Inactivation of a broad spectrum of viruses and parasites by photochemical treatment of plasma and platelets using amotosalen and ultraviolet A light

Abstract

BACKGROUND The INTERCEPT Blood System pathogen reduction technology (PRT), which uses amotosalen and ultraviolet A light treatment (amotosalen/UV‐PRT), inactivates pathogens in plasma and platelet components (PCs). This review summarizes data describing the inactivation efficacy of amotosalen/UVA‐PRT for a broad spectrum of viruses and parasites. METHODS Twenty‐five enveloped viruses, six nonenveloped viruses (NEVs), and four parasites species were evaluated for sensitivity to amotosalen/UVA‐PRT. Pathogens were spiked into plasma and PC at high titers. Samples were collected before and after PRT and assessed for infectivity with cell cultures or animal models. Log reduction factors (LRFs) were defined as the difference in infectious titers before and after amotosalen/UV‐PRT. RESULTS LRFs of ≥4.0 log were reported for 19 pathogens in plasma (range, ≥4.0 to ≥7.6), 28 pathogens in PC in platelet additive solution (PC‐PAS; ≥4.1‐≥7.8), and 14 pathogens in PC in 100% plasma (PC‐100%; (≥4.3‐>8.4). Twenty‐five enveloped viruses and two NEVs were sensitive to amotosalen/UV‐PRT; LRF ranged from >2.9 to ≥7.6 in plasma, 2.4 or greater to greater than 6.9 in PC‐PAS and >3.5 to >6.5 in PC‐100%. Infectious titers for four parasites were reduced by >4.0 log in all PC and plasma (≥4.9 to >8.4). CONCLUSION Amotosalen/UVA‐PRT demonstrated effective infectious titer reduction for a broad spectrum of viruses and parasites. This confirms the capacity of this system to reduce the risk of viral and parasitic transfusion‐transmitted infections by plasma and PCs in various geographies.

Screening for SARS‐CoV‐2 antibodies in convalescent plasma in Brazil: Preliminary lessons from a voluntary convalescent donor program

“…There are evidences that SARS‐CoV‐2 might not be transfused by blood components 76 . However, pathogen reduction should not be neglected in case it is already available, particularly due to its capacity of coronavirus inactivation 77,78 . The possibility of having hundreds or thousands of donors participating in CCP programs (intended for older, immunosuppressed patients or patients with different comorbidities), harboring detectable RNA for many days after recovery (especially after the standard 28‐day temporary deferral period), some with no molecular tests as screening procedures and no PR methods applicable, should be regarded with caution.…”

Sepsis from an apheresis platelet contaminated with Acinetobacter calcoaceticus/baumannii complex bacteria and Staphylococcus saprophyticus after pathogen reduction

“…This report represents the first case of a confirmed STR associated with a pathogen-reduced PLT unit, although possible STRs have been reported. 4 Using the INTER-CEPT process, PR is also considered robust for a wide variety of viruses and parasites 22 ; however, breakthrough cases of hepatitis E virus, a known PR-resistant virus, have occurred. 23,24 Our investigation demonstrated that the INTERCEPT process was successfully performed and that >5.9-log/mL in vitro inactivation occurred for both ACBC and SS isolates provided by the hospital microbiology laboratory.…”

Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units

“…Pathogen inactivation technology poses an additional layer of safety to reduce the risk of pathogen transmission. AS pathogen inactivation, which we evaluated in our study, efficiently inactivates blood borne viruses and other pathogens of concern in human plasma, 13 also HIV, HBV and HCV (viruses which could be transmitted despite the usage of state of the art screening tests during a window period).…”

“…The key objectives for this production method are the prevention of transmission of infectious agents and the preservation of the haemostatic capacity as well as the clinical effectiveness. AS‐treatment of plasma effectively inactivates a broad spectrum of pathogens, including newly emerging pathogens 13,14 . In vitro studies revealed a moderate loss of coagulation factors post PI‐treatment, with an overall retention meeting the regulatory criteria for therapeutic use 15,16 .…”