Evaluation of the digene hybrid capture II CT-ID test for detection of Chlamydia trachomatis in endocervical specimens.
The performance characteristics of the new signal amplification-based Hybrid Capture (HC) II CT-ID test system (Digene, Silver Spring, Md.) with endocervical specimens were compared to those of tissue culture and PCR (AMPLICOR CT PCR; Roche Molecular Systems, Branchburg, N.J.) for detection of Chlamydia trachomatis in 587 women. HC II CT-ID identified 62 of 65 confirmed C. trachomatis-positive patients (sensitivity of 95.4%) and was negative for 517 of 522 patients who were negative by culture and PCR (specificity of 99.0%). Twelve of the 65 confirmed positive patients were negative by culture but were identified by both HC II CT-ID and PCR (sensitivity of culture was 81.5% [P < 0.01]). In comparison, PCR detected 59 of 65 positive specimens (sensitivity of 90.8%) and had a specificity of 99.6% (520 of 522). These results demonstrate that the Digene HC II CT-ID test is a highly sensitive and specific assay for the detection of C. trachomatis infection in endocervical specimens.
Girdner
J L
JL
Division of Infectious Diseases, The Johns Hopkins University, Baltimore, Maryland 21205, USA.
Cullen
A P
AP
Salama
T G
TG
He
L
L
Lorincz
A
A
Quinn
T C
TC
D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000382:microbiology*; D002692:Chlamydia trachomatis / Q000302:isolation & purification*; D005260:Female; D019085:Fluorescent Antibody Technique, Direct; D006801:Humans; D008163:Luminescent Measurements; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity