title: Comparison of an industry-derived LCx Chlamydia pneumoniae PCR research kit to in-house assays performed in five laboratories.
abstract: In a multicenter comparison of PCR assays utilizing 120 quantitated samples of 16 Chlamydia pneumoniae isolates, an LCx research-use-only (RUO) PCR developed by Abbott Laboratories demonstrated 100% sensitivity on 48 samples with >1 copy of DNA per microl of specimen. The sensitivities of five in-house PCR assays ranged from 54 to 94% for the same samples. All six assays showed decreased sensitivities as the DNA copy numbers of the samples decreased. Overall, sensitivities ranged from 68% for the LCx PCR assay to 29% for one of the in-house tests. The LCx RUO PCR and three of the five in-house PCR tests reported no false positives with the 24 negative samples. Increasing the number of replicates tested increased the sensitivities of all of the assays, including the LCx PCR. The LCx RUO assay showed high reproducibility for a single technologist and between technologists, with a kappa agreement of 0.77. The within-center agreements of the five in-house PCR tests varied from 0.19 to 0.74 on two challenges of 60 specimens 1 month apart. The LCx C. pneumoniae RUO PCR shows excellent potential for use in clinical studies, which could enable standardization of results in the field.
authors.affiliation: McMaster University, St. Joseph's Healthcare, Hamilton, Ontario, Canada. chernesk@mcmaster.ca
authors.forename: Max
authors.initials: M
authors.lastname: Chernesky
authors.forename: Marek
authors.initials: M
authors.lastname: Smieja
authors.forename: Julius
authors.initials: J
authors.lastname: Schachter
authors.forename: James
authors.initials: J
authors.lastname: Summersgill
authors.forename: Laura
authors.initials: L
authors.lastname: Schindler
authors.forename: Natalie
authors.initials: N
authors.lastname: Solomon
authors.forename: Karen
authors.initials: K
authors.lastname: Campbell
authors.forename: LeeAnn
authors.initials: L
authors.lastname: Campbell
authors.forename: Alison
authors.initials: A
authors.lastname: Cappuccio
authors.forename: Charlotte
authors.initials: C
authors.lastname: Gaydos
authors.forename: Sylvia
authors.initials: S
authors.lastname: Chong
authors.forename: Jeanne
authors.initials: J
authors.lastname: Moncada
authors.forename: Jack
authors.initials: J
authors.lastname: Phillips
authors.forename: Dan
authors.initials: D
authors.lastname: Jang
authors.forename: Billie Jo
authors.initials: BJ
authors.lastname: Wood
authors.forename: Astrid
authors.initials: A
authors.lastname: Petrich
authors.forename: Margaret
authors.initials: M
authors.lastname: Hammerschlag
authors.forename: Mike
authors.initials: M
authors.lastname: Cerney
authors.forename: James
authors.initials: J
authors.lastname: Mahony
mesh_terms: D001431:Bacteriological Techniques / Q000592:standards / Q000706:statistics & numerical data; D023521:Chlamydophila Infections / Q000175:diagnosis / Q000382:microbiology; D016993:Chlamydophila pneumoniae / Q000235:genetics* / Q000302:isolation & purification*; D004269:DNA, Bacterial / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004269:DNA, Bacterial