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Multicenter comparison of laboratory performance in cytomegalovirus and E pstein– B arr virus viral load testing using international standards
Author(s) -
Rychert Jenna,
DanzigerIsakov Lara,
YenLieberman Belinda,
Storch Gregory,
Buller Richard,
Sweet Stewart C.,
Mehta Aneesh K.,
Cheeseman Jennifer A.,
Heeger Peter,
Rosenberg Eric S.,
Fishman Jay A.
Publication year - 2014
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12473
Subject(s) - viral load , medicine , transplantation , standardization , clinical trial , cytomegalovirus , multicenter trial , immunology , virology , virus , viral disease , multicenter study , herpesviridae , pathology , randomized controlled trial , computer science , operating system
Background Infections with cytomegalovirus ( CMV ) and E pstein– B arr virus ( EBV ) remain important in solid organ transplantation. Quantitative viral nucleic acid testing is a major advance to patient management. These assays are limited by a lack of standardization, resulting in viral load measurements that differ among clinical laboratories. The variability in viral load measurements makes interpretation of multicenter clinical trials data difficult. This study compares the current practices in CMV and EBV viral load testing at four large transplant centers participating in multicenter Clinical Trials in Organ Transplantation and the Clinical Trials in Organ Transplantation in Children (CTOT and CTOTC). Methods Viral load testing was performed on well‐defined viral preparations according to standard operating procedures at each site. Results Among centers, CMV viral load testing was accurate compared to WHO International Standards and within acceptable variation for this testing method. E pstein– B arr virus viral load data were more variable and less accurate despite the use of international standards. Conclusions These data suggest that comparison of CMV , but not EBV , viral load measurements at these sites is possible using current assays and control standards. Standardization of these assays is facilitated using the WHO International Standards and will allow comparison of viral load results among transplant centers. Assay standardization must be performed prior to initiation of multicenter trials.