26437 Chlamydia trachomatis and Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplifications, Varies (MCTGC)

​Chlamydia trachomatis and Neisseria gonorrhoeae, Misc Sites, Nucleic Acid Amp, Varies (MCTGC), Chlamydia trachomatis RNA amplification, Neisseria gonorrhoeae RNA amplification, Gonorrhoeae, Gonorrhea

​Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in non-FDA-approved specimen types

This test is not intended for use in medico-legal applications.

This test is not useful for the detection of Chlamydia pneumoniae.

Specimen source is required.

Submit only one of the above specimens.

Collection Instructions Ocular with Aptima Collection Multitest Swab or Aptima Swab Collection System:

1. Swab site using Aptima Collection Multitest Swab or Aptima Collection Unisex Swab.

Note: The white swab provided within the collection kit is a cleaning swab and should not be used for collection. Discard the white cleaning swab.

2. Place collection swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

3. Cap tube securely and label tube with patient's entire name and collection date and time.

4. Transport swab container and store (refrigerated is preferred) within 60 days of collection.

Collection Instructions for Peritoneal fluid with Aptima Thin Prep Transport Tube:

1. Transfer specimen into the Aptima Specimen Transfer Tube within 24 hours of collection.

2. Cap tube securely and label tube with patient's entire name and collection date and time.

3. Transport Aptima Specimen Transfer Tube (refrigerated is preferred) within 30 days of collection.

All specimens will be evaluated at Mayo Clinc Laboratories for test suitability.

​Results should be interpreted in conjunction with other laboratory and clinical information.

A negative test result does not exclude the possibility of infection. Improper specimen collection, concurrent antibiotic therapy, presence of inhibitors, or low numbers of organisms in the specimen (ie, below the sensitivity of the test) may cause false-negative test results.

In low-prevalence populations, positive results must be interpreted carefully as false-positive results may occur more frequently than true-positive results in this setting.

In general, this assay should not be used to assess therapeutic success or failure, since nucleic acids from these organisms may persist for 3 weeks or more following antimicrobial therapy.

No interference is expected with swab specimens due to:

-Blood

-Lubricants and spermicides

This assay does not detect Chlamydia pneumoniae.

This report is intended for use in clinical monitoring or management of patients; it is not intended for use in medico-legal applications.

Appropriate specimen collection and handling is necessary for optimal assay performance.

Chlamydia is caused by the obligate intracellular bacterium Chlamydia trachomatis and is the most prevalent sexually transmitted bacterial infection 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 as well as 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 syndrome). C trachomatis can be transmitted from the mother during delivery and is associated with conjunctivitis and pneumonia. Finally, C trachomatis may cause hepatitis and pharyngitis in adults.

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, reinfection 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 sexually transmitted infection (STI), with 301,174 cases of gonorrhea reported to CDC in 2009. 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 as well as 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 C trachomatis and N gonorrhoeae infections. However, organisms are labile in vitro, therefore, 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.(4-6) Immunoassays and non-amplification DNA tests are also available for C trachomatis and N gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAAT.

Improved screening rates and increased sensitivity of NAAT testing have resulted in an increased number of accurately diagnosed cases of both chlamydia and gonorrhea. 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.

​A positive result indicates that rRNA of Chlamydia trachomatis and/or Neisseria gonorrhoeae is present in the specimen tested and strongly supports a diagnosis of chlamydial/gonorrheal infection.

A negative result indicates that rRNA for C trachomatis and/or N gonorrhoeae was not detected in the specimen.

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 N 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.

This test has not been shown to cross react with commensal (nonpathogenic) Neisseria species present in the oropharynx.