title: External quality assessment program for Chlamydia trachomatis diagnostic testing by nucleic acid amplification assays.
abstract: We report the results from 57 Australian diagnostic laboratories testing two external quality assessment panels using either the Roche Amplicor Chlamydia trachomatis test (R-PCR) or the Abbott LCx Chlamydia trachomatis assay (A-ligase chain reaction [LCR]). Panel samples were either normal urine spiked with Chlamydia trachomatis antigen or clinical urine specimens. There was no significant difference between laboratories or between assays in detection of C. trachomatis-positive clinical samples. Only at the lower limit of detection of the assays did the R-PCR demonstrate increased sensitivity over the A-LCR in the detection of C. trachomatis antigen. However, it was found that single-sample testing could lead to decreased test sensitivity. Detection of the presence of inhibitors of nucleic acid amplification differed between laboratories.
authors.affiliation: National Serology Reference Laboratory, Australia, St Vincent's Institute of Medical Research, Fitzroy, VIC 3065, Australia. sally@nrl.gov.au
authors.forename: Sally
authors.initials: S
authors.lastname: Land
authors.forename: Sepehr
authors.initials: S
authors.lastname: Tabrizi
authors.forename: Anthony
authors.initials: A
authors.lastname: Gust
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Johnson
authors.forename: Susan
authors.initials: S
authors.lastname: Garland
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Dax
mesh_terms: D001315:Australia; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007753:Laboratories; D022521:Ligase Chain Reaction; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D016133:Polymerase Chain Reaction; D011786:Quality Control; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014556:Urine / Q000382:microbiology
chemical_list: D011933:Reagent Kits, Diagnostic