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Test ID: MGRNA Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies

Reporting Name

N. gonorr, Misc, Amplified RNA

Useful For

Detection of Neisseria gonorrhoeae for non-FDA approved specimen types

 

This test is not intended for use in medico-legal applications.

Specimen Type

Varies


Ordering Guidance


This test is used for specimens that are not 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


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)

Specimen Type: Ocular (corneal/conjunctiva)

Container/Tube: Aptima Collection Multitest Swab or Aptima Swab Collection System

Specimen Volume: Swab

Collection Instructions:

1. Swab site using Aptima Collection Multitest Swab or 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 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. Transport swab container 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

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. Transport Aptima Specimen Transfer Tube (refrigerated is preferred) 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 Saturday

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 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 N gonorrhoeae infection. However, 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 the recommended method for diagnosis in most cases.(2-5) Immunoassays and non-amplification DNA tests are also available for N gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAAT.(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.

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 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. Centers for Disease Control and Prevention. 2002. Reporting of laboratory-confirmed chlamydial infection and gonorrhea by providers affiliated with three large Managed Care Organizations-United States, 1995-1999. MMWR Morb Mortal Wkly Rep. 2002;51:256-259

2. Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines, 2015. MMWR Morb Mortal Wkly Rep. 2015 Jun 5;64(RR-03):1-137

3. Crotchfelt KA, Pare B, Gaydos C, Quinn TC: Detection of Chlamydia trachomatis by the GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay (AMP CT) in urine specimens from men and women and endocervical specimens from women. J Clin Microbiol. 1998 Feb;36(2):391-394

4. Gaydos CA, Quinn TC, Willis D, et al: Performance of the APTIMA Combo 2 assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens. J Clin Microbiol. 2003 Jan;41(1):304-309

5. Chernesky MA, Jang DE: APTIMA transcription-mediated amplification assays for Chlamydia trachomatis and Neisseria gonorrhoeae. Expert Rev Mol Diagn. 2006 Jul;6(4):519-525

Report Available

1 to 4 days

Method Name

Transcription Mediated Amplification

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-gisti