Molecular diagnosis of Neisseria gonorrhoeae infection in the United States

Document Type

Journal Article

Publication Date



Expert Opinion on Medical Diagnostics


Confirmatory testing, Gonococcal urethritis, Gonorrhea, Molecular diagnostics, Neisseria gonorrhoeae, Nucleic acid hybridization, Polymerase chain reaction, Sexually transmitted infection, Signal amplification, Strand displacement amplification, Test-of-cure, Transcription-mediated amplification


Background: Gonorrhea, with its Neisseria gonorrhoeae etiology, is the second most common bacterial sexually transmitted infection in the United States and is most often transmitted through asymptomatic individuals. N. gonorrhoeae is a fastidious organism and can be susceptible to killing during transport to the laboratory; hence, diagnostic methods that do not require organism viability are becoming more commonplace in the clinical setting. Objective: This review summarizes traditional and molecular-based diagnostic modalities specific to N. gonorrhoeae. Several commercially available, FDA-approved molecular methods to diagnose N. gonorrhoeae infection include nucleic acid hybridization, signal amplification, polymerase chain reaction, strand displacement amplification and transcription-mediated amplification. Results/conclusion: Molecular-based methods are rapid, reliable and effective genital specimen screening measures, especially when applied to areas of high disease prevalence. However, clinical and analytical sensitivity for some commercial systems decreases dramatically when testing urine samples. Moreover, crossreactivity to non-pathogenic Neisseria species has been documented for selected methods. Therapeutic decisions may increasingly become compromised owing to a lack of cultured N. gonorrhoeae for antimicrobial susceptibility testing. In vitro experiments suggest that transcription-mediated amplification has greater analytical sensitivity than the other molecular-based methods now available. The development of future molecular testing could address conundrums associated with confirmatory testing, medicolegal testing, testing for cure and detection of antimicrobial-resistant strains. © 2009 Informa UK Ltd All rights reserved.

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