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Test ID: GCRNA Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies

Reporting Name

Neisseria gonorrhoeae Amplified RNA

Useful For

Detection of Neisseria gonorrhoeae

 

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

Clinical Information

Gonorrhea is caused by the bacterium Neisseria gonorrhoeae and is a common sexually transmitted infection (STI).(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 as well as vaginal, urethral, and/or rectal discharge. Potential 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)

 

Routine bacterial culture was previously considered the gold standard test for diagnosis of N gonorrhoeae infection. However, the bacteria 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 specific than NAAT.(2-5)

 

Improved screening and performance of NAAT testing has 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 treatment as soon as possible and reduces the risk of disease spread. Prompt treatment reduces the risk of complications 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.

Report Available

1 to 4 days

Day(s) Performed

Monday through Saturday

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;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

Method Name

Transcription Mediated Amplification

Specimen Type

Varies


Necessary Information


Specimen source is required.



Specimen Required


Submit only 1 of the following specimens:

 

Swab specimen 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.

 

Supplies: Swab, Aptima Male/Female Collection (T583)

Specimen Type: Endocervix

Container/Tube: Aptima Collection Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Use cleaning swab (white shaft) to remove excess mucus from endocervix and discard.

2. Insert second swab (blue shaft) 1 to 1.5 cm into endocervical canal, and rotate swab gently for 30 seconds. Avoid touching vaginal wall when removing swab.

3. Place second swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

4. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

5. Transport and store swab container at 2 to 30° C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.

 

Supplies: Swab, Aptima Multitest Swab Specimen Collection Kit (T584)

Specimen Type: Vaginal

Container/Tube: Aptima Collection Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

2. Place swab into 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 and store swab container at 2 to 30° C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.

 

Supplies: Swab, Aptima Male/Female Collection (T583)

Specimen Type: Urethra (Males Only)

Container/Tube: Aptima Collection Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to collection.

2. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.

3. Once inserted, rotate swab gently at least 1 full rotation using sufficient pressure to ensure swab comes into contact with all urethral surfaces. Allow swab to remain inserted for 2 to 3 seconds.

4. Place swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name, and date and time of collection.

6. Transport and store swab container at 2 to 30° C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.

 

Supplies: Aptima Urine Transport Tube (T582)

Specimen Type: Urine (Males and Females)

Container/Tube: Aptima Urine Specimen Transport Tube

Specimen Volume: 15-20 mL

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to specimen collection.

2. Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.

3. Transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided within 24 hours of collection. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation at Mayo Clinic Laboratories.

4. Transport and store urine specimen transport container at 2 to 30° C (refrigerate is preferred temperature) within 30 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.

 

Supplies: Aptima Thin Prep Transport Tube (T652)

Specimen Type: ThinPrep Specimen (Endocervix)

Container/Tube: ThinPrep (also called PreservCyt) Collection Kit

Specimen Volume: 1 mL

Collection Instructions:

1. Aliquot ThinPrep specimen for Chlamydia and/or Neisseria testing before processing for Pap smear. For each specimen, use a new pair of clean gloves.

2. Vortex ThinPrep/PreservCyt vial 3 to 10 seconds. Within 1 minute of vortexing:

a. Transfer 1 mL of specimen into the Aptima Specimen Transfer Tube using a disposable transfer pipette or a pipette tip containing a filter (aerosol barrier or hydrophobic plug).

b. Process only 1 ThinPrep and transfer tube set at a time.

c. Recap Aptima Specimen Transfer Tube tightly and gently invert 3 times to mix.

3. Label Aptima transfer tube with appropriate label.

4. Use remainder of ThinPrep specimen for Pap testing.

5. Transport and store specimen transfer container at 2 to 30° C (refrigerate is preferred temperature) within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for 12 months.

 

Supplies:

Swab, Aptima Male/Female Collection (T583)

Swab, Aptima Multitest Swab Specimen Collection Kit (T584)

Specimen Type: Oral/throat or rectal/anal

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.


Specimen Minimum Volume

Endocervix in PreservCyt: 1mL
Urine: 2 mL
Swabs (Endocervical, Urethral, Vaginal, Oral/throat, Anal/Rectal): Entire collection

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) APTIMA VIAL
  Ambient  APTIMA VIAL
  Frozen  APTIMA VIAL

Reference Values

Negative

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87591

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GCRNA Neisseria gonorrhoeae Amplified RNA 43305-2

 

Result ID Test Result Name Result LOINC Value
SRC17 SOURCE: 31208-2
34875 Neisseria gonorrhoeae amplified RNA 43305-2

Forms

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

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

mml-gisti