Prevention of cytomegalovirus disease in transplant recipients. Evaluation of real-time PCR CMV, clinic correlation and cutoff determination of pre-emptive therapy
Abstract number: P1173
Martín-Gandul C., Cordero E., Sánchez M., Cabello V., Fijo J., Bernal C., Lage E., De la Cruz F., Aguilar M., Rodriguez M.J., García E.
Objectives: Preemtive therapy guided by threshold viral replication allows optimizing cytomegalovirus (CMV) infection therapy. There is not a standarised and validated cut off point to guide preemptive CMV therapy in organ transplant patients. The aims of this sudy are: 1. To study the correlationship between CMV viral load and the spectrum of CMV infection in transplant recipients. 2. To set up a cutoff point of CMV viral load to start preemtive therapy.
Methods: A prospective cohort study was performed from october 2008 to june 2009. Every trasplant recipients with viral replication detected by PCR CMV were included. SPSS V15.0 was used for descriptive analysis and G-Stat 2.0 for analysis by ROC (Receiver Operating Characteristics) curves of sensitivity and specificity in the full spectrum of cutoff points in the over range of observed results.
Results: One hundred and twenty patients were included: 104 solid organ transplant recipients (28 liver, 63 renal, 1 liver-renal, 11 heart) and 16 allogeneic hematopoietic stem cell transplant recipients. Median age was 53 years (range 973), 64.7% were male and 16.6% were at high risk for CMV infection. There were 7 episodes (5.83%) of CMV organ disease (four gastritis, one colitis, one duodenitis, one pneumonitis and retinitis), 6 episodes (5%) of viral syndrome and 107 episodes (89.17%) of asyntomatic infection. Fifty-two patients (43.3%) received preemptive therapy. The median CMV copies at the start of therapy was 4325 copies /ml, interquartile range (1662.50 to 9265). After assessing the different cutoff points by ROC curves, 2130 copies/ml was defined as the best cutoff point for early therapy initiation, with specificity 94.67%, sensitivy 84.62%, negative predective value 99.37% and positive predictive value 9.09%. The area under the curve (AUC) ROC of 87.9% represents a high accuracy in the diagnostic test.
Conclusions: 1. Real time PCR CMV is an effective predictive dignostic test to guide preemptive therapy. 2. 2130 copies /ml is defined as the best cutoff point for starting preemptive therapy. 3. A cutoff point higher than 5000 and 10000 copies/ml as suggested in the literature is not acceptable in our experience because there were lower levels of CMV replication in a significant proportion of patients with CMV organ disease. 4. New studies are needed to validate this cutoff point in a external cohort.
|Session name:||Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Vienna, Austria, 10 - 13 April 2010|
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