title: Utilization of a real-time PCR assay for diagnosis of Babesia microti infection in clinical practice.
abstract: Babesiosis is an emerging tick-borne disease mainly caused Babesia microti, a protozoan that infects erythrocytes. Microscopic examination of blood smears is the current gold standard for detection of Babesia infection, but this diagnostic test has several limitations. We developed and assessed the clinical utilization of a multiplex real-time PCR assay targeting the 18S rRNA gene of B. microti and the human gapdh gene. The limit of detection of this PCR assay was approximately 1-3parasites/μl of blood. The assay showed a diagnostic sensitivity and probable specificity of 100% based on testing 145 retrospective and 185 prospective blood specimens from controls and patients with confirmed babesiosis. Notably, the PCR assay was more sensitive than blood smear examination in patients during and following anti-babesia drug therapy. Our study suggests that PCR testing is as good or better than a blood smear for detection of B. microti in routine clinical practice. PCR testing may confirm the presence of babesiosis in patients whose level of infection is too low for reliable microscopic detection.
authors.affiliation: Department of Pathology, New York Medical College, Valhalla, NY, United States; Department of Pathology and Clinical Laboratories, Westchester Medical Center, Valhalla, NY, United States. Electronic address: guiqing_wang@nymc.edu.
authors.forename: Guiqing
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Medicine, New York Medical College, Valhalla, NY, United States.
authors.forename: Gary P
authors.initials: GP
authors.lastname: Wormser
authors.affiliation: Department of Pathology and Clinical Laboratories, Westchester Medical Center, Valhalla, NY, United States.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhuge
authors.affiliation: Department of Medicine, New York Medical College, Valhalla, NY, United States.
authors.forename: Patrick
authors.initials: P
authors.lastname: Villafuerte
authors.affiliation: Department of Pathology and Clinical Laboratories, Westchester Medical Center, Valhalla, NY, United States.
authors.forename: Dawn
authors.initials: D
authors.lastname: Ip
authors.affiliation: Department of Pathology and Clinical Laboratories, Westchester Medical Center, Valhalla, NY, United States.
authors.forename: Christine
authors.initials: C
authors.lastname: Zeren
authors.affiliation: Department of Pathology, New York Medical College, Valhalla, NY, United States; Department of Medicine, New York Medical College, Valhalla, NY, United States; Department of Pathology and Clinical Laboratories, Westchester Medical Center, Valhalla, NY, United States.
authors.forename: John T
authors.initials: JT
authors.lastname: Fallon
mesh_terms: D000818:Animals; D041001:Babesia microti / Q000235:genetics / Q000302:isolation & purification*; D001404:Babesiosis / Q000175:diagnosis*; D001483:Base Sequence; D016054:DNA, Protozoan / Q000235:genetics; D005260:Female; D006801:Humans; D008297:Male; D008969:Molecular Sequence Data; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods; D018512:Parasitemia; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D016415:Sequence Alignment; D017282:Tick-Borne Diseases / Q000175:diagnosis*
chemical_list: D016054:DNA, Protozoan
keywords: Babesia microti; Babesiosis; Giemsa stain; Microscopic examination; Real-time PCR