26464 Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies (MGRNA)

Neisseria gonorrhoeae RNA amplification

Gonorrhoeae

Gonorrhea

Neisseria gonorrhoeae RNA Probe

Detection of Neisseria gonorrhoeae for non-FDA approved specimen types

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

Ordering Guidance:

This test is used for specimens that are not FDA approved for this assay. Acceptable non-FDA-approved specimen types are ocular swabs and peritoneal fluid. For FDA-approved specimen types, order GCRNA / Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies.

​Swab specimens must be collected using an Aptima Collection Unisex Swab (T583) or Aptima Collection Multitest Swab (T584). These swabs are contained in the Aptima Collection Kit.

Necessary Information:  Specimen source is required.

Specimen Type: Ocular (corneal/conjunctiva):

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.

Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid):

1. Transfer 1 mL of 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 Clinic Laboratories for test suitability.

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.

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.

No interference is expected with swab specimens due to:

-Blood

-Lubricants and spermicides

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.(1,2) 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).(1,2) The CDC currently recommends dual antibiotic treatment due to emerging antimicrobial resistance.(2)

Culture was previously considered to be the gold standard test for diagnosis of N gonorrhoeae infection. 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.(2-5) Immunoassays and non-amplification DNA tests are also available for N gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAAT.(2-5)

Improved screening rates and increased sensitivity of NAAT testing have resulted in an increased number of accurately diagnosed cases.(2-5) 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 the presence of rRNA of Neisseria gonorrhoeae.

A negative result indicates that rRNA for 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 settings in which a patient's clinical signs and symptoms or risk factors are inconsistent with gonococcal urogenital infection, positive results should be carefully assessed and the patient retested by other methods (eg, culture for N gonorrhoeae), if appropriate.