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A double-blinded, prospective study to define antigenemia and quantitative real-time polymerase chain reaction cutoffs to start preemptive therapy in low-risk, seropositive, renal transplanted recipients.
- Source :
-
Transplantation [Transplantation] 2014 Nov 27; Vol. 98 (10), pp. 1077-81. - Publication Year :
- 2014
-
Abstract
- Background: Cytomegalovirus (CMV) disease occurs in 16% to 20% of low-risk, CMV-positive renal transplant recipients. The cutoffs for quantitative real-time polymerase chain reaction (qPCR) or phosphoprotein (pp65) antigenemia (pp65emia) for starting preemptive therapy have not been well established.<br />Methods: We measured qPCR and pp65emia weekly from day 7 to day 120 after transplantation, in anti-CMV immunoglobulin G–positive donor and recipient pairs. Patients and physicians were blinded to the test results. Suspicion of CMV disease led to the order of new tests. In asymptomatic viremic patients, the highest pp65emia and qPCR values were used, whereas we considered the last value before diagnosis in those with CMV disease.<br />Results: We collected a total of 1,481 blood samples from 102 adult patients. Seventeen patients developed CMV disease, 54 presented at least one episode of viremia that cleared spontaneously, and 31 never presented viremia. Five patients developed CMV disease after the end of the study period. The median (95% confidence interval) pp65emia and qPCR values were higher before CMV disease than during asymptomatic viremia (6 [9–82] vs. 3 [1–14] cells/10(6) cells; P<0.001 and 3,080 [1,263–15,605] vs. 258 [258–1,679] copies/mL; P=0.008, respectively). The receiver operating characteristic curve showed that pp65emia 4 cells/10(6) cells or greater showed a sensitivity and specificity to predict CMV disease of 69% and 81%, respectively (area, 0.769; P=0.001), with a positive predictive value of 37% and a negative predictive value of 93%. For qPCR 2,000 copies/mL or higher, the positive predictive value and negative predictive value were 57% and 91%, respectively (receiver operating characteristic area, 0.782; P=0.000).<br />Conclusion: With these cutoffs, both methods are appropriate for detecting CMV disease.
- Subjects :
- Adult
Antigens, Viral genetics
Cytomegalovirus genetics
Cytomegalovirus isolation & purification
Cytomegalovirus Infections virology
Double-Blind Method
Early Diagnosis
Female
Humans
Male
Middle Aged
Phosphoproteins blood
Phosphoproteins genetics
Phosphoproteins immunology
Predictive Value of Tests
Prospective Studies
Real-Time Polymerase Chain Reaction
Risk Factors
Viral Matrix Proteins blood
Viral Matrix Proteins genetics
Viral Matrix Proteins immunology
Viremia diagnosis
Viremia etiology
Viremia virology
Antigens, Viral blood
Cytomegalovirus immunology
Cytomegalovirus Infections diagnosis
Cytomegalovirus Infections etiology
Kidney Transplantation adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1534-6080
- Volume :
- 98
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 24839894
- Full Text :
- https://doi.org/10.1097/TP.0000000000000189