title: Clinical performance of a commercial real-time PCR assay for Aspergillus DNA detection in serum samples from high-risk patients: comparison with a galactomannan enzyme immunoassay.
abstract: We investigated the clinical performance of a polymerase chain reaction (PCR)-based commercial platform, the Myconostica MycAssay™ Aspergillus (MAP), for fungal DNA detection in the serum of patients at risk of invasive aspergillosis (IA). Sixty-four hospitalized patients were prospectively enrolled and a total of 71 different episodes were investigated (30 episodes were clinically/microbiologically classified as IA and 41 as control episodes). When MAP was compared to the galactomannan (GM) assay, no significant differences were found in terms of sensitivity (46.7% vs. 50.0%), specificity (97.6% vs. 95.1%), positive predictive value (PPV) (93.3% vs. 88.2%), and negative predictive value (NPV) (71.4% vs. 72.2%). The corresponding areas under the curve (AUC) of the receiver operating characteristic (ROC) curves were also superimposable. Overall, because of the good agreement between the two assays and considering the high specificity and PPV of the MAP, we suggest the use of this PCR-based platform as a second-level examination for the evaluation of clinically undefined cases where culture or GM have provided positive results.
authors.affiliation: Dipartimento Interaziendale Integrato di Medicina di Laboratorio e Anatomia Patologica, Struttura Complessa di Microbiologia e Virologia, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.|Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università degli Studi di Bologna, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Pini
authors.affiliation: Dipartimento Interaziendale Integrato di Medicina di Laboratorio e Anatomia Patologica, Struttura Complessa di Microbiologia e Virologia, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Bettua
authors.affiliation: Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica, Università degli Studi di Modena e Reggio Emilia, Istituti Biologici, Via Campi 287, 41125, Modena, Italy.|Dipartimento di Scienze della Salute, Università degli Studi di Milano, Polo Universitario San Paolo, Milano, Italy.
authors.forename: C F
authors.initials: CF
authors.lastname: Orsi
authors.affiliation: Dipartimento Interaziendale Integrato di Medicina di Laboratorio e Anatomia Patologica, Struttura Complessa di Microbiologia e Virologia, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Venturelli
authors.affiliation: Dipartimento Attività Integrata (DAI) di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Ematologia, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Faglioni
authors.affiliation: Dipartimento Attività Integrata (DAI) di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Ematologia, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Forghieri
authors.affiliation: Dipartimento Attività Integrata (DAI) di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Ematologia, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Bigliardi
authors.affiliation: DAI di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Malattie dell'Apparato Respiratorio, Università degli Studi di Modena e Reggio Emilia, Modena, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Luppi
authors.affiliation: Divisione di Anestesiologia e Terapia Intensiva, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Girardis
authors.affiliation: Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica, Università degli Studi di Modena e Reggio Emilia, Istituti Biologici, Via Campi 287, 41125, Modena, Italy. elisabetta.blasi@unimore.it.
authors.forename: E
authors.initials: E
authors.lastname: Blasi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001228:Aspergillosis / Q000175:diagnosis*; D001230:Aspergillus / Q000235:genetics*; D004271:DNA, Fungal / Q000097:blood*; D005260:Female; D016469:Fungemia / Q000175:diagnosis; D005690:Galactose / Q000031:analogs & derivatives; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008351:Mannans / Q000097:blood; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D004271:DNA, Fungal; D008351:Mannans; C012990:galactomannan; D005690:Galactose
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