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Journal of Clinical Microbiology, March 1999, p. 681-685, Vol. 37, No. 3
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Head-to-Head Evaluation of Five Chlamydia Tests Relative to a Quality-Assured Culture Standard

Wilbert J. Newhall,1,2 Robert E. Johnson,1,* Susan DeLisle,1,3 David Fine,3 Alula Hadgu,1 Bessie Matsuda,4,dagger Donna Osmond,5 Joyce Campbell,5 and Walter E. Stamm6

Centers for Disease Control and Prevention, Atlanta, Georgia1; JSI Research and Training Institute, Denver, Colorado2; The Center for Health Training,3 Washington State Health Department Laboratory,5 and University of Washington,6 Seattle, Washington; and Oregon State Health Department Laboratory, Portland, Oregon4

Received 23 July 1998/Returned for modification 15 October 1998/Accepted 15 December 1998

Nucleic acid amplification tests offer superior sensitivity for the detection of Chlamydia trachomatis infection, but many laboratories still use nonamplification methods because of the lower cost and ease of use. In spite of their availability for more than a decade, few studies have directly compared the nonamplification tests. Such comparisons are still needed in addition to studies that directly compare individual nonamplification and amplification tests. The purpose of this study was to evaluate and compare the performance characteristics relative to culture of five different tests for the detection of C. trachomatis with and without confirmation of positive results. The tests were applied to endocervical specimens from 4,980 women attending family planning clinics in the northwestern United States. The five nonculture tests included Chlamydiazyme (Abbott), MicroTrak direct fluorescent antibody (DFA) (Syva), MicroTrak enzyme immunoassay (EIA) (Syva), Pace 2 (Gen-Probe), and Pathfinder EIA (Sanofi/Kallestad). All positive results obtained with a nonculture test (except MicroTrak DFA) were confirmed by testing the original specimens with a blocking antibody test (Chlamydiazyme), a cytospin DFA (MicroTrak EIA and Pathfinder EIA), and a probe competition assay (Pace 2). The prevalence of culture-proven chlamydia was 3.9%. The sensitivities of the nonculture tests were in a range from 62 to 75%, and significant differences between tests in terms of sensitivity were observed. The positive predictive value for each test was 0.85 or higher. The specificities of the nonculture tests without performance of confirmations were greater than 99%. Performing confirmatory tests eliminated nearly all of the false positives.

* Corresponding author. Mailing address: Division of STD Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd., Mailstop E-02, Atlanta, GA 30333. Phone: (404) 639-1894. Fax: (404) 639-8610. E-mail: rej1{at}cdc.gov.

dagger Retired.

Journal of Clinical Microbiology, March 1999, p. 681-685, Vol. 37, No. 3
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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