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Test Code CGRNA Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies

Important Note

Use TML Test Code 308072110 for the following specimen types:  Urine, cervix, vagina.

Additional Codes

Torrance Memorial Test Code: 256128714

Reporting Name

Chlamydia/Gonorrhoeae Amplified RNA

Useful 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.

Method Name

Transcription Mediated Amplification

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: 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 Stability Information

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

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
Reject

Reference Values

Chlamydia trachomatis

Negative

 

Neisseria gonorrhoeae

Negative

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

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

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.

Profile Information

Test ID Reporting Name Available Separately Always Performed
CTRNA Chlamydia trachomatis Amplified RNA Yes Yes
GCRNA Neisseria gonorrhoeae Amplified RNA Yes Yes

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Microbiology Test Request (T244)