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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 | ||
Reference Values
Negative
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 |
Interpretation
A positive result indicates the presence of nucleic acid from Neisseria gonorrhoeae and strongly supports the diagnosis of gonorrheal infection.
A negative result indicates the absence of N gonorrhoeae nucleic acid. 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 inconclusive indicates that a new specimen should be collected.
The predictive value of an assay depends on the prevalence of the disease in any specific population. In settings with a high prevalence of sexually transmitted infections, positive assay results have a high likelihood of being true-positive results. In settings with a low prevalence of sexually transmitted infections, 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.
Clinical Reference
1. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
2. Adamson PC, Klausner JD. Diagnostic tests for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens. J Clin Microbiol. 2022;60(4):e0021121. doi:10.1128/JCM.00211-21
Report Available
1 to 4 daysMethod Name
Transcription Mediated Amplification
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.