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HelpTest Code CGRNA Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies
Reporting Name
Chlamydia/Gonorrhoeae Amplified RNAUseful For
Detecting Chlamydia trachomatis and/or Neisseria gonorrhoeae
This test is not intended for use in medico-legal applications.
This test is not useful for the detection of other Chlamydia species.
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CTRNA | Chlamydia trachomatis Amplified RNA | Yes | Yes |
| GCRNA | Neisseria gonorrhoeae Amplified RNA | Yes | Yes |
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: 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 second swab into transport tube provided in collection kit.
6. Snap off swab at score line so swab 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 Collection Kit (T584)
Container/Tube: Aptima Multitest Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.
2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.
3. Place 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 collection date and time.
5. 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. Specimens 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 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.
5. Place swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
6. Cap tube securely, and label tube with patient's entire name and collection date and time.
7. 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 ThinPrep Transport Tube (T652)
Container/Tube: ThinPrep (also called PreservCyt) Collection Kit
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. Within 1 minute of vortexing:
a. Transfer 1 mL of specimen into the Aptima ThinPrep Transport Tube (ie, 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.
4. Label Aptima transfer tube with appropriate label.
5. Use remainder of ThinPrep specimen for Papanicolaou testing.
6. 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 Multitest Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.
2. Swab site using Aptima Multitest Swab (pink shaft).
3. Place collection swab in 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 collection date and time.
5. 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: Swab, Aptima Multitest Swab Collection Kit (T584)
Container/Tube: Aptima Multitest Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimens must be collected using the Aptima Multitest Swab 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. 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 collection date and time.
5. 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 Minimum Volume
Urine: 2 mL
Endocervical/cervix in PreservCyt or Swab specimens: 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
Chlamydia trachomatis
Negative
Neisseria gonorrhoeae
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
87491 - Chlamydia trachomatis
87591 - Neisseria gonorrhoeae
87801 - If appropriate for government payers
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CGRNA | Chlamydia/Gonorrhoeae Amplified RNA | 64017-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| SRC14 | SOURCE: | 31208-2 |
| SRC17 | SOURCE: | 31208-2 |
| 34875 | Neisseria gonorrhoeae amplified RNA | 43305-2 |
| 34874 | Chlamydia trachomatis amplified RNA | 43304-5 |
Interpretation
A positive result indicates the presence of nucleic acid from Chlamydia trachomatis or Neisseria gonorrhoeae and strongly supports a diagnosis of chlamydial or gonorrheal infection.
A negative result indicates that nucleic acid from C trachomatis or N gonorrhoeae was not detected in the specimen. 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 setting in which a patient's clinical signs and symptoms or risk factors are inconsistent with gonococcal or chlamydial 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. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
2. Adamson PC, Klausner JD. Diagnostic test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens. J Clin Microbiol. 2022;60(4):e0021121. doi:10.1128/JCM.00211-21
Report Available
1 to 4 daysMethod Name
Transcription Mediated Amplification
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)
-Microbiology Test Request (T244)