Trichomonas amplified probe
Trichomonas amplified probe-8940
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 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 collections:
- Patient should not have urinated for at least 1 hour prior to specimen collection
- Female patients should not cleanse labial area prior to providing the specimen
Vaginal swab specimens:
- 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.
- 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.
- 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.
- 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.
- Immediately place the swab into the transport tube so that the score line is at the top of the tube.
- Carefully break the swab shaft at the score line against the side of the tube.
- Immediately discard the top portion of the swab shaft.
- Tightly screw the cap onto the tube.
Aptima Multitest swab specimen collection kit
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.
- 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.
- If refrigerated, urine may be transferred to the transport tube at the collection site within 24 hours.
- Re-cap urine specimen transport tube tightly.
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
- 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 vaginal or urine (eye, rectal, throat specimens, etc.)
- Leaking container
Target capture with transcription-mediated amplification
Negative
|
Aptima Trichomonas Female Assay Performance |
||
|
Specimen Type |
Sensitivity |
Specificity |
|
Vaginal Swab Asymptomatic |
100% |
98.9% |
|
Urine Asymptomatic |
95.5% |
99.0% |
|
Overall Asymptomatic |
98.4% |
99.7% |
|
Vaginal Swab Symptomatic |
100% |
99.1% |
|
Urine Symptomatic |
95.2% |
98.9% |
|
Symptomatic Overall |
98.4% |
99.1% |
|
Aptima Trichomonas Male Urine Assay Performance |
||
|
|
Sensitivity |
Specificity |
|
Symptomatic |
100% |
99.7% |
|
Asymptomatic |
100% |
99.9% |
|
Overall |
100% |
99.8% |