Comparison of quantitative cytomegalovirus real-time PCR in whole blood and pp65 antigenemia assay: clinical utility of CMV real-time PCR in hematopoietic stem cell transplant recipients.
Successful preemptive therapy for cytomegalovirus (CMV) infection in transplant patients depends on the availability of sensitive, specific, and timely diagnostic tests for CMV infection. Although the pp65 antigenemia assay has been widely used for this purpose, real-time quantification of CMV DNA has recently been recognized as an alternative diagnostic approach. However, the guidelines for antiviral therapy based on real-time quantitative polymerase chain reaction (RQ-PCR) have yet to be established. From November 2004 to March 2005, a total of 555 whole blood samples from 131 hematopoietic stem cell transplant (HSCT) recipients were prospectively collected. RQ-PCR was conducted using an Artus CMV LC PCR kit (QIAGEN). Both qualitative and quantitative correlations were drawn between the two methods. Exposure to the antiviral agent influenced the results of the two assays. Additionally, the discrepancy was observed at low levels of antigenemia and CMV DNA load. Via ROC curve analysis, the tentative cutoff value for preemptive therapy was determined to be approximately 2x10(4) copies/mL (sensitivity, 80.0%; specificity, 50.0%) in the high risk patients, and approximately 3x10(4) copies/mL (sensitivity, 90.0%; specificity, 70.0%) in the patients at low risk for CMV disease. Further study to validate the optimal cutoff value for the initiation of preemptive therapy is currently underway.
Choi
Su-Mi
SM
Department of Internal Medicine, The Catholic Hemopoietic Stem Cell Transplantation Center, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Lee
Dong-Gun
DG
Lim
Jihyang
J
Park
Sun Hee
SH
Choi
Jung-Hyun
JH
Yoo
Jin-Hong
JH
Lee
Jong-Wook
JW
Kim
Yonggoo
Y
Han
Kyungja
K
Min
Woo-Sung
WS
Shin
Wan-Shik
WS
Kim
Chun-Choo
CC
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003587:Cytomegalovirus / Q000235:genetics / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000628:therapy; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010750:Phosphoproteins / Q000032:analysis / Q000276:immunology; D016133:Polymerase Chain Reaction / Q000379:methods*; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014763:Viral Matrix Proteins / Q000032:analysis / Q000276:immunology
D004279:DNA, Viral; D010750:Phosphoproteins; D011933:Reagent Kits, Diagnostic; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa