title: Comparison of Digene hybrid capture 2 and conventional culture for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens.
abstract: Digene's Hybrid Capture 2 (HC2) CT/GC, CT-ID, and GC-ID DNA tests were evaluated by comparison to traditional culture methods for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections in 669 cervical specimens from high-risk female populations attending two sexually transmitted disease clinics. For detection of either or both infections, the HC2 CT/GC test algorithm had 93.8% sensitivity and 95.9% specificity compared to those of culture. After resolution of discrepant results by direct fluorescent-antibody (DFA) staining or PCR assay, the relative sensitivity and specificity of the HC2 CT/GC test algorithm increased to 94.8 and 99.8%, while the values for culture were 83.6% (McNemar's P value, 0.0062) and 100%, respectively. For detection of the individual pathogens, the relative sensitivities for the HC2 CT-ID and GC-ID tests were 97.2 and 92.2% and the specificities were greater than 99% compared to culture adjucated by DFA staining and PCR. Test performance varied at the two clinics: the HC2 CT/GC algorithm, CT-ID, and GC-ID tests had significantly higher sensitivities (McNemar's P value, <0.05) than that of culture for the population at one clinic as well as for the combined populations. At the other clinic, the HC2 tests performed as well as culture.
authors.affiliation: Digene Corporation, Gaithersburg, Maryland 20878, USA.
authors.forename: Ling H
authors.initials: LH
authors.lastname: Darwin
authors.forename: Allison P
authors.initials: AP
authors.lastname: Cullen
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Arthur
authors.forename: Carole D
authors.initials: CD
authors.lastname: Long
authors.forename: Kim R
authors.initials: KR
authors.lastname: Smith
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Girdner
authors.forename: Edward W
authors.initials: EW
authors.lastname: Hook
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Quinn
authors.forename: Attila T
authors.initials: AT
authors.lastname: Lorincz
mesh_terms: D000465:Algorithms; D002584:Cervix Uteri / Q000382:microbiology*; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D003470:Culture Media; D005260:Female; D019085:Fluorescent Antibody Technique, Direct; D006069:Gonorrhea / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D008163:Luminescent Measurements; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D003470:Culture Media; D011933:Reagent Kits, Diagnostic