title: Multicenter Evaluation of BD Max Enteric Parasite Real-Time PCR Assay for Detection of Giardia duodenalis, Cryptosporidium hominis, Cryptosporidium parvum, and Entamoeba histolytica.
abstract: Common causes of chronic diarrhea among travelers worldwide include protozoan parasites. The majority of parasitic infections are caused by Giardia duodenalis, Entamoeba histolytica, Cryptosporidium parvum, and Cryptosporidium hominis Similarly, these species cause the majority of parasitic diarrhea acquired in the United States. Detection of parasites by gold standard microscopic methods is time-consuming and requires considerable expertise; enzyme immunoassays and direct fluorescent-antibody (DFA) stains have lowered hands-on time for testing, but improvements in sensitivity and technical time may be possible with a PCR assay. We performed a clinical evaluation of a multiplex PCR panel, the enteric parasite panel (EPP), for the detection of these common parasites using the BD Max instrument, which performs automated extraction and amplification. A total of 2,495 compliant specimens were enrolled, including 2,104 (84%) specimens collected prospectively and 391 (16%) specimens collected retrospectively. Approximately equal numbers were received in 10% formalin (1,273 specimens) and unpreserved (1,222 specimens). The results from the EPP were compared to those from alternate PCR and bidirectional sequencing (APCR), as well as DFA (G. duodenalis and C. parvum or C. hominis) or trichrome stain (E. histolytica). The sensitivity and specificity for prospective and retrospective specimens combined were 98.2% and 99.5% for G. duodenalis, 95.5% and 99.6 for C. parvum or C. hominis, and 100% and 100% for E. histolytica, respectively. The performance of the FDA-approved BD Max EPP compared well to the reference methods and may be an appropriate substitute for microscopic examination or immunoassays.
authors.affiliation: Parasitology Laboratory, Wadsworth Center, NYSDOH, Albany, New York, USA s.antenucci@health.ny.gov.
authors.forename: S
authors.initials: S
authors.lastname: Madison-Antenucci
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: R F
authors.initials: RF
authors.lastname: Relich
authors.affiliation: Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: L
authors.initials: L
authors.lastname: Doyle
authors.affiliation: Parasitology Laboratory, Wadsworth Center, NYSDOH, Albany, New York, USA.
authors.forename: N
authors.initials: N
authors.lastname: Espina
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: D
authors.initials: D
authors.lastname: Fuller
authors.affiliation: Becton Dickinson and Company, Sparks, Maryland, USA.
authors.forename: T
authors.initials: T
authors.lastname: Karchmer
authors.affiliation: Becton, Dickinson and Company, Quebec, Quebec, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Lainesse
authors.affiliation: Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Mortensen
authors.affiliation: The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
authors.forename: P
authors.initials: P
authors.lastname: Pancholi
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: W
authors.initials: W
authors.lastname: Veros
authors.affiliation: Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Harrington
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D057205:Automation, Laboratory / Q000379:methods; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D003458:Cryptosporidium / Q000235:genetics / Q000302:isolation & purification*; D004748:Entamoeba histolytica / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D016829:Giardia lamblia / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007411:Intestinal Diseases, Parasitic / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014481:United States; D055815:Young Adult