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HelpTest Code MGRNA Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies
Reporting Name
N. gonorr, Misc, Amplified RNAUseful For
Detecting Neisseria gonorrhoeae in non-US Food and Drug Administration-approved specimen types
This test is not intended for use in medico-legal applications.
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
VariesOrdering Guidance
This test is used for specimens that are not US Food and Drug Administration (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.
Necessary Information
Specimen source is required.
Specimen Required
Submit only 1 of the following specimens:
Specimen Type: Ocular (corneal/conjunctiva)
Supplies:
Aptima Unisex Swab Collection Kit (T583)
Aptima Multitest Swab Specimen Collection Kit (T584)
Container/Tube: Aptima Multitest Swab or Aptima Collection Unisex Swab
Specimen Volume: Swab
Collection Instructions:
1. Swab site using Aptima Multitest Swab or Aptima Collection Unisex Swab. Specimens must be collected using either of these options.
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. Maintain swab container at 2 to 30° C (refrigerate temperature is preferred), transport within 60 days of collection.
Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)
Supplies: Aptima Thin Prep Transport Tube (T652)
Container/Tube: Aptima specimen transfer tube
Specimen Volume: 1 mL
Collection Instructions:
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. Maintain Aptima specimen transfer tube at 2 to 30° C (refrigerate temperature is preferred), transport within 30 days of collection.
Specimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | APTIMA VIAL | |
| Ambient | APTIMA VIAL | ||
| Frozen | APTIMA VIAL | ||
Day(s) Performed
Monday through Sunday
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. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
87591
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MGRNA | N. gonorr, Misc, Amplified RNA | 43305-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| SRC22 | SOURCE: | 31208-2 |
| 34508 | N. gonorr, Misc, Amplified RNA | 43305-2 |
Clinical Information
Gonorrhea is caused by the bacterium Neisseria gonorrhoeae. It is a very common sexually transmitted infection (STI), with over 677,000 cases of gonorrhea reported to the Centers for Disease Control and Prevention (CDC) in 2020. 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 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 STIs, 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 N gonorrhoeae infections. However, these 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 considered the reference standard method for diagnosis in most cases. Immunoassays and nonamplification 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 have resulted in an increased number of accurately diagnosed cases. Improved detection rates result from improved performance characteristics of the assays and 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.
Cautions
This report is intended for 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
Report Available
1 to 4 daysSpecimen Retention Time
7 daysReject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Method Name
Transcription Mediated Amplification
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Secondary ID
61646Alias: GC GEN-PROBE Miscellaneous Sites
Aptima unisex collection kit: