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Journal of Clinical Microbiology, November 1999, p. 3668-3671, Vol. 37, No. 11
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.
Ability of the Digene Hybrid Capture II Test To
Identify Chlamydia trachomatis and Neisseria
gonorrhoeae in Cervical Specimens
Julius
Schachter,1,*
Edward W.
Hook III,2
William M.
McCormack,3
Thomas C.
Quinn,4
Max
Chernesky,5
Sylvia
Chong,5
Jennifer I.
Girdner,4
Paula B.
Dixon,2
Lynette
DeMeo,3
Eva
Williams,1
Allison
Cullen,6 and
Attila
Lorincz6
Chlamydia Research Laboratory, Department of
Laboratory Medicine, University of California, San Francisco, San
Francisco, California1; Division of
Infectious Diseases, University of Alabama, Birmingham,
Alabama2; Division of Infectious
Diseases, State University of New York, Brooklyn, New
York3; Division of Infectious
Diseases, Johns Hopkins University, Baltimore,4
and Digene Corporation, Silver Spring,6
Maryland; and St. Joseph's Hospital, McMaster University,
Hamilton, Ontario, Canada
Received 17 March 1999/Returned for modification 1 June
1999/Accepted 9 August 1999
The Digene Hybrid Capture II (HCII CT/GC) test is a combination
test designed to detect Chlamydia trachomatis and
Neisseria gonorrhoeae in a single specimen. It is a nucleic
acid hybridization test which uses signal amplification to increase
sensitivity. We compared its performance to that of culture on cervical
specimens from 1,370 women. Direct fluorescent-antibody assay was used
to resolve discrepant results for C. trachomatis. Samples
were collected with a proprietary cervical brush or with endocervical
swabs. The HCII CT/GC test proved to be sensitive and specific in
detecting these organisms. Compared to N. gonorrhoeae
culture, it had a sensitivity of 93% (87/94) and a specificity of
98.5% (1,244/1,263). Compared to C. trachomatis culture,
the sensitivity was 97.7% (129/132) and specificity was 98.2%
(1,216/1,238). Testing of some specimens with discrepant results by PCR
suggested that the test would actually prove to be even more specific
if it were compared to a nucleic acid amplification test (NAAT). The
sensitivity of C. trachomatis culture was somewhat less, at
88.6% (117/132). The endocervical brush appeared to be better than
Dacron swabs for collecting specimens. The HCII CT/GC test offers an
attractive format that allows simultaneous detection of C. trachomatis and N. gonorrhoeae with a single
specimen. An initial positive result is followed by repeat tests with
probes to identify chlamydiae or gonococci. This test is more sensitive
than C. trachomatis culture and is at least as sensitive as
culture for gonococci. It deserves further evaluation and comparison
with NAATs and may well offer an attractive alternative for diagnosis
and screening of these infections.
*
Corresponding author. Mailing address: Chlamydia
Research Laboratory, Department of Laboratory Medicine, University of
California, San Francisco, 1001 Potrero Ave., SFGH 3416, San Francisco,
CA 94110. Phone: (415) 824-5115. Fax: (415) 821-8945. E-mail:
jsch{at}itsa.ucsf.edu.
Journal of Clinical Microbiology, November 1999, p. 3668-3671, Vol. 37, No. 11
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.
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