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Journal of Clinical Microbiology, February 2002, p. 641-644, Vol. 40, No. 2
0095-1137/01/$04.00+0     DOI: 10.1128/JCM.40.02.641-644.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Comparison of Digene Hybrid Capture 2 and Conventional Culture for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Cervical Specimens

Ling H. Darwin,¹ Allison P. Cullen,^1* Patrick M. Arthur,^1, Carole D. Long,^1, Kim R. Smith,² Jennifer L. Girdner,³ Edward W. Hook III,² Thomas C. Quinn,³ and Attila T. Lorincz¹

Digene Corporation, Gaithersburg, Maryland 20878,¹ University of Alabama at Birmingham, Birmingham, Alabama 35294,² Johns Hopkins University, Baltimore, Maryland 21205³

Received 14 March 2001/ Returned for modification 15 September 2001/ Accepted 9 November 2001

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.

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