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Bacteriology

Evaluation of the Digene Hybrid Capture II Assay with the Rapid Capture System for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

B. Van Der Pol, J. A. Williams, N. J. Smith, B. E. Batteiger, A. P. Cullen, H. Erdman, T. Edens, K. Davis, H. Salim-Hammad, V. W. Chou, L. Scearce, J. Blutman, W. J. Payne
B. Van Der Pol
1Indiana University School of Medicine, Indianapolis, Indiana
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  • For correspondence: bvanderp@iupui.edu
J. A. Williams
1Indiana University School of Medicine, Indianapolis, Indiana
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N. J. Smith
1Indiana University School of Medicine, Indianapolis, Indiana
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B. E. Batteiger
1Indiana University School of Medicine, Indianapolis, Indiana
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A. P. Cullen
2Digene Corporation, Gaithersburg, Maryland
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H. Erdman
2Digene Corporation, Gaithersburg, Maryland
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T. Edens
2Digene Corporation, Gaithersburg, Maryland
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K. Davis
2Digene Corporation, Gaithersburg, Maryland
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H. Salim-Hammad
2Digene Corporation, Gaithersburg, Maryland
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V. W. Chou
2Digene Corporation, Gaithersburg, Maryland
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L. Scearce
2Digene Corporation, Gaithersburg, Maryland
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J. Blutman
2Digene Corporation, Gaithersburg, Maryland
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W. J. Payne
2Digene Corporation, Gaithersburg, Maryland
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DOI: 10.1128/JCM.40.10.3558-3564.2002
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    FIG. 1.

    (a) Comparison of initial results of HC2-RCS and HC2-M; (b) results of HC2-M and HC2-RCS for C. trachomatis; (c) HC2-M and HC2-RCS results for N. gonorrhoeae.

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  • TABLE 1.

    Comparison of HC2-RCS and HC2-M

    HC2-RCS resultaNo. of samples
    CT/GC assay algorithmCT-ID assay with EZRAbGC-ID assay with EZRA
    HC2-M positiveHC2-M negativeHC2-M positiveHC2-M negativeHC2-M positiveHC2-M negative
    Positive911741281
    Negative21,17131,18711,235
    κ0.9830.9720.965
    • ↵ a Pooled data from prospective study and repository samples (n = 1,265).

    • ↵ b EZRA, equivocal-zone resolution algorithm.

  • TABLE 2.

    Performance characteristics for detection of chlamydial infections

    AssayAnalysis methodSensitivityaSpecificityaPositive predictive value (%)Negative predictive value (%)
    HC2-RCS CT-IDIdentification results alone analyzed for all samples43/45 (95.6)285/285 (100)10099.3
    HC2-RCS CT-IDIdentification results considered only if CT/GC assay was positive42/45 (93.3)285/285 (100)10099.0
    PCR44/45 (97.8)283/285 (99.3)95.799.6
    Culture33/45 (73.3)285/285 (100)10096.0
    • ↵ a The data indicate number of positive samples/total number of samples tested (percent).

  • TABLE 3.

    Performance characteristics for detection of gonococcal infections

    AssayAnalysis methodSensitivityaSpecificityaPositive predictive value (%)Negative predictive value (%)
    HC2-RCS GC-IDIdentification results alone analyzed for all samples21/21 (100)306/309 (99.0)87.5100
    HC2-RCS GC-IDIdentification results considered only if CT/GC assay was positive21/21 (100)307/309 (99.4)91.3100
    PCR21/21 (100)306/309 (99.0)87.5100
    Culture19/21 (90.5)309/309 (100)10099.4
    • ↵ a The data indicate number of positive samples/total number of samples tested (percent).

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Evaluation of the Digene Hybrid Capture II Assay with the Rapid Capture System for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
B. Van Der Pol, J. A. Williams, N. J. Smith, B. E. Batteiger, A. P. Cullen, H. Erdman, T. Edens, K. Davis, H. Salim-Hammad, V. W. Chou, L. Scearce, J. Blutman, W. J. Payne
Journal of Clinical Microbiology Oct 2002, 40 (10) 3558-3564; DOI: 10.1128/JCM.40.10.3558-3564.2002

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Evaluation of the Digene Hybrid Capture II Assay with the Rapid Capture System for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
B. Van Der Pol, J. A. Williams, N. J. Smith, B. E. Batteiger, A. P. Cullen, H. Erdman, T. Edens, K. Davis, H. Salim-Hammad, V. W. Chou, L. Scearce, J. Blutman, W. J. Payne
Journal of Clinical Microbiology Oct 2002, 40 (10) 3558-3564; DOI: 10.1128/JCM.40.10.3558-3564.2002
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KEYWORDS

Chlamydia trachomatis
Neisseria gonorrhoeae
polymerase chain reaction
Sexually Transmitted Diseases, Bacterial

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