BackgroundBabesia spp. is an intraerythrocytic parasite that causes human babesiosis and its transmission by transfusion has been extensively demonstrated. The aim of this study was to ascertain the efficacy of an ultravioletC (UVC)-based pathogen inactivation system in the reduction of Babesiadivergens-infected platelet (PLT) concentrates and to determine the parasite's ability to survive in PLT concentrates stored under blood bank conditions. Study Design and MethodsThis study was conducted using in vitro cultures of B.divergens. The detection limit of the culture assay was established and, subsequently, 15 buffy coat-derived PLT concentrates (BC-PCs) were inoculated with 10(7)B.divergens-infected red blood cells. Infected BC-PCs were irradiated with 0.2J/cm(2) UVC light using the THERAFLEX UV-Platelets method (Macopharma). Viability and parasite growth were evaluated before and after inactivation. Culture growth kinetics were monitored by DNA incorporation of [H-3]thymidine. The ability of B.divergens to survive in PLT concentrates was also analyzed. ResultsThe limit of detection in cultures was established at 0.1x10(-6)% parasites. The THERAFLEX UV-Platelets system inactivated B.divergens to below the limit of detection in 12 of 15 BC-PCs (log reduction, >6.0) and to the limit of detection (log reduction, 5.0) in three of 15. It was also demonstrated that B.divergens remains viable in BC-PCs stored up to 7 days. ConclusionSince B.divergens can survive in PLT concentrates and given the performance of UVC, this system could be considered as an alternative to prevent B.divergens and other Babesia species from being transmitted through PLT transfusions.
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US FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Gubernot, Diane M.
;
Lucey, Charles T.
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US FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Lucey, Charles T.
;
Lee, Karen C.
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US PHS, Rockville, MD USA
Off Biostat & Epidemiol, Rockville, MD USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Lee, Karen C.
;
Conley, Gilliam B.
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Off Compliance & Biol Qual, Rockville, MD USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Conley, Gilliam B.
;
Holness, Leslie G.
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US FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Holness, Leslie G.
;
Wise, Robert P.
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US PHS, Rockville, MD USA
Off Biostat & Epidemiol, Rockville, MD USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
机构:
US FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Gubernot, Diane M.
;
Lucey, Charles T.
论文数: 0引用数: 0
h-index: 0
机构:
US FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Lucey, Charles T.
;
Lee, Karen C.
论文数: 0引用数: 0
h-index: 0
机构:
US PHS, Rockville, MD USA
Off Biostat & Epidemiol, Rockville, MD USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Lee, Karen C.
;
Conley, Gilliam B.
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h-index: 0
机构:
Off Compliance & Biol Qual, Rockville, MD USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Conley, Gilliam B.
;
Holness, Leslie G.
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h-index: 0
机构:
US FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA
Holness, Leslie G.
;
Wise, Robert P.
论文数: 0引用数: 0
h-index: 0
机构:
US PHS, Rockville, MD USA
Off Biostat & Epidemiol, Rockville, MD USAUS FDA, Ctr Biol Evaluat & Res, Off Blood Res & Review, Rockville, MD 20857 USA