The performance of a strand displacement amplification assay (the BDProbeTec-SDA assay) in detecting Neisseria gonorrhoeae in urine specimens was evaluated. When performed under stringent quality control conditions, the BDProbeTec-SDA assay is a sensitive, specific, and efficient method for the screening of large numbers of noninvasively obtained specimens. Because the predictive value of an assay is a function of the prevalence of the disease, culture confirmation is needed for samples with positive results from populations in which the prevalence of a disease is low or in situations in which false-positive results may have important medical, psychosocial, or medicolegal consequences.
Genitourinary tract infections due to Chlamydia trachomatisand Neisseria gonorrhoeae are major causes of morbidity in sexually active individuals (7). Approximately 3 million new cases of C. trachomatis infection and 650,000 new cases of N. gonorrhoeae infection occur annually in the United States Asymptomatic infections in both men and women, along with coinfections and overlapping symptoms, can make specific clinical diagnosis difficult. Failure to provide effective treatment can lead to epididymitis in men and pelvic inflammatory disease and its sequelae of infertility, ectopic pregnancy, and chronic pelvic pain in women (12). There also is some evidence that gonococcal infections may facilitate the transmission of human immunodeficiency virus (6). As a result, prevention and control efforts increasingly are being focused on early diagnosis and treatment, especially in high-risk adolescents and young adults Յ24 years of age.The reference standard for detection of N. gonorrhoeae has been isolation by culture (1, 5), which has a high specificity and which can be used for susceptibility testing (1). Disadvantages include stringent transport and storage requirements and a bacterial growth time of 2 days or more. In addition, detection by culture usually involves an invasive procedure: a pelvic examination for women and insertion of an urethral swab for men.For a variety of specimens to be tested for N. gonorrhoeae or C. trachomatis including urethral and endocervical swab and urine specimens, nucleic acid detection assays such as PCR, ligase chain reaction, and transcription-mediated amplification possess higher sensitivities than older methods (2-4, 8-11, 13). However, each of these tests has limitations including variable sensitivities to inhibitors; limited throughput; high labor costs; and requirements for separate sample preparation, amplification, and detection areas and dedicated equipment. Thus, there is a need for a more user-friendly, sensitive, and specific diagnostic system which can test for C. trachomatis and N. gonorrhoeae simultaneously in large numbers of noninvasively obtained specimens.The BDProbeTec-SDA system (Becton Dickinson Microbiology Systems, Sparks, Md.) is a new semiautomated system which uses strand displacement amplification for the simultaneous detection of C. trachomatis and N. gonorrhoeae. Products...