Ordering Guidance

This test should be ordered only on prior Neisseria gonorrhoeae positive specimens or a new specimen collection from a patient who previously tested positive for N gonorrhoeae by the Hologic Aptima Combo 2 assay (eg, CGRNA / Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies; GCRNA / Chlamydia trachomatis, Nucleic Acid Amplification, Varies; MCTGC / Chlamydia trachomatis and Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies; MGRNA / Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies) or by an alternative N gonorrhoeae molecular assay.

Additional Testing Requirements

A prior positive Neisseria gonorrhoeae result from the Hologic Aptima Combo 2 assay or another N gonorrhoeae molecular assay is required prior to performing this test.

Shipping Instructions

If submitting a previously tested specimen that resulted as positive for Neisseria gonorrhoeae, ensure that the sample is tightly capped with a non-penetrable cap on the specimen transport tube. Maintain recommended storage and shipping requirements indicated below.

Necessary Information

Specimen source is required.

Specimen Required

If testing is being performed on a previously tested specimen that resulted as positive, submit that specimen.

If testing is being performed on a newly collected specimen, submit only 1 of the following specimens:

Specimen Type: Ocular (corneal/conjunctiva)

Supplies:

-Aptima Unisex Swab Collection Kit (T583)

-Aptima Multitest Swab Specimen Collection Kit (T584)

Container/Tube: Aptima Multitest Swab or Aptima Collection Unisex Swab

Specimen Volume: 1 Swab

Collection Instructions:

1. Swab site using Aptima Multitest Swab or Aptima Collection Unisex Swab. Specimens must be collected using either of these options.

Note: The white swab provided within the collection kit is a cleaning swab and should not be used for collection. Discard the white cleaning swab.

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

3. Snap off swab at score line so it 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), transport within 60 days of collection.

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: 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.