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Journal of Clinical Microbiology, June 1998, p. 1630-1633, Vol. 36, No. 6
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Evaluation of the Abbott LCx Ligase Chain Reaction Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Urine and Genital Swab Specimens from a Sexually Transmitted Disease Clinic Population

Karen C. Carroll,1,2,* William E. Aldeen,2 Michael Morrison,2 Roberta Anderson,3 Deborah Lee,3 and Susan Mottice1,4

Department of Pathology, University of Utah Health Sciences Center,1 Associated Regional and University Pathologists,2 Salt Lake City-County Sexually Transmitted Disease Clinic,3 and Bureau of Epidemiology and Laboratory Services Utah Department of Health,4 Salt Lake City, Utah4

Received 3 December 1997/Returned for modification 17 February 1998/Accepted 24 March 1998

The Abbott LCx ligase chain reaction (LCR) assay for the simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae was evaluated by using swab and urine specimens from 562 patients. C. trachomatis results by LCR were compared to those by the Gen-Probe PACE 2 assay, whereas N. gonorrhoeae results by LCR were compared to those by culture. The Gen-Probe and LCR assays were performed according to the manufacturers' instructions. Gram-negative diplococci growing on modified Thayer-Martin medium were confirmed as N. gonorrhoeae by the GonoGen II assay. Supplemental data analysis was performed by major outer membrane protein PCR for C. trachomatis and probes for pilin gene detection for N. gonorrhoeae. A true-positive result for each pathogen was defined as a positive result for all three or two of three assays. Overall agreement among the six assays was 94.8%. C. trachomatis prevalence was 16.2%; N. gonorrhoeae prevalence was 5.5%. The overall sensitivity and specificity, respectively, for each test (after supplemental data analysis) were as follows: for C. trachomatis, Gen-Probe, 65.9 and 100%; LCR on urine, 90.1 and 100%; LCR on swab specimens, 96.7 and 100%; and for N. gonorrhoeae, culture, 80.6 and 100%; LCR on urine, 93.5 and 99.8%; and LCR on swab specimens, 96.8 and 100%. For women, the N. gonorrhoeae culture was very insensitive compared to its performance in men (58.3 versus 94.7%, respectively). For C. trachomatis, the Gen-Probe assay's sensitivity was lower for men than for women (62.3 versus 71.1%, respectively). The sensitivity for C. trachomatis detection by LCR on urethral and cervical swab specimens was 96.2 and 97.4% for men and women, respectively. For men, swab results were slightly better than urine results for both pathogens (sensitivity for C. trachomatis in swab and urine specimens, 96.2 and 92.5%, respectively; sensitivity for N. gonorrhoeae in swab and urine specimens, 100 and 94.7%, respectively), while for women, cervical swabs were superior in sensitivity to urine samples for detecting C. trachomatis (swab, 97.4%; urine, 81.6%) and equivalent for N. gonorrhoeae (swab, 92.3%; urine, 91.6%). The LCx LCR appears to be both sensitive and specific for the detection of C. trachomatis and N. gonorrhoeae when performed on urine or genital swab samples. Swab samples had better sensitivity than urine samples for the detection of both pathogens.

* Corresponding author. Mailing address: Department of Pathology 5C130 SOM, University of Utah Health Sciences Center, 50 N. Medical Dr., Salt Lake City, UT 84132. Phone: (801) 585-5863. Fax: (801) 581-4517. E-mail: Karen_Carroll{at}medschool.med.utah.edu.

Journal of Clinical Microbiology, June 1998, p. 1630-1633, Vol. 36, No. 6
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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