Useful For

Detection of Neisseria gonorrhoeae DNA from genital specimens.

Clinical Information

Clinical manifestations of Neisseria gonorrhoeae (NG) infections are numerous. In men, acute urethritis presents itself after 1 – 10 day incubation period with urethral discharge and dysuria. The majority of NG infections are symptomatic. Acute epididymitis is the most common complication, especially in young men. In woman, the primary site of infection is the endocervix. There is a high prevalence of co-infections with CT, Trichomonas vaginalis and bacterial vaginosis; many women remain asymptomatic and therefore remain undiagnosed. Predominant symptoms are increased discharge, dysuria, and intermenstrual bleeding. Pelvic inflammatory disease can occur in 10 – 20% of woman, combined with endometritis, salpingitis, tubo-ovarian abscess, pelvic peritonitis, and perihepatitis. Other gonococcal infected sites are the rectum, pharynx, conjunctiva, and to a lesser degree the disease presents as disseminated gonococcal infection. Infants from infected mothers can develop conjunctivitis.

Epidemiology in Newfoundland and Labrador can be found in the Communicable Disease Report: Gonococcal: – https://www.health.gov.nl.ca/health/publichealth/cdc/mdr/Gonorrhoea_v28n1_June_2011.pdf

Reference Values

NOT DETECTED

Interpretation

NG

DETECTED: indicates the presence of N. gonorrhoeae DNA. This assay is not intended as a test of cure as non-viable CT may be detected when performed < 3 weeks after completion of therapy. In cases of treatment failure isolation/culture should be attempted.

NOT DETECTED: absence of N. gonorrhoeae DNA.

INDETERMINATE: the specimen submitted contained substances inhibitory to the assay. Please recollect a specimen to complete follow up.

Clinical Reference

Roche Molecular Systems Inc. Cobas® 4800 CT/NG Test: Package insert. Roche Diagnostics GmbH, Mannheim.

Janda, WM., and Gaydos, C. 2007. Neisseria, p601 – 620. In Murray, P. R., Baron, E. J., Jorgensen, J. H., Landry, M. L., and Pfaller, M. A. Manual of Clinical Microbiology, 9^th ed., vol. 2. ASM Press, American Society for Microbiology, Washington, DC.