Neisseria gonorrhoeae RNA by TMA : 1000376

Test Code
GCRNA or 1000376

Alias/See Also
Gonorrhoeae; N. gonorrhoeae

CPT Codes
87591

Instructions
Specimen may be submitted using Aptima Unisex Swab Kit (Client Supply # 11071), Aptima Vaginal Swab Collection Kit (Client Supply # B30079), or Aptima Urine Collection Kit (Client Supply # 11072) (see below for Aptima instructions). Pap specimen may also be submitted in cytology (Pap) vials: Cytc ThinPrep vial (Client Supply # P70098) or SurePath vial (Client Supply # P490527).

Aptima collection:

Endocervical: APTIMA Combo 2 Unisex Swab Kit
1. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. Note: To remove excess mucus from the cervical os, a large-tipped cleaning swab (not provided) may be used. Discard swab after use.
2. Insert the specimen collection swab (blue shaft swab in the package with green printing) into the endocervical canal.
3. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
6. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents.
7. Recap the swab specimen transport tube tightly.

Vaginal Specimen (Clinician Collected): Aptima Vaginal Swab Collection Kit
1. Collect vaginal fluid sample using the Gen-Probe APTIMA vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid.
2. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube.
3. Tightly screw on the cap.
NOTE: The APTIMA Vaginal Swab Collection Kit is the only Collection Kit approved for vaginal specimens. DO NOT use the APTIMA Combo 2 Unisex Swab Collection Kit for collecting vaginal specimens.

Male urethra: APTIMA Combo 2 Unisex Swab Kit
1. The patient should not have urinated for at least one hour prior to specimen collection.
2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm into the urethra.
3. Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling.
4. Withdraw the swab carefully.
5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube.
6. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents.
7. Recap the swab specimen transport tube tightly.
Note: Do not use the white-shafted swab provided in the kit.
Specify the exact specimen source/origin.

Urine: APTIMA Urine Collection Kit
1. The patient should not have urinated for at least one hour prior to specimen collection.
2. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen.
3. Remove the cap and 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 label.
4. Re-cap the urine specimen transport tube tightly. This is now known as the processed urine specimen.

Transport Container
Refer to specimen collection instructions for endocervical, vaginal, urethral, or urine submission in Aptima transport tube. Pap (cytology) should be submitted in Cytc ThinPrep vial or SurePath vial.

Transport Temperature
Ambient.

Specimen Stability
Swab: Ambient: 60 days; Refrigerated: 60 days; Frozen: 12 months

Processed urine: Ambient: 30 days; Refrigerated: 30 days; Frozen: 12 months

Pap (cytology): Ambient: 30 days; Refrigerated: 30 days; Frozen: Unacceptable

Methodology
Nucleic Acid Amplification Test (NAAT) based on Gen Probe APTIMA Combo 2, TMA (Transcription Mediated Amplification)

Setup Schedule
Monday - Friday

Report Available
1-4 days

Limitations
Positive results may persist for several weeks after successful treatment for the organism.

Reference Range
Target Not Detected

Performing Laboratory
med fusion



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.