title: Multicenter Evaluation of Clinical Diagnostic Methods for Detection and Isolation of Campylobacter spp. from Stool.
abstract: The use of culture-independent diagnostic tests (CIDTs), such as stool antigen tests, as standalone tests for the detection of Campylobacter in stool is increasing. We conducted a prospective, multicenter study to evaluate the performance of stool antigen CIDTs compared to culture and PCR for Campylobacter detection. Between July and October 2010, we tested 2,767 stool specimens from patients with gastrointestinal illness with the following methods: four types of Campylobacter selective media, four commercial stool antigen assays, and a commercial PCR assay. Illnesses from which specimens were positive by one or more culture media or at least one CIDT and PCR were designated "cases." A total of 95 specimens (3.4%) met the case definition. The stool antigen CIDTs ranged from 79.6% to 87.6% in sensitivity, 95.9 to 99.5% in specificity, and 41.3 to 84.3% in positive predictive value. Culture alone detected 80/89 (89.9% sensitivity) Campylobacter jejuni/Campylobacter coli-positive cases. Of the 209 noncases that were positive by at least one CIDT, only one (0.48%) was positive by all four stool antigen tests, and 73% were positive by just one stool antigen test. The questionable relevance of unconfirmed positive stool antigen CIDT results was supported by the finding that noncases were less likely than cases to have gastrointestinal symptoms. Thus, while the tests were convenient to use, the sensitivity, specificity, and positive predictive value of Campylobacter stool antigen tests were highly variable. Given the relatively low incidence of Campylobacter disease and the generally poor diagnostic test characteristics, this study calls into question the use of commercially available stool antigen CIDTs as standalone tests for direct detection of Campylobacter in stool.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA chf3@cdc.gov.
authors.forename: Collette
authors.initials: C
authors.lastname: Fitzgerald
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Patrick
authors.affiliation: Sacramento County Public Health Laboratory, Sacramento, California, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Gonzalez
authors.affiliation: Sacramento County Public Health Laboratory, Sacramento, California, USA.
authors.forename: Joshua
authors.initials: J
authors.lastname: Akin
authors.affiliation: University of California Davis School of Medicine, Sacramento, California, USA.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Polage
authors.affiliation: California Emerging Infections Program, Oakland, California, USA.
authors.forename: Kate
authors.initials: K
authors.lastname: Wymore
authors.affiliation: Colorado Department of Public Health and Environment, Denver, Colorado, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Gillim-Ross
authors.affiliation: Colorado Department of Public Health and Environment, Denver, Colorado, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Xavier
authors.affiliation: Colorado Department of Public Health and Environment, Denver, Colorado, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sadlowski
authors.affiliation: Exempla St. Joseph Hospital, Denver, Colorado, USA.
authors.forename: Jan
authors.initials: J
authors.lastname: Monahan
authors.affiliation: Connecticut Emerging Infections Program, New Haven, Connecticut, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Hurd
authors.affiliation: Yale-New Haven Hospital, New Haven, Connecticut, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Dahlberg
authors.affiliation: Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Jerris
authors.affiliation: Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
authors.forename: Renee
authors.initials: R
authors.lastname: Watson
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Monica
authors.initials: M
authors.lastname: Santovenia
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: David
authors.initials: D
authors.lastname: Mitchell
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Cassandra
authors.initials: C
authors.lastname: Harrison
authors.affiliation: Georgia Department of Public Health, Atlanta, Georgia, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Tobin-D'Angelo
authors.affiliation: State Hygienic Laboratory at the University of Iowa, Iowa City, Iowa, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: DeMartino
authors.affiliation: State Hygienic Laboratory at the University of Iowa, Iowa City, Iowa, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Pentella
authors.affiliation: Maryland Department of Health and Mental Hygiene, Baltimore, Maryland, USA.
authors.forename: Jafar
authors.initials: J
authors.lastname: Razeq
authors.affiliation: Maryland Department of Health and Mental Hygiene, Baltimore, Maryland, USA.
authors.forename: Celere
authors.initials: C
authors.lastname: Leonard
authors.affiliation: Maryland Department of Health and Mental Hygiene, Baltimore, Maryland, USA.
authors.forename: Carrianne
authors.initials: C
authors.lastname: Jung
authors.affiliation: Maryland Department of Health and Mental Hygiene, Baltimore, Maryland, USA.
authors.forename: Ria
authors.initials: R
authors.lastname: Achong-Bowe
authors.affiliation: Maryland Department of Health and Mental Hygiene, Baltimore, Maryland, USA.
authors.forename: Yaaqobah
authors.initials: Y
authors.lastname: Evans
authors.affiliation: Maryland Department of Health and Mental Hygiene, Baltimore, Maryland, USA.
authors.forename: Damini
authors.initials: D
authors.lastname: Jain
authors.affiliation: Minnesota Department of Health, St. Paul, Minnesota, USA.
authors.forename: Billie
authors.initials: B
authors.lastname: Juni
authors.affiliation: Minnesota Department of Health, St. Paul, Minnesota, USA.
authors.forename: Fe
authors.initials: F
authors.lastname: Leano
authors.affiliation: Minnesota Department of Health, St. Paul, Minnesota, USA.
authors.forename: Trisha
authors.initials: T
authors.lastname: Robinson
authors.affiliation: Minnesota Department of Health, St. Paul, Minnesota, USA.
authors.forename: Kirk
authors.initials: K
authors.lastname: Smith
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Rachel M
authors.initials: RM
authors.lastname: Gittelman
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Garrigan
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Irving
authors.initials: I
authors.lastname: Nachamkin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods*; D002167:Campylobacter / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D002169:Campylobacter Infections / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult