title: Diagnostic utility of quantitative plasma cytomegalovirus DNA PCR for cytomegalovirus end-organ diseases in patients with HIV-1 infection.
abstract: OBJECTIVE
  To investigate the diagnostic value of quantitative plasma cytomegalovirus (CMV)-DNA polymerase chain reaction (PCR) for CMV end-organ diseases (CMV-EOD) in patients with HIV-1 infection.
  
  
  METHODS
  Single-center cross-sectional study.
  
  
  METHODS
  The study subjects were HIV-1-infected patients with CD4 ≤200 per microliter, who had undergone ophthalmologic examination with plasma CMV-DNA PCR measured within 7 days. CMV retinitis and other CMV-EOD were diagnosed according to the ACTG criteria. PCR value was converted into the WHO international standard.
  
  
  RESULTS
  CMV retinitis and all CMV-EOD were diagnosed in 23 (5%) and 37 (8%) of the 461 study patients, respectively. CMV-DNA was undetectable (<185 IU/mL) in 2 patients with CMV retinitis and 1 with encephalitis. The area under the receiver operating characteristic curve of CMV-DNA for CMV retinitis and all CMV-EOD were 0.80 [95% confidence interval (CI): 0.71 to 0.89] and 0.82 (0.75 to 0.89), respectively. The sensitivity, specificity, positive predictive value, and negative predictive value for each cutoff value of CMV-DNA were as follows: for CMV retinitis, ≥10,086 IU/mL: 26.1%, 94.1%, 18.8%, 96%; ≥2946 IU/mL; 56.5%, 86.8%, 18.3%, 97.4%; ≥959 IU/mL; 60.9%, 78.1%, 12.7%, 97.4%; detectable CMV-DNA (≥185 IU/mL): 91.3%, 48.2%, 8.5%, 99.1%; for all CMV-EOD: ≥10,086 IU/mL: 32.4%, 95.3%, 37.5%, 94.2%; ≥2946 IU/mL; 54.1%, 88%, 28.2%, 95.6%; ≥959 IU/mL; 62.2%, 79.5%, 20.9%, 96%; detectable CMV-DNA; 91.9%, 49.5%, 13.7%, 98.6%.
  
  
  CONCLUSIONS
  Plasma CMV-DNA PCR has a high diagnostic value for both CMV retinitis and all CMV-EOD in patients with advanced HIV-1 infection. A cutoff value of CMV-DNA ≥10,086 IU/mL and ≥2946 IU/mL yields high specificity, whereas undetectable CMV-DNA load (<185 IU/mL) likely rules out CMV-EOD.
authors.affiliation: *AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan; †Center for AIDS Research, Kumamoto University, Kumamoto, Japan; and ‡Department of Ophthalmology, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Mizushima
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nishijima
authors.forename: Shigeko
authors.initials: S
authors.lastname: Yashiro
authors.forename: Katsuji
authors.initials: K
authors.lastname: Teruya
authors.forename: Yoshimi
authors.initials: Y
authors.lastname: Kikuchi
authors.forename: Naomichi
authors.initials: N
authors.lastname: Katai
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Gatanaga
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000175:diagnosis / Q000821:virology*; D000328:Adult; D003430:Cross-Sectional Studies; D003587:Cytomegalovirus / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000821:virology*; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D015497:HIV-1 / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010949:Plasma / Q000821:virology; D011237:Predictive Value of Tests; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D004279:DNA, Viral