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HelpTest Code Billings Clinic: 9718 Mayo: MGRNA Neisseria gonorrhoeae, Miscellaneous Sites, by Nucleic Acid Amplification
Reporting Name
N. gonorr, Misc, Amplified RNAPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Detection of Neisseria gonorrhoeae for non-FDA approved specimen types
Method Name
Transcription Mediated Amplification
Specimen Type
VariesAdvisory Information
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. For FDA-approved specimen types, order GCRNA / Neisseria gonorrhoeae by Nucleic Acid Amplification.
Necessary Information
Specimen source is required.
Specimen Required
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.
Submit only 1 of the following specimens:
Supplies:
Swab, Aptima Male/Female Collection (T583)
Swab, Aptima Multitest Swab Specimen Collection Kit (T584, formerly called Aptima Vaginal Swab Specimen Collection Kit)
Specimen Type: Oral/throat or ocular (corneal/conjunctiva) or rectal/anal
Container/Tube: Aptima Collection Multitest Swab (T584), or Aptima Swab Collection System (T583)
Specimen Volume: Swab
Collection Instructions:
1. Swab site using Aptima Collection Multitest Swab (T584) or Aptima Collection Unisex Swab (T583).
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.
Supplies: Aptima Thin Prep Transport Tube (T652)
Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)
Container/Tube: Aptima Specimen Transfer Tube (T652)
Specimen Volume: 1 mL
Collection Instructions:
1. Transfer 1 mL of specimen into the Aptima Specimen Transfer Tube (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
Oral/Throat, Ocular, Anal/Rectal Swabs: Entire collection
Peritoneal Fluid: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | APTIMA VIAL | |
| Ambient | APTIMA VIAL | ||
| Frozen | APTIMA VIAL | ||
Reject Due To
| All specimens will be evaluated at Mayo Clinic Laboratories for test suitability. |
Reference Values
Negative
Interpretation
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 or chlamydial urogenital infection, positive results should be carefully assessed and the patient retested by other methods (eg, culture for N gonorrhoeae), if appropriate.
Day(s) and Time(s) Performed
Monday through Saturday; Varies
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 U.S. 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 |