Comparison of Digene hybrid capture 2 and conventional culture for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens.
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.
Darwin
Ling H
LH
Digene Corporation, Gaithersburg, Maryland 20878, USA.
Cullen
Allison P
AP
Arthur
Patrick M
PM
Long
Carole D
CD
Smith
Kim R
KR
Girdner
Jennifer L
JL
Hook
Edward W
EW
Quinn
Thomas C
TC
Lorincz
Attila T
AT
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
D003470:Culture Media; D011933:Reagent Kits, Diagnostic