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Test Code GCRNA Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


Necessary Information


Specimen source is required.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Endocervix/Cervix

Supplies: Aptima Unisex Swab Collection Kit (T583)

Container/Tube: Aptima Unisex Swab

Specimen Volume: 1 Swab

Collection Instructions:

1. Specimens must be collected using the Aptima Unisex Swab Collection Kit.

2. Use cleaning swab (white shaft) to remove excess mucus from endocervix/cervix.

3. Discard the cleaning swab.

4. 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.

5. Place blue swab into transport tube provided in collection kit.

6. Snap off blue swab at score line so it fits into closed tube.

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

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

 

Specimen Type: Vaginal

Supplies: Aptima Multitest Swab Specimen Collection Kit (T584)

Container/Tube: Aptima Multitest Swab

Specimen Volume: 1 Swab

Collection Instructions:

1. Specimen must be collected using the Aptima Multitest Swab Specimen Collection Kit.

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

3. Place pink swab into transport tube provided in collection kit.

4. Snap off pink swab at score line so it fits into closed tube.

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

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

 

Specimen Type: Urethra (Males Only)

Supplies: Swab, Aptima Unisex Swab Collection Kit (T583)

Container/Tube: Aptima Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Specimen must be collected using the Aptima Unisex Swab Collection Kit.

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

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

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

5. Place blue swab in transport tube provided in collection kit.

6. Snap off blue swab at score line so it fits into closed tube.

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

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

 

Specimen Type: Urine

Supplies: Aptima Urine Transport Tube (T582)

Container/Tube: Aptima urine specimen transport tube

Specimen Volume: 15 to 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. Within 24 hours of collection. transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube.

4. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation at Mayo Clinic Laboratories.

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

 

Specimen Type: ThinPrep Specimen (Endocervix/Cervix)

Supplies: Aptima Specimen Transfer Kit (T652)

Container/Tube: Aptima specimen transfer tube

Specimen Volume: 1 mL

Collection Instructions:

1. Collect ThinPrep sample as per normal collection process.

2. ThinPrep specimen must be aliquoted (as outlined below) before it is processed for Papanicolaou testing (Pap smear).

3. Vortex ThinPrep/PreservCyt vial 3 to 10 seconds.

4. Within 1 minute of vortexing:

 a. Transfer 1 mL of specimen into the Aptima specimen transport 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.

5. Label Aptima specimen transfer tube with appropriate label.

6. Use remainder of ThinPrep specimen for Pap testing.

7. Maintain specimen transport tube at 2 to 8° C (refrigerate temperature is preferred) and transport within 30 days of collection, or within 14 days if stored at 15 to 30° C. If longer storage is needed, freeze at -20 to -70° C for 12 months.

 

Specimen Type: Oropharynx/Pharynx/Throat

Supplies: Aptima Multitest Swab Collection Kit (T584)

Container/Tube: Aptima Collection Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Specimens must be collected using Aptima Multitest Swab Specimen Collection Kit.

2. Swab site using Aptima Collection Multitest Swab (pink shaft).

3. Place pink swab in transport tube provided in collection kit.

4. Snap off pink swab at score line so it fits into closed tube.

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

6. Maintain swab container at either 4 to 30° C (refrigerate temperature is preferred) or -20 to -70° C, and transport within 60 days of collection.

 

Specimen Type: Rectal/Anal

Supplies: Aptima Multitest Swab Collection Kit (T584)

Container/Tube: Aptima Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Specimens must be collected using Aptima Multitest Swab Specimen Collection Kit.

2. Insert swab into rectum about 3 to 5 cm past anal margin and gently rotate swab for 10 seconds.

3. Place collection swab in transport tube provided in collection kit.

4. Snap off swab at score line so it fits into closed tube.

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

6. Maintain swab container at either 4 to 30° C (refrigerate temperature is preferred) or -20 to -70° C, and transport within 60 days of collection.


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

CPT Code Information

87591

Clinical Information

Gonorrhea is caused by the bacterium Neisseria gonorrhoeae. It is a very common sexually transmitted infection (STI), with over 677,000 cases of gonorrhea reported to the Centers for Disease Control and Prevention (CDC) in 2020. Like chlamydia, 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, 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 STIs, inconsistent condom use, new or multiple sex partners, and women in certain demographic groups such as those in communities with high STI prevalence). The CDC currently recommends dual antibiotic treatment due to emerging antimicrobial resistance.

 

Culture was previously considered to be the gold standard test for diagnosis of Chlamydia trachomatis and N gonorrhoeae infections. However, these 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 considered the reference standard method for diagnosis in most cases. Immunoassays and nonamplification DNA tests are also available for C trachomatis and N gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAAT.

 

Improved screening rates and increased sensitivity of NAAT testing have resulted in an increased number of accurately diagnosed cases. Improved detection rates result from improved performance characteristics of the assays and 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 infertility in women.

Report Available

1 to 4 days

Reject Due To

Midstream urine specimen
Clean catch urine specimen
Overfilled or underfilled urine transport tubes
Specimen collected into a SurePath device
Transport tubes containing a cleaning swab or more than 1 swab
Multiple sources on single tube
Reject

Method Name

Transcription Mediated Amplification

Forms

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