BACKGROUND: Although serologic screening or WBC reduction of blood components can reduce the incidence of transfusion-transmitted CMV (TT-CMV) infection, 'breakthrough' cases of TT-CMV still occur and may produce serious sequelae. NAT of blood components for CMV DNA has been proposed to further reduce the risks of TT-CMV. However, large-scale studies to determine the utility of validated CMV NAT assays for donor screening have not been reported. STUDY DESIGN AND METHODS: Coded whole-blood samples (n=1000) were tested for the presence of CMV DNA using two CMV PCR assays previously validated in a multicenter trial (a nested PCR assay directed at the CMV UL93 open-reading frame and the Roche Monitor assay). Corresponding plasma samples were tested in parallel for the presence of anti-CMV using other assays (Abbott CMV EIA and Fujirebio/Olympus CMV particle agglutination assays). RESULTS: In total 416 and 514 of the samples tested as CMV-seropositive and -seronegative, respectively, by both antibody assays. The remaining 70 samples had discrepant serology results. Only 2 of the 1000 samples (both seropositive) had reproducibly detectable CMV DNA (positive in at least three of four replicates). CMV DNA was not reproducibly detected in seronegative samples or in samples with discrepant serology results. CONCLUSIONS: Although previous investigations showed frequent detection of CMV DNA in healthy CMV-seropositive (and some seronegative) blood donors, these studies were relatively small and the performance characteristics of their assays were difficult to evaluate. In contrast, the present large cross-sectional study of US donors utilized two previously validated PCR assays and demonstrated that CMV DNA is only rarely detectable in seropositive donors. Thus, the use of CMV PCR assays with optimal performance characteristics did not increase the detection of potentially infectious blood components beyond that provided by current serologic screening assays.
BACKGROUND: Although serologic screening or WBC reduction of blood components can reduce the incidence of transfusion-transmitted CMV (TT-CMV) infection, 'breakthrough' cases of TT-CMV still occur and may produce serious sequelae. NAT of blood components for CMV DNA has been proposed to further reduce the risks of TT-CMV. However, large-scale studies to determine the utility of validated CMV NAT assays for donor screening have not been reported. STUDY DESIGN AND METHODS: Coded whole-blood samples (n=1000) were tested for the presence of CMV DNA using two CMV PCR assays previously validated in a multicenter trial (a nested PCR assay directed at the CMV UL93 open-reading frame and the Roche Monitor assay). Corresponding plasma samples were tested in parallel for the presence of anti-CMV using other assays (Abbott CMV EIA and Fujirebio/Olympus CMV particle agglutination assays). RESULTS: In total 416 and 514 of the samples tested as CMV-seropositive and -seronegative, respectively, by both antibody assays. The remaining 70 samples had discrepant serology results. Only 2 of the 1000 samples (both seropositive) had reproducibly detectable CMV DNA (positive in at least three of four replicates). CMV DNA was not reproducibly detected in seronegative samples or in samples with discrepant serology results. CONCLUSIONS: Although previous investigations showed frequent detection of CMV DNA in healthy CMV-seropositive (and some seronegative) blood donors, these studies were relatively small and the performance characteristics of their assays were difficult to evaluate. In contrast, the present large cross-sectional study of US donors utilized two previously validated PCR assays and demonstrated that CMV DNA is only rarely detectable in seropositive donors. Thus, the use of CMV PCR assays with optimal performance characteristics did not increase the detection of potentially infectious blood components beyond that provided by current serologic screening assays.
Authors: Volkmar Schottstedt; Johannes Blümel; Reinhard Burger; Christian Drosten; Albrecht Gröner; Lutz Gürtler; Margarethe Heiden; Martin Hildebrandt; Bernd Jansen; Thomas Montag-Lessing; Ruth Offergeld; Georg Pauli; Rainer Seitz; Uwe Schlenkrich; Johanna Strobel; Hannelore Willkommen; Carl-Heinz Wirsing von König Journal: Transfus Med Hemother Date: 2010-11-17 Impact factor: 3.747
Authors: Cassandra D Josephson; Marta-Inés Castillejo; Angela M Caliendo; Edmund K Waller; James Zimring; Kirk A Easley; Michael Kutner; Christopher D Hillyer; John D Roback Journal: Transfus Med Rev Date: 2011-02-23
Authors: Christoph Steininger; George F Widhopf; Emanuela M Ghia; Christopher S Morello; Katrina Vanura; Rebecca Sanders; Deborah Spector; Don Guiney; Ulrich Jäger; Thomas J Kipps Journal: Blood Date: 2012-01-10 Impact factor: 22.113
Authors: Michelle A Neller; Kristin Ladell; James E McLaren; Katherine K Matthews; Emma Gostick; Johanne M Pentier; Garry Dolton; Andrea J A Schauenburg; Dan Koning; Ana Isabel C A Fontaine Costa; Thomas S Watkins; Vanessa Venturi; Corey Smith; Rajiv Khanna; Kelly Miners; Mathew Clement; Linda Wooldridge; David K Cole; Debbie van Baarle; Andrew K Sewell; Scott R Burrows; David A Price; John J Miles Journal: Immunol Cell Biol Date: 2015-03-24 Impact factor: 5.126