Clinical and Interpretive

This assay is used in the detection of Chlamydia trachomatis or Neisseria gonorrhoeae.

Chlamydia is caused by the obligate intracellular bacterium Chlamydia trachomatis and is the most prevalent sexually transmitted bacterial infection (STI) in the United States. In 2010, 1.3 million documented cases were reported to the CDC. Given that 3 out of 4 infected women and 1 out of 2 infected men will be asymptomatic initially, the actual prevalence of disease is thought to be much greater than reported. The organism causes genitourinary infections in women and men and may be associated with dysuria and vaginal, urethral, or rectal discharge. In women, complications include pelvic inflammatory disease, salpingitis, and infertility. Approximately 25% to 30% of women who develop acute salpingitis become infertile. Complications among men are rare, but include epididymitis and sterility. Rarely, genital chlamydial infection can cause arthritis with associated skin lesions and ocular inflammation (Reiter���s syndrome). Chlamydia trachomatis can be transmitted from the mother during deliver and is associated with conjunctivitis and pneumonia. Finally, Chlamydia trachomatis may cause hepatitis and pharyngitis in adult.

Once detected, the infection is easily treated by a short course of antibiotic therapy. Annual Chlamydia screening is now recommended for all sexually active women age 25 years and younger, and for older women with risk factors for infection, such as a new sex partner or multiple sex partners. The CDC also recommends that all pregnant women be given a screening test for chlamydia infection. Repeat testing for test-of-cure is NOT recommended after treatment with a standard treatment regimen unless patient compliance is in question, re-infection is suspected, or the patient���s symptoms persist. Repeat testing of pregnant women, 3 weeks after completion of therapy, is also recommended to ensure therapeutic cure.

Gonorrhea is caused by the bacterium Neisseria gonorrhoeae. It is also a very common STI, with 301,174 cases of gonorrhea reported to CDC in 2009. Like Chlamydia, many infections in women are asymptomatic, and the true prevalence of gonorrhea is likely much higher than reported. The organism causes genitourinary infections in women and men and may be associated with dysuria and vaginal, urethral, or rectal discharge. Complications include pelvic inflammatory disease in women and gonococcal epididymitis and prostatitis in men. Gonococcal bacteremia, pharyngitis, and arthritis may also occur. Infection in men is typically associated with symptoms that would prompt clinical evaluation. Given the risk for asymptomatic infection in women, screening is recommended for women at increased risk of infection (eg, women with previous gonorrhea or other STI, inconsistent condom use, new or multiple sex partners, and women in certain demographic groups such as those in communities with high STI prevalence.) The CDC currently recommends dual antibiotic treatment due to emerging antimicrobial resistance.

Culture was previously considered to be the gold standard test for diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection. However, these organisms are labile in vitro, and precise specimen collection, transportation, and processing conditions are required to maintain organism viability which is necessary for successful culturing. In comparison, nucleic acid amplification testing (NAAT) provides superior sensitivity and specificity and is now the recommended method for diagnosis in most cases. Immunoassays and non-amplification DNA tests are also available for Chlamydia trachomatis and Neisseria gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAATs.

Improved screening rates and increased sensitivity of NAAT testing have resulted in an increased number of accurately diagnosed cases. Improved detection rates result from both the increased performance of the assay and the patients��� easy acceptance of urine testing. Early identification of infection enables sexual partners to seek testing and/or treatment as soon as possible and reduces the risk of disease spread. Prompt treatment reduces the risk of infertility in women.The predictive value of an assay depends on the prevalence of the disease in any particular population. In settings with a high prevalence of sexually transmitted disease, positive assay results have a high likelihood of being true positives. In settings with a low prevalence of sexually transmitted disease, or in any setting in which a patient���s clinical signs and symptoms or risk factors are inconsistent with gonococcal or chlamydial urogenital infection, positive results should be carefully assessed and the patient retested by other methods (eg, culture for Neisseria gonorrhoeae), if appropriate.

A negative result does not exclude the possibility of infection. If clinical indications strongly suggest gonococcal or chlamydial infection, additional specimens should be collected for testing. A result of indeterminate indicates that a new specimen should be collected.