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person scanning plasma bag on mirasol device

Mirasol Pathogen Reduction Technology

Reduce the pathogen load in donated blood and inactivate residual white blood cells

A proactive approach to improved blood safety

No matter where you are located, increased travel, climate change, evolving pathogens, emerging pandemics, and the need to advance healthcare practices have put global blood safety at the forefront of industry focus.

With all this change, it’s time to take a proactive approach to protecting patients from the potential dangers of donated blood.

The Mirasol™ Pathogen Reduction Technology (PRT) System can help you do that by reducing the pathogen load of a broad range of disease-causing viruses, bacteria, and parasites.

The system also inactivates residual white blood cells found in blood components,1,2,3 which may help to reduce transfusion reactions in patients. 

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Powerful, proven, and so much potential

The Mirasol PRT system is the only pathogen reduction technology system shown in a human clinical trial to reduce the transfusion-transmitted infection (TTI) of a disease, reducing TTI of malaria by 87%.4

The right balance for better blood

We believe better blood safety should provide the right balance of efficacy and ease-of-use while maintaining the quality of blood components for patients who need them. Mirasol is a simple system that has the power to deliver better patient care, reducing the risks associated with the lifesaving gift of blood.

The Mirasol PRT system

You know better than anyone — these are challenging times. The Mirasol system allows you to meet the needs of your business by optimizing the balance of cost, efficacy, and safety of your blood products.5,6

Mirasol PRT provides an added layer of protection against tested pathogens (HIV, HBV, HCV) during the window period,7 as well as against untested/emerging pathogens. It uses a combination of riboflavin (vitamin B2), a nontoxic and nonmutagenic substance,8 and UV light.

Mirasol reduces the pathogen load of a broad range of disease-causing viruses, bacteria and parasites and inactivates residual white blood cells in blood products.1,2,3 For example:

  • Mirasol reduces the viral load of SARS-CoV-2, which causes COVID-19, below the limit of detection in plasma and platelets.9,10
  • Mirasol is the only PRT system to date shown to reduce the incidence of transfusion-transmitted malaria infection in patients receiving whole blood transfusion.4
  • Mirasol is effective at inactivating non-enveloped viruses,11,12,13 such as HAV and model parvovirus B19 and HEV, a category of viruses shown to be resistant to other available PRT (such as Intercept).14

HIV = human immunodeficiency virus; HAV, HBV, HCV, HEV = heptatitis A, B, C, and E viruses; UV = ultraviolet.

Mirasol requires minimum handling and few procedure steps and allows for immediate product release.15

  • With Mirasol, urgent requests for treated blood products can be accommodated in a shorter timeframe.16
  • Mirasol requires only one system to treat platelets, plasma and whole blood with a single compound: riboflavin (vitamin B2).
  • Because riboflavin is nontoxic and nonmutagenic,17,8 there is no compound removal step in the Mirasol process.
  • Convenient data management enables easy and effective data reporting while helping to prevent operator errors.

The routine use of Mirasol may replace bacterial testing,11 gamma irradiation18 and cytomegalovirus (CMV) screening (if leukoreduction is used),1,2,3 and may reduce the expired product discard rate (based on a seven-day shelf life for platelets in PAS).15 Operational practices may vary by center.

There is no compound removal step17 in the Mirasol process. That means you can expect these benefits as compared with other pathogen reduction technologies:

  • Minimal platelet loss, less than < 5% for both apheresis- and WB-derived buffy coat platelets19,20,21
  • Avoidance of extra platelet agitators
  • Avoidance of the potential need to manage two different inventories of blood products (one for the compound removal step and one for storage)

PAS = platelet additive solution; WB = whole blood.

With Mirasol, there are no known contraindications for use1,2,3 and no acute/long-term effects for patients, including pediatrics,22,23 because riboflavin and its photoproducts are nontoxic and nonmutagenic.8

For processing staff, there are no additional health hazard risks or precautions required for product handling24 because there is no need to remove the chemical compound.17

From a trusted partner

The Mirasol PRT system is a solution offered by Terumo Blood and Cell Technologies, a global leader in blood component technologies. We provide a comprehensive portfolio and dedicated expertise in all steps of blood transfusion and therapeutic apheresis.

Once the technology is in place, we continue to serve you with:

  • Education and training
  • Technical support
  • Clinical and scientific support
  • Customer support
  • User groups and professional networks

How it works

The right path to advancing blood safety: Safe, simple, effective

The Mirasol PRT system uses a combination of riboflavin (vitamin B2) — a non-toxic, non-mutagenic compound — and a specific spectrum of ultraviolet (UV) light to inactivate viruses, bacteria, parasites, and white blood cells that may be present in collected blood products.

The Mirasol PRT system consists of three main components:
  • A disposable kit — includes an illumination/storage bag and sterile riboflavin solution
  • The Mirasol Illuminator — provides UV light and agitation during the Mirasol treatment
  • Mirasol Manager software — integrates and manages data reporting and storage

During treatment, a blood product is mixed with the riboflavin solution and placed into the Illuminator, where it is exposed to UV light. There is no need to remove riboflavin or its photoproducts. After illumination, the treated products are ready for transfusion or placement into storage.

Mode of action

The Mirasol technology causes irreversible changes to the RNA and DNA of viruses, bacteria, parasites, and white blood cells, preventing them from replicating and causing disease.

Riboflavin + UV light = irreversible inactivation of pathogens and white blood cells

The process

Platelets, plasma, and whole blood in three simple steps

Step one: The product is transferred to the Mirasol illumination/storage bag.
Step two: Riboflavin solution is added and mixed with the product.
Step three: The mixture is then exposed to UV light.

Clinical experience with Mirasol-treated platelets

Clinical Study: PREPAReS

The Pathogen Reduction Evaluation & Predictive Analytical Rating Score (PREPAReS) clinical trial is the most comprehensive clinical trial to date demonstrating the non-inferiority of Mirasol-treated platelets. In addition, Terumo Blood and Cell Technologies hosted a webinar, “Clinical Experience With Mirasol-Treated Platelets,” presented by Dr. Jeffey McCullough, an international leader in research and practice of transfusion medicine and blood safety.  

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Clinical Study: IPTAS

The Italian Platelet Technology Assessment Study (IPTAS) was designed as two independent, randomized controlled trials (RCTs) conducted simultaneously in six hematological centers in Italy to assess the effectiveness and safety of pathogen-reduced versus non-pathogen-reduced platelets. Although conclusions on non-inferiority could not be drawn due to low statistical power, the study provides additional information on the safety and efficacy of pathogen-reduced platelets treated with two commercial pathogen-reduction technologies.

View study results

Featured resources

For operator's manuals and Instructions for Use, visit our eIFU website: Terumo.eifu.com. For more information, visit Help.TerumoBCT.com.

See how Mirasol can improve blood safety at your blood center.  
 

Connect with our experts

Disclaimers and notes

The Mirasol PRT system is in conformance with the Medical Device Directive.

The Mirasol PRT system has received the CE mark for platelet, plasma, and whole blood applications.

  1. Terumo Blood and Cell Technologies. Mirasol Platelet Disposable Kit for Treatment in Platelet Additive Solution Instructions for Use. December 2016. Part no. 777710-058.
  2. Terumo Blood and Cell Technologies. Mirasol Plasma Disposable Kit Instructions for Use. Part no. 777712-011.   
  3. Terumo Blood and Cell Technologies. Mirasol Whole Blood Disposable Kit Instructions for Use. Part no. 777714-014.  
  4. Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S. Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial. Lancet. 2016;387(10029):1753-1761.  
  5. Custer B, Agapova M, Martinez RH. The cost-effectiveness of pathogen reduction technology as assessed using a multiple risk reduction model. Transfusion. 2010;50(11):2461-2473.  
  6. Agapova M, Lachert E, Brojer E, Letowska M, Grabarczyk P, Custer B, et al. Introducing pathogen reduction technology in Poland: a cost-utility analysis. Transfus Med Hemother. 2015;42(3):158-165.  
  7. Kleinman SH, Lelie N, Busch MP. Infectivity of human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus and risk of transmission by transfusion. Transfusion. 2009;49(11):2454-2489.  
  8. Piper J, et al. Evaluation of genotoxicity and acute toxicity risks associated with a riboflavin based pathogen inactivation process. Presented at: 22nd Annual Meeting of the American College of Toxicology; November 2001; Washington, D.C.  
  9. Keil SD, Ragan I, Yonemura S, Hartson L, Dart NK, Bowen R. Inactivation of severe acute respiratory syndrome coronavirus 2 in plasma and platelet products using a riboflavin and ultraviolet light‐based photochemical treatment. Vox Sang. 2020;115(6):495-501.  
  10. Ragan I, Hartson L, Pidcoke H, Bowen R, Goodrich R. Pathogen reduction of SARS-CoV-2 virus in plasma and whole blood using riboflavin and UV light. PLOS ONE. 2020;15(5):e0233947.  
  11. Ruane PH, Edrich R, Gampp D, Keil SD, Leonard RL, Goodrich RP. Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion. 2004;44:877-885.  
  12. Marschner S, Goodrich R. Pathogen reduction technology treatment of platelets, plasma and whole blood using riboflavin and UV light. Transfus Med Hemother. 2011;38(1):8-18.  
  13. Owada T, Kaneko M, Matsumoto C, et al. Establishment of culture systems for genotypes 3 and 4 hepatitis E virus (HEV) obtained from human blood and application of HEV inactivation using a pathogen reduction technology system. Transfusion. 2014;54(11):2820-2827.  
  14. Cerus. INTERCEPT Brochure. 2016. Part no. MKT-EN 00147-01 v3.0.  
  15. Jimenez-Marco T, Garcia-Recio M, Girona-Llobera E. Our experience in riboflavin and ultraviolet light pathogen reduction technology for platelets: from platelet production to patient care. Transfusion. 2018;58(8);1881-1889.  
  16. Sutton S, Smith D. A report on the evaluation of two pathogen reduction/inactivation systems at the Western Province Blood Transfusion Service. Presented at: 34th South Africa National Blood Transfusion Congress; Sun City; 2017.  
  17. Boehnke C, Reuter U, Flach U, Schuh-Hofer S, Einhaupl KM, Arnold G. High-dose riboflavin treatment is efficacious in migraine prophylaxis: an open study in a tertiary care centre. Eur J Neurol. 2004;11(7):475-477.  
  18. Fast LD, DiLeone G, Marschner S, et al. Inactivation of human white blood cells in platelet products after pathogen reduction technology treatment in comparison to gamma irradiation. Transfusion. 2011;51(7):1397-1404.  
  19. Marciniak-Bielak D. A feasibility study of OrbiSac buffy coat platelet concentrates treated with the Mirasol PRT system. Vox Sang. 2011;101(suppl 1):187.  
  20. Van der Meer PF, Couture C, Hervig T, et al. Experiences with semi-routine production of riboflavin and UV-B pathogen-inactivated platelet concentrates in three blood centres. Vox Sang. 2017;112(1):9-17.  
  21. Coene GC, De Schrijver E, Sabot B, Dereen D, Reynaerts I, Vandekerckhove P. In vitro and in vivo evaluation of Mirasol pathogen reduction technology treated platelets stored in SSP+. Vox Sanq. 2011;101(suppl 1):188.  
  22. Piotrowski D, Przybylska-Baluta Z, Jimenez-Marco T, et al. Passive haemovigilance of blood components treated with a riboflavin-based pathogen reduction technology. Blood Transfus. 2018;16(4):348-351.  
  23. Olsen JH, Hertz H, Kruger Kjaer S, Bautz A, Mellemkjaer L, Boice JD. Childhood leukemia following phototherapy for neonatal hyperbilirubinemia (Denmark). Cancer Causes Control. 1996;7(4):411-414.  
  24. Terumo Blood and Cell Technologies. Mirasol System―Riboflavin Solution Globally Harmonized System of Classification and Labeling of Chemicals (GHS)―Safety Data Sheet (SDS). Part no. 777701-519A.  

 

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