Reported in the U.S., Latin America and Caribbean| AABB Awarded Charitable Grant from Cerus to Support Hemovigilance Program | Science Section: What We're Reading | Calendar of Events
AABB Authorizes Use of the INTERCEPT Blood System for Platelets to Reduce the Risk of Transfusion-Associated Graft versus Host Disease
Cerus recently announced that AABB has granted the requests of the first four U.S. blood centers and hospitals to use INTERCEPT pathogen reduction in place of irradiation to satisfy AABB's requirement to reduce the risk of transfusion-associated graft versus host disease (TA-GvHD).

In letters received by Blood Bank of Delmarva, SunCoast Blood Bank, the National Institutes of Health and Community Blood Center, the AABB's Blood Bank and Transfusion Services Standards Program Unit (BBTS SPU) stated that, "[b]ased on the evaluation of relevant data and current use of the INTERCEPT Blood System for pathogen reduction, it is the intent of the BBTS SPU to propose an interim standard to the 29th edition allowing for the practice described." Upon issuance of this interim standard, blood centers and hospitals will no longer need to request a variance to use the INTERCEPT Blood System for Platelets in place of irradiation.


Read the full press release
Seven-Year Study Highlights Failure to Detect Septic Transfusion Reactions, Need for Additional Safety Measures1
A recent study conducted at the University Hospitals Case Medical Center evaluated patients that received bacterially contaminated platelet components over 7 years (2007-2013) via passive and active surveillance methods. Active surveillance detected 20 bacterially contaminated platelet units of ~51,000 platelet units transfused, resulting in 5 septic transfusion reactions. None of the 5 were reported by passive surveillance. Study results suggest that transfusion-associated sepsis may be significantly under-reported due to passive surveillance methods, and that additional FDA approved measures such as pathogen reduction may be needed to further mitigate the risk.

1. Hong, H et al., Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance. Blood. Nov 23, 2015.

Read the abstract here (subscription may be required for full access).
Zika Virus Reported in the U.S., Latin America and Caribbean*
The Zika virus, a mosquito-borne pathogen, has reached the Americas with cases confirmed in 14 Latin American or Caribbean countries, with the most recent cases reported in Hawaii, Florida,1 Illinois,1 Texas and Puerto Rico.2-4 The potential for Zika transmission via blood transfusion was demonstrated during an outbreak in French Polynesia in 2013/2014, in which 2.8% of the blood donors were found to be positive via nucleic acid testing.5 The potential risk for transfusion transmission is heightened by the fact that most cases are asymptomatic, and no commercially available blood screening assay exists. Pathogen reduction has been demonstrated as effective in inactivating arboviruses such as chikungunya, West Nile virus (WNV) and dengue viruses.6,7

1. Sun, L. Florida, Illinois officials report travel-related Zika virus cases The Washington Post January 20, 2016
2. Enserink M. An obscure mosquito-borne disease goes global. Science. November 27, 2015.
3. McNeil DG. U.S. becomes more vulnerable to tropical diseases like Zika. The New York Times. January 4, 2016
4. Collins F. Zika virus confirmed in US Patient. CBS News. January 12, 2016.
5. Musso D, Nhan T, Robin E, et al. 2014. Potential for Zika virus transmission through blood transfusion demonstrated
    during an outbreak in French Polynesia, November 2013 to February 2014. Euro Surveill. 19.
6. INTERCEPT Blood System for Plasma [Package Insert]. Concord, CA: Cerus Corporation; 2015.
7. INTERCEPT Blood System for Platelets [Package Insert]. Concord, CA: Cerus Corporation; 2015.
AABB Awarded Charitable Grant from Cerus to Support Hemovigilance Program
AABB announced in October 2015 the receipt of a restricted charitable grant from Cerus to support its efforts in developing its hemovigilance program. The grant will be used to support activities such as to engage in hospital outreach efforts to expand hemovigilance participation, provide hemovigilance training to hospital sites for those participating in the program, and to develop a US hemovigilance protocol that includes the collection of data associated with the transfusion of pathogen reduced products.

“We are proud to support AABB in their endeavor to further advance a U.S. hemovigilance system,” said William ’Obi’ M. Greenman, President and CEO of Cerus. “AABB’s efforts to collect adverse event data are in line with our work to reduce the risk of transfusion-transmitted diseases through pathogen reduction.”

Read AABB’s full press release.
Science Section: What We're Reading

A Systematic Review of Transfusion-Associated Graft-Versus-Host Disease
Kopolovic, I et al. Blood. July 2015
Read the abstract here (subscription may be required for full access)

First Documented Transmission of Trypanosoma cruzi Infection through Blood Transfusion in a Child with Sickle-Cell Disease in Belgium
Blumental, S et al. PLoS Negl Trop Dis. October 2015
Read the abstract here (subscription may be required for full access)

Detection of Septic Transfusion Reactions to Platelet Transfusions by Active and Passive Surveillance
Hong, H et al. Blood. November 2015
Read the abstract here (subscription may be required for full access)

Transfusion-Transmitted Anaplasmosis from a Leukoreduced Platelet Pool
Fine, AB et al. Transfusion. December 2015
Read the abstract here (subscription may be required for full access)

Inactivation of Zika Virus in Plasma with Amotosalen and Ultraviolet A Illumination *
Aubry, M et al. Transfusion. January 2016
Read the abstract here (subscription may be required for full access)
Calendar of Events

BMT Tandem Meetings | Feb 18-22, 2016 | Honolulu, HI
Additional information


ABC (America's Blood Centers) Annual Meeting | March 12-14, 2016 | Jacksonville, FL
Additional information


CBBS (California Blood Bank Society) Annual Meeting | April 6-9, 2016 | San Diego, CA
Additional Information

ASFA (American Society for Apheresis) Annual Meeting | May 4-7, 2016 | Rancho Mirage, CA
Additional Information

CSTM (Canadian Society of Transfusion Medicine) Annual Meeting | May 11-15, 2016 | Vancouver, BC
Additional Information
 *Data for pathogen reduction of ZIKA by the INTERCEPT Blood System, pathogen reduction system, has not been submitted for FDA review.

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.

CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS and PRECAUTIONS: Only INTERCEPT Processing Sets for platelets and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl) phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

PLATELETS: INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.


PLASMA: Amotosalen-treated plasma may cause the following adverse reaction Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

Rx only. For full prescribing information, please see package insert.
MAN-EN-00165-07
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