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Test Code Billings Clinic: 9718 Mayo: MGRNA Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies

Reporting Name

N. gonorr, Misc, Amplified RNA

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful 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.

Method Name

Transcription Mediated Amplification


Ordering 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 Type

Varies

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

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 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.

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

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

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.