CMV antigenemia and quantitative viral load assessments in hematopoietic stem cell transplant recipients |
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| Authors: | Laura Cardeñoso Benjamin A. Pinsky Irmeli Lautenschlager Shagufta Aslam Bryan Cobb Regis A. Vilchez Hans H. Hirsch |
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| Affiliation: | 1. Hospital Universitario de la Princesa, Madrid, Spain;2. Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA;3. Department of Virology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland;4. Roche Molecular Systems, Inc., Pleasanton, CA, USA;5. Division of Infection Diagnostics (“Institute for Medical Microbiology”), Department Biomedicine (Haus Petersplatz), University of Basel, Basel, Switzerland;6. Transplantation & Clinical Virology, Department Biomedicine (Haus Petersplatz), University of Basel, Basel, Switzerland;7. Infectious Diseases & Hospital Epidemiology, University Hospital Basel, Basel, Switzerland;1. Department of Clinical Medicine, University of Bologna, Bologna, Italy;2. Operative Unit of Microbiology and Virology, Sant’Orsola-Malpighi Hospital, Bologna, Italy;3. Scientific Affairs, Abbott Diagnostici, Roma, Italy;1. Department of Dermatology, Poznan University of Medical Sciences, Poland;2. Department of Haematology, Poznan University of Medical Sciences, Poland;3. Department of Microbiology, Poznan University of Medical Sciences, Poland;4. Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Chalubinskiego 1, 50–368 Wroclaw, Poland;1. Service of Dermatology, Complexo Hospitalar Universitário Prof. Edgard Santos, Federal University of Bahia, Rua Dr. Augusto Viana, s/n, Canela, CEP: 40.110-060, Salvador, Bahia, Brazil;2. Laboratory of Experimental Pathology (LAPEX), CPQGM–FIOCRUZ, Bahia, Rua Waldemar Falcão 121, Candeal, CEP: 40296-710, Salvador, Bahia, Brazil;3. Service of Pathology, Complexo Hospitalar Universitário Prof. Edgard Santos, Federal University of Bahia, Rua Dr. Augusto Viana, s/n, Canela, CEP: 40.110-060, Salvador, Bahia, Brazil |
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| Abstract: | BackgroundSensitive and reliable diagnostic tests are essential for the prevention of cytomegalovirus (CMV) disease after hematopoietic stem cell transplantation (HSCT). pp65 antigenemia and polymerase chain reaction (PCR) assays are commonly used to monitor CMV in HSCT recipients. However, there is considerable intra- and inter-laboratory variability in the results, which impact comparability and clinical practice.Objectives/study designUsing 380 samples from 135 HSCT recipients, we compared the new FDA approved quantitative PCR assay, COBAS® AmpliPrep/COBAS® TaqMan® CMV test (CAP/CTM CMV test) developed and standardized using the 1st WHO International Standard for CMV with pp65 antigenemia and COBAS® AMPLICOR MONITOR CMV tests.ResultsThe median time between transplantation and testing samples was 57 days (range, 0–207 days). The median CMV load (log10) was 3.17 IU/mL (3.21 copies/mL). Among samples with detectable CMV load, 52% were negative by pp65 antigenemia. CMV loads were higher in pp65 antigenemia-positive than in negative samples. One pp65-antigenemia-positive cell per 100,000 leukocytes corresponded to a median CMV load of 1200 IU/mL. CMV loads determined by the CAP/CTM CMV test were slightly lower than the ones by the AMPLICOR MONITOR CMV test (?0.15 [95% CI, ?0.18 to ?0.13] copies/mL), but slope differences indicated only limited co-linearity.ConclusionsThe CAP/CTM CMV test is more sensitive than pp65 antigenemia and the AMPLICOR MONITOR CMV test in HSCT recipients. The lower limit of quantification and co-linearity with the international WHO standard renders the CAP/CTM CMV test suitable for future clinical trials defining viral load thresholds of CMV therapy. |
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