title: [Analytical performances of real-time PCR by Abbott RealTime CMV with m2000 for the detection of cytomegalovirus in urine].
abstract: Congenital cytomegalovirus (CMV) infection is the leading cause of sensoneurinal disability due to infectious congenital disease. The diagnosis of congenital CMV infection is based on the search of CMV in the urine within the first two weeks of life. Viral culture of urine is the gold standard. However, the PCR is highly sensitive and faster. It is becoming an alternative choice. The objective of this study is the validation of real-time PCR by Abbott RealTime CMV with m2000 for the detection of cytomegalovirus in urine. Repeatability, reproducibility, detection limit and inter-sample contamination were evaluated. Urine samples from patients (n=141) were collected and analyzed simultaneously in culture and PCR in order to assess the correlation of these two methods. The sensitivity and specificity of PCR were also calculated. The Abbott RealTime CMV PCR in urine is an automated and sensitive method (detection limit 200 UI/mL). Fidelity is very good (standard deviation of repeatability: 0.08 to 0.15 LogUI/mL and reproducibility 0.18 LogUI/mL). We can note a good correlation between culture and Abbott RealTime CMV PCR (kappa 96%). When considering rapid culture as reference, real-time PCR was highly sensitive (100%) and specific (98.2%). The real-time PCR by Abbott RealTime CMV with m2000 is optimal for CMV detection in urine.
authors.affiliation: Laboratoire de virologie, Centre hospitalier universitaire de Nice, Hôpital de l'Archet, Nice, France.
authors.forename: Anne
authors.initials: A
authors.lastname: De Monte
authors.affiliation: Laboratoire de virologie, Centre hospitalier universitaire de Nice, Hôpital de l'Archet, Nice, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cannavo
authors.affiliation: Laboratoire de virologie, Centre hospitalier universitaire de Nice, Hôpital de l'Archet, Nice, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Caramella
authors.affiliation: Laboratoire de virologie, Centre hospitalier universitaire de Nice, Hôpital de l'Archet, Nice, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Ollier
authors.affiliation: Laboratoire de virologie, Centre hospitalier universitaire de Nice, Hôpital de l'Archet, Nice, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Giordanengo
mesh_terms: D057205:Automation, Laboratory; D003587:Cytomegalovirus / Q000235:genetics / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000151:congenital / Q000175:diagnosis* / Q000235:genetics / Q000652:urine; D006801:Humans; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000379:methods; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation* / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016482:Urinalysis / Q000295:instrumentation / Q000379:methods / Q000592:standards; D014773:Virology / Q000295:instrumentation / Q000379:methods
keywords: Abbott RealTime CMV; CMV; analytical performances; real time PCR; urine