A Probable Case of West Nile Virus Transfusion Transmission  |  Amustaline (S-303) Treatment Inactivates High Levels of Zika Virus in RBC components  |  Plasma Treated with INTERCEPT Retains Activity for Hemostasis After 5 days Post-Thaw Storage  |  Science Section: What We're Reading  |  Calendar of Events
A probable case of West Nile virus transfusion transmission
A probable case of WNV transfusion transmitted infection (TTI) was recently reported by Groves et al., in which a 78-year old man received 14 blood components while undergoing aortic valve replacement and coronary bypass surgery. The patient was discharged 7 days after surgery, then later re-admitted and diagnosed with aseptic meningitis and encephalitis.1 The patient was positive for WNV IgM and IgG antibodies in his cerebrospinal fluid and serum, respectively; he died 51 days after having received the implicated fresh frozen plasma (FFP) unit. All blood components received were non-reactive for mini-pool (MP) and individual donation NAT; however, one MP-NAT result did have an elevated signal-to-cut off ratio. The donor corresponding to a donation from that MP reported symptoms consistent with a viral infection 3-5 days post donation, and tested IgM/IgG positive upon follow up. While the patient had not shown symptoms of WNV before the surgery, mosquito bites were reported after initial hospital discharge and could have been the source of the infection; however, findings strongly suggest that WNV had been likely transmitted through transfusion.
Groves JA et al. Transfusion. 5 February 2017.DOI:10.1111/trf.14018.
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Amustaline (S-303) treatment inactivates high levels of Zika virus in RBC components
A recent study published in Transfusion by Laughhunn et al. is the first to demonstrate the in vitro use of the INTERCEPT Blood System for Red Blood Cells to inactivate high Zika virus (ZIKV) titers in red blood cell components to the limit of detection. The INTERCEPT Blood System for Red Blood Cells, which is currently in development, uses amustaline (S-303) that forms covalent crosslinks and adducts with nucleic acids to inactivate pathogens.1 In this study, red blood cell components were spiked with a ZIKV strain isolated from the 2013 outbreak in the French Polynesia at levels higher than detected in asymptomatic blood donors. Spiked specimens were tested for RNA viral loads before and after INTERCEPT use, and no ZIKV infectivity was detected immediately after INTERCEPT treatment or after five serial passages in cell culture. Data from this study complements previous studies2 that show ZIKV inactivation to the limit of detection in all blood components3 and demonstrates the inactivation of the ZIKV at levels seen in asymptomatic donors.

Laughhunn A et al. Transfusion. 5 February 2017. DOI:10.1111/trf.13993
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Santa Maria F. et al. AABB Annual Meeting, Orlando, Fl. Sept 2016. DOI:10.1111/trf.13807
2Read the Abstract (S16-010C) [Full Subscription Required]

Aubry M. et al. 2015 Aug 18. DOI:10.1111/trf.13271
3Read the Article
Plasma Treated with INTERCEPT retains activity for hemostasis after 5 days post-thaw storage
Plasma thawed and stored at 1 to 6°C for up to 5 days provides rapid availability in emergencies and reduces plasma waste, but it carries the risk of coagulation factor loss, bacterial and/or viral contamination.1 A recent study (Erickson et al.) examined coagulation, hemostatic, antithrombotic, and activation activity in thawed plasma treated with INTERCEPT prior to freezing; plasma frozen within 8 hours (FFP) and plasma frozen within 24 hours (PF24) were evaluated. Multiple factors in the INTERCEPT treated plasma demonstrated levels similar to those found in the Circular of Information For the Use of Human Blood and Blood Components-2013 (COI)2, indicating retention of procoagulant and antithrombotic activity after 5 days post-thaw storage at 1 to 6°C.*

Erickson et al. Transfusion. 1 February 2017. DOI:10.1111/trf.13973
1Read the Article Here                   

Circular of Information For the Use of Human Blood Components (COI). AABB, American Red Cross, ABC, ASBP. November 2013.
2Read the COI Here        
Science Section: What We’re Reading

Patient Outcomes and Amotosalen/UVA-treated Platelets Utilization in Massively Transfused Patients
Nussbaumer et al. Vox Sanguin. 15 February 2017. DOI: 10.1111/vox.12489
Read the Article Here 

First Zika-positive donations in the Continental United States
Galel et al. Transfusion. 5 February 2017. DOI: 10.1111/trf.14029
Read the Article Here 

Septic Transfusion Case Caused by a Platelet Pool with Visible Clotting Due to Contamination with Staphylococcus aureus
Loza-Correa M et al. Transfusion. 16 February 2017. DOI: 10.1111/trf.14049
Read the Article Here [Full Subscription Required for Access]   

Persistence of Zika Virus in Body Fluids-Preliminary Report
Paz-Bailey G et al. NEJM. 14 February 2017. DOI: 10.1056/NEJMoa1613108

Read the Article Here [Full Subscription Required for Access]  

The Thor Group and the Way (far) Forward: Transfusion Medicine Support is Vital to the Mission!
James R. Stubbs Transfusion. 5 February 2017. DOI 10.1111/trf.14011
Read the Article Here [Full Subscription Required for Access] 

CDC Issues Yellow Fever Alert in Brazil

CDC. February 2017.
Read the Article Here 

Malaria Drugs Fail For the First Time on Patients in UK

James Gallagher. BBC. 31 January 2017.
Read the Article Here 

Zika Virus and Blood Transfusion: The Experience of French Polynesia
Bierlaire et al. Transfusion. 10 February 2017. DOI:10.1111/trf.14028
Read the Article Here [Subscription Required for Full Access] 
Calendar of Events
ABC (America's Blood Centers) Spring Meeting
March 24-29, 2017 | Washington DC  
Additional Information

CSTM (Canadian Society for Transfusion Medicine)
April 20-23, 2017 | Ottowa, Canada  
Additional Information

SCA (Society of Cardiovascular Anesthesiologists)
April 22-26, 2017 | Orlando, FL  
Additional Information

ASPHO (The American Society of Pediatric Hematology/Oncology)
April 26-29, 2017 | Montreal, Canada  
Additional Information
Data for pathogen reduction of the Zika and Yellow Fever virus by the INTERCEPT Blood System, pathogen reduction system, have not been submitted for FDA review.

*INTERCEPT treated plasma 5 day post thaw storage data has not been submitted to the FDA.

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.

INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.

Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-20
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