Roth, Nathan J. and Schaefer, Wolfram and Alexander, Rick and Elliott, Kevin and Elliott-Browne, Wlenyeno and Knowles, Jonathan and Wenzel, Juergen J. and Simon, Toby L. (2017) Low hepatitis E virus RNA prevalence in a large-scale survey of United States source plasma donors. TRANSFUSION, 57 (12). pp. 2958-2964. ISSN 0041-1132, 1537-2995
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND: Hepatitis E virus (HEV) is a small, nonenveloped, single-stranded, RNA virus of emerging concern in industrialized countries. HEV transmission through transfusion of blood components has been reported, but not via plasma-derived medicinal products (PDMPs) manufactured with virus inactivation and/or removal steps. This study aimed to determine the prevalence of HEV among US source plasma donors. STUDY DESIGN AND METHODS: Samples were collected from US source plasma donors at centers across the United States and were initially screened for HEV RNA in 96-sample minipools using the Roche cobas HEV test on the cobas 8800 system. Assuming a sensitivity of 18.6 IU/mL, the minipool screening strategy allowed for reliable detection of individual donations with HEV RNA titers of more than 2 x 10(3) IU/mL. Reactive minipools were resolved to individual donations, which were further analyzed to quantify viral RNA concentration, determine HEV genotype, and immunoglobulin (Ig)G and IgM HEV antibody status. RESULTS: A total of 128,020 samples were collected from 96 CSL Plasma centers in the United States, representing 27 states. The prevalence of HEV RNA-positive samples was 0.002% with three unique HEV-positive donors identified, all HEV Subgenotype 3a. Virus titers of HEV-positive samples were relatively low (10(3)-10(4) IU HEV RNA/mL). One positive donation was HEV IgG seropositive. CONCLUSION: Routine screening of US source plasma donations for HEV would not substantially improve the safety of most PDMPs. The low prevalence and potential viral load of HEV, together with effective virus reduction steps in manufacturing processes, results in a low residual risk and acceptable safety margins for PDMPs derived from US plasma donors.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PASSENGER LYMPHOCYTE SYNDROME; STEM-CELL TRANSPLANTATION; VERSUS-HOST-DISEASE; KIDNEY-TRANSPLANTATION; HEMOLYTIC-ANEMIA; LIVER-TRANSPLANTATION; TRANSFUSION REACTIONS; BOWEL TRANSPLANT; ABO; RECIPIENT; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 13:19 |
| Last Modified: | 13 Feb 2019 11:55 |
| URI: | https://pred.uni-regensburg.de/id/eprint/1767 |
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