Home
HelpTest Code GCRNASO Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies
Additional Codes
Mayo Test Code: GCRNA
Reporting Name
Neisseria gonorrhoeae Amplified RNAUseful For
Detecting Neisseria gonorrhoeae
This test is not intended for use in medico-legal applications.
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
VariesNecessary 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
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 |
Cautions
Care must be taken to avoid cross-contamination during handling of PreservCyt solution liquid Papanicolaou (Pap) specimens. If testing PreservCyt specimens processed with the ThinPrep 2000 processor, it is important to follow procedures to reduce the risk for cross-contamination during Pap processing, such as bleaching of the PreservCyt filter cap and changing gloves between each sample. Refer to the ThinPrep 2000 Processor Operator's Manual and the Aptima specimen for more guidance.
The performance of endocervical, vaginal, and male urethral swab specimens, urine specimens, and PreservCyt solution liquid Pap specimens has not been evaluated in adolescents less than 14 years. The performance of vaginal swab specimens has not been evaluated in pregnant women.
This report is intended for clinical monitoring or management of patients; it is not intended for use in medico-legal applications.
Appropriate specimen collection and handling is necessary for optimal assay performance.
Results should be interpreted in conjunction with other laboratory and clinical information.
A negative test result does not exclude the possibility of infection. Improper specimen collection, concurrent antibiotic therapy, presence of inhibitors, or low numbers of organisms in the specimen (ie, below the sensitivity of the test) may cause false-negative test results.
In low-prevalence populations, positive results must be interpreted carefully, as false-positive results may occur more frequently than true-positive results in this setting.
In general, this assay should not be used to assess therapeutic success or failure since nucleic acids from these organisms may persist for 3 weeks or more following antimicrobial therapy.
The presence of mucous does not interfere with this assay. However, this test requires endocervical cells, and if excess mucous is not removed prior to collection, adequate numbers of these cells may not be obtained.
No interference is expected with swab specimens due to:
-Blood
-Lubricants and spermicides
The effects of tampon use, douching, specimen types other than those listed in Specimen Required, and specimen collection variables have not been determined.
Testing of urine specimens with this method is not intended to replace cervical exam and endocervical sampling for diagnosis of urogenital infection; infections may result from other causes, or concurrent infections may occur.
Testing urine specimens as the sole test for identifying female patients with gonococcal infections may miss some infected individuals.
Performance estimates for urine specimens are based on evaluation of urine obtained from the first part of the urine stream; performance on midstream collections has not been determined.
This assay has not been shown to cross-react with commensal (nonpathogenic) Neisseria species in the oropharynx.
Report Available
1 to 4 daysSpecimen Retention Time
7 daysReject 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.