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HelpTest ID MGRNA Neisseria gonorrhoea, Miscellaneous Sites, by Nucleic Acid Amplification (GEN-PROBE)
Useful For
Detection of Neisseria gonorrhoeae
Testing Algorithm
This test is used for specimens that are not FDA approved for this assay. Acceptable non-FDA-approved specimen types are ocular, oral, anal or rectal swabs, and peritoneal fluid.
Method Name
Transcription Mediated Amplification
Reporting Name
N. gonorr, Misc, Amplified RNASpecimen Type
VariesSpecimen source is required.
Submit only 1 of the following specimens:
Swab specimen must be collected using an APTIMA Collection Unisex Swab (Supply T583) or APTIMA Collection Vaginal Swab (Supply T584). These swabs are contained in the APTIMA Collection Kit.
Specimen Type: Oral/throat or ocular (corneal/conjunctiva) or rectal/anal
Container/Tube: APTIMA Swab Collection System (Supply T583)
Specimen Volume: Swab
Collection Instructions:
1. Swab site using 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 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 date and time of collection.
4. Transport swab container to laboratory and store (refrigerated is preferred) within 60 days of collection.
Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)
Container/Tube: APTIMA Specimen Transfer Tube (Supply T652)
Specimen Volume: 1 mL
Collection Instructions:
1. Transfer 1 mL of specimen into the APTIMA Specimen Transfer Tube (Supply T652) within 24 hours of collection.
2. Cap tube securely, and label tube with patient's entire name, and date and time of collection.
3. Transport APTIMA Specimen Transfer Tube to laboratory (refrigerated is preferred) within 30 days of collection.
Specimen Minimum Volume
Peritoneal Fluid: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Refrigerated (preferred) | |
| Ambient | ||
| Frozen | ||
Clinical Information
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 Neisseria gonorrhoeae infection. However, 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.(2-5) Immunoassays and nonamplification DNA tests are also available for Neisseria gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAATs.(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.
Reference Values
Negative
Cautions
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.
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.
The presence of mucous does not interfere with this assay. However, this test requires endocervical cells, and if excess mucous is not removed prior to collection, adequate numbers of these cells may not be obtained.
No interference is expected with swab specimens due to:
-Blood
-Lubricants and spermicides
The effects of use of tampons, douching, specimen types other than those listed in Specimen Required, and specimen collection variables have not been determined.
Testing of urine specimens with this method is not intended to replace cervical exam and endocervical sampling for diagnosis of urogenital infection; infections may result from other causes or concurrent infections may occur.
Testing urine specimens as the sole test for identifying female patients with gonococcal infections may miss some infected individuals.
Performance estimates for urine specimens are based on evaluation of urine obtained from the first part of the urine stream; performance on midstream collections has not been determined.
Day(s) Performed
Monday through Saturday; varies
Report Available
1 dayPerforming Laboratory
Mayo Medical Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer’s instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
87591