Diagnosis of Trichomonas vaginalis infection in male or female patients.

Trichomonas vaginalis is the most common curable sexually transmitted disease (STD) agent in the U.S. It causes vaginitis, urethritis, pelvic inflammatory disease, preterm births, low-birth-weight infants, and increased risk of HIV transmission.

Due to the high prevalence of T. vaginalis in all female age groups, it is suggested that both symptomatic and asymptomatic women who are screened for Chlamydia trachomatis and Neisseria gonorrhoeae should also be screened for T. vaginalis.

• To ensure proper endocervical sampling, excess mucus should be removed.
• Urine and vaginal swab specimen sampling is not designed to replace cervical exams and endocervical specimen for diagnosis of female urogenital infections. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.
• Performance with other specimen types has not been evaluated.
• Therapeutic failure or success cannot be determined with APTIMA Trichomonas vaginalis Assay since nucleic acid may persist following appropriate antimicrobial therapy.
• Results from the APTIMA Trichomonas vaginalis Assay should be interpreted in conjunction with other clinical data available to the clinician.
• Performance of the vaginal swab specimen has not been evaluated in pregnant women or women less than 14 years of age.
• A negative result does not preclude a possible infection because the presence of Trichomonas tenax or Pentatrichomonas hominis in a specimen may affect the ability to detect T. vaginalis rRNA. T. tenax is a commensal of the oral cavity, and P. hominis is a commensal of the large intestine.

Urine:

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

Aptima Unisex swab specimen collection kit

Female endocervical or male urethral swab collections

Aptima Multitest swab specimen collection kit

Vaginal swab collections

Endocervical swab 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 swab 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 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.

Male urethral swab specimens:

Use Aptima Unisex swab specimen collection kit.

1. Insert specimen collection swab (blue shaft swab in package with green printing) 2 to 4 cm into urethra.
2. Gently rotate swab clockwise for 2 to 3 seconds in urethra to ensure adequate sampling and carefully withdraw the swab.
3. Remove cap from swab specimen transport tube and immediately place specimen collection swab into specimen transport tube.
4. Carefully break swab shaft at score line and discard the top portion of the swab shaft; use care to avoid splashing contents.
5. Tightly screw the cap onto the tube.

Aptima Multitest swab specimen collection kit

Aptima Unisex 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.

Direct patient to provide first-catch urine (approximately 20 to 30 mL of initial urine stream) into urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity.

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. Re-cap urine specimen transport tube tightly.

Aptima Urine specimen collection kit (AHL)

Swab:

Ambient - 60 days

Refrigerated - 60 days

Urine:

Ambient - 30 days                                                 

Refrigerated - 30 days

• Improper label (unlabeled or mislabeled)
• Time delay between time of collection and receipt of specimen
• Improper transport container
• Improper transport temperature
• Interfering substances
• No swabs, two swabs or white swab in transport media
• Pink Swab in Unisex Specimen Collection transport media
• Blue Swab in Multitest Specimen Collection transport media
• Catheterized urine
• Urine transport tube not filled “Fill Area” (above or below-rejected)
• Urine not in Aptima transport tube (client may transfer urine to Transport Tube within 24hr of collection.  Due to nucleic acid cross-contamination issues, this must be done at the client site and will not be done at Allina Labs.)
• M4 or M5 media
• Sources other than female endocervical, vaginal, male urethral and male or female urine (eye, rectal, throat specimens, etc.)
• Leaking container

Target capture with transcription-mediated amplification

Negative