Neisseria gonorrhoeae (GC) is a common sexually transmitted infection and may be asymptomatic. N. gonorrhoeae primarily causes a lower genital tract infection, but if untreated, may cause disseminated disease or pelvic inflammatory disease with endometritis, salpingitis, pelvic peritonitis, and tubo-ovarian abscesses.

This test should be ordered in patients with symptoms of cervicitis or urethritis, as well as for screening asymptomatic patients.

Male urethral swab specimens:

Patient should not have urinated for at least 1 hour prior to specimen collection.

Male and female urine specimens:

• Patient should not have urinated for at least 1hr prior to specimen collection.
• Female patients should not cleanse labial area prior to providing the specimen

Aptima Unisex swab kit

Female endocervical or male urethral sample collections

Aptima Multitest swab transport media

Oral/mouth, rectal or vaginal sample collections

If patient has had a hysterectomy, collect vaginal or urine.

Endocervical specimens:

Use Aptima Unisex Swab Specimen Collection Kit 

Specimen will be rejected if collected with Aptima Vaginal Swab Specimen Collection Kit.

1. Remove excess mucus from cervical os and surrounding mucosa using cleaning swab (white-shafted swab in package with red printing). Discard the white swab.
2. Insert specimen collection swab (blue-shafted swab in package with green printing) into endocervical canal.
3. Gently rotate swab clockwise for 10 to 30 seconds in endocervical canal to ensure adequate sampling.
4. Withdraw swab carefully; avoid any contact with vaginal mucosa.
5. Remove cap from swab specimen transport tube and immediately place specimen collection swab into specimen transport tube.
6. Carefully break swab shaft at scoreline and discard the top portion of the swab shaft; use care to avoid splashing contents.
7. Re-cap swab specimen transport tube tightly.

Vaginal specimens:

Use Aptima Multitest swab specimen collection kit. 

Specimen will be rejected if collected with Aptima Unisex swab specimen collection Kit.

1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Vaginal Swab Specimen Collection Kit. 
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line. 
3. Carefully insert the swab into the vagina about 2 inches past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin.
4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Vaginal swab Specimen Collection Kit.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Carefully break the swab shaft at the score line against the side of the tube.
7. Immediately discard the top portion of the swab shaft.
8. Tightly screw the cap onto the tube.

1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
3. Carefully insert the swab into the rectum about 1-2 inches (3-5 cm) past the anal margin and gently rotate the swab for 5 to 10 seconds. Withdraw the swab without touching the skin.
4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Carefully break the swab shaft at the score line against the side of the tube.
7. Immediately discard the top portion of the swab shaft.
8. Tightly screw the cap onto the tube.

1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
3. Carefully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall, then withdraw the swab without touching the inside of the cheeks or tongue.
4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Carefully break the swab shaft at the score line against the side of the tube.
7. Immediately discard the top portion of the swab shaft.
8. Tightly screw the cap onto the tube.

Aptima Multitest swab specimen collection kit or

Aptima Unisex swab specimen collection kit

Screw cap plastic container (sterile) 

• Patient should not have urinated for at least 1hr prior to specimen collection.
• Female patients should not cleanse labial area prior to providing the specimen.

1. Direct patient to provide first-catch urine (approximately 20 to 30 mL of initial urine stream) into urine collection cup free of any preservatives.
• The cup should be removed from the urine stream when 20-30 mL of urine is in the cup. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity and should not be sent for testing.

Urine specimens must be transferred to an Aptima specimen transport tube by the collecting site, within 24 hours of collection, and prior to specimen transport.

1. Remove cap from urine specimen transport tube and transfer 2 ml of urine into urine specimen transport tube using disposable pipette provided. The correct volume of urine has been added when fluid level is between black fill lines on urine specimen transport tube label.
2. If refrigerated, urine may be transferred to the transport tube at the collection site within 24 hours.
3. Tightly screw the cap onto the tube.

Aptima urine specimen collection kiit

Swab:

Ambient (preferred) - 60 days

Refrigerated - 60 days

Frozen - NO

Urine:

Ambient (preferred) - 30 days

Refrigerated - 30 days

Frozen - NO

• No swab, white swab, or two swabs in Aptima swab transport tube
• Swab not from Aptima Unisex swab collection kit
• Pink-shafted swab for cervical, endocervical, or urethral source
• Blue-shafted swab for vaginal, oral or rectal source
• Collection from vaginal cuff source
• Midstream or clean catch urine
• Urine collected for chemistry testing or cultures cannot be used for GC or Chlamydia PCR testing
• Urine transport tube not filled to “Fill area” (above or below – rejected)
• Urine not in Aptima transport tube
  • Client may transfer urine to transport tube within 24 hours of collection.
  • Due to nucleic acid cross-contamination issues, this must be done at the client site and will not be done at Allina Health Laboratory.
  • If the urine has not been opened in the lab, it may be returned to the client to be transferred to the transport tube; otherwise, recollect.)
• Frozen specimens
• Sources other than female endocervical, oral, rectal, vaginal, male urethral or voided urine
• Improper label (unlabeled or mislabeled)
• Time delay between time of collection and receipt of specimen
• Improper transport container
• Improper transport temperature
• Interfering substances
• Inappropriate specimen type
• Leaking container

Target Capture with Transcription-Mediated Amplification

Negative

Medical necessity