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Journal of Clinical Microbiology, December 2000, p. 4382-4386, Vol. 38, No. 12
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Evaluation of Nucleic Acid Amplification Tests as Reference Tests for Chlamydia trachomatis Infections in Asymptomatic Men

Robert E. Johnson,1,* Timothy A. Green,2 Julius Schachter,3 Robert B. Jones,4 Edward W. Hook III,5 Carolyn M. Black,2 David H. Martin,6 Michael E. St. Louis,1 and Walter E. Stamm7

National Center for HIV, STD, and TB Prevention1 and National Center for Infectious Diseases,2 Centers for Disease Control and Prevention, Atlanta, Georgia; Department of Laboratory Medicine, University of California, San Francisco, California3; School of Medicine, Indiana University, Indianapolis, Indiana4; Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama5; School of Medicine, Louisiana State University, New Orleans, Louisiana6; and Department of Medicine, University of Washington, Seattle, Washington7

Received 9 March 2000/Returned for modification 28 June 2000/Accepted 21 September 2000

Urine ligase chain reaction (LCR) and PCR tests and urethral swab culture were compared for their abilities to detect Chlamydia trachomatis infection in 3,639 asymptomatic men by using one-, two-, and three-test reference standards. Frozen urine at four of five participating centers was also tested by a transcription-mediated amplification assay which was used as a reference test. LCR increased the yield of positive results by 27% and PCR increased the yield of positive results by 26% over the yield of positive results by culture (n = 295). LCR and PCR sensitivities were similar, ranging from 80.4 to 93.5%, depending on the reference standard. Culture sensitivity was substantially less. A multiple-test standard yielded LCR, PCR, and culture specificities of 99.6%, with or without discrepant analysis. Test performance varied among centers partly due to different interpretations of the testing protocols. The study confirms that urine LCR and PCR for the detection of C. trachomatis have substantially improved sensitivities over that of urethral swab culture for testing of asymptomatic men, enabling screening of this important target group. These tests, perhaps in combination, are also candidate reference tests for the conduct of test evaluation studies.

* Corresponding author. Mailing address: Division of STD Prevention, M.S. E02, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. Phone: (404) 639-1894. Fax: (404) 639-8610. E-mail: rejl{at}cdc.gov.

Journal of Clinical Microbiology, December 2000, p. 4382-4386, Vol. 38, No. 12
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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