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Research
Type of the Paper: Article Homogenous Gamma-Irradiation by a Linear Accelerator for Inactivation of viruses in Plasma Samples, a Pilot Study with HIV-1-Infected Plasma
Martin Schipperus
Corresponding Author
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BACKGROUND
The risk of the transmission of (emerging) infectious diseases via blood products is a major public health concern. Therefore, it has been a long-sought goal to find a cost-effective way to sterilise blood after collection. No pathogen inactivation (PI) techniques are available for red blood cells on the market yet, though phase III trials are currently performed. γ-irradiation could theoretically inactivate viruses in red blood cells (RBCs). The dose of γ-irradiation needed to achieve sterility causes irreversible damage to the red blood cells and is therefore not suitable for PI of RBC concentrates. Inhomogeneous irradiation has always been used in the past, but leads to inconsistent measurements and uncertainty of results. By contrast, homogeneous irradiation may achieve the sterility assurance level (SAL) at much lower doses. If a maximum of 25 Gy of homogeneous γ-irradiation is able to sterilise blood products, this would be a very attractive PI method for RBC products.
METHODS
This proof-of-concept study aims to sterilise HIV-1 infected plasma using homogeneous γ-irradiation. Six HIV-1 infected plasma samples were irradiated with 25 Gy of homogeneous γ-irradiation. HIV-1 RNA-loads before and after were compared.
RESULTS
No difference was found in the HIV-1 RNA loads within the limitations of the test used before and after the irradiation. Therefore, homogeneous γ-irradiation appears not to be feasible as a PI-technique for HIV-1 in RBC products.
CONCLUSION
This inevitably means SAL will not be achieved for all viruses with up to 25 Gy of homogeneous γ-irradiation.
Keywords
HIV-1, pathogen inactivation, transfusion, homogeneous gamma-irradiation
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This is a preprint. It has not completed peer review.
Research
Type of the Paper: Article Homogenous Gamma-Irradiation by a Linear Accelerator for Inactivation of viruses in Plasma Samples, a Pilot Study with HIV-1-Infected Plasma
Martin Schipperus
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 18 May, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
BACKGROUND
The risk of the transmission of (emerging) infectious diseases via blood products is a major public health concern. Therefore, it has been a long-sought goal to find a cost-effective way to sterilise blood after collection. No pathogen inactivation (PI) techniques are available for red blood cells on the market yet, though phase III trials are currently performed. γ-irradiation could theoretically inactivate viruses in red blood cells (RBCs). The dose of γ-irradiation needed to achieve sterility causes irreversible damage to the red blood cells and is therefore not suitable for PI of RBC concentrates. Inhomogeneous irradiation has always been used in the past, but leads to inconsistent measurements and uncertainty of results. By contrast, homogeneous irradiation may achieve the sterility assurance level (SAL) at much lower doses. If a maximum of 25 Gy of homogeneous γ-irradiation is able to sterilise blood products, this would be a very attractive PI method for RBC products.
METHODS
This proof-of-concept study aims to sterilise HIV-1 infected plasma using homogeneous γ-irradiation. Six HIV-1 infected plasma samples were irradiated with 25 Gy of homogeneous γ-irradiation. HIV-1 RNA-loads before and after were compared.
RESULTS
No difference was found in the HIV-1 RNA loads within the limitations of the test used before and after the irradiation. Therefore, homogeneous γ-irradiation appears not to be feasible as a PI-technique for HIV-1 in RBC products.
CONCLUSION
This inevitably means SAL will not be achieved for all viruses with up to 25 Gy of homogeneous γ-irradiation.
Figure 1
Figure 2