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Test Code Billings Clinic: 7000 Mayo: GCRNA Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies

Reporting Name

Neisseria gonorrhoeae Amplified RNA

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Detecting Neisseria gonorrhoeae

 

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

Method Name

Transcription Mediated Amplification


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 Specimen Collection Kit (T584)

Container/Tube: Aptima Multitest Swab

Specimen Volume: 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 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. 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 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 (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 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 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: 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. 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

Varies

Specimen Minimum Volume

Urine: 2 mL
Endocervix/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

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

Negative

Interpretation

A positive result indicates the presence of nucleic acid from Neisseria gonorrhoeae and supports a diagnosis of gonorrhea.

 

A negative result indicates that nucleic acid from N gonorrhoeae was not detected. A negative result does not exclude the possibility of infection. If clinical indications strongly suggest gonococcal 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 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.

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

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.