Table 1.

Definitions of Cytomegalovirus Disease Not Changed From Previous Publication

Disease Entity	Proven	Probable
Pneumonia	Clinical symptoms and/or signs of pneumonia such as new infiltrates on imaging, hypoxia, tachypnea, and/or dyspnea combined with CMV documented in lung tissue by virus isolation, rapid culture, histopathology, immunohistochemistry, or DNA hybridization techniques
GI disease	Proven disease requires upper and/or lower GI symptoms plus macroscopic mucosal lesions plus CMV documented in tissue by histopathology, virus isolation, rapid culture, immunohistochemistry, or in situ nucleic acid hybridization techniques; studies should give information regarding the presence or absence of gut GVHD in HCT recipients	This requires upper and/or lower GI symptoms and CMV documented in tissue by histopathology, virus isolation, rapid culture, immunohistochemistry, or in situ nucleic acid hybridization but without the requirement for macroscopic mucosal lesions; it should, however, be noted that this definition may increase the risk of false positives, lowering the statistical sensitivity to a therapeutic effect; studies should report the presence or absence of gut GVHD in hematopoietic cell transplant recipients
Hepatitis	Abnormal liver function tests plus CMV documented in tissue by histopathology, immunohistochemistry, virus isolation, rapid culture, or DNA hybridization techniques plus the absence of other documented cause of hepatitis	Not defined
Encephalitis and ventriculitis	CNS symptoms plus detection of CMV in CNS tissue by virus isolation, rapid culture, immunohistochemical analysis, in situ hybridization, or preferably quantitative polymerase chain reaction	CNS symptoms plus detection of CMV in cerebrospinal fluid without visible contamination of blood plus abnormal imaging results or evidence of encephalitis on electroencephalogram
Nephritis	Detection of CMV by virus isolation, rapid culture, immunohistochemical analysis, or in situ hybridization in a kidney allograft biopsy specimen obtained from a patient with renal dysfunction together with the identification of histologic features of CMV infection	Not defined
Cystitis	Detection of CMV by virus isolation, rapid culture, immunohistochemical analysis, or in situ hybridization in a bladder biopsy specimen obtained from a patient with cystitis together with the identification of conventional histologic features of CMV infection	Not defined
Myocarditis	Detection of CMV by virus isolation, rapid culture, immunohistochemical analysis, or in situ hybridization in a heart biopsy specimen obtained from a patient with myocarditis together with the identification of conventional histologic features of CMV infection	Not defined
Pancreatitis	Detection of CMV by virus isolation, rapid culture, immunohistochemical analysis, or in situ hybridization in a pancreatic biopsy specimen obtained from a patient with pancreatitis together with the identification of conventional histologic features of CMV infection	Not defined
Other end-organ disease	CMV can also cause disease in other organs, and the definitions of these additional disease categories include the presence of compatible symptoms and signs and documentation of CMV by biopsy by virus isolation, rapid culture, immunohistochemical analysis, or in situ hybridization	Not defined

Abbreviations: CMV, cytomegalovirus; CNS, central nervous system; GI, gastrointestinal; GVHD, graft-versus-host disease; HCT, hematopoietic cell transplant.